Casodex 50 mg 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

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 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 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.

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).

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) 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

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

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

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.

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.

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.

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

What Casodex 50 mg Film-coated Tablets contains

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

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

Casodex 50 mg Film-coated Tablets are manufactured by