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Bicalutamide 50 Mg Film-Coated Tablets

Document: leaflet MAH GENERIC_PL 40378-0134 change

PIL Size 160x 290 mm Bicalutamide 150 mg - PIL


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.

-    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. Do not pass it on to others.

It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Bicalutamide is and what it is used for

2.    Before you take Bicalutamide

3.    How to take Bicalutamide

4.    Possible side effects

5.    How to store Bicalutamide

6.    Further information

1.    WHAT BICALUTAMIDE IS AND WHAT IT IS USED FOR

The name of your medicine is Bicalutamide 50 mg Film-coated Tablets. Bicalutamide tablets are film-coated and contain the active ingredient bicalutamide. Each tablet contains 50 milligrams of bicalutamide.

Bicalutamide is one of a group of medicines called anti-androgens. It works by blocking the effects of male hormones such as testosterone.

Bicalutamide is used to treat prostate cancer.

2.    BEFORE YOU TAKE BICALUTAMIDE Do not take Bicalutamide

•    if you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of this medicine (see 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

Take special care with Bicalutamide

Please tell your doctor if:

•    you have liver problems

•    you have diabetes and are already taking an ‘LHRH analogue’. These include goserelin, buserelin, leuprorelin and triptorelin.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

•    In particular, are you taking oral anti-coagulants (to prevent blood clots), some anti-histamines (terfenadine or astemizole), cisapride (for some types of indigestion), ciclosporin (to suppress your immune system) or calcium channel blockers (to treat high blood pressure or some heart conditions)? If so, tell your doctor.

•    If you go into hospital, let the medical staff know you are taking Bicalutamide.

Pregnancy and breast-feeding

Bicalutamide 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.

Important information about some of the ingredients of Bicalutamide

This medicinal product 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 Bicalutamide 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:

•    take it as soon as you remember.

•    do not take a double dose to make up for a forgotten dose. If you are worried, ask your doctor or pharmacist for advice. If you have any further questions on the use of this product, ask your doctor or pharmacist.



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4. POSSIBLE SIDE EFFECTS


Like all medicines, Bicalutamide can cause side effects, although not everybody gets them.

Contact your doctor or seek medical help immediately, if you experience any of the following:

Very common side effects (affects more than 1 in 10 people):

•    Pain in your abdomen

•    Blood in your urine

Common side effects (affects less than 1 in 10 people):

•    yellowing of the skin or white of your eyes (jaundice), these may be signs of liver problems Uncommon side effects (affects less than 1 in 100 people):

•    serious breathlessness or sudden worsening of breathlessness, possibly with a cough or fever.These may be inflammation of the lungs called interstitial lung disease

•    serious allergic reactions which causes severe itching of the skin (with raised lumps), rash or swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing or breathing

Other possible side effects:

Tell your doctor if any of the following side effects bother you.

Very common (affects 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 (affects less than 1 in 10 people):

•    loss of appetite •    reduced sex drive

•    indigestion    •    wind (flatulence)

•    dry skin    •    itching

•    weight gain    •    chest pain


depression • feeling sleepy hair loss    • hair re-growth or growth of extra hair

skin rash    • being unable to get an erection (impotence)

reduced heart function • heart attack


Rare (affects less than 1 in 10,000 people)

• liver failure with possible fatal outcome


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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


5. HOW TO STORE BICALUTAMIDE

Keep out of the reach and sight 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 30°C.

Keep your tablets in the original package they came in.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.


6. FURTHER 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 hydroxy propyl 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 tablets, with B50 on one side and plain on the 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

APTIL Pharma Limited,

9th floor, CP. House, 97-107 Uxbridge Road, Ealing, London W5 5TL Manufacturer:

APC Pharmaceuticals & Chemicals (Europe) Limited,

9th floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL


This leaflet was last amended 04/2012

Apt 1

A harma


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