Bicalutamide
Bicalutamide 150mg Film-coated Tablets
1. What Bicalutamide is and what it is used for
Bicalutamide 150mg Film-coated Tablets (called Bicalutamide throughout this leaflet) belong to a group of
medicines called anti-androgens. Anti-androgens act against the effects of androgens (male sex hormones) in the body.
Bicalutamide is used in adult men for the treatment of prostate cancer without metastases, when castration or
other types of treatment are not appropriate or acceptable.
It may be used in combination with radiotherapy or prostate surgery in early treatment programmes.
2. Before you take Bicaltumide
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 the 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.
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 together with any of the following medicines:
• terfenadine or astemizole (for hay fever or allergy)
• cisapride (for stomach problems)
If you take Bicalutamide 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:
• 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, preferably 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 your doctor tells you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Bicaltumide
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.
- 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 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.
4. 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:
• 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 (uncommon, affecting less than 1 in 100 people)
• 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 with possible fatal outcome (uncommon, affecting less than 1 in 100 people)
• Blood in urine (common, affecting less than 1 in 10 people)
• Abdominal pain (common, affecting less than 1 in 10 people)
• Yellow skin and eyes (jaundice). These may be symptoms of liver impairment (common, affecting less than 1 in 10 people)
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
• rash
• feeling weak
Common side effects (affecting less than 1 in 10 people):
• anaemia (change in the number of red blood cells with signs such as malaise, white colour of the skin, sleepiness etc.)
• loss of appetite
• sleepiness, dizziness
• hot flushes
• nausea (feeling sick), constipation (difficulty on passing stools), indigestion, flatulence (wind)
• itching
• dry skin, loss of hair or hair regrowth
• weight gain
• reduced sex drive, depression
• impotence (difficulty in getting or keeping an erection, or in ejaculating)
• chest pain, oedema
Rare side effects (affecting less than 1 in 1000 people):
• hepatic failure with possible fatal outcome
Occasionally Bicalutamide may be associated with changes in your blood, which may require your doctor to do certain blood tests.
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.
5. 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.
6. Further information
What Bicalutamide 150mg film-coated tablets contain
• the active substance is Bicalutamide. Each tablet contains 150mg 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 150mg film-coated tablets look like and contents of the pack
White, round, biconvex film-coated tablets with “BCM 150″ in one side.
Each pack contains 28 film-coated tablets in a blister pack.
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