Casodex 150 mg Film-coated Tablets.

• 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.

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

• if you are a woman.
• 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).

Casodex must not be given to children.

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.

Talk to your doctor or pharmacist before taking Casodex:

• if you have problems with your liver. Your doctor may do blood tests before and during your treatment with 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 are taking Casodex, you and/or your partner should use birth control while you are taking Casodex and for 130 days after stopping Casodex. Talk to your doctor if you have any questions about birth control.

If you go into hospital, tell the medical staff that you are taking Casodex.

Casodex must not be given to children or adolescents.

Your doctor may do blood tests to check for any changes to your blood.

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-histamines (terfenadine or astemizole).

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 illness).

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). Blood thinners or medicines to prevent blood clots. Your doctor may do blood tests before and during your treatment with Casodex.
• 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).

• Casodex must not be given to a woman.

Casodex is not likely to affect your ability to drive or use any tools or machines. However, some people may occasionally feel sleepy while taking Casodex. If this happens to you, ask your doctor or pharmacist for advice.

Avoid direct exposure to excessive sunlight or UV light while you are taking Casodex.

Lactose 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.

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

Casodex must not be given to children.

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

If you forget to take a dose, skip the missed dose and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

Allergic reactions (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.

Also tell your doctor straight away if you notice any of the following:

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 (affects less than 1 in 1,000 people) liver failure.
• Pain in your abdomen.
• Blood in your urine.

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).

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

• Skin rash.
• Swelling and tenderness of your breasts.
• Feeling weak.

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

• Hot flushes.
• Feeling sick (nausea).
• Itching.
• Dry skin.
• Problems getting an erection (erectile dysfunction).
• Putting on weight.
• Reduced sex drive and reduced fertility.
• Hair loss.
• Hair re-growth or growth of extra hair.
• Low levels of red blood cells (anaemia). This may make you feel tired or look pale.
• Loss of appetite.
• Depression.
• Feeling sleepy.
• Indigestion.
• Dizziness.
• Constipation.
• Wind (flatulence).
• Chest pain.
• Swelling.

Rare (affects less than 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 side effects. You may not get any of them.

If you get any side effects, talk to your doctor or pharmacist. 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.gov.uk/yellowcard 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.

The active substance is bicalutamide 150 mg. Each tablet contains 150 mg bicalutamide.

The other ingredients (excipients) are:

• Tablet core: lactose monohydrate, magnesium stearate, povidone, carboxymethyl amidon sodium.
• Film-coating material: hypromellose, macrogol 300, titanium dioxide.

Casodex 150 mg film-coated tablets are white and are provided in blister 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.

The Marketing Authorisation for Casodex 150 mg Film-coated Tablets is held by

Casodex 150 mg Film-coated Tablets are manufactured by