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Bicalutamide 150 Mg Film-Coated Tablets

Document: leaflet MAH GENERIC_PL 22983-0002 change

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 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet

1.    What Bicalutamide 150 mg is and what it is used for

2.    What you need to know before you take Bicalutamide 150 mg

3.    How to take Bicalutamide 150 mg

4.    Possible side effects

5.    How to store Bicalutamide 150 mg

6.    Contents of the pack and other information

1.    What Bicalutamide 150 mg is and what it is used for

Bicalutamide 150 mg contains a medicine called bicalutamide. This belongs to a group of

medicines called ‘anti-androgens’.

•    Bicalutamide 150 mg 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 150 mg

DO NOT take Bicalutamide 150 mg if:

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

•    You are already taking a medicine called cisapride or certain anti-histamine medicines (terfenadine or astemizole).

•    You are a woman.

Do not take Bicalutamide 150 mg if any of the above apply to you. If you are not sure, talk to

your doctor or pharmacist before taking Bicalutamide 150 mg.

Bicalutamide 150 mg must not be given to children.

Warnings and precautions

Talk to your doctor before taking Bicalutamide 150 mg if:

•    You have problems with your liver. Your doctor may do blood tests before and during your treatment with Bicalutamide 150 mg.

•    if you suffer from 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 150 mg.

If you go into hospital, tell the medical staff that you are taking Bicalutamide 150 mg.

Other medicines and Bicalutamide 150 mg

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Do not take Bicalutamide 150 mg if you are already taking any of the following medicines:

•    Cisapride (used for some types of indigestion).

•    Certain anti-histamine medicines (terfenadine or astemizole).

Also, tell your doctor if you are taking any of the following medicines:

•    Medicines taken by mouth to prevent blood clots (oral anti-coagulants). Your doctor may do blood tests before and during your treatment with Bicalutamide 150 mg.

•    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).

Bicalutamide 150 mg 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 breast-feeding

This medicine must never be taken by women.

Driving and using machines

•    Bicalutamide 150 mg is not likely to affect your ability to drive or use any tools or machines.

•    However, some people may occasionally feel sleepy while taking Bicalutamide 150 mg. If this happens to you, ask your doctor or pharmacist for advice.

Bicalutamide 150 mg contains lactose

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 150 mg

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

•    The usual dose for an adult is one tablet each day.

•    Swallowed the tablet whole with a drink of water.

•    Try to take your tablet at the same time each day.

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

If you take more Bicalutamide 150 mg than you should

If you take more Bicalutamide 150 mg than you should, talk to your doctor or go to the next hospital straight away.

If you forget to take Bicalutamide 150 mg

•    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 (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:

Common (may affect up to 1 in 10 people):

•    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 people) liver failure.

•    Pain in your abdomen.

•    Blood in your urine.

Uncommon (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’.

Other possible side-effects:

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

•    Skin rash.

•    Swelling and tenderness of your breasts.

•    Feeling weak.

Common side effects (may affect up to 1 in 10 people)

•    Hot flushes.

•    Feeling sick (nausea).

•    Itching.

•    Dry skin.

•    Problems getting an erection (erectile dysfunction).

•    Putting on weight.

•    Reduced sex drive and reduced fertility.

•    Hair loss.

•    Hair re-growth or growth of extra hair.

•    Low levels of red blood cells (anaemia). This may make you feel tired or look pale.

•    Loss of appetite.

•    Depression.

•    Feeling sleepy.

•    Indigestion.

•    Dizziness.

•    Constipation.

•    Wind (flatulence).

•    Chest pain.

•    Swelling.

Rare side effects (may affect up to 1 in 1,000 people):

•    Increased skin sensitivity to sunlight.

Not known (frequency cannot be estimated from the available data):

•    Changes in ECG (QT prolongation)

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. 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Bicalutamide 150 mg

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 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.

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.

6. Contents of the pack and other information

What Bicalutamide 150 mg contains

•    The active substance is bicalutamide (150 mg).

•    The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate, crospovidone, povidone K-29/32, sodium lauryl sulphate.

The ingredients in the tablet coating are: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E171).

What Bicalutamide 150 mg looks like and contents of the pack

The tablets are white, round, biconvex film-coated tablets, debossed with BCM150 on one side.

The tablets are white round, film coated tablets, imprinted with BCM150 on one side. They are available in packs of 5, 7, 10, 14, 20, 28, 30, 40, 50, 56, 80, 84, 90, 98, 100, 140, 200 or 280.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Kiron Pharmaceutica BV Sterreschansweg 79 6522 GM Nijmegen The Netherlands

Manufacturer:

Synthon Hispania S.L.

Castello 1, Poilgno Las Salinas Sant Boi de Llobregat Spain

Synthon BV Microweg 22 6545 CM Nijmegen The Netherlands

This leaflet was last revised in 10/2015.