BICALUTAMIDE 50 MG TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the user

Bicalutamide 50 mg 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What Bicalutamide 50 mg Tablets are and what they are used for

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

• 3. How to take Bicalutamide 50 mg Tablets

• 4. Possible side effects

• 5. How to store Bicalutamide 50 mg Tablets

• 6. Contents of the pack and other information

• 1. What Bicalutamide 50 mg Tablets are and what they are used for

Bicalutamide 50 mg Tablets contains a medicine called bicalutamide. This belongs to a group of medicines called ‘anti-androgens’.

• Bicalutamide 50 mg Tablets are 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 50 mg tabletsdo not take bicalutamide 50 mg tablets: if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).

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

Do not take Bicalutamide 50 mg Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bicalutamide 50 mg Tablets.

Bicalutamide must not be given to children.

Warnings and precautions

Talk to your doctor or pharmacist before taking Bicalutamide 50 mg Tablets:

• if you have any of the following: 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 50 mg Tablets.
• if you are taking blood thinners or medicines to prevent blood clots.
• if you have problems with your liver.
• if you have diabetes and are already taking an ‘LHRH analogue’. These include goserelin, buserelin, leuprorelin and triptorelin.
• if you go into hospital, tell the medical staff that you are taking Bicalutamide.
• if you are taking Bicalutamide 50 mg Tablets, you and/or your partner should use birth control while you are taking Bicalutamide 50 mg Tablets and for 130 days after stopping Bicalutamide 50 mg Tablets. Talk to your doctor if you have any questions about birth control.

Other medicines and Bicalutamide 50 mg Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because bicalutamide can affect the way other medicines work. Also some other medicines can affect the way bicalutamide works.

Do not take Bicalutamide 50 mg Tablets if you are already taking any of the following medicines:

• Cisapride (used for some types of indigestion).
• Certain anti-histamine medicines (terfenadine or astemizole).

Bicalutamide 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.

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

• Medicines taken by mouth to prevent blood clots (oral anti-coagulants) e.g. warfarin. Blood thinners or medicines to prevent blood clots.
• 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).

Pregnancy, breast-feeding and fertility

Bicalutamide must not be taken by women, including pregnant women or mothers who are breast-feeding their babies.

Bicalutamide may have an effect on male fertility which could be reversible.

Driving and using machines

Bicalutamide is not likely to affect you being able to drive or use any tools or machines.

However, if you feel sleepy take care with these activities.

Bicalutamide 50 mg Tablets contains lactose

Bicalutamide 50 mg Tablets contains lactose monohydrate, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Information about sodium content in Bicalutamide 50 mg Tablets

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take bicalutamide 50 mg tablets

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

• The recommended dose for an adult is one tablet each day.
• Swallow 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 50 mg Tablets than you should

If you take more Bicalutamide 50 mg Tablets than prescribed by your doctor, talk to a doctor or go to a hospital straight away.

If you forget to take a Bicalutamide 50 mg Tablet

• 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 or nurse.

4. possible side effects

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

Allergic reactions

These are 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:

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

• Pain in your abdomen.
• Blood in your urine.
• 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.
• 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’.
• Changes in ECG (QT prolongation).

Other possible side effects:

• 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 (may affect up to 1 in 10 people)

• Loss of 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.
• Reduced heart function.
• Heart attack.

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

• Increased skin sensitivity to sunlight.

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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5.     how to store bicalutamide 50 mg tablets

• Keep your tablets in the container they came in.
• This medicinal product does not require any special storage conditions.
• 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 carton. The expiry date refers to the last day of that month.

Contents of the pack and other information

What Bicalutamide 50 mg Tablets contains

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

The other ingredients are lactose monohydrate (see section 2, Bicalutamide 50 mg Tablets contains lactose), sodium starch glycolate (Type A), povidone K-30, magnesium stearate opadry II 85F 18422 white

What Bicalutamide 50 mg Tablets look like and contents of the pack

Bicalutamide 50 mg Tablets are film-coated, white, round, biconvex 7 mm tablets marked with ‘B 50’ on one side.

Pack sizes:

Bicalutamide 50 mg Tablets are supplied in blister packs of 10, 14, 28, 30, 40, 50, 60, 90, or 100 tablets.

Marketing Authorisation Holder:

Torrent Pharma (UK) Ltd, 3rd Floor, Nexus Building

4 Gatwick Road

Crawley West

Sussex RH10 9BG

United Kingdom

Manufacturer:

Actavis Nordic

A/S 0rnegardsvej

16 DK-2820

Gentoffe

Denmark

This leaflet was last revised in 06/2021.