BICALUTAMIDE 50 MG FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this medicine.
- 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. 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 get 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 is and what it is used for
- 2. Before you take bicalutamide
- 3. How to take bicalutamide
- 4. Possible side effects
- 5. How to store bicalutamide
- 6. Further information
What Bicalutamide Is And What It Is Used For
Bicalutamide 50mg Film-coated Tablets (called bicalutamide throughout this leaflet) are used for the treatment of advanced prostate carcinoma. It is taken together with a drug known as a Luteinising Hormone-Releasing Hormone (LHRH) analogue - an additional hormone treatment - or with surgical removal of the testicles.
Bicalutamide is one of a group of medicines known as the non-steroidal anti-androgens. The active substance bicalutamide blocks the undesired effect of the male sex hormones (androgens) and inhibits cell growth in the prostate.
In a daily dose of 50 mg:
It is used in combination with other treatments such as drugs that reduce the androgen levels in the body.
Before You Take Bicalutamide
Do not take bicalutamide:
- if you are allergic (hypersensitive) to bicalutamide or any of the other ingredients
- if you take terfenadine (for hay fever or allergy), astemizole (for hay fever or allergy) or cisapride (for stomach problems)
- Bicalutamide should not be given to women, including pregnant women or nursing mothers, or to children or adolescents.
Take special care with bicalutamide:
- if your liver is moderately or severely impaired. The drug should 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 (bilirubin, transaminases, alkaline phosphatase). If severe disturbances to liver function develop, treatment with bicalutamide should be discontinued.
- If your renal function is severely impaired. The drug should only be taken after your doctor has carefully considered possible benefits and risks.
- 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.
Do not take bicalutamide with any of the following medicines:
- terfenadine or astemizole (for hay fever or allergy)
- cisapride (for stomach problems)
If you take bicalutamide together with any 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:
- warfarin or any similar medicine to prevent blood clots
- ciclosporin (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow)
- cimetidine (to treat stomach ulcers)
- ketoconazole (used to treat fungal infections of the skin and nails)
- calcium channel blockers (to treat high blood pressure)
Taking bicalutamide with food and drink
Take one bicalutamide tablet, preferable at the same time of the day with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Bicalutamide is contra-indicated in females and must not be given to pregnant women or breast-feeding mothers.
Women should not take bicalutamide.
Bicalutamide may induce a period of sub-fertility or infertility in men.
Driving and using machines
There is a possibility that these tablets could make you feel dizzy or drowsy. If you are affected in this way, you should not drive or operate machinery.
Important information about some of the ingredients of bicalutamide
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How To Take Bicalutamide
Always take bicalutamide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The doctor prescribes an appropriate dosage for you personally. The usual dosage is one tablet daily. Read the instruction label on the package.
Tablets are swallowed whole with some liquid. Try to take the tablet at approximately the same time each day.
Do not stop taking your tablets even if you are feeling well, unless your doctor tells you.
If you take more bicalutamide than you should
If you have taken too many tablets, contact your doctor or the nearest hospital as soon as possible. Take the remaining tablets or the pack with you so the doctor can identify what you have taken.
If you forget to take bicalutamide
If you forget to take your daily dose, skip the missed dose and wait until the next administration time. Do not take a double dose to make up for a forgotten dose.
If you stop taking bicalutamide
Do not stop using the drug even if you feel healthy unless advised to do so by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, bicalutamide can cause side effects, although not everybody gets them.
You should contact your doctor straight away if you notice any of the following serious side effects:
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 get an inflammation of the lungs called interstitial lung disease.
Rare serious side effects (affecting less than 1 out of 1,000 people):
- Yellowing of the skin or whites of the eyes caused by liver problems (including liver failure).
Other side effects:
Tell your doctor if any of the following side effects bother you:
Very common side effects (affecting more than 1 in 10 people):
- tender or enlarged breast tissue
- reduced sexual desire, erection problems, impotence
- hot flushes
Common side effects (affecting less than 1 in 10 people):
- nausea (feeling sick)
- diarrhoea or constipation
- dizziness
- difficulty in sleeping
- skin rash, itching, sweating, excessive body hair
- feeling weak
- weight gain
- diabetes mellitus
- oedema
- general pain, pelvic pain
- chills
- blood tests which show changes in the way the liver is working
- reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
Uncommon side effects (affecting less than 1 in 100 people):
- loss of appetite, weight loss
- depression
- high blood sugar
- drowsiness
- shortness of breath
- dry mouth, indigestion, flatulence (wind)
- hair loss
- needing to urinate during the night, blood in the urine
- abdominal pain, chest pain, headache, back pain, neck pain
Rare side effects (affecting less than 1 in 1000 people):
- vomiting
- dry skin
Very rare side effects (affecting less than 1 in 10,000 people):
- chest pain 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, abnormal ECG heart tracing.
- reduction in blood platelets which increases risk of bleeding or bruising
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.
How To Store Bicalutamide
Bicalutamide does not require any special storage conditions. Store in the original package.
Keep out of the reach and sight of children.
Do not use bicalutamide after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not use if you notice some visible signs of medicine deterioration.
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.
Further Information
What Bicalutamide 50mg film-coated tablets contain:
- the active substance is bicalutamide. Each tablet contains 50mg bicalutamide
- the other ingredients are lactose monohydrate, povidone K-29/32, crospovidone Type A, sodium lauryl sulphate, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 4000.
What Bicalutamide 50mg film-coated tablets look like and contents of the pack
White, round, biconvex film-coated tablets with "BCM 50" in one side.
Each pack contains 28 film-coated tablets in a blister pack.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
The Manufacturer is:
or
This leaflet was last revised in December 2008
169631/2/1
Laetus 110
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