Bicalutamide 50mg Film-Coated Tablets.
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Package leaflet: Information for the user
BICALUTAMIDE 50 mg FILM-COATED TABLETS
Bicalutamide
Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Bicalutamide Tablets is and what it is used for
2. What you need to know before you take Bicalutamide Tablets
3. How to take Bicalutamide Tablets
4. Possible side effects
5. How to store Bicalutamide Tablets
6. Contents of the pack and other information
1. What Bicalutamide tablet is and what it is used for
Pharmacotherapeutic group: Hormone antagonists and related agents, anti-androgens.
Bicalutamide is used for the treatment of advanced prostatic carcinoma. It is taken together with a drug known as a luteinising hormone-releasing hormone (LHRH) analogue - an additional hormone treatment - or with accompanying surgical removal of the testicles. Bicalutamide is one of a group of medicines known as the non-steroidal antiandrogens. The active substance bicalutamide blocks the undesired effect of the male sex hormones (androgens) and inhibits cell growth in the prostate in this way.
2. What you need to know before you take Bicalutamide Tablets
Do not take Bicalutamide Tablets:
• If you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman, adolescent or child
• If you are taking of terfenadine or astemizole (for hay fever or allergy) or cisapride (for stomach disorders) with Bicalutamide Tablets 50mg.
Bicalutamide tablets must not be taken by woman or children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide tablets.
• If your liver functioning is moderately or severely impaired.
The drug should then only be taken after your doctor has carefully considered possible benefits and risks. If this is the case, your doctor will regularly performs tests of liver function (bilirubin, transaminases, alkaline phosphatase). If severe disturbances to liver function develop, treatment with bicalutamide should be discontinued.
• If your renal functions is severely impaired. The drug should then only be taken after your doctor has carefully considered possible benefits and risks.
• If you have diabetes and are already taking an ‘LHRH analogue’. These include goserelin, buserelin, leuprorelin and triptorelin.
Please tell your doctor if you have any of the following: Any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Bicalutamide tablets.
Other medicines and Bicalutamide tablets:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Bicalutamide tablets can affect the way other medicines work. Also some other medicines can affect the way Bicalutamide tablets works.
Do not take Bicalutamide tablets if you are already taking any of the following medicines:
• Cisapride (used for some types of indigestion).
• Certain anti-histamine medicines (terfenadine or astemizole).
Bicalutamide tablets might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs(e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
Also, tell your doctor or pharmacist if you are taking any of the following medicines:
- Medicines taken by mouth to prevent blood clots (oral anti-coagulants).
- Ciclosporin (to suppress your immune system)
- Cimetidine (to treat stomach problems)
- Ketoconazole (to treat infections caused by a fungus)
- Calcium channel blockers (to treat high blood pressure or some heart condition)
Driving and using machines:
Your medicine is unlikely to adversely affect the ability to drive a vehicle or to operate machinery. However, some people may occasionally feel dizzy or drowsy after taking Bicalutamide Tablets. If this happens to you, you should exercise caution when carrying out such tasks.
Bicalutamide Tablets contains lactose
Bicalutamide Tablets contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Bicalutamide Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The usual dosage of Bicalutamide tablets is one tablet daily. Swallow the tablet whole with a drink of water. Try to take your tablet at the same time each day.
If you take more Bicalutamide Tablets than you should
If you take more than prescribed dose, contact your doctor. In the case of an overdose, contact the nearest hospital immediately. If possible, take your tablets or the box with you to show the doctor what you have taken.
If you forget to take Bicalutamide Tablets
If you forget to take your medicine, take your dose when you remember and then take your next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop using Bicalutamide Tablets
Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
L
Allergic reactions:
These are uncommon (may affect up to 1 in 100 people).
• Rash, itching or hives on the skin.
• Swelling of the face, lips, tongue, throat or other parts of the body.
• Shortness of breath, wheezing or trouble breathing.
If this happens to you, see a doctor straight away.
Also tell your doctor straight away if you notice any of the following: Very common (may affect more than 1 in 10 people):
• Pain in your abdomen.
• Blood in your urine.
Common (may affect up to 1 in 10 people):
• 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.
Uncommon (may affect up to 1 in 100 people):
• 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’.
Not known (frequency cannot be estimated from the available data):
• Changes in ECG (QT prolongation).
Other possible side effects:
Very common (may affect more than 1 in 10 people)
• Low levels of red blood cells (anaemia). This may make you feel tired or look pale.
• Dizziness.
• Swelling and tenderness of your breasts.
• Enlargement of breast in men.
• Feeling weak.
• Hot flushes.
• Constipation.
• Feeling sick (nausea).
• Swelling.
Common (may affect up to 1 in 10 people)
• Loss of appetite.
• Indigestion.
• Wind (flatulence).
• Putting on weight.
• Itching.
• Dry skin.
• Skin rash.
• Problems getting an erection (erectile dysfunction).
• Reduced sex drive.
• Depression.
• Feeling sleepy.
• Hair loss.
• Hair re-growth or growth of extra hair.
• Chest pain.
• Reduced heart function.
• Heart attack.
Rare (may affect up to 1 in 1,000 people)
• Increased skin sensitivity to sunlight.
Your doctor may do blood tests to check for any changes to your blood. Do not be concerned by this list of possible side effects. You may not get any of them.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
For UK - You can also report side effects directly via the Yellow Card Scheme at:
For Ireland- You can also report side effects directly via HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
For Malta- ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GZR-1368 Gzira Website:
www.medicinesauthority. gov. mt e-mail:
postlicensing.medicinesauthority@gov
.mt
5. How to store Bicalutamide Tablets
• This medicinal product does not require any special storage conditions
• Keep out of the sight and reach of children.
• Do not use Bicalutamide Tablets after the expiry date which is stated on the Carton and blister (EXP). The expiry date refers to the last day of that month e.g. mm/yyyy.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Bicalutamide Tablets contains:
The active substance is Bicalutamide.
Each film-coated tablet contains 50mg of bicalutamide.
Excipients:
Tablet core:
lactose monohydrate
sodium starch glycolate (Type A)
povidone K-30
magnesium stearate.
Film coat:
Hypromellose E5 titanium dioxide E171 Macrogol 400.
What Bicalutamide Tablets looks like and content of the pack:
Bicalutamide 50 mg film-coated Tablet is a white to off white, round biconvex, film-coated tablets debossed ‘B 50’ on one side and plain on other side.
Bicalutamide 50 mg film-coated Tablets are packed in blisters in pack of 14, 20, 28, 30, 60, 84, 90, 98 or 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow,
Middlesex HA1 4HF,
United Kingdom
The leaflet was last revised in 10/2015.