POM: Prescription only medicine
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.
Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL17780/0340.
Bicalutamide 50mg Film-coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
BICALUTAMIDE 50 MG FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BICALUTAMIDE
Do not take bicalutamide:
Warnings and precautions
Talk to your doctor or pharmacist before taking bicalutamide
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:
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:
Taking 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 been told by your doctor that 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 product 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:
Uncommon serious side effects (may affect up to 1 in 100 people):
Serious allergic reaction which causes:
If this happens to you, see a doctor straight away.
Also tell your doctor straightaway if you notice any of the following side effects:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Other possible side effects:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Your doctor may do blood tests to check for any changes to your blood.
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 50mg film-coated tablets contain:
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:
This leaflet was last revised in June 2013
169631-05 - Laetus 1321
One Onslow Street, Guildford, Surrey, GU1 4YS
+44 (0) 1483 554831
+44 (0)1483 505 515
+44 (0)845 372 7101