The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Please click on the link to the left to view the PIL in PDF format.
Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: PL17780/0341.
Bicalutamide 150mg Film-coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
BICALUTAMIDE 150 MG FILM-COATED TABLETS
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 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
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 male sex hormones (androgens) 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BICALUTAMIDE
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 or 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 women and must not be given to pregnant women or breast-feeding mothers.
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.
3. HOW TO TAKE BICALUTAMIDE
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.
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.
4. POSSIBLE SIDE EFFECTS
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:
Common (may affect up to 1 in 10 people):
- Blood in urine
- Abdominal pain
- Yellow skin and eyes (jaundice). These may be symptoms of liver impairment.
Uncommon (may affect up to 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 with possible fatal outcome
Other possible side effects:
Very common side effects (may affect more than 1 in 10 people):
- Feeling weak
- Tender or enlarged breasts
Common side effects (may affect up to 1 in 10 people):
- Low levels of red blood cells (anaemia). This may make you feel tired or look pale
- Decreased appetite
- Sleepiness, dizziness.
- Hot flushes.
- Nausea (feeling sick), constipation (difficulty on passing stools), indigestion, flatulence (wind).
- Itching, dry skin, loss of hair or hair re-growth.
- Weight gain
- Reduced sex drive
- Chest pain, swelling
- Being unable to get an erection
- Changes in liver enzymes
- 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE BICALUTAMIDE
This medicinal product does not require any special storage conditions. Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
6. CONTENTS OF THE PACK AND OTHER 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.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
One Onslow Street
The Manufacturer is:
Microweg 22 - 6545
Polígono las Salinas
08830 Sant Boi de Llobregat
This leaflet was last revised in June 2013
The preparations being discontinued are:
- Bicalutamide 150mg tablets (Zentiva)
The pharmaceutical company has decided to discontinue the product and so it may not be available in the future. This document has been left on the eMC for information purposes.
One Onslow Street, Guildford, Surrey, GU1 4YS
+44 (0) 1483 554831
+44 (0)1483 505 515
+44 (0)845 372 7101