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Package leaflet: Information for the patient

Bicalutamide 50 mg film-coated tablets

(bicalutamide)

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

Your medicine contains the active ingredient bicalutamide. Bicalutamide is a non-steroidal antiandrogen which blocks the actions of Androgen (male sex hormone) released naturally in your body.

Bicalutamide can help treat cancer of the prostate gland when you are also receiving another medicine by injection (a luteinizing hormonereleasing hormone (LHRH) agonist such as goserelin, buserelin, leuprorelin or triptorelin), or if you have had your testes removed (castrated).

2. What you need to know before you take Bicalutamide

Do not take Bicalutamide:

•    if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in Section 6).

•    if you are already taking other medicines such as certain antihistamines (terfenadine, astemizole) or cisapride (for some types of indigestion).

•    if you are a woman, child or adolescent, as bicalutamide treats a condition found only in men.

Warnings and precautions

Talk to your doctor or pharmacist before

using Bicalutamide:

•    if you have liver problems

•    if you have diabetes, or at risk of developing diabetes (for example your doctor has told you that you have raised levels of sugar in the blood after you have eaten). If you take bicalutamide whilst you also receive an LHRH agonist

(such as goserelin, buserelin, leuprorelin and triptorelin) your blood sugar levels may increase. Therefore, your blood glucose level may need to be closely monitored.

•    if you have 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.

Other medicines and Bicalutamide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Do not take Bicalutamide if you are already taking any of the following medicines:

•    Cisapride (used for some types of indigestion).

•    Certain antihistamine medicines (terfenadine or astemizole).

Tell your doctor or pharmacist if you are taking any of the following medicines:

•    Cimetidine (for heartburn or gut ulcers).

•    Ketoconazole (anti-fungal medicine).

•    Ciclosporin (to supress your immune system). Your doctor may want to monitor you when you start or stop the treatment with bicalutamide.

•    Medicines taken to prevent blood clots (oral anticoagulants e.g. warfarin) Your doctor may do blood tests before and during your treatment with bicalutamide

•    Calcium channel blockers (to treat high blood pressure or some heart conditions).

•    Midazolam (which may be used in people with severe epileptic fits, during surgery, or to help people relax and sleep).

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).

Pregnancy and breastfeeding

Do not take bicalutamide if you are a woman. Bicalutamide should not be given to pregnant women or breast feeding mothers.

Driving and using machines

Bicalutamide should not affect your ability to drive or use tools or machinery. However, some people may occasionally feel sleepy while taking bicalutamide. If bicalutamide does make you feel sleepy, do not drive or use machines.

Bicalutamide contains lactose monohydrate.

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.

•    Take the tablets with a glass of water.

•    Do not chew the tablets.

•    Try to take them at the same time each day.

Adults (including older people)

The recommended dose is one tablet daily, with or without food.

Use in children and adolescents

Do not give bicalutamide to children and adolescents.

Patients with liver problems

If you have liver problems your doctor will arrange for you to have regular blood tests.

If you take more Bicalutamide than you should

If you take too much of your medicine, tell your doctor immediately or go to your nearest casualty department.

If you forget to take Bicalutamide

Take it as soon as you remember unless it is almost time for your next dose. If this happens, skip the missed dose and take the next dose on time. Do not take a double dose (two doses at the same time) to make up for a forgotten tablet.

If you stop taking Bicalutamide

Do not stop taking this medicine, even if you are feeling well, unless your doctor tells you to.

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.

Serious side effects

Tell your doctor straight away or go to your nearest hospital casualty department right away if you have any of the following side effects:

•    heart attack (symptoms include chest pain which can feel as if it is travelling to other parts of your body such as the left arm, jaw and neck, shortness of breath, and anxiety). This may affect up to 1 in 10 people

•    swelling of the lips, tongue, throat or face or difficulty breathing or swallowing, or a rash, swollen itchy skin. You may be allergic to this medicine. These effects are uncommon (may affect up to 1 in 100 people).

Also tell your doctor straight away if you notice any of the following:

•    heart failure (reduced heart function with shortness of breath, swelling of the feet or legs due to fluid build-up). This may affect up to 1 in 10 people

•    yellowing of the skin or whites of your eyes (jaundice), dark urine. These may be signs of liver problems (common side effects, may affect up to 1 in 10 people) or in rare cases (may affect up to 1 in 1,000 people) liver failure.

•    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'. These effects are uncommon (may affect up to 1 in 100 people).

•    changes in the electrical activity of the heart (which may show up in tests which show how the heart is working known as "ECG" tests). The frequency cannot be estimated from the available data.

Other side effects:

Very common side effects (may affect more than 1 in 10 people) include:

•    enlarged or tender breasts

•    dizziness

•    stomach pain or discomfort

•    constipation difficulty or delay in emptying bowels

•    nausea (feeling sick)

•    blood in the urine

•    feeling weak

•    oedema (swelling of the face, hands or feet)

•    anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness), hot flushes

Common side effects (may affect up to 1 in

10 patients) include:

•    lack of appetite

•    lack of sex drive

•    inability to get or maintain an erection

•    feeling depressed

•    sleepiness

•    indigestion

•    flatulence (wind)

•    hair loss

•    hair re-growth or excessive growth of hair

•    rash

•    dry or itchy skin

•    weight gain

•    raised liver enzyme levels in the blood

•    chest pain

Heart failure and heart attacks have been reported in clinical trials with patients taking bicalutamide whilst also receiving an LHRH agonist (such as goserelin, buserelin, leuprorelin and triptorelin ), but not in patients taking bicalutamide alone. Therefore, it is not known if these events are caused by bicalutamide alone.

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

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 after "EXP". The expiry date refers to the last day of that month.

Store below 30°C.

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 to protect the environment.

6.    Contents of the pack and other information

What Bicalutamide film-coated tablets contain -

•    The active substance is bicalutamide.

•    The other ingredients are lactose monohydrate, povidone, sodium starch glycolate and magnesium stearate in the tablet core. The tablet coating contains lactose monohydrate, hypromellose (E464), titanium dioxide (E171) and triacetin.

What Bicalutamide film-coated tablets looks like and contents of the pack

The tablets are white, round and marked 'BIC 50' on one side and 'G' on the other.

Bicalutamide film-coated tablets are available in blister packs of 28, 30, 40, 90 and 100 tablets, and plastic bottles of 28, 30, 100, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire EN6 1TL, United Kingdom

Manufacturer

Generics [UK] Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Delpharm Lille SAS, ZI de Roubaix Est, Rue de Toufflers, 59390 Lys-lez-Lannoy, France

This leaflet was last revised in November 2014

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