Bicalutamide 150mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
What is in this leaflet:
1. What bicalutamide is and what it is used for
2. What you need to know before you take bicalutamide
3. How to take bicalutamide
4. Possible side effects
5. How to store bicalutamide
6. Contents of the pack and other information
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.
Do not take bicalutamide
• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
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.
Other medicines and bicalutamide
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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)
Bicalutamide with food, drink and alcohol
Take one bicalutamide tablet, preferably at the same time of the day with or without food.
Pregnancy, breast-feeding and fertility
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.
This product contains lactose.
If you have an intolerance to some sugars, contact your doctor before taking this medicine.
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 doctor prescribes an appropriate dosage for you personally. The recommended 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 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 medicine, ask your doctor or pharmacist.
Like all medicines, this medicine 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, may affect up to 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, may affect up to 1 in 100 people)
• Blood in urine (common, may affect up to 1 in 10 people)
• Abdominal pain (common, may affect up to 1 in 10 people)
• Yellow skin and eyes (jaundice). These may be symptoms of liver impairment. (common, may affect up to 1 in 10 people)
Tell your doctor if any of the following side effects bother you:
Very common side effects (may affect more than 1 in 10 people):
• Rash
• Feeling weak
• Tender or enlarged breast tissue
Common side effects (may affect up to 1 in 10 people):
• Weight gain
• Anaemia (change in the number of red blood cells with signs such as malaise, white colour of the skin, sleepiness etc.)
• Dizziness, sleepiness
• Constipation (difficulty on passing stools), indigestion, flatulence (wind), nausea (feeling sick)
• Loss of hair or hair re-growth or growth of extra hair, dry skin, itching
• Loss of appetite
• Hot flush
• Chest pain, oedema
• Changes in liver enzymes
• Being unable to get an erection
• Reduced sex drive, depression
Rare side effects (may affect up to 1 in 1000 people):
• Hepatic failure
Occasionally bicalutamide may be associated with changes in your blood, which may require your doctor to do certain blood tests.
Bicalutamide does not require any special storage conditions. Keep this medicine out of the sight and reach of children.
Do not use bicalutamide after the expiry date which is stated on the carton (EXP). The expiry date refers to the last day of that month.
Do not use if you notice some visible signs of medicine deterioration.
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.
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.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
The Manufacturer is: Synthon BV., Microweg 22 - 6545 cm Nijmegen, The Netherlands or Synthon Hispania S.L., C/Castello 1, Polfgono las Salinas, 08830 Sant Boi de Llobregat (Barcelona), Spain
This leaflet was last revised in July 2012.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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