Bicalutamide 50mg Film-Coated Tablets.
Package leaflet: Information for the user Bicalutamide 50 mg film-coated tablets (Bicalutamide)
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
This medicine contains a medicine called bicalutamide. This belongs to a group of medicines called ‘anti-androgens'.
• This medicine is used to treat prostate cancer.
• It works by blocking the effects of male hormones such as testosterone.
2. What you need to know before you take Bicalutamide Do not take Bicalutamide
• if you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of this medicine (listed in 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
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bicalutamide.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide if:
• you have liver problems
• you have diabetes and are already taking an ‘LHRH analogue'. These include goserelin, buserelin, leuprorelin and triptorelin. In this case, your blood sugar (blood glucose) control may get affected.
• you have any of the following: any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Bicalutamide.
• you go into hospital, tell the medical staff that you are taking Bicalutamide.
Other medicines and Bicalutamide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Bicalutamide can affect the way other medicines work. Also some other medicines can affect the way Bicalutamide works.
Do not take Bicalutamide if you are already taking any of the following medicines:
• Cisapride (used for some types of indigestion).
• Certain anti-histamine medicines (terfenadine or astemizole).
Bicalutamide might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
Also, tell your doctor or pharmacist if you are taking any of the following medicines:
• Medicines taken by mouth to prevent blood clots (oral anti-coagulants).
• Ciclosporin (to suppress your immune system).
• Calcium channel blockers (to treat high blood pressure or some heart conditions).
• Cimetidine (for stomach problems).
• Ketoconazole (to treat infections caused by a fungus).
Pregnancy and breast-feeding
This medicine 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.
Sunlight or Ultraviolet (UV) light
Avoid direct exposure to excessive sunlight or UV-light while you are taking Bicalutamide.
Bicalutamide tablet 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 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
• If you forget to take a dose, skip the missed dose and take the next dose as usual.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
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.
Allergic reactions
These are uncommon (may affect up to 1 in 100 people):
The symptoms can include sudden onset of:
- Rash, itching or hives on the skin.
- Swelling of the face, lips, tongue, throat or other parts of the body.
- Shortness of breath, wheezing or trouble breathing.
If this happens to you, see a doctor straight away.
Also tell your doctor straight away if you notice any of the following:
Very common side effects (may affect more than 1 in 10 people)
• pain in your abdomen
• blood in your urine
Common side effects (may affect up to 1 in 10 people)
• yellowing of the skin or white of your eyes (jaundice), these may be signs of liver problems or in rare cases (may affect up to 1 in 1,000 people) liver failure.
Uncommon side effects (may affect up to 1 in 100 people)
• Serious shortness of breath or shortness of breath which suddenly gets worse. This may be with a cough or high temperature (fever). These may be signs of an inflammation of the lungs called ‘interstitial lung disease'.
Not known (frequency cannot be estimated from the available data):
• Changes in ECG (QT prolongation).
Other possible side effects
Tell your doctor if any of the following side effects bother you.
Very common (may affect more than 1 in 10 people)
• dizziness
• constipation
• feeling sick (nausea)
• swelling and tenderness of your breasts
• hot flushes
• feeling weak
• swelling of hands feet, arms or legs (oedema)
• low levels of red blood cells (anaemia), this may make you feel tired or look pale
Common (may affect up to 1 in 10 people)
• loss of appetite
• reduced sex drive
• depression
• feeling sleepy
• indigestion
• wind (flatulence)
• hair loss
• hair re-growth or growth of extra hair
• dry skin
• itching
• skin rash
• being unable to get an erection (impotence)
• weight gain
• chest pain
• reduced heart function
• heart attack
Rare (may affect up to 1 in 1000 people)
• liver failure with possible fatal outcome
• Increased skin sensitivity to sunlight
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 effects. You may not have any of them.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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
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 after “EXP”. The expiry date refers to the last day of that month.
Store below 25°C.
Store in original package
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 contains
• The active substance is bicalutamide. Each tablet contains 50 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 50 mg Film-coated tablets are white to off-white circular biconvex, film-coated tablet debossed with “50” on one side and plain on other side. They are available in packs of 14 or 28 tablets.
Bicalutamide tablets are also available as 150 mg tablets in packs of 10, 20, 30, 40, 50, 80, 90, 100, 200 or 14, 28, 56, 84, 140 and 280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom Manufacturer:
Cipla (EU) Limited, 20 Balderton Street, London, W1K 6TL, United Kingdom.
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium This leaflet was last revised in 05/2015.
