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                                                                    <h2 class="date-header">
                                                                        <span>
                   Tuesday, October 11, 2016
                                                                        </span>
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                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/carbomix-activated-charcoal-50g-beacon.html">
                                                                                        Carbomix (activated charcoal) 50g (Beacon Pharmaceuticals)
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
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                                                                                    <div class="contentBox">
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            1. Name Of The Medicinal Product
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Carbomix 50g Granules for Oral Suspension
                                                                                            <br>
                                                                                        </p>
                                                                                        <h2>
                                                                                        </h2>
                                                                                        <h2>
                                                                                            <br>
                                                                                            2. Qualitative And Quantitative Composition
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Charcoal Activated 81.3% w/w
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Also contains glycerol (5g/50g activated charcoal) as an excipient.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For a full list of excipients, see section 6.1.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            3. Pharmaceutical Form
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Granules for oral suspension
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Odourless black granules.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            4. Clinical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.1 Therapeutic Indications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Emergency treatment of acute oral poisoning or drug overdose. Carbomix adsorbs toxic substances and reduces or prevents systematic absorption. The shorter the time interval between ingestion of the toxicant and the administration of Carbomix, the greater is the benefit for the patient. However, as the absorption of massive drug overdoses is often retarded in acute conditions of intoxication, even the delayed administration of Carbomix may be beneficial. In severe intoxication, repeated administration of Carbomix is recommended to prevent absorbed drug being released (in an unbound state) in the lower intestinal tract or to expedite the elimination and prevent the re-absorption of any drug undergoing enterohepatic circulation.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.2 Posology And Method Of Administration
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Carbomix granules should be mixed with water and swallowed as a suspension under medical supervision.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Adults (including the Elderly)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            50g activated charcoal (one standard treatment pack), repeated if necessary.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Children under 12 years
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            25g activated charcoal (half the contents of the standard pack, repeated if necessary.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            If a large quantity of toxicant has been ingested, and where there is a risk to life, a dose of 50g is recommended.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Carbomix should be given as soon as possible after the ingestion of the potential poison.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The contents of the bottle are made up to the red band with water and shaken thoroughly.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The suspension is then taken orally or given by intragastric tube using the applicator provided. Carbomix may be administered after emesis or gastric lavage and may be used concurrently with parenteral antidotes such as acetylcystine.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            When ipecac syrup is used to induce emesis, it is recommended that Carbomix be administered only after vomiting has been induced and completed, since ipecac syrup is adsorbed by the charcoal thus preventing emesis.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.3 Contraindications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There are no contraindications to the use of Carbomix but see under (4.4).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.4 Special Warnings And Precautions For Use
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The value of Carbomix in the treatment of poisoning by strong acids, alkalis and other corrosive substances is limited. It should also be borne in mind that the presence of charcoal will render difficult any immediate endoscopy that may be required. Carbomix is poor at binding cyanide, iron salts and some solvents including methanol, ethanol and ethylene glycol. In cases where the toxicant has diuretic properties or has been ingested with alcohol, plenty of fluid should be given after the administration of Carbomix. Carbomix should not be used concurrently with systemically active oral emetics or oral antidotes such as methionine since such agents would be adsorbed by the charcoal.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Carbomix should only be administered to unconscious patients who have a cuffed endotracheal tube in place to protect the airway.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Carbomix contains glycerol as an excipient, which may cause headache, stomach upset and diarrhoea.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The purpose of the product is to interact with other medicaments and toxicants taken in overdosage. There are no systemic interactions because the product is not absorbed from the gut.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.6 Pregnancy And Lactation
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There is no evidence to suggest that Carbomix should not be used during pregnancy or lactation. The product is not systemically absorbed.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.7 Effects On Ability To Drive And Use Machines
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            None (the product is not systemically absorbed).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.8 Undesirable Effects
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In general, Carbomix is well tolerated. Some patients may however experience constipation or diarrhoea.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Activated charcoal has been associated with bezoar formation, intestinal obstruction and, rarely, intestinal perforation following multiple dosing &ndash; although a direct causative association has not been demonstrated.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Faecal impaction has been reported in a patient treated for an overdose of a diuretic with alcohol
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Aspiration of activated charcoal has been reported to cause airway obstruction and appropriate precautions should be taken.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Activated charcoal will produce black stools which may be alarming to the patient but is medically insignificant.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.9 Overdose
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Not applicable. In theory severe constipation would result from excessive use and this could be treated with laxatives.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            5. Pharmacological Properties
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.1 Pharmacodynamic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Activated charcoal has well documented adsorptive properties and is effective in reducing the absorption of a wide range of toxicants, including drugs taken in overdose. From the gut, in addition, there is evidence that the administration of activated charcoal can enhance the elimination of some compounds by creating an effective concentration gradient from the circulation to the gut.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.2 Pharmacokinetic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Activated charcoal is not systemically absorbed.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.3 Preclinical Safety Data
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No findings have been reported which add to the prescribing information given in other sections.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            6. Pharmaceutical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.1 List Of Excipients
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Citric Acid
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Acacia
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Glycerol
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.2 Incompatibilities
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Carbomix should not be used concurrently with systemically active oral emetics or oral antidotes such as methionine since such agents would be adsorbed by the charcoal.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.3 Shelf Life
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Unopened: 5 years.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            After reconstitution: 24 hours.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.4 Special Precautions For Storage
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Store below 25&deg; C
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Keep container tightly closed
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.5 Nature And Contents Of Container
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            HDPE bottle and cap containing 50g of activated charcoal (in 61.5g of granules).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.6 Special Precautions For Disposal And Other Handling
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For instructions on reconstitution and use, see section 4.2.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Product description after reconstitution: black suspension.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Any unused product or waste material should be disposed of in accordance with local requirements.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            7. Marketing Authorisation Holder
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Beacon Pharmaceuticals Ltd
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            85 High Street
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Tunbridge Wells
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Kent TN1 1YG
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            8. Marketing Authorisation Number(S)
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            PL 18157/0020
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            9. Date Of First Authorisation/Renewal Of The Authorisation
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            13/10/2009
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            10. Date Of Revision Of The Text
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            18/01/2010
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
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                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/casodex-50-mg-film-coated-tablets_11.html">
                                                                                        Casodex 50 mg Film-coated Tablets
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
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                                                                                        <br>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                            </h2>
                                                                                            <p>
                                                                                                <br>
                                                                                                <b>
                                                                                                    Casodex 50 mg Film-coated Tablets
                                                                                                </b>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                bicalutamide
                                                                                            </p>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Read all of this leaflet carefully before you start taking this medicine.
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Keep this leaflet. You may need to read it again.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If you have any further questions, ask your doctor or pharmacist.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    In this leaflet:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listNoBullet">
                                                                                                    <li>
                                                                                                        1. What Casodex is and what it is used for
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        2. Before you take Casodex
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        3. How to take Casodex
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        4. Possible side effects
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        5. How to store Casodex
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        6. Further information
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                What Casodex is and what it is used for
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Casodex contains a medicine called bicalutamide. This belongs to a group of medicines called &lsquo;anti-androgens&rsquo;.
                                                                                            </p>
                                                                                            <br>
                                                                                            <ul class="listStandard">
                                                                                                <li>
                                                                                                    Casodex is used to treat prostate cancer.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    It works by blocking the effects of male hormones such as testosterone.
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Before you take Casodex
                                                                                            </h2>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Do not take Casodex if:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        You are allergic (hypersensitive) to bicalutamide or any of the other ingredients of this medicine (listed in Section 6: Further information).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        You are already taking a medicine called cisapride or certain anti-histamine medicines (terfenadine or astemizole).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        You are a woman.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    Do not take Casodex if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Casodex.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Casodex must not be given to children.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Take special care with Casodex
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Check with your doctor or pharmacist before taking Casodex if:
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        You have problems with your liver.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        You have diabetes and are already taking an &lsquo;LHRH analogue&rsquo;. These include goserelin, buserelin, leuprorelin and triptorelin.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    If you go into hospital, tell the medical staff that you are taking Casodex.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Taking other medicines
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Do not take Casodex if you are already taking any of the following medicines:
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Cisapride (used for some types of indigestion).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Certain anti-histamine medicines (terfenadine or astemizole).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    Also, tell your doctor if you are taking any of the following medicines:
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Medicines taken by mouth to prevent blood clots (oral anti-coagulants).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Ciclosporin (to suppress your immune system).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Calcium channel blockers (to treat high blood pressure or some heart conditions).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Driving and using machines
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Casodex is not likely to affect you being able to drive or use any tools or machines.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        However, if you feel sleepy take care with these activities.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Important information about some of the ingredients of Casodex
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Casodex contains lactose monohydrate, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                How to take Casodex
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Always take Casodex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
                                                                                            </p>
                                                                                            <br>
                                                                                            <ul class="listStandard">
                                                                                                <li>
                                                                                                    The usual dose for an adult is one tablet each day.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Swallow the tablet whole with a drink of water.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Try to take your tablet at the same time each day.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Do not stop taking this medicine even if you feel well, unless your doctor tells you to.
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    If you take more Casodex than you should
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    If you take more Casodex than prescribed by your doctor, talk to a doctor or go to a hospital straight away.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    If you forget to take Casodex
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        If you forget to take a dose, skip the missed dose and take the next dose as usual.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Possible side effects
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Like all medicines, Casodex can cause side effects, although not everybody gets them.
                                                                                            </p>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Allergic reactions:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    These are uncommon (affect less than 1 in 100 people). The symptoms can include sudden onset of:
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Rash, itching or hives on the skin.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Swelling of the face, lips, tongue, throat or other parts of the body.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Shortness of breath, wheezing or trouble breathing.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    If this happens to you,
                                                                                                    <b>
                                                                                                        see a doctor straight away.
                                                                                                    </b>
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Also tell your doctor straight away if you notice any of the following:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Very common (affects more than 1 in 10 people):
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Pain in your abdomen.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Blood in your urine.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    <br>
                                                                                                    Common (affects less than 1 in 10 people):
                                                                                                    <br>
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Yellowing of the skin or whites of your eyes (jaundice). These may be signs of liver problems or in rare cases (affects less than 1 in 1,000 people) liver failure.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    Uncommon (affects less than 1 in 100 people):
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Serious shortness of breath or shortness of breath which suddenly gets worse. This may be with a cough or high temperature (fever). These may be signs of an inflammation of the lungs called &lsquo;interstitial lung disease&rsquo;.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Other possible side effects:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    <br>
                                                                                                    <b>
                                                                                                        Very common (affects more than 1 in 10 people)
                                                                                                    </b>
                                                                                                    <br>
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Dizziness.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Constipation.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Feeling sick (nausea).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Swelling and tenderness of your breasts.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Hot flushes.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Feeling weak.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Swelling.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Low levels of red blood cells (anaemia). This may make you feel tired or look pale.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    <br>
                                                                                                    <b>
                                                                                                        Common (affects less than 1 in 10 people)
                                                                                                    </b>
                                                                                                    <br>
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        Loss of appetite.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Reduced sex drive.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Depression.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Feeling sleepy.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Indigestion.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Wind (flatulence).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Hair loss.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Hair re-growth or growth of extra hair.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Dry skin.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Itching.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Skin rash.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Being unable to get an erection (impotence).
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Weight gain.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        Chest pain.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                                <p>
                                                                                                    Your doctor may do blood tests to check for any changes to your blood.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Do not be concerned by this list of possible side effects. You may not get any of them.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <p>
                                                                                                If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                How to store Casodex
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul class="listStandard">
                                                                                                <li>
                                                                                                    Keep your tablets in the container they came in.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Do not store above 30&deg;C.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Do not use your tablets after the expiry date which is stated on the carton.
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                            <p>
                                                                                                Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Further information
                                                                                            </h2>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    What Casodex 50 mg Film-coated Tablets contain
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    The other ingredients are lactose monohydrate, magnesium stearate, hypromellose, macrogol 300, povidone, sodium starch glycolate and titanium dioxide (E171).
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    What Casodex 50 mg Film-coated Tablets look like and contents of the pack
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Casodex 50 mg Film-coated Tablets are white and come in packs of 28 tablets.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Marketing Authorisation Holder and Manufacturer
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    The Marketing Authorisation for Casodex 50 mg Film-coated Tablets is held by
                                                                                                </p>
                                                                                                <br>
                                                                                                <div class="addressBlock" lang="en">
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        AstraZeneca UK Limited
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        600 Capability Green
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        Luton
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        LU1 3LU
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        UK
                                                                                                    </div>
                                                                                                    <br>
                                                                                                </div>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Casodex 50 mg Film-coated Tablets are manufactured by
                                                                                                </p>
                                                                                                <br>
                                                                                                <div class="addressBlock" lang="en">
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        AstraZeneca UK Limited
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        Silk Road Business Park
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        Macclesfield
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        Cheshire
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        SK10 2NA
                                                                                                    </div>
                                                                                                    <br>
                                                                                                    <div class="addressElement">
                                                                                                        UK
                                                                                                    </div>
                                                                                                    <br>
                                                                                                </div>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <p>
                                                                                                To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                0800 198 5000 (UK only)
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Please be ready to give the following information:
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                <br>
                                                                                                <b>
                                                                                                    Product name Casodex 50 mg Film-coated Tablets
                                                                                                </b>
                                                                                                <br>
                                                                                                <br>
                                                                                                <br>
                                                                                                Reference number 17901/0005
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                This is a service provided by the Royal National Institute of Blind People.
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <p>
                                                                                            Leaflet updated: November 2009
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            &copy; AstraZeneca 2009
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Casodex is a trade mark of the AstraZeneca group of companies.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            ONC 09 0036
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <p>
                                                                                            P026675
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
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                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/casodex-150-mg-film-coated-tablets_11.html">
                                                                                        Casodex 150 mg Film-coated Tablets.
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
                                                                                    <div class="post-header-line-1">
                                                                                    </div>
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                                                                                <div class="post-body entry-content" id="post-body-5192213469181023064" itemprop="description articleBody">
                                                                                    <div class="contentBox">
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            1. Name Of The Medicinal Product
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Casodex
                                                                                            <sup>
                                                                                                &reg;
                                                                                            </sup>
                                                                                            150 mg Film-coated Tablets
                                                                                            <br>
                                                                                        </p>
                                                                                        <h2>
                                                                                        </h2>
                                                                                        <h2>
                                                                                            <br>
                                                                                            2. Qualitative And Quantitative Composition
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Each tablet contains 150 mg bicalutamide (INN).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For excipients, see section 6.1.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            3. Pharmaceutical Form
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Film-coated tablet.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            White.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            4. Clinical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.1 Therapeutic Indications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Casodex 150 mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Casodex 150 mg is also indicated for the management of patients with locally advanced, non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.2 Posology And Method Of Administration
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Adult males including the elderly: The dosage is one 150 mg tablet to be taken orally once a day.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Casodex 150 mg should be taken continuously for at least 2 years or until disease progression.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Renal impairment: No dosage adjustment is necessary for patients with renal impairment.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Hepatic impairment: No dosage adjustment is necessary for patients with mild hepatic impairment. Increased accumulation may occur in patients with moderate to severe hepatic impairment (see section 4.4).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.3 Contraindications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Casodex 150 mg is contraindicated in females and children (see section 4.6).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Casodex 150 mg must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any of the excipients of this product.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Co-administration of terfenadine, astemizole or cisapride with Casodex is contraindicated (see section 4.5).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.4 Special Warnings And Precautions For Use
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Initiation of treatment should be under the direct supervision of a specialist.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Bicalutamide is extensively metabolised in the liver. Data suggest that its elimination may be slower in subjects with severe hepatic impairment and this could lead to increased accumulation of bicalutamide
                                                                                            <i>
                                                                                                .
                                                                                            </i>
                                                                                            Therefore, Casodex 150 mg should be used with caution in patients with moderate to severe hepatic impairment.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Periodic liver function testing should be considered due to the possibility of hepatic changes. The majority of changes are expected to occur within the first 6 months of Casodex therapy.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Severe hepatic changes and hepatic failure have been observed rarely with Casodex 150 mg, and fatal outcomes have been reported (see section 4.8). Casodex 150 mg therapy should be discontinued if changes are severe.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For patients who have an objective progression of disease together with elevated PSA, cessation of Casodex therapy should be considered.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Bicalutamide has been shown to inhibit cytochrome P450 (CYP 3A4), as such, caution should be exercised when co-administered with drugs metabolised predominantly by CYP 3A4 (see sections 4.3 and 4.5).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                In vitro
                                                                                            </i>
                                                                                            studies have shown that R-bicalutamide is an inhibitor of CYP 3A4, with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity. Although clinical studies using antipyrine as a marker of cytochrome P450 (CYP) activity showed no evidence of a drug interaction potential with Casodex, mean midazolam exposure (AUC) was increased by up to 80%, after co-administration of Casodex for 28 days. For drugs with a narrow therapeutic index such an increase could be of relevance. As such, concomitant use of terfenadine, astemizole and cisapride is contraindicated (see section 4.3) and caution should be exercised with the co-administration of Casodex with compounds such as ciclosporin and calcium channel blockers. Dosage reduction may be required for these drugs particularly if there is evidence of enhanced or adverse drug effect. For ciclosporin, it is recommended that plasma concentrations and clinical condition are closely monitored following initiation or cessation of Casodex therapy.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Caution should be exercised when prescribing Casodex with other drugs which may inhibit drug oxidation e.g. cimetidine and ketoconazole. In theory, this could result in increased plasma concentrations of bicalutamide which theoretically could lead to an increase in side effects.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <i>
                                                                                                In vitro
                                                                                            </i>
                                                                                            studies have shown that bicalutamide can displace the coumarin anticoagulant, warfarin, from its protein binding sites. It is therefore recommended that if Casodex 150 mg is started in patients who are already receiving coumarin anticoagulants, prothrombin time should be closely monitored.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.6 Pregnancy And Lactation
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Bicalutamide is contraindicated in females and must not be given to pregnant women or nursing mothers.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.7 Effects On Ability To Drive And Use Machines
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Casodex is unlikely to impair the ability of patients to drive or operate machinery. However, it should be noted that occasionally somnolence may occur. Any affected patients should exercise caution.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.8 Undesirable Effects
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In this section, undesirable effects are defined as follows: Very common (
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-weight: bold">
                                                                                            <br>
                                                                                            Table 1 Frequency of Adverse Reactions
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            System Organ Class
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Frequency
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Event
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Blood and the lymphatic system disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Anaemia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Immune system disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Hypersensitivity, angioedema and urticaria
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Metabolism and nutrition disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Decreased appetite
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Psychiatric disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Decreased libido
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Depression
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Nervous system disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Dizziness
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Somnolence
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Vascular disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Hot flush
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Respiratory, thoracic and mediastinal disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Interstitial lung disease. Fatal outcomes have been reported.
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Gastrointestinal disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Abdominal pain
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Constipation
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Dyspepsia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Flatulence
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Nausea
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Hepato-biliary disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Hepatotoxicity, jaundice, hypertransaminasaemia
                                                                                                            <sup>
                                                                                                                a
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Rare
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Hepatic failure. Fatal outcomes have been reported.
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Skin and subcutaneous tissue disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Very common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Rash
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Alopecia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Hirsuitism/hair re-growth
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Dry skin
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Pruritis
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Renal and urinary disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Haematuria
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Reproductive system and breast disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Very common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Gynaecomastia and breast tenderness
                                                                                                            <sup>
                                                                                                                b
                                                                                                            </sup>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Erectile dysfunction
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            General disorders and administration site conditions
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Very common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Asthenia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        &nbsp;
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Chest pain
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Oedema
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 32%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Investigations
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 34%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Weight increased
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p>
                                                                                            <br>
                                                                                            a. Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following cessation of therapy.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            b. The majority of patients receiving Casodex 150 mg as monotherapy experience gynaecomastia and/or breast pain. In studies these symptoms were considered to be severe in up to 5% of the patients. Gynaecomastia may not resolve spontaneously following cessation of therapy, particularly after prolonged treatment (
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.9 Overdose
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There is no human experience of overdosage. There is no specific antidote; treatment should be symptomatic. Dialysis may not be helpful, since bicalutamide is highly protein bound and is not recovered unchanged in the urine. General supportive care, including frequent monitoring of vital signs, is indicated.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            5. Pharmacological Properties
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.1 Pharmacodynamic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Antiandrogen, ATC code L02 B B03
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Bicalutamide is a non-steroidal antiandrogen, devoid of other endocrine activity. It binds to the wild type or normal androgen receptor without activating gene expression, and thus inhibits the androgen stimulus. Regression of prostatic tumours results from this inhibition. Clinically, discontinuation of Casodex can result in the 'antiandrogen withdrawal syndrome' in a subset of patients.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Casodex 150 mg was studied as a treatment for patients with localised (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer in a combined analysis of three placebo controlled, double-blind studies in 8113 patients, where Casodex was given as immediate hormonal therapy or as adjuvant to radical prostatectomy or radiotherapy, (primarily external beam radiation). At 9.7 years median follow up, 36.6% and 38.17% of all Casodex and placebo-treated patients, respectively, had experienced objective disease progression.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            A reduction in risk of objective disease progression was seen across most patient groups but was most evident in those at highest risk of disease progression. Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No overall survival difference was seen at 9.7 years median follow up with 31.4% mortality (HR= 1.01; 95% CI 0.94 to1.09). However, some trends were apparent in exploratory subgroup analyses.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Data on progression-free survival and overall survival over time based on Kaplan-Meier estimates for patients with locally advanced disease are summarised in the following tables:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-weight: bold; text-decoration: underline">
                                                                                            <br>
                                                                                            Table 1 Proportion of locally advanced disease patients with disease progression over time by therapy sub-group
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Analysis population
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Treatment Arm
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Events (%) at 3 years
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Events (%) at 5 years
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Events (%) at 7 years
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Events (%) at 10 years
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Watchful waiting (n=657)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Casodex 150 mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            19.7%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            36.3%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            52.1%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            73.2%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            placebo
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            39.8%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            59.7%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            70.7%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            79.1%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Radiotherapy (n=305)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Casodex 150 mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            13.9%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            33.0%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            42.1%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            62.7%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            placebo
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            30.7%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            49.4%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            58.6%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            72.2%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Radical prostatectomy (n=1719)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Casodex 150 mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            7.5%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            14.4%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            19.8%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            29.9%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            placebo
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            11.7%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            19.4%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            23.2%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            30.9%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p style="font-weight: bold; text-decoration: underline">
                                                                                            <br>
                                                                                            Table 2 Overall survival in locally advanced disease by therapy sub-group
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Analysis population
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Treatment Arm
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Events (%) at 3 years
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Events (%) at 5 years
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Events (%) at 7 years
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p style="font-weight: bold">
                                                                                                            <br>
                                                                                                            Events (%) at 10 years
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Watchful waiting (n=657)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Casodex 150 mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            14.2%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            29.4%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            42.2%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            65.0%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            placebo
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            17.0%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            36.4%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            53.7%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            67.5%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Radiotherapy (n=305)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Casodex 150 mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.2%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            20.9%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            30.0%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            48.5%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            placebo
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            12.6%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            23.1%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            38.1%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            53.3%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Radical prostatectomy (n=1719)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Casodex 150 mg
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            4.6%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            10.0%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            14.6%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            22.4%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            placebo
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            4.2%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            8.7%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 17%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            12.6%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 16%; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            20.2%
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p>
                                                                                            <br>
                                                                                            For patients with localised disease receiving Casodex alone, there was no significant difference in progression free survival. There was no significant difference in overall survival in patients with localised disease who received Casodex as adjuvant therapy, following radiotherapy (HR=0.98; 95% CI 0.80 to 1.20) or radical prostatectomy (HR=1.03; 95% CI 0.85 to 1.25). In patients with localised disease, who would otherwise have been managed by watchful waiting, there was also a trend toward decreased survival compared with placebo patients (HR=1.15; 95% CI 1.00 to 1.32). In view of this, the benefit-risk profile for the use of Casodex is not considered favourable in patients with localised disease.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In a separate programme, the efficacy of Casodex 150 mg for the treatment of patients with locally advanced non-metastatic prostate cancer for whom immediate castration was indicated, was demonstrated in a combined analysis of 2 studies with 480 previously untreated patients with non-metastatic (M0) prostate cancer. At 56% mortality and a median follow-up of 6.3 years, there was no significant difference between Casodex and castration in survival (hazard ratio = 1.05 [CI 0.81 to 1.36]); however, equivalence of the two treatments could not be concluded statistically.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In a combined analysis of 2 studies with 805 previously untreated patients with metastatic (M1) disease at 43% mortality, Casodex 150 mg was demonstrated to be less effective than castration in survival time (hazard ratio = 1.30 [CI 1.04 to 1.65]), with a numerical difference in estimated time to death of 42 days (6 weeks) over a median survival time of 2 years.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Bicalutamide is a racemate with its antiandrogen activity being almost exclusively in the R-enantiomer.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.2 Pharmacokinetic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Bicalutamide is well absorbed following oral administration. There is no evidence of any clinically relevant effect of food on bioavailability.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The (S)-enantiomer is rapidly cleared relative to (R)-enantiomer, the latter having a plasma elimination half-life of about 1 week.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            On daily administration of Casodex 150 mg, the (R)-enantiomer accumulates about 10-fold in plasma as a consequence of its long half-life.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Steady state plasma concentrations of the (R)-enantiomer, of approximately 22 microgram/ml are observed during daily administration of Casodex 150 mg. At steady state, the predominantly active (R)-enantiomer accounts for 99% of the total circulating enantiomers.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The pharmacokinetics of the (R)-enantiomer are unaffected by age, renal impairment or mild to moderate hepatic impairment. There is evidence that for subjects with severe hepatic impairment, the (R)-enantiomer is more slowly eliminated from plasma.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Bicalutamide is highly protein bound (racemate 96%, (R)-enantiomer&gt;99%) and extensively metabolised (oxidation and glucuronidation); its metabolites are eliminated via the kidneys and bile in approximately equal proportions.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In a clinical study the mean concentration of R-bicalutamide in semen of men receiving Casodex 150 mg was 4.9 microgram/ml. The amount of bicalutamide potentially delivered to a female partner during intercourse is low and equates to approximately 0.3 microgram/kg. This is below that required to induce changes in offspring of laboratory animals.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.3 Preclinical Safety Data
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Bicalutamide is a potent antiandrogen and a mixed function oxidase enzyme inducer in animals. Target organ changes, including tumour induction (Leydig cells, thyroid, liver) in animals, are related to these activities. Enzyme induction has not been observed in man and none of these findings is considered to have relevance to the treatment of patients with prostate cancer. Atrophy of seminiferous tubules is a predicted class effect with antiandrogens and has been observed for all species examined. Full reversal of testicular atrophy was 24 weeks after a 12-month repeated dose toxicity study in rats, although functional reversal was evident in reproduction studies 7 weeks after the end of an 11 week dosing period. A period of subfertility or infertility should be assumed in man.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            6. Pharmaceutical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.1 List Of Excipients
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Casodex 150 mg includes the following excipients:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <span style="text-decoration: underline">
                                                                                                Tablet core
                                                                                            </span>
                                                                                            : Lactose Monohydrate, Magnesium Stearate, Povidone, Carboxymethyl amidon sodium.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <span style="text-decoration: underline">
                                                                                                Film-coating material
                                                                                            </span>
                                                                                            : Hypromellose, Macrogol 300, Titanium Dioxide.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.2 Incompatibilities
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Not applicable.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.3 Shelf Life
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            4 years.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.4 Special Precautions For Storage
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Do not store above 30&deg;C.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.5 Nature And Contents Of Container
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            PVC/Aluminium foil blister pack comprising strips of 5, 10 and 14 tablets to give pack sizes of 10, 20, 30, 40, 50, 80, 90, 100, 200 or 14, 28, 56, 84, 140 and 280 tablets.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Not all pack sizes may be marketed.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.6 Special Precautions For Disposal And Other Handling
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No special requirements.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            7. Marketing Authorisation Holder
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            AstraZeneca UK Ltd.,
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            600 Capability Green,
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Luton, LU1 3LU, UK.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            8. Marketing Authorisation Number(S)
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            PL 17901/0006
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            9. Date Of First Authorisation/Renewal Of The Authorisation
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            18
                                                                                            <sup>
                                                                                                th
                                                                                            </sup>
                                                                                            June 2000/16
                                                                                            <sup>
                                                                                                th
                                                                                            </sup>
                                                                                            June 2004
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            10. Date Of Revision Of The Text
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            24
                                                                                            <sup>
                                                                                                th
                                                                                            </sup>
                                                                                            November 2010
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
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                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cetirizine-hydrochloride-10mg-tablets.html">
                                                                                        Cetirizine Hydrochloride 10mg Tablets
                                                                                    </a>
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                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            1. Name Of The Medicinal Product
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cetirizine Hydrochloride 10mg Tablets.
                                                                                            <br>
                                                                                        </p>
                                                                                        <h2>
                                                                                        </h2>
                                                                                        <h2>
                                                                                            <br>
                                                                                            2. Qualitative And Quantitative Composition
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Each film-coated tablet contains 10mg of Cetirizine Hydrochloride.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Excipient: 91 mg lactose /film-coated tablet.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For a full list of excipients, see section 6.1.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            3. Pharmaceutical Form
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Film-coated Tablet.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            White, capsule shaped, biconvex film coated tablets with score line on one side and 'C' and 'L' imprints on either side of score line, other side being plain.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            4. Clinical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.1 Therapeutic Indications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <span style="text-decoration: underline">
                                                                                                Adults and adolescents over 12 years of age
                                                                                            </span>
                                                                                            :
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Symptomatic treatment of allergic rhinitis (seasonal and perennial), associated allergic conjunctivitis, and chronic idiopathic urticaria.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <span style="text-decoration: underline">
                                                                                                Children 6-12 years
                                                                                            </span>
                                                                                            :
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Symptomatic treatment of allergic rhinitis (seasonal and perennial), and chronic idiopathic urticaria.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.2 Posology And Method Of Administration
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <span style="text-decoration: underline">
                                                                                                Adults and adolescents over 12 years of age
                                                                                            </span>
                                                                                            : One tablet daily.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            If drowsiness occurs, the tablet can be administered in the evening.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <span style="text-decoration: underline">
                                                                                                Children 6-12 years old, weighing 30 kg and more
                                                                                            </span>
                                                                                            :
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            One tablet daily or 5 mg (&frac12; tablet) taken twice daily (morning and evening).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            <span style="text-decoration: underline">
                                                                                                Childern 6-12 years old, weighing less than 30 kg
                                                                                            </span>
                                                                                            :
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            5 mg (&frac12; tablet) taken once daily.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Children 2-5 years:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cetirizine hydrochloride 10 mg Tablets are not recommended for use in children of 2 to 5 years of age; other oral pharmaceutical forms of cetirizine hydrochloride should be used in this age group.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In patients with moderate renal impairment the dose should be adjusted to 5 mg (1/2 a tablet a day). Caution should be exercised in patients with mild to moderate renal impairment or impaired liver function (see section 4.4).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There is no evidence that the dose needs to be modified for healthy elderly patients.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The duration of the treatment may vary depending on the symptoms. For the treatment seasonal allergic rhinitis treatment should be according to disease history and should be stopped once symptoms have resolved. For the treatment with cetirizine dihydrochloride in chronic urticaria or chronic allergic rhinitis there is up to one year's clinical experience. Clinical trials in children have not exceeded four weeks.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="font-weight: bold">
                                                                                            <br>
                                                                                            Method of administration
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            This tablet is for oral use.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.3 Contraindications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Hypersensitivity to cetirizine hydrochloride or to any of the excipients.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Patients with severe renal impairment.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.4 Special Warnings And Precautions For Use
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In some patients, long term treatment with cetirizine hydrochloride tablets may lead to an increased risk of caries due to mouth dryness. The patients should therefore be informed about the importance of oral hygiene.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            At impaired hepatic function and renal function, the elimination of cetirizine hydrochloride may be impaired. Caution should be exercised when administering cetirizine hydrochloride to these patients. (see sections 4.2 and 4.3).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cetirizine hydrochloride may potentiate the effects of alcohol. Therefore caution is recommended at concomitant use of alcohol.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Caution is recommended with concomitant use of CNS depressants.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cetirizine hydrochloride contains lactose. It should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Allergy testing: Use of cetirizine hydrochloride must be discontinued three days before allergy tests.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cetirizine hydrochloride may potentiate the effects of alcohol. Therefore caution is recommended at concomitant use of alcohol. Caution is recommended during concomitant use of CNS depressants.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.6 Pregnancy And Lactation
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Data on a limited number of exposed pregnancies indicate no adverse effects of cetirizine hydrochloride on pregnancy or on health of foetus/new born child. To date no other relevant epidemiological data are available.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post natal development (see section 5.3). Caution should be exercised when prescribing to pregnant women.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Breast-feeding
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cetirizine has been reported to be excreted in human milk. Cetirizine hydrochloride should be avoided during lactation.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.7 Effects On Ability To Drive And Use Machines
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cetirizine hydrochloride may have minor or moderate influence on the patient's ability to react.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            This should be considered when extra alertness is required e.g. when driving. Cetirizine hydrochloride may potentiate the effects of alcohol and CNS depressants.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.8 Undesirable Effects
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Very common (
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Blood and lymphatic system disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Very rare: thrombocytopenia
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Immune system disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Rare: hypersensitivity
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Very rare: anaphylactic shock
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Psychiatric disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Uncommon: agitation
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Rare: aggression, confusion, depression, hallucination, insomnia
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Nervous system disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Common: headache, somnolence
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Uncommon: dizziness, paraesthesia
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Rare: convulsions
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Very rare: syncope, dysgeusia
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Eye disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Very rare: accommodation disorder, blurred vision, oculogyric crisis, especially in children
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Cardiac disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Rare: tachycardia, palpitations
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Respiratory, thoracic and mediastinal disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Uncommon: pharyngitis, rhinitis (in children)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Gastrointestinal disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Common: dry mouth
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Uncommon: abdominal complaints such as abdominal pains, nausea, diarrhoea, digestive disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Hepatobiliary disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Rare: abnormal hepatic function (increased transaminases, alkaline, phosphatase, gamma-GT and bilirubin)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Very rare: hepatitis
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Skin and subcutaneous tissue disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Uncommon: rash, pruritus
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Rare: urticaria
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Very rare: angioneurotic oedema, erythema multiforme
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Renal and urinary disorders
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Very rare: dysuria, enuresis, micturition difficulties
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            General disorders and administration site conditions
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Common: fatigue
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Uncommon: asthenia, malaise
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Rare: oedema
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Investigations
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Rare: weight increase
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.9 Overdose
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Toxicity: Limited experience of overdosing. 20 mg to a 2 year old, 30 mg to a 3 year old and 40 mg to an 11 year old did not give any symptoms. 60 mg to a 4 year old gave mild intoxication, 400 mg to a 14 year old gave mild symptoms while 400-500 mg to an adult gave no symptoms at all.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Symptoms of overdosage reported with antihistamine substances: Somnolence, unconsciousness and/or excitation (principally in children). Ataxia, tremor, headache, hallucinations, seizures, dry mouth, flush, hyperthermia, mydriasis, urine retention tachycardia and in the case of massive doses, possible fall in blood pressure and arrhythmias. Nausea and vomiting. Also extrapyramidal symptoms are possible. Cetirizine hydrochloride has a low sedative and anticholinergic effect. Sedation can be a symptom of overdose, it can occur after a single dose of less than 50 mg.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Treatment: At the present time there is no specific antidote. Experience of overdosing is limited and no severe intoxication has been reported to date. Primary treatment should be gastric lavage, if justified and charcoal. Symptomatic treatment should be instituted in the case of acute intoxication, such as diazepam for seizures or acute dystonias.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            5. Pharmacological Properties
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.1 Pharmacodynamic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pharmacotherapeutic group: Antihistamines for systemic use. Piperazine derivatives.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            ATC code: R06AE07
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cetirizine hydrochloride is a racemate and an anti-allergic with specific histamine H1-receptor blocking characteristics.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cetirizine hydrochloride inhibits cutaneous reactions in allergic individuals by VIP (Vasoactive Intestinal Polypeptide) and the P substance, neuropeptides that are considered involved in the allergic reaction. Effect is reached within 2 hours with a maximum effect after 4 hours, and remains for at least 24 hours. In allergic individuals, cetirizine hydrochloride inhibits the recruitment of eosinophils after stimulation with allergens and unselective histamine liberators, by a mechanism that is not primarily explained by the H1-receptor blocking characteristics of the pharmaceutical.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.2 Pharmacokinetic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cetirizine hydrochloride is absorbed with small inter-individual variations. Cetirizine hydrochloride has not been given intravenously, therefore the bioavailability, clearance and distribution volume (Vd) are unknown. Maximum plasma concentration is achieved within 1 hour and the terminal half-life is about 10 hours in adults and 6 hours in children between the age of 6-12 years. The grade of protein binding in plasma is about 93%. Cetirizine is metabolised to a small extent with a known inactive main metabolite. Cetirizine is eliminated to 60% in unchanged form via the kidneys within 96 hours. At repeated administration there is no accumulation at hand, nor is the absorption or elimination affected. At impaired kidney function, the elimination is slower and the half-life is prolonged. Elimination will also be decreased in cases of hepatic impairment.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There is no evidence that the pharmacokinetics of cetirizine hydrochloride is altered in elderly patients unless renal or hepatic function is reduced.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.3 Preclinical Safety Data
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction, genotoxicity or carcinogenicity.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            6. Pharmaceutical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.1 List Of Excipients
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Tablet core:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Lactose monohydrate
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Maize starch
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Povidone K30
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Magnesium stearate
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Film-coat:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Hypromellose
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Titanium Dioxide (E171)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Macrogol 400
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.2 Incompatibilities
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Not applicable.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.3 Shelf Life
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            2 years.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.4 Special Precautions For Storage
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Do not store above 25&ordm;C. Store in the original package.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.5 Nature And Contents Of Container
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            PVC/Aluminium blister
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pack size 7, 10, 14, 20, 30, 40, 50, 60, 80, 100 and 100x1 (unit dose).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Not all pack sizes may be marketed.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.6 Special Precautions For Disposal And Other Handling
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No special requirements.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            7. Marketing Authorisation Holder
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sandoz Limited
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Woolmer Way
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Bordon
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Hampshire, GU35 9QE
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            8. Marketing Authorisation Number(S)
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            PL 04416/0381
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            9. Date Of First Authorisation/Renewal Of The Authorisation
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            30 April 2002
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            28 April 2008
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            10. Date Of Revision Of The Text
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            13 February 2009
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
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                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cardene-20mg-and-30mg-capsules.html">
                                                                                        Cardene 20mg and 30mg capsules
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
                                                                                    <div class="post-header-line-1">
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                                                                                <div class="post-body entry-content" id="post-body-3064655417015960341" itemprop="description articleBody">
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                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                            </h2>
                                                                                            <p>
                                                                                                <br>
                                                                                                <b>
                                                                                                    UK
                                                                                                </b>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                <br>
                                                                                                <b>
                                                                                                    Cardene
                                                                                                    <sup>
                                                                                                    </sup>
                                                                                                    20 mg and 30 mg capsules
                                                                                                </b>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                <br>
                                                                                                <b>
                                                                                                    Nicardipine hydrochloride
                                                                                                </b>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                            <br>
                                                                                            <p>
                                                                                                <br>
                                                                                                <b>
                                                                                                    Please read this leaflet carefully before you start to take your medicine.
                                                                                                </b>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                <br>
                                                                                                <b>
                                                                                                    If you have any questions or are not sure about anything, ask your doctor or pharmacist.
                                                                                                </b>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                What is Cardene?
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cardene contains the active ingredient nicardipine hydrochloride which belongs to the class of drugs called calcium channel blockers. These cause relaxation of the smooth muscle of the blood vessels causing these vessels to widen or dilate.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cardene capsules come in two strengths. Each capsule contains either 20 mg or 30 mg of nicardipine hydrochloride.
                                                                                            </p>
                                                                                            <br>
                                                                                            <ul class="listStandard">
                                                                                                <li>
                                                                                                    The 20 mg capsule is coloured blue and white.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    The 30 mg capsule is coloured blue and pale blue.
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                            <p>
                                                                                                They also contain the additional ingredients: starch, magnesium stearate, gelatin, indigotine E132, titanium dioxide El71.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Both strengths of capsules are available in packs of 56.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                The Product Licence holder is
                                                                                            </p>
                                                                                            <br>
                                                                                            <div class="addressInline" lang="en">
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Astellas Pharma Limited
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Lovett House
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Lovett Road
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Staines
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Middx
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    TW18 3AZ
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    UK
                                                                                                </div>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <p>
                                                                                                This medicine is made by
                                                                                            </p>
                                                                                            <br>
                                                                                            <div class="addressInline" lang="es">
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Farmasierra, S.A.
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Carretera de Ir&uacute;n
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Km. 26,200
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    San Sebasti&aacute;n de los Reyes
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    28700 Madrid
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Spain
                                                                                                </div>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                            <p>
                                                                                                The site where batch release takes place is
                                                                                            </p>
                                                                                            <br>
                                                                                            <div class="addressInline" lang="nl">
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Astellas Pharma Europe BV
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Hogemaat 2
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    Meppel
                                                                                                </div>
                                                                                                <br>
                                                                                                <div class="addressElement">
                                                                                                    The Netherlands
                                                                                                </div>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                What is Cardene used for?
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Your medicine is used for the treatment of
                                                                                                <u>
                                                                                                    mild to moderate
                                                                                                </u>
                                                                                                high blood pressure (hypertension) and to help prevent attacks of chest pain diagnosed by your doctor as
                                                                                                <u>
                                                                                                    chronic stable
                                                                                                </u>
                                                                                                angina. Chronic stable angina is a pattern of attacks of chest pain that are predictable and reproducible under certain conditions such as after exercise, stress or in cold weather. They are short in duration and can be relieved by rest or
                                                                                                <br>
                                                                                                certain drugs.
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                When must Cardene not be used?
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul class="listStandard">
                                                                                                <li>
                                                                                                    If you are allergic to nicardipine or other dihydropyridines, or any of the ingredients Cardene contains.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    If you have had a recent heart attack (ie. within the last month), or a condition called advanced aortic stenosis which is narrowing of your aortic heart valve.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    If your chest pain is diagnosed by your doctor as
                                                                                                    <u>
                                                                                                        unstable
                                                                                                    </u>
                                                                                                    angina. For example, if the pattern of attacks of chest pain changes and occur without exertion, you should contact your doctor immediately.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    If you need immediate relief of chest pain in a sudden or acute angina attack. This situation should be treated with a different class of medicine.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    to try to prevent the occurrence of future heart attacks (if you have already had at least one heart attack).
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Cardene is not recommended for patients under the age of 18.
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    When should you be extra careful when using/while taking Cardene?
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Make sure your doctor knows if you:
                                                                                                </p>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        have a heart, liver or kidney condition, or have had a stroke.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        are taking other medicines including those not prescribed by your doctor. This is extremely important, as using
                                                                                                        <u>
                                                                                                            more than one medicine at the same time
                                                                                                        </u>
                                                                                                        can strengthen or weaken the effect of either Cardene or other medicines. Examples of such effects have been reported for Cardene when also taking digoxin, cimetidine, cyclosporin and other blood pressure lowering drugs amongst other medicines. Rifampicin or grapefruit juice should not be taken with Cardene, since they could also interact and alter the effects of Cardene.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        are about to undergo an operation. You must tell the doctors in the hospital that you are taking Cardene.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        if you experience
                                                                                                        <u>
                                                                                                            sudden
                                                                                                        </u>
                                                                                                        dizziness, light-headedness or palpitations on treatment with Cardene, let your doctor know. Sometimes Cardene can cause too great a fall in blood pressure which, if not dealt with, could damage your heart or brain.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    May Cardene be used during pregnancy or while breast feeding?
                                                                                                </h3>
                                                                                                <br>
                                                                                                <ul class="listStandard">
                                                                                                    <li>
                                                                                                        You should NOT take these capsules if you are pregnant. You must tell your doctor if you are
                                                                                                        <u>
                                                                                                            pregnant
                                                                                                        </u>
                                                                                                        , if you think you are pregnant or if you intend to become pregnant.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                    <li>
                                                                                                        You should NOT breast feed if you are taking these capsules.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                How should Cardene be taken?
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul class="listStandard">
                                                                                                <li>
                                                                                                    Always take your medicine
                                                                                                    <u>
                                                                                                        exactly
                                                                                                    </u>
                                                                                                    as your doctor tells you to and do not stop treatment unless he/she tells you to do so:
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                            <ul class="listNoBullet">
                                                                                                <li>
                                                                                                    The usual dose is 20-30 mg, every 8 hours. Your doctor may vary this according to your symptoms and blood pressure. The label will tell you how much to take and how often. If you are not sure, ask your doctor or pharmacist.
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                            <ul class="listStandard">
                                                                                                <li>
                                                                                                    Capsules should be swallowed with a glass of water, preferably at the same time each day. (NB. Do not use grapefruit juice).
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    If you forget to take a dose, take another dose as soon as you remember provided there are at least 3 hours between doses. If this is not possible, do not take the missed dose. Do not take two doses together.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Do not change the prescribed dose of your medicine yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                What are the possible unwanted effects of Cardene?
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                This medicine sometimes causes side-effects. These are usually mild and tend to pass with time, but if they trouble you consult your doctor.
                                                                                            </p>
                                                                                            <br>
                                                                                            <div class="section">
                                                                                                <br>
                                                                                                <h3>
                                                                                                    Common side effects are:
                                                                                                </h3>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Headache, ankle swelling (oedema), heat sensation, facial flushing, sensation of fast heart beats (palpitations), nausea, dizziness.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    In some patients Cardene may cause an attack of angina (chest pain) shortly after first starting to take the capsules. If this happens to you, do not take any further doses and contact your doctor. In addition a few patients experience an increase in the severity or frequency of chest pain during treatment with Cardene. If this happens to you, you must inform your doctor as soon as possible.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    Other less frequent side-effects include heart complaints, drowsiness, sleeplessness, ringing in the ears, pins and needles, psychological upset, itching, rashes, diffculty in passing urine or an increase in passing urine, shortness of breath, stomach upsets, and rarely, depression, increase in bruising and impotence.
                                                                                                </p>
                                                                                                <br>
                                                                                                <p>
                                                                                                    If you are concerned about these or any other unwanted effects talk to your doctor.
                                                                                                </p>
                                                                                                <br>
                                                                                            </div>
                                                                                            <br>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                How should Cardene be stored?
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul class="listStandard">
                                                                                                <li>
                                                                                                    Keep this medicine out of the reach and sight of children.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Do not store above 25 &deg;C.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    This medicine must not be used after the date (EXP) printed on the pack. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="section">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Further information:
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                You can get more information on Cardene from your doctor or pharmacist.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                <br>
                                                                                                <b>
                                                                                                    Date of last review
                                                                                                </b>
                                                                                                <br>
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                July 2005
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                118143
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                14121/3
                                                                                            </p>
                                                                                            <br>
                                                                                        </div>
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                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/care-decongestant-oral-liquid.html">
                                                                                        Care Decongestant Oral Liquid
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
                                                                                    <div class="post-header-line-1">
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                                                                                    <div class="contentBox">
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            1. Name Of The Medicinal Product
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Galsud Linctus or Care Decongestant Oral Liquid
                                                                                            <br>
                                                                                        </p>
                                                                                        <h2>
                                                                                        </h2>
                                                                                        <h2>
                                                                                            <br>
                                                                                            2. Qualitative And Quantitative Composition
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p style="font-weight: bold">
                                                                                            <br>
                                                                                            Active Ingredient:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pseudoephedrine hydrochloride BP 30.0mg (Per 5ml Dose).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For full list of excipients, see section 6.1
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            3. Pharmaceutical Form
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Oral Liquid
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            A deep orange coloured liquid
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            4. Clinical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.1 Therapeutic Indications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Indicated for the relief of nasal, sinus and upper respiratory congestion.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.2 Posology And Method Of Administration
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For oral administration.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Adults and children over 12 years:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Two 5ml spoonfuls three times daily.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Elderly:
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Adult dose is appropriate.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.3 Contraindications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Galsud Linctus should not be used in patients hypersensitive to pseudoephedrine, or any of the other ingredients. It is contra-indicated in patients receiving monoamine oxidase inhibitors or who have received these agents in the last two weeks. Galsud Linctus is contra-indicated in patients with severe renal impairment.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Children under 12 years of age
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.4 Special Warnings And Precautions For Use
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Caution should be used in prescribing Galsud Linctus for patients with cardiovascular disease including hypertension, those with diabetes, hyper-thyroidism, raised intraoccular pressure, prostatic enlargement, bladder dysfunction or renal impairment.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Amaranth (E123) and Sunset Yellow (E110) may cause allergic reactions. Sodium Hydroxybenzoates (E215, E217 &amp; E219) may cause allergic reactions (possibly delayed).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Galsud linctus contains 1.0 vol % ethanol (alcohol), ie, up to 154 mg per dose (10ml), equivalent to 4ml beer or 2ml of wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast feeding women, children and high risk groups such as patients with liver disease or epilepsy.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Do not exceed the stated dose
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Do not take with other cough and cold medicines
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Do not give to children under 12 years
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Caution should be exercised with patients receiving other sympathomimetic agents, appetite suppressants or amphetamine type agents. Pseudoephedrine may antagonise the pressor effects of antihypertensive agents, severe hypertension may occur in patients receiving beta blockers. Hypertensive crisis may occur if pseudoephedrine is co-administered with MAOIs.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There may be an increased risk of arrhythmias if pseudoephedrine is given to patients receiving cardiac glycosides or tricyclic antidepressants.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The antibacterial agent furazolidone is known to cause progressive inhibition of monoamine oxidase. Although there have been no reports of hypertensive crisis, it may not be administered concurrently with Galsud Linctus.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.6 Pregnancy And Lactation
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No data are available on the use of Galsud Linctus in pregnancy. Pseudoephedrine has been used for many years without reports of serious problems.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            However, caution is required and pseudoephedrine should be avoided during the first trimester of pregnancy. Pseudoephedrine has been detected in human milk with a small percentage of the total maternal dose potentially administered to the suckling infant. Although the effects on the infant have not been monitored the risk is judged to be low.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.7 Effects On Ability To Drive And Use Machines
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            None stated.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.8 Undesirable Effects
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pseudoephedrine may cause insomnia, anxiety, restlessness, tremor, tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting and headache in some patients. Skin rashes and urinary retention in men have occasionally been reported. Sleep disturbances and hallucinations have been reported rarely. A fixed drug eruption, in the form of erythematous nodular patches, has been rarely associated with pseudoephedrine. Rare cases of psychosis have occurred following misuse of pseudoephedrine.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.9 Overdose
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The symptoms of overdose include irritability, nervousness, tremor, palpitations, convulsions, urinary retention, hypertension, restlessness, difficulty in micturition, nausea, vomiting, tachycardia and cardiac arrhythmias.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Overdose should be treated by general supportive measures. In the event of gross overdose, the stomach should be emptied using airway protective gastric lavage. Respiratory and circulatory function should be maintained by supportive measures. Convulsions should be controlled using anti-convulsant therapy. Catheterisation of the bladder may be required.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            5. Pharmacological Properties
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.1 Pharmacodynamic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pharmacotherapeutic Group: Nasal decongestant for systemic use
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sympathomimetics: ATC code: R01B A02
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory tract decongestant. Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation in systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.2 Pharmacokinetic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pseudoephedrine hydrochloride is readily and completely absorbed from the gastro-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.3 Preclinical Safety Data
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There are no pre-clinical data of relevance that are additional to the presciber, which are additional to those already included in other sections of the SmPC.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            6. Pharmaceutical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.1 List Of Excipients
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Citric Acid Monohydrate
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sodium Hydroxybenzoates (E215, E217 &amp; E219)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Alcohol 96%
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Amaranth (E123)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sunset Yellow FCF (E110)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Carmellose Sodium
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Saccahrin Sodium
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Menthol
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Condensed Milk Flavour (F12516)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Orange Flavour (17.40.7040)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Glycerol
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Purified Water
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.2 Incompatibilities
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            None stated.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.3 Shelf Life
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            24 months.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.4 Special Precautions For Storage
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Store below 25&deg;C. Protect from light.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.5 Nature And Contents Of Container
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            100ml amber glass bottle with a 28mm tamper evident child resistant closure with a low density polyethylene plug.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The 100ml bottle will be cartonned and a 5ml/2.5 ml double-ended CE marked spoon included.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.6 Special Precautions For Disposal And Other Handling
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            None stated.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            7. Marketing Authorisation Holder
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Thornton &amp; Ross Ltd
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Linthwaite
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Huddersfield
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            HD7 5QH
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            United Kingdom
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            8. Marketing Authorisation Number(S)
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            PL 00240/0107
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            9. Date Of First Authorisation/Renewal Of The Authorisation
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            08 July 2002
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            30 January 2004
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            10. Date Of Revision Of The Text
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            17/02/2010
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
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                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/catacrom-sodium-cromoglicate-2.html">
                                                                                        Catacrom Sodium Cromoglicate 2% Preservative Free Unit Dose Eye Drops
                                                                                    </a>
                                                                                </h3>
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                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            1. Name Of The Medicinal Product
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Catacrom 2% w/v eye drops, solution.
                                                                                            <br>
                                                                                        </p>
                                                                                        <h2>
                                                                                        </h2>
                                                                                        <h2>
                                                                                            <br>
                                                                                            2. Qualitative And Quantitative Composition
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sodium cromoglicate 2.0% w/v.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Each individual single-dose-unit contains 6mg of sodium Cromoglicate in 0.3ml of solution
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For a full list of excipients, see section 6.1.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            3. Pharmaceutical Form
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Eye drops, solution (eye drops)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Clear, colourless solution drops in a single dose container.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The eye drops are sterile and preservative free.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            4. Clinical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.1 Therapeutic Indications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Indicated for the relief and treatment of seasonal and perennial allergic conjunctivitis.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.2 Posology And Method Of Administration
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Topical ophthalmic use.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Adults, children and the elderly: one or two drops into each eye four times per day, or as directed by the doctor.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.3 Contraindications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Known hypersensitivity to sodium cromoglicate.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.4 Special Warnings And Precautions For Use
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Catacrom 2% w/v eye drops are sterile, preservative free and presented in a single use container which should be discarded after use.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            None known.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.6 Pregnancy And Lactation
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Catacrom 2% w/v eye drops should be used with caution in pregnancy, especially during the first trimester. Extensive experience with sodium cromoglicate suggests that there are no adverse effects on fetal development. Nevertheless, it should only be used in pregnancy where there is a clinical need.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            It is not known whether sodium cromoglicate is excreted in breast milk; however, on the basis of its physicochemical properties, it is considered unlikely. There is no evidence that the use of sodium cromoglicate has any undesirable effects on the baby.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.7 Effects On Ability To Drive And Use Machines
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            As with all eye drops, transient blurring of vision may occur on instillation. Do not drive or operate machinery until normal vision is restored.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.8 Undesirable Effects
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            On instillation, transient stinging or burning may occur. Rarely, other symptoms of local irritation have been reported.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.9 Overdose
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Medical supervision only should be necessary.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            If the solution is accidentally ingested, as sodium cromoglicate is only poorly absorbed, no action other than medical supervision should be necessary.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            5. Pharmacological Properties
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.1 Pharmacodynamic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pharmacotherapeutic group: Other antiallergics; Cromoglicate acid
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            ATC-code: SO1G X01
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The solution exerts its effect locally in the eye. Sodium cromoglicate has been shown to inhibit the degranulation of sensitised mast cells occurring after exposure to specific antigens. Sodium cromoglicate inhibits release of histamine and various membrane derived mediators from mast cells.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sodium cromoglicate has no intrinsic antihistaminic or vasoconstrictor activity.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.2 Pharmacokinetic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Limited systemic absorption may be expected via ocular instillation.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In normal volunteers, analysis of drug excretion has shown that approximately 0.03% of sodium cromoglicate is absorbed following ocular administration.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.3 Preclinical Safety Data
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            6. Pharmaceutical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.1 List Of Excipients
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Purified water
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Sodium chloride
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.2 Incompatibilities
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            None known. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.3 Shelf Life
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Unopened: 3 years.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            After opening the sachet: use contents within 28 days.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            After opening the single-dose unit: Use immediately after opening the single-dose unit. Discard any unused contents.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.4 Special Precautions For Storage
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Do not store above 25&deg;C. Store in the original package.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.5 Nature And Contents Of Container
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Catacrom 2% w/v eye drops is available in 0.3 ml low density polyethylene single-dose containers. The single dose containers are packed into laminate sachets, within a cardboard carton.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pack sizes: 10, 12, 18, 20, 24, 30 or 90 single doses
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Not all pack sizes may be marketed.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.6 Special Precautions For Disposal And Other Handling
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For single use only. Discard immediately after first use. Any unused product or waste material should be disposed of in accordance with the local requirements.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            7. Marketing Authorisation Holder
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Moorfields Eye Hospital NHS Foundation Trust
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Trading as Moorfields Pharmaceuticals
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            34 Nile Street
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            London N1 7TP
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            8. Marketing Authorisation Number(S)
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            PL11412/0002
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            9. Date Of First Authorisation/Renewal Of The Authorisation
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            06/08/2009
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            10. Date Of Revision Of The Text
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            06/08/2009
                                                                                            <br>
                                                                                        </p>
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                                                                                                (109)
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                                                                                            <ul class="posts">
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/carbomix-activated-charcoal-50g-beacon.html">
                                                                                                        Carbomix (activated charcoal) 50g (Beacon Pharmace...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/casodex-50-mg-film-coated-tablets_11.html">
                                                                                                        Casodex 50 mg Film-coated Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/casodex-150-mg-film-coated-tablets_11.html">
                                                                                                        Casodex 150 mg Film-coated Tablets.
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cetirizine-hydrochloride-10mg-tablets.html">
                                                                                                        Cetirizine Hydrochloride 10mg Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cardene-20mg-and-30mg-capsules.html">
                                                                                                        Cardene 20mg and 30mg capsules
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/care-decongestant-oral-liquid.html">
                                                                                                        Care Decongestant Oral Liquid
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/catacrom-sodium-cromoglicate-2.html">
                                                                                                        Catacrom Sodium Cromoglicate 2% Preservative Free ...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cefuroxime-1500-mg-powder-for-solution.html">
                                                                                                        Cefuroxime 1500 mg powder for solution for injecti...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cefotaxime-2g-powder-for-solution-for.html">
                                                                                                        Cefotaxime 2g Powder for solution for injection or...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/catapres-tablets.html">
                                                                                                        Catapres Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/carace-20-plus-tablets.html">
                                                                                                        CARACE 20 PLUS Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/care-ibuprofen-for-children-oral.html">
                                                                                                        Care Ibuprofen for Children Oral Suspension
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cedocard-retard-20-tablets.html">
                                                                                                        Cedocard Retard 20 Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cerezyme-200-u-powder-for-concentrate.html">
                                                                                                        Cerezyme 200 U powder for concentrate for solution...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cayston-75-mg-powder-and-solvent-for.html">
                                                                                                        Cayston 75 mg powder and solvent for nebuliser sol...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/clarithromycin-500-mg-powder-for.html">
                                                                                                        Clarithromycin 500 mg, Powder for Concentrate for ...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/coaprovel-150-125-mg-300-125-mg-and-300_10.html">
                                                                                                        CoAprovel 150 / 12.5 mg, 300 / 12.5 mg and 300 / 2...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/compound-macrogol-oral-powder-sugar-free_10.html">
                                                                                                        Compound Macrogol Oral Powder Sugar Free.
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cymex-cream.html">
                                                                                                        Cymex Cream
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cozaar-25-mg-ml-powder-and-solvent-for.html">
                                                                                                        COZAAR 2.5 mg / ml powder and solvent  for oral su...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/compound-macrogol-oral-powder-sugar-free.html">
                                                                                                        Compound Macrogol Oral Powder Sugar Free.
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cream-of-magnesia-bp-boots-company-plc.html">
                                                                                                        Cream of Magnesia BP (Boots Company plc)
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/colifoam_10.html">
                                                                                                        Colifoam
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/coaprovel-150-125-mg-300-125-mg-and-300.html">
                                                                                                        CoAprovel 150 / 12.5 mg, 300 / 12.5 mg and 300 / 2...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/clopixol-conc-injection.html">
                                                                                                        Clopixol Conc Injection
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/co-codamol-eff.html">
                                                                                                        Co-Codamol eff.
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/co-dydramol-tablets-10-500mg-leaflet.html">
                                                                                                        Co-dydramol Tablets 10 / 500mg leaflet (Actavis UK...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/clotam-rapid.html">
                                                                                                        Clotam Rapid.
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/colifoam.html">
                                                                                                        Colifoam
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/clomethiazole-192-mg-capsules.html">
                                                                                                        Clomethiazole 192 mg Capsules
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/co-codamol-8-500-effervescent-tablets.html">
                                                                                                        Co-codamol 8 / 500 Effervescent Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/clopidogrel-75mg-film-coated-tablets.html">
                                                                                                        Clopidogrel 75mg Film-Coated Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/codeine-phosphate-syrup-bpc-1973.html">
                                                                                                        Codeine Phosphate Syrup BPC 1973
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/co-codamol-tablets-8-500mg-p.html">
                                                                                                        Co-codamol Tablets 8 / 500mg (P)
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cervarix.html">
                                                                                                        Cervarix
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/colomycin-injection.html">
                                                                                                        Colomycin Injection
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/calcough-six-plus-formerly-calcough.html">
                                                                                                        Calcough Six Plus (Formerly Calcough Chesty)
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cancidas-formerly-caspofungin-msd.html">
                                                                                                        CANCIDAS (formerly Caspofungin MSD)
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cancidas-70-mg-formerly-caspofungin-msd.html">
                                                                                                        CANCIDAS 70 mg (formerly Caspofungin MSD)
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/ciproxin-tablets-250mg.html">
                                                                                                        Ciproxin Tablets 250mg
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/chloromytol-05-w-v-eye-drops.html">
                                                                                                        Chloromytol 0.5% w / v Eye Drops
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/celsentri-150mg-film-coated-tablets.html">
                                                                                                        Celsentri 150mg film-coated tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cialis-10-mg-film-coated-tablets.html">
                                                                                                        Cialis 10 mg film-coated tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/clarithromycin-250mg-and-500mg-film.html">
                                                                                                        Clarithromycin 250mg and 500mg film-coated tablets...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cialis-5mg-film-coated-tablets.html">
                                                                                                        Cialis 5mg film-coated tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/chirocaine-75mg-ml-solution-for_6.html">
                                                                                                        Chirocaine 7.5mg / ml solution for injection / con...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/chlorhexidine-gluconate-antiseptic_27.html">
                                                                                                        CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH PEPPE...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/ciproxin-suspension.html">
                                                                                                        Ciproxin Suspension
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/citrafleet-powder-for-oral-solution.html">
                                                                                                        CitraFleet Powder for Oral Solution
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/citalopram-40-mg-tablets.html">
                                                                                                        Citalopram 40 mg Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cipramil-tablets_6.html">
                                                                                                        Cipramil Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/chloramphenicol-ophthalmic-ointment.html">
                                                                                                        Chloramphenicol Ophthalmic Ointment
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/chloraprep.html">
                                                                                                        ChloraPrep
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/chirocaine-75mg-ml-solution-for.html">
                                                                                                        Chirocaine 7.5mg / ml solution for injection / con...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cipramil-tablets.html">
                                                                                                        Cipramil Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/ciproxin-tablets-250mg-bayer-plc.html">
                                                                                                        Ciproxin Tablets 250mg (Bayer plc)
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/chlorpromazine-100mg-tablets.html">
                                                                                                        Chlorpromazine 100mg Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/chlorhexidine-gluconate-antiseptic_6.html">
                                                                                                        CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH ORIGI...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/ciprofibrate-100mg-tablets.html">
                                                                                                        Ciprofibrate 100mg Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/citalopram-40mg-tablets-sandoz-limited.html">
                                                                                                        Citalopram 40mg Tablets (Sandoz Limited )
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/chlorhexidine-gluconate-antiseptic.html">
                                                                                                        CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH PEPPE...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cimzia.html">
                                                                                                        Cimzia
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/citalopram-10mg-tablets-sandoz-limited.html">
                                                                                                        Citalopram 10mg Tablets (Sandoz Limited )
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/chlorphenamine-elixir-bp.html">
                                                                                                        Chlorphenamine Elixir BP
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cetraben-emollient-cream.html">
                                                                                                        Cetraben Emollient Cream
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cisplatin-50mg-freeze-dried-powder-for.html">
                                                                                                        Cisplatin 50mg Freeze Dried Powder for Injection
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/chirocaine-0625mg-ml-or-125mg-ml.html">
                                                                                                        Chirocaine 0.625mg / ml or 1.25mg / ml solution fo...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/celectol-200-tablets.html">
                                                                                                        Celectol 200 Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/celectol-400-tablets.html">
                                                                                                        Celectol 400 Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/casodex-50-mg-film-coated-tablets.html">
                                                                                                        Casodex 50 mg Film-coated Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/carboplatin-10mg-ml-concentrate-for.html">
                                                                                                        Carboplatin 10mg / ml concentrate for solution for...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cerazette-75-microgram-film-coated.html">
                                                                                                        Cerazette 75 microgram film-coated tablet
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/casodex-150-mg-film-coated-tablets.html">
                                                                                                        Casodex 150 mg Film-coated Tablets.
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cefalexin-250mg-tablets.html">
                                                                                                        Cefalexin 250mg Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cefalexin-250mg-capsules.html">
                                                                                                        Cefalexin 250mg Capsules
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cardioxane-500mg-powder-for-solution.html">
                                                                                                        Cardioxane 500mg powder for solution for infusion
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/carbo-dome-cream.html">
                                                                                                        Carbo-Dome Cream
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/care-chlorhexidine-digluconate-02-w-v_4.html">
                                                                                                        Care Chlorhexidine Digluconate 0.2% w / v Antisept...
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cefalexin-500mg-tablets.html">
                                                                                                        Cefalexin 500mg Tablets
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/catapres-tablets-300mcg.html">
                                                                                                        Catapres Tablets 300mcg
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cardene-sr-30-and-45mg.html">
                                                                                                        Cardene SR 30 and 45mg
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/care-antiseptic-first-aid-cream_4.html">
                                                                                                        Care Antiseptic First Aid Cream
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/ceanel-concentrate-ferndale.html">
                                                                                                        Ceanel Concentrate (Ferndale Pharmaceuticals Ltd)
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cardene-20-and-30mg.html">
                                                                                                        Cardene 20 and 30mg
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/cefalexin-500mg-capsules.html">
                                                                                                        Cefalexin 500mg Capsules
                                                                                                    </a>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <a href="https://articlesierraleone.blogspot.com/2016/10/carbimazole-20mg-archimedes-pharma-uk.html">
                                                                                                        Carbimazole 20mg (Archimedes Pharma UK Ltd)
                                                                                                    </a>
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