Bicalutamide 50mg Film-Coated Tablets.
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.
• Keep this leaflet. You may need to read it again.
• Ifyouhave any further questions, ask your doctor or pharmacist.
• 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.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Bicalutamide 50 mg is and what it is used for
2. BeforeyoutakeBicalutamide50mg
3. How to take Bicalutamide 50 mg
4. Possible side effects
5. Howto store Bicalutamide 50 mg
6. Further information
1. WHAT BICALUTAMIDE 50 mg IS AND WHAT IT IS USED FOR
Bicalutamide 50 mg is used for the treatment of advanced prostate cancer. It is taken together with a drug known as an luteinising hormone-releasing hormone (LHRH) analogue which reduces the levels of androgens (male sex hormones) within the body, or with accompanying surgical removal of the testicles. The active ingredient of Bicalutamide 50 mg film-coated tablets, bicalutamide, belongs to a group of medicines called non-steroidal anti-androgens. It blocks the undesired effect of the male sex hormones (androgens) and inhibits cell growth in the prostate in this way.
2. BEFORE YOU TAKE BICALUTAMIDE 50 mg
Do not take Bicalutamide 50 mg
• if you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of Bicalutamide 50 mg film coated tablets
• if you are already taking terfenadine or astemizole (for hay fever or allergy), or cisapride (for stomach disorders).
Bicalutamide 50 mg should not be taken by women or must not be given to children or adolescents. Take special care with Bicalutamide 50 mg
• if your liver function 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 perform tests of liver function. If severe disturbances to liver function develop, treatment with Bicalutamide 50 mg should be discontinued.
• ifyour renal function is severely impaired. Thedrug should then only be taken after your doctor has carefully consideredpossible benefits andrisks.
• if you suffer from heart disease. If this is the case, your doctor should regularly monitor your heart function.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you take Bicalutamide 50 mg together with one of the following medicines, the effect of bicalutamide as well as the other medicine may be influenced. Please speak to your doctor before taking any of these medicines together with Bicalutamide 50 mg.
• warfarin or any similar medicine to prevent blood clots,
• terfenadine or astemizole (for hay fever or allergy),
• cisapride (for stomach disorders),
• ciclosporin (used to suppress your immune system to prevent and treat rejection of a transplanted organ or bone marrow),
• calcium channel blockers (used to treat high blood pressure or some heart conditions)
• cimetidine (used to treat stomach ulcers),
• ketoconazole (used to treat fungal infections of the skin andnails).”
Taking Bicalutamide 50 mg with food and drink
Bicalutamide 50 mg can be taken before, during or after a meal, but also you can take them without food. The film coated tablet should be swallowed with some water or another liquid.
Pregnancy and breast-feeding
Bicalutamide 50 mg is contra-indicated..in females and must not be given to pregnant or breast-feeding mothers.
Driving and using machines
Bicalutamide 50 mg is unlikely to adversely affect your ability to drive a car or to operate machinery. However, some people may occasionally feel dizzy or drowsy after taking Bicalutamide 50 mg. If this happens to you, you should exercise caution when carrying out such tasks._If you suffer from dizziness or drowsiness you would be best advised not to carry out such tasks. However if you still drive a car or use machines you should exercise extra caution.
Important information about some of the ingredients of Bicalutamide 50 mg film-coated tablets
Bicalutamide 50 mg film-coated tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor immediately.
3. HOW TO TAKE BICALUTAMIDE 50 mg
Always take Bicalutamide 50 mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one film coated tablet daily. It is better to take the film coated tablet at the same time every day. The film coated tablet should be swallowed with some water or another liquid without being chewed and can be taken with or without food.
Children and adolescents
This medicine is not recommended for patients under the age of 18 years.
If you take more Bicalutamide 50 mg than you should
If you take more than your normal dose, contact your doctor. In the case of an overdose, contact the nearest hospital immediately. If possible, take your film-coated tablets or the box with you to show the doctor what you have taken.
If you forget to take Bicalutamide 50 mg
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 dose. If you are worried, ask your doctor or pharmacist for advice.
If you stop taking Bicalutamide 50 mg
Do not stop taking your film coated tablets, even if you are feeling well, unless your doctor tells you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Bicalutamide 50 mg can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
Contact your doctor or seek medical help immediately if you experience any of the following serious
side effects
Very rare (estimated frequency is less than 1 person out of 10,000):
• Liver failure
• Chest pain (angina) and heart failure (which may be associated with breathlessness, especially on exertion, a fast heart beat, swelling in the limbs and mottling of the skin), irregular heart beat (arrythmia), abnormalECG heart tracing.
• Reduction in blood platelets which increases the risk of bleeding or bruising (thrombocytopenia).
Uncommon serious side effects (affecting less than 1 in 100 people):
• Serious allergic reaction which causes swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing or breathing or severe itching of the skin with raised lumps.
• Serious breathlessness, or sudden worsening of breathlessness, possibly with a cough or fever. Some patients taking Bicalutamide 50 mg get an inflammation of the lungs called interstitial lung disease.
The following side effects are possible for Bicalutamide 50 mg:
Side effects that are very common (estimated frequency is more than 1 person out of 10):
• tender or enlarged breast tissue; • hot flushes;
• impotence (erectile dysfunction), • reduced sex drive
Side effects that are common (estimated frequency is less than 1 person out of 10 but more than 1 out of
100):
• diarrhoea; • itching;
• feeling weak; • sleeplessness;
• having frequent loose or liquid bowel • liverchanges;
movements,
• chills;
• sweating;
• weight gain;
• dizziness;
• rash;
• excessive hair growth;
general pain and swelling; constipation;
reduction in red blood cells which can make the skin pale and cause weakness or breathlessness; pelvic pain; nausea;
diabetes mellitus
Side effects that are uncommon (estimated frequency is less than 1 person out of 100 but more than 1 out of 1,000):
indigestion; hair loss; allergic reactions;
or sudden worsening ofbreathlessness;
drowsiness;
blood in urine;
depression; weight loss; breathlessness; abdominal pain;
• hyperglycaemia (high blood sugar «
levels);
• which may cause difficulty in swallowing.
Rare side effects (estimated frequency is less than 1 person out of 1,000 but more than 1 out of 10,000): vomitting; dry skin
Occasionally, Bicalutamide 50 mg may be associated with changes in your blood which may require your doctor to do certain blood tests.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
needing to urinate during the night; inflammation of the lungs called interstitial lung disease; neck pain; dry mouth; anorexia;
severe itching of the skin (with raised lumps) or swelling of the face; tongue and/or throat;
5. HOW TO STORE BICALUTAMIDE 50 mg
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Bicalutamide 50 mg film-coated tablets after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Bicalutamide 50 mg film-coated tablets contain
• The active substance is bicalutamide. Each film-coated tablet contains 50mg bicalutamide.
The other ingredients are:
Tablet core:
Lactose monohydrate, Povidone K-25, Sodium starch glycolate Type A, Magnesium Stearate.
Film coating:
Opadry OY-S-9622 which contains Hypromellose 5cp (E464), Titanium dioxide (E171) and Propylene Glycol.
What Bicalutamide 50 mg looks like and contents of the pack
Bicalutamide 50 mg is supplied as white, round, biconvex film coated tablets.
The film coated tablets are packed in blister packs containing 28 tablets contained in a carton. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Generics (Europe) Ltd
Laxmi House, 2B Draycott Avenue Kenton, Middlesex, HA3 0BU, UK
Manufacturer
GenepharmS.A
lS^klmMarathonosAvenue, 153 51 PalliniAttikis, Greece
This medicinal product is authorised in the Member States of the EEA under the following names:
UK Bicalutamide 50 mg film-coated tablets
CZ,SK&PL Binabic50mg
HU Binabic50mgFilmtabletta
This leaflet was last approved in 10/2010.