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PATIENT INFORMATION LEAFLET

Bicalutamide 50 mg Tablets

(bicalutamide)

The name of this medicine is Bicalutamide 50 mg Tablets, which will be referred to as Bicalutamide Tablets throughout this leaflet.

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 further questions, please ask your doctor or pharmacist.

•    This medicine has been prescribed for you personally and you should 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. See section 4

1. WHAT BICALUTAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Bicalutamide Tablets are used to treat prostate cancer.

Bicalutamide is one of a group of medicines called anti-androgens. It has been shown that the growth of tumours of the prostate gland may be dependent on male hormones. Since bicalutamide blocks the action of androgens, it can be used to treat tumours of the prostate gland.

Do not take Bicalutamide Tablets if you are:

•    allergic to bicalutamide or to any of the other ingredients in the tablets (these are listed in section 6, Further Information)

•    a woman or a child

•    if you are taking the medicines terfenadine or astemizole (antihistamines) or cisapride (for some types of indigestion).

Take special care with Bicalutamide Tablets

Before you take Bicalutamide Tablets you should tell your doctor if you:

•    have liver problems

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

•    have been told you have an intolerance to some sugars. Each Bicalutamide Tablet contains 61 mg of lactose monohydrate.

If any of the above apply to you talk to your doctor who will decide what to do.

Taking other medicines

You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your Bicalutamide Tablets:

•    oral anticoagulants (such as warfarin) used to thin the blood

•    calcium channel blockers (such as verapamil or diltiazem) used to treat high blood pressure or some heart conditions

•    cimetidine (used to treat ulcers)

•    ketoconazole (used to treat fungal infections)

•    ciclosporin (used to suppress the immune system following transplant surgery).

It may still be all right for you to take Bicalutamide Tablets and your doctor will be able to decide what is suitable for you.

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

Pregnancy and breast-feeding

Women must not take Bicalutamide Tablets.

Driving and using machines

Some people may occasionally feel drowsy when taking Bicalutamide Tablets. If this happens to you, you should exercise caution if you drive or operate machinery.

Important information about some of the ingredients of Biaclutamide Tablets

These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Dosage

Always take Bicalutamide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose for Bicalutamide Tablets is as follows:-

Adults and elderly men: the dose is one tablet daily. The tablet should be swallowed whole with plenty of water. Take your tablet at the same time each day.

Bicalutamide Tablets are not suitable for use by females.

If you take more Bicalutamide Tablets than you should

If you have accidentally taken more than your prescribed dose, contact your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.

If you forget to take your dose of Bicalutamide Tablets    <

Do not worry. Take your dose when you remember and then take your next dose at the 3 usual time. Do not take two doses at the same time.    ^r">

If you have any further questions on the use of this product, ask your doctor or pharmacist for advice.

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

Allergic reactions:

These are uncommon (affect less than 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:

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

•    Pain in your abdomen

•    Blood in your urine

Common (affects less than 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 (affects less than 1 in 1,000 people) liver failure

•    Myocardial Infarction (fatal outcomes have been reported).

•    Cardiac failure

Uncommon (affects less than 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’

•    Hypersensitivity, angioedema (serious allergic reaction which causes swelling of the face or throat),urticaria (hives)

Other possible side effects:

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

•    Low levels of red blood cells (anaemia). This may make you feel tired or look pale Common (affects less than 1 in 10 people)

•    Decreased 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

•    Hepatotoxicity, jaundice, raised transaminases (hypertransaminasaemia).

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 yourdoctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via United Kingdom Yellow Card Scheme Website: www.mhra.qov.uk/vellowcard

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

Keep Bicalutamide Tablets out of the sight and reach of children.

Store in the original package to protect the tablets from moisture.

Do not use Bicalutamide Tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. If you have any Bicalutamide Tablets left after completing your course of treatment, please return them to your pharmacist who will dispose of them safely. These measures will help protect the environment.

What Bicalutamide Tablets contain:

The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.

The other ingredients are lactose monohydrate, maize starch, sodium lauryl sulphate, povidone, crospovidone, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol and titanium dioxide (E171).

What Bicalutamide Tablets look like and the contents of the pack:

Bicalutamide 50 mg Tablets are white, round, film-coated tablets.

Your medicine is available in blisters containing 28 tablets.

Marketing Authorisation Holder:

Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK.

Manufacturer responsible for batch release: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK.

This information is available in alternative formats upon request.

This leaflet was last approved in January 2013.