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<span>
Tuesday, October 11, 2016
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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>
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<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 – 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° 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>
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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>
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<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>
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<br>
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<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 ‘anti-androgens’.
</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 ‘LHRH analogue’. 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 ‘interstitial lung disease’.
</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°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>
© 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>
</div>
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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>
®
</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>
<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>
<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>
<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>
<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>
</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>
</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>
</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>
</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>
</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>
</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>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°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>
<br>
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<a href="https://articlesierraleone.blogspot.com/2016/10/cetirizine-hydrochloride-10mg-tablets.html">
Cetirizine Hydrochloride 10mg Tablets
</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>
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 (½ 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 (½ 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 25ºC. 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">
</div>
</div>
<div class="post-body entry-content" id="post-body-3064655417015960341" itemprop="description articleBody">
<div class="contentBox">
<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 Irún
</div>
<br>
<div class="addressElement">
Km. 26,200
</div>
<br>
<div class="addressElement">
San Sebastián 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 °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>
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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 & 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 & 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°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 & 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>
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<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>
<div class="post-header">
<div class="post-header-line-1">
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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°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>
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