Bicalutamide 150 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Bicalutamide 150 mg Film-coated Tablets
(Bicalutamide)
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 gets 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
1. WHAT BICALUTAMIDE IS AND WHAT IT IS USED FOR
The name of your medicine is Bicalutamide 150 mg Film-coated Tablets. Bicalutamide tablets are film-coated and contain the active ingredient bicalutamide. Each tablet contains 150 milligrams of bicalutamide.
Bicalutamide is one of a group of medicines called anti-androgens. It works by blocking the effects of male hormones such as testosterone.
Bicalutamide is used in adult men for the treatment of prostate cancer without metastases, when castration or other types of treatment are not indicated or unacceptable.
It may be used in combination with radiotherapy or prostate surgery in early treatment programmes.
2. BEFORE YOU TAKE BICALUTAMIDE Do not take Bicalutamide if:
• if you have ever had an allergic reaction to bicalutamide or any of the other ingredients of this medicine (section 6)
• if you are already taking a medicine called cisapride or certain anti-histamine medicines (terfenadine or astemizole)
• if you are a woman or a child
Take special care with Bicalutamide
Please tell your doctor if you are suffering from any disorder or disease which affects your liver Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
• In particular, are you taking oral anti-coagulants (to prevent blood clots), some anti-histamines (terfenadine or astemizole), cisapride (for some types of indigestion), ciclosporin (to suppress your immune system) or calcium channel blockers (to treat high blood pressure or some heart conditions)? If so, tell your doctor.
• If you go into hospital, let the medical staff know you are taking Bicalutamide.
Pregnancy and breast-feeding
Bicalutamide must not be taken by women, including pregnant women or mothers who are breast-feeding their babies. Driving and using machines
Your medicine is unlikely to affect your ability to drive or to operate machinery. However, some people may occasionally feel drowsy when taking Bicalutamide. If this happens, you should exercise caution when carrying out such tasks.
Important information about some of the ingredients of Bicalutamide
This medicinal 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 Bicalutamide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• The usual dose for an adult is one tablet daily.
• Swallow the tablet whole with a drink of water.
• Try to take your tablet at the same time each day.
• Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you to.
If you take more Bicalutamide than you should
If you take more Bicalutamide than prescribed, contact your doctor or go to the nearest hospital immediately.
If you forget to take Bicalutamide:
• take it as soon as you remember.
• do not take a double dose to make up for a forgotten dose. If you are worried, ask your doctor or pharmacist for advice. If you have any further questions on the use of this product, ask your doctor or pharmacist.
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Like all medicines, Bicalutamide can cause side effects, although not everybody gets them.
Contact your doctor or seek medical help immediately, if you experience any of the following:
Common side effects (affects less than 1 in 10 people):
• Pain in your abdomen
• Blood in your urine
• yellowing of the skin or white of your eyes (jaundice), these may be signs of liver problems Uncommon side effects (affects less than 1 in 100 people):
• serious breathlessness or sudden worsening of breathlessness, possibly with a cough or fever.These may be inflammation of the lungs called interstitial lung disease
• serious allergic reactions which causes severe itching of the skin (with raised lumps), rash or swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing or breathing
Other possible side effects:
Tell your doctor if any of the following side effects bother you.
Very common (affects more than 1 in 10 people):
• tender or enlarged breast tissue
• rash
• feeling weak
Common (affects less than 1 in 10 people):
• low levels of red blood cells (anaemia), this may
• being unable to get an erection (impotence) •
make you feel tired or sleepiness, dizziness constipation itching weight gain chest pain, oedema
look pale
• hot flushes
• indigestion
• dry skin
• reduced sex drive, depression
Rare (affects less than 1 in 10,000 people)
• liver 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.
Do not be concerned by this list of possible events. You may not have any of them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not take Bicalutamide after the expiry date which is stated on the container after “EXP”. The expiry date refers to the last day of that month.
Store below 30°C.
Keep your tablets in the original package they came in.
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 contains
• The active substance is bicalutamide. Each tablet contains 150 mg of bicalutamide.
• The other ingredients are lactose monohydrate, maize starch, crospovidone, povidone, sodium lauryl sulphate, colloidal anhydrous silica, magnesium stearate,
• The film coat contains hydroxypropyl methyl cellulose, titanium dioxide (E171), polyethylene glycol 400.
What Bicalutamide looks like and contents of the pack
Bicalutamide 150 mg Film-coated tablets are white to off white, circular, biconvex film coated tablets with B150 on one side and plain on the other side.They are available in packs of 10,20,30,40,50,80,90,100,200 or 14,28,56,84,140 and 280 tablets.
Bicalutamide tablets are also available as 50 mg tablets in packs of 14 or 28 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
APTIL Pharma Limited,
9th floor, CP. House, 97-107 Uxbridge Road, Ealing, London W5 5TL Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL
