BICALUTAMIDE 150MG FILM COATED TABLETS

Active substance: BICALUTAMIDE

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5. How to store Casodex
Do not store above 30C. Keep your tablets in the original pack. If your doctor decides to stop your treatment, return your unused tablets to your pharmacist. Do not take your tablets after the expiry date on the pack. Keep out of the reach and sight of children. Your tablets could harm them. If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Casodex 150mg Film-coated Tablets
(bicalutamide)

Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is Casodex 150mg Film-coated Tablets but will be referred to as Casodex throughout this leaflet.

6. Further information
What Casodex contains
Each tablet contains 150mg of bicalutamide. Each tablet contains a number of inactive ingredients which allow it to be made. These are lactose monohydrate, carboxymethyl amidon sodium, povidone, magnesium stearate, hypromellose, macrogol 300 and titanium dioxide (E171). Warning: 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.

In this leaflet:
1. What Casodex is and what it is used for 2. Before you take Casodex 3. How to take Casodex 4. Possible side effects 5. How to store Casodex 6. Further information

What Casodex looks like and contents of the pack
Casodex comes as round, biconvex, white, film-coated tablets marked with casodex 150 on one side and a 'logo' on the other side. Casodex come in calendar blister packs of 28 tablets. Translation of the days of the week into English from Italian as given on the blister pack is as follows: LUN MON MAR TUE MER WED GIO THUR VEN FRI SAB SAT DOM SUN

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.

2. Before you take Casodex
Do not take Casodex if:
You are allergic (hypersensitive) to bicalutamide or any of the other ingredients of this medicine (listed in Section 6: Further information). You are already taking a medicine called cisapride or certain anti-histamine medicines (terfenadine or astemizole). 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.

Manufactured by: AstraZeneca GmbH, Plankstadt, Germany. Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU. Casodex 150mg Film-coated Tablets Leaflet date: 11.05.2012 Casodex is a registered trademark of the AstraZeneca Group of companies. PL No: 18799/1972 POM

Take special care with Casodex
Check with your doctor before you take Casodex if: You have problems with your liver. Your doctor may do blood tests before and during your treatment with Casodex. If you go into hospital, tell the medical staff that you are taking Casodex.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. 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). Also, tell your doctor if you are taking any of the following medicines: Medicines taken by mouth to prevent blood clots (oral anti-coagulants). 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).

4. Possible side effects
Like all medicines, Casodex can cause side effects, although not everybody gets them.

Allergic reactions (uncommon, affects less than 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:
Common (affects less than 1 in 10 people): Pain in your abdomen. Blood in your urine. Uncommon (affects less than 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. Yellowing of the skin or whites of your eyes (jaundice). These may be signs of liver damage.

Driving and using machines
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.

Important information about some of the ingredients of Casodex
Casodex contains lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

Other possible side effects: Very common (affects more than 1 in 10 people)
Skin rash. Swelling and tenderness of your breasts. Feeling weak.

Common (affects less than 1 in 10 people)
Hot flushes. Feeling sick (nausea). Itching. Dry skin. Being unable to get an erection (impotence). Weight gain. Reduced sex drive and reduced fertility. Hair loss. Hair regrowth 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.

3. How to take Casodex
Always take Casodex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual 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 you should, 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.

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. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Bicalutamide
Do not store above 30C. Keep your tablets in the original pack. If your doctor decides to stop your treatment, return your unused tablets to your pharmacist. Do not take your tablets after the expiry date on the pack. Keep out of the reach and sight of children. Your tablets could harm them. If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bicalutamide 150mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is Bicalutamide 150mg Film-coated Tablets but will be referred to as Bicalutamide throughout this leaflet.

6. Further information
What Bicalutamide contains
Each tablet contains 150mg of bicalutamide. Each tablet contains a number of inactive ingredients which allow it to be made. These are lactose monohydrate, carboxymethyl amidon sodium, povidone, magnesium stearate, hypromellose, macrogol 300 and titanium dioxide (E171). Warning: 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.

In this leaflet:
1. What Bicalutamide is and what it is used for 2. Before you take Bicalutamide 3. How to take Bicalutamide 4. Possible side effects 5. How to store Bicalutamide 6. Further information

What Bicalutamide looks like and contents of the pack
Bicalutamide comes as round, biconvex, white, film-coated tablets marked with Bicalutamide 150 on one side and a 'logo' on the other side. Bicalutamide come in calendar blister packs of 28 tablets. Translation of the days of the week into English from Italian as given on the blister pack is as follows: LUN MON MAR TUE MER WED GIO THUR VEN FRI SAB SAT DOM SUN

1. What Bicalutamide is and what it is used for
Bicalutamide contains a medicine called bicalutamide. This belongs to a group of medicines called anti-androgens. Bicalutamide is used to treat prostate cancer. It works by blocking the effects of male hormones such as testosterone.

2. Before you take Bicalutamide
Do not take Bicalutamide if:
You are allergic (hypersensitive) to bicalutamide or any of the other ingredients of this medicine (listed in Section 6: Further information). You are already taking a medicine called cisapride or certain anti-histamine medicines (terfenadine or astemizole). You are a woman. Do not take Bicalutamide if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bicalutamide. Bicalutamide must not be given to children.

Manufactured by: AstraZeneca GmbH, Plankstadt, Germany Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU. Bicalutamide 150mg Film-coated Tablets Leaflet date: 11.05.2012 PL No: 18799/1972 POM

Take special care with Bicalutamide
Check with your doctor before you take Bicalutamide if: You have problems with your liver. Your doctor may do blood tests before and during your treatment with Bicalutamide. If you go into hospital, tell the medical staff that you are taking Bicalutamide.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. Do not take Bicalutamide if you are already taking any of the following medicines: Cisapride (used for some types of indigestion). Certain anti-histamine medicines (terfenadine or astemizole). Also, tell your doctor if you are taking any of the following medicines: Medicines taken by mouth to prevent blood clots (oral anti-coagulants). Your doctor may do blood tests before and during your treatment with Bicalutamide. 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).

4. Possible side effects
Like all medicines, Bicalutamide can cause side effects, although not everybody gets them. Allergic reactions (uncommon, affects less than 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:
Common (affects less than 1 in 10 people): Pain in your abdomen. Blood in your urine. Uncommon (affects less than 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. Yellowing of the skin or whites of your eyes (jaundice). These may be signs of liver damage.

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

Important information about some of the ingredients of Bicalutamide
Bicalutamide contains lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

Other possible side effects: Very common (affects more than 1 in 10 people)
Skin rash. Swelling and tenderness of your breasts. Feeling weak.

Common (affects less than 1 in 10 people)

3. How to take Bicalutamide
Always take Bicalutamide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual 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 than you should
If you take more Bicalutamide than you should, talk to a doctor or go to a hospital straight away.

If you forget to take Bicalutamide
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.

Hot flushes. Feeling sick (nausea). Itching. Dry skin. Being unable to get an erection (impotence). Weight gain. Reduced sex drive and reduced fertility. Hair loss. Hair regrowth 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. 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. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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