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Package leaflet:

Casodex 50 mg

Bicalutamide

Information for the user

Film-coated Tablets

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 Casodex is and what it is used for

2.    What you need to know before you take Casodex

3.    How to take Casodex

4.    Possible side effects

5.    How to store Casodex

6.    Contents of the pack and other information

1. What Casodex is and what it is used for

Casodex contains a medicine called bicalutamide. This belongs to a group of medicines called ‘anti-androgens’.

•    Casodex is used to treat prostate cancer.

•    It works by blocking the effects of male hormones such as testosterone.

Casodex 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).

•    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).

Driving and using machines

Casodex 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.

Casodex contains lactose

Casodex 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.

2. What you need to know before you take Casodex

3. How to take Casodex

Do not take Casodex:

•    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 Casodex if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Casodex.

Casodex must not be given to children.

Warnings and precautions

Talk to your doctor or pharmacist before taking Casodex:

•    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 Casodex.

•    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 Casodex.

Other medicines and Casodex

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 Casodex can affect the way other medicines work. Also some other medicines can affect the way Casodex works.

Do not take Casodex if you are already taking any of the following medicines:

•    Cisapride (used for some types of indigestion).

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

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 Casodex than you should

If you take more Casodex than prescribed by your doctor, talk to a doctor or go to a hospital straight away.

If you forget to take Casodex

•    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.

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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.

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’.

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

•    Changes in ECG (QT prolongation).

Other possible side effects:

Very common (may affect 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 (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: www.mhra.qov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

The other ingredients are lactose monohydrate (see section 2, Casodex contains lactose), magnesium stearate, hypromellose, macrogol 300, povidone, sodium starch glycolate and titanium dioxide (E171).

What Casodex 50 mg Film-coated Tablets look like and contents of the pack

Casodex 50 mg Film-coated Tablets are white and come in packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Casodex 50 mg Film-coated Tablets is held by AstraZeneca UK Limited, 600 Capability Green, Luton,

LU1 3LU, UK.

Casodex 50 mg Film-coated Tablets are manufactured by AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Casodex 50 mg Film-coated Tablets Reference number 17901/0005

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in November 2014

© AstraZeneca 2014 Casodex is a trade mark of the AstraZeneca group of companies.

ONC 14 00046

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5. How to store Casodex

•    Keep your tablets in the container they came in.

•    Do not store above 30°C.

•    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.

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 Casodex 50 mg Film-coated Tablets contains

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

AstraZeneca

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