Bicalutamide 50 mg film-coated tablets

• 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.

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

• if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6)
• if you are already taking terfenadine or astemizole (for hay fever or allergy), or cisapride (for stomach disorders).

Bicalutamide should not be taken by women or must not be given to children and adolescents.

Talk to your doctor or pharmacist before taking Bicalutamide

• if you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Bicalutamide.
• if you are taking blood thinners or medicines to prevent blood clots
• if your liver function is moderately or severely impaired. The drug should then 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.
• if you have diabetes and are already taking an “LHRH analogue”. These include goserelin, buserelin, leuprorelin and triptorelin.
• if you have any questions about birth control. You and/or your partner should use birth control while you are taking Bicalutamide and for 130 days after stopping Bicalutamide.

Bicalutamide must not be given to children and adolescents.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 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 (for stomach disorders)
• terfenadine or astemizole (for hay fever or allergy).

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).

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 your immune system to prevent and treat rejection of a transplanted organ or bone marrow)
• calcium channel blockers (used to treat high blood pressure or some heart conditions)
• cimetidine (used to treat stomach ulcers)
• ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamide can be taken before, during or after a meal, but also you can take this medicine without food. The film coated tablet should be swallowed with some water or another liquid.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Bicalutamide is contraindicated in females and must not be given to pregnant women or breast-feeding mothers.

Bicalutamide may have an effect on male fertility which could be reversible.

Bicalutamide is unlikely to affect your ability to drive or to operate machinery. However, some people may occasionally feel drowsy when taking bicalutamide.

If you suffer from drowsiness you would be best advised not to carry out such tasks. However if you still drive a car or use machines you should exercise extra caution.

Avoid direct exposure to excessive sunlight or UV-light while you are taking Bicalutamide.

Bicalutamide 50 mg film-coated tablets contain lactose monohydrate, which is a type of sugar.

If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor immediately.

This medicine is not recommended for patients under the age of 18 years.

If you have taken too many tablets contact your doctor or the nearest hospital as soon as possible.

Take with you the remaining tablets or the pack so the doctor can identify what you have taken.

If you forget to take your daily dose, skip it when you remember it and then take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you are worried, ask your doctor or pharmacist for advice.

Do not stop taking your film-coated tablets even if you feel healthy unless so advised by your doctor.

These are uncommon (may affect up to 1 in 100 users). 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.

Very common (may affect more than 1 in 10 users)

• pain in your abdomen
• blood in your urine.

Common (may affect up to 1 in 10 users)

• yellowing of the skin or whites of your eyes (jaundice). These may be signs of liver problems or in rare cases (may affect up to 1 in 1,000 users) liver failure.

Uncommon (may affect up to 1 in 100 users)

• 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).

Very common (may affect more than 1 in 10 users)

• dizziness
• constipation
• feeling sick (nausea)
• swelling and tenderness of your breasts
• hot flushes
• feeling weak
• swelling
• low levels of red blood cells (anaemia). This may make you feel tired and or look pale.

Common (may affect up to 1 in 10 users)

• 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 users)

• increased skin sensitivity to sunlight.

Your doctor may do blood tests to check for any changes to your blood.

Do not be concerned by this list of possible side effects. You may not get any of them.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is bicalutamide. Each film-coated tablet contains 50 mg bicalutamide.
• The other ingredients are:
  Tablet core: lactose monohydrate, magnesium stearate, sodium starch glycolate Type A, povidone.
  Film coating: opadry II white (33F28627) containing hypromellose 6CP (E464), titanium dioxide (E171), macrogol 3000.

Bicalutamide 50 mg film-coated tablet is a white to off white, circular, biconvex, film-coated tablet debossed with ‘485’ on one side and plain on the other side, and contains 50 mg bicalutamide.

Bicalutamide 50 mg film-coated tablets are available in packs of 28, 30 and 84 tablets.

Not all pack sizes may be marketed.