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Package leaflet: Information for the user

Bicalutamide 150 mg, film-coated tablets

bicalutamide

What is 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 belongs to the group of anti-androgens. Anti-androgens act against the effects of androgens (male sex hormones).

Bicalutamide is used in adult men for the treatment of prostate cancer without metastates, when castration or other types of treatment are not indicated or unacceptable.

It may be used in combination with radiotherapy or prostate surgery in early treatment programmes.

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).

•    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.

Warnings and precautions

Take special care with Bicalutamide 150 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 this applies to you and you have not already discussed this with your doctor, talk to your doctor or pharmacist before taking these tablets.

Other medicines and Bicalutamide 150 mg

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

•    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 150 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 any of the medicines listed above or any other medicines.

Taking Bicalutamide 150 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.

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 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.

If you take more Bicalutamide 150 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 150 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 dose. Just take the normal dose at the usual time.

If you stop taking Bicalutamide 150 mg

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.

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

Other possible side-effects of the medicine are:

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

•    Rash

•    Breast soreness

•    Developments of breasts in males

•    Feeling weak

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

•    Hot flushes

•    Low numbers of red blood cells (anaemia)

•    Decreased appetite

•    Lower sex drive

•    Depression

•    Dizziness

•    sleepiness

•    Pain in the stomach or chest

•    Constipation and wind

•    Acid indigestion

•    Feeling sick

•    Changes to liver function including yellowing of the skin and whites of the eyes (jaundice)

•    Hair loss

•    Increased hair growth

•    Dry skin

•    Itching of the skin

•    Presence of blood in the urine (haematuria)

•    Difficulty in gaining an erection

•    Swelling of the hands, feet, arms or legs (oedema)

•    Weight increase

Uncommon side effects (may affect up

to 1 in 100 people):

•    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 people):

•    Liver failure (fatal outcomes have been reported)

Note: Treatment with Bicalutamide 50 mg plus another hormonal treatment (LHRH analogues) has been associated with the occurrence of heart failure and heart attacks.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

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 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 be 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. Each tablet contains 150 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).

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.

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.

Not all pack sizes may be marketed.