Document: leaflet ACTAVIS_PL 14048-0022 change

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Bicalutamide 50 mg, film-coated tablet

bicalutamide

What is in this leaflet:

1.    What Bicalutamide 50 mg is and what it is used for

2.    What you need to know before you take Bicalutamide 50 mg

3.    How to take Bicalutamide 50 mg

4.    Possible side effects

5.    How to store Bicalutamide 50 mg

6.    Contents of the pack and other information

1.    What Bicalutamide 50 mg is and what it is used for

Bicalutamide is an antiandrogen. This means it blocks the actions of male hormones (androgens) in the body. It also reduces the amount of male hormones made in the body.

Bicalutamide Synthon 50 mg is used in adult men to treat prostate cancer if you are also taking medicines called luteinising hormone-releasing hormone (LHRH)-analogues e.g. gonadorelin or have had or will soon have a surgical castration.

2.    What you need to know before you take Bicalutamide 50 mg

Do not take Bicalutamide Synthon 50 mg

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

•    if you are female

•    if the tablets are to be given to a child

•    if you are taking terfenadine or astemizole which are used to treat allergies or cisapride which is used to treat heartburn and acid reflux.

Warning and precautions

Take special care with Bicalutamide 50 mg

•    if you have a liver disease. Your doctor may decide to do blood tests to check your liver is working properly while you are taking this medicine.

•    if you have diabetes. Treatment with bicalutamide in combination with luteinising hormonereleasing hormone (LHRH) analogues may alter your blood sugar level. Your dosage of insulin and/or oral antidiabetic medicines may need to be adjusted.

If any of these apply to you and you have not already discussed these with your doctor, talk to your doctor or pharmacist before taking these tablets.

Other medicines and Bicalutamide 50 mg

Other medicines may be affected by bicalutamide. They, in turn, may affect how well bicalutamide works. Bicalutamide can interact with:

AAAE5568

•    Cyclosporin (used to supress the immune system to prevent and treat rejection of a transplanted organ or bone marrow). This is because bicalutamide may increase the concentration of a substance called creatinine in your plasma and your doctor may take blood samples to monitor this.

•    Midazolam (a medicine which is used to relieve anxiety before surgery or certain procedures or as an anaesthetic before and during surgery). You must tell your doctor or dentist you are taking bicalutamide if you need an operation or are very anxious in hospital.

•    Terfenadine or astemizole which are used to treat allergies or cisapride which is used to treat heartburn and acid reflux (See section 2, Do not take Bicalutamide Synthon 50 mg).

•    a type of medicine called a calcium channel blocker e.g. diltiazem or verapamil. These are used to treat heart problems, angina and high blood pressure.

•    medicines to thin your blood e.g. warfarin.

•    Cimetidine for acid reflux or stomach ulcers, or ketoconazole an antifungal medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take of the medicines listed above or any other medicines.

Bicalutamide 50 mg with food and drink

The tablets do not need to be taken with food but must be swallowed whole with a glass of water.

Pregnancy and breast-feeding

This medicine must never be taken by women.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine should not affect your ability to drive or use machines however some people may feel sleepy while taking this medicine. If you think your medicine is making you feel sleepy you must talk to your doctor or pharmacist before driving or using machines.

Important information about the ingredients of Bicalutamide Synthon 50 mg

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Bicalutamide Synthon 50 mg

Always take this medicine exactly as your doctor has told you. Check with your pharmacist if you are not sure.

The recommended dose of this medicine is one tablet, once a day. This must be swallowed whole with a glass of water. Try to take the medicinal product approximately at the same time each day.

You should start taking these tablets at least 3 days before starting treatment with LHRH analogues e.g. gonadorelin, or at the same time as undergoing surgical castration.

If you take more Bicalutamide Synthon 50 mg than you should

If you think that you may have taken more tablets than you should, 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. He or she may decide to monitor your body function until the effects of bicalutamide have worn off.

If you forget to take Bicalutamide Synthon 50 mg If you think that you may have missed a dose of bicalutamide talk to your doctor or pharmacist. Do not take a double dose to make up for a forgotten	5. How to store Bicalutamide 50 mg Keep this medicine out of the sight and reach of children.
dose. Just take the normal dose at the usual time. If you stop taking Bicalutamide Synthon 50 mg Do not stop taking this medicine even if you are feeling well unless your doctor tells you to.	Do not use this medicine after the expiry date stated on the blister and carton after 'EXP' The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.
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.	This medicinal product does not require any special storage condition. 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.
If you get any of the following symptoms tell your doctor immediately or go to the casualty department at your nearest hospital. These are very serious side effects. •    Skin rash, itching, hives, peeling, blistering or crusting of the skin •    Swelling of the face or neck, lips, tongue or throat which may cause difficulty in breathing or swallowing •    Breathing problems with or without a cough and fever •    Yellow coloration of the skin or the eyes	6. Contents of the pack and other information What Bicalutamide 50 mg contains •    The active substance is bicalutamide. Each tablet contains 50 mg bicalutamide. •    The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate, crospovidone, povidone K-29/32, sodium laurilsulfate The ingredients in the tablet coating are: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E171).
Other possible side-effects of the medicine are: Very common side effects (may affect more than 1 in 10 people): •    Low numbers of red blood cells (anaemia) •    Breast soreness	What Bicalutamide 50 mg looks like and contents of the pack The tablets are white, round, biconvex film-coated tablets, debossed with BCM50 on one side.
•    Developments of breasts in males •    Hot flushes •    Dizziness •    Pain in the stomach or pelvis	They are available in blisters of 5, 7, 10, 14, 20, 28, 30, 40, 50, 56, 80, 84, 90, 98, 100, 140, 200, and 280 tablets.
•    Constipation •    Feeling sick	Not all pack sizes may be marketed.
•    Presence of blood in the urine (haematuria) •    Feeling weak •    Swelling of the hands, feet, arms or legs (oedema) Common side effects (may affect up to 1 in 10 people): •    Lower sex drive	Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Synthon BV Microweg 22 6545 CM Nijmegen The Netherlands
•    Depression •    Sleepiness •    Acid indigestion •    Wind •    Changes to liver function including yellowing of the skin and whites of the eyes (jaundice) •    Hair loss	Manufacturer Synthon BV Microweg 22 6545 CM Nijmegen The Netherlands
•    Increased hair growth •    Dry skin •    Rash •    Itching of the skin •    Difficulty in gaining an erection •    Weight increase	Synthon Hispania S.L. Castello 1 Poligono Las Salinas 08830 Sant Boi de Llobregat Spain
•    Decreased appetite •    Pain in the chest	PL 14048/0022; Bicalutamide 50 mg, film-coated tablets
•    Heart attack (fatal outcomes have been reported) •    Heart problems which can cause shortness of breath or ankle swelling Uncommon side effects (may affect up to 1 in 100 peoples: Allergic reactions (hypersensitivity reactions). The symptoms of these may include: skin rash, itching, hives, peeling, blistering or crusting of the skin, swelling of the face or neck, lips, tongue or throat which may cause difficulty in breathing or swallowing •    An inflammation of the lungs called interstitial lung disease (fatal outcomes have been reported). The symptoms of this may include severe breathlessness with a cough or fever Rare side effects (may affect up to 1 in 1,000 peoples: •    Liver failure (fatal outcomes have been reported.	This leaflet was last revised in November 2012
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. AAAE5568	^actav/s Actavis, Barnstaple, EX32 8NS, UK