CASODEX 50 MG FILM-COATED TABLETS
Active substance: BICALUTAMIDE
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P029830
Casodex 50 mg Film-coated Tablets
bicalutamide
Read all of this leaflet carefully before you start taking this medicine.
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
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
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.
Take special care with Casodex
Leaflet updated: November 2010 AstraZeneca 2010 Casodex is a trade mark of the AstraZeneca group of companies. ONC 10 0052
Check with your doctor or pharmacist before taking Casodex if: You have problems with your liver. 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.
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.
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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). Ciclosporin (to suppress your immune system). Calcium channel blockers (to treat high blood pressure or some heart conditions).
Driving and using machines
Common (affects less than 1 in 10 people)
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.
Important information about some of the ingredients of Casodex
Casodex contains lactose monohydrate, 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.
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
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.
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 Casodex
Keep your tablets in the container they came in. Do not store above 30C. Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them. Do not use your tablets after the expiry date which is stated on the carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
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.
4. Possible side effects
Like all medicines, Casodex can cause side effects, although not everybody gets them.
Allergic reactions:
These are uncommon (affect 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:
6. Further information
What Casodex 50 mg Film-coated Tablets contain
The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide. The other ingredients are lactose monohydrate, 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 Marketing Authorisation Holder and Manufacturer
Very common (affects more than 1 in 10 people): Pain in your abdomen. Blood in your urine. Common (affects less than 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. 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.
Other possible side effects: Very common (affects more than 1 in 10 people)
Casodex 50 mg Film-coated Tablets are white and come in packs of 28 tablets. 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 Reference number Casodex 50 mg Film-coated Tablets 17901/0005
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.
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This is a service provided by the Royal National Institute of Blind People.
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Casodex 50 mg Film-coated Tablets
bicalutamide
Read all of this leaflet carefully before you start taking this medicine.
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
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
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.
Take special care with Casodex
Leaflet updated: November 2010 AstraZeneca 2010 Casodex is a trade mark of the AstraZeneca group of companies. ONC 10 0052
Check with your doctor or pharmacist before taking Casodex if: You have problems with your liver. 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.
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.
4 1
3/12/10 12:00:12
P029830-1 Leaflet.indd 1
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). Ciclosporin (to suppress your immune system). Calcium channel blockers (to treat high blood pressure or some heart conditions).
Driving and using machines
Common (affects less than 1 in 10 people)
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.
Important information about some of the ingredients of Casodex
Casodex contains lactose monohydrate, 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.
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
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.
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 Casodex
Keep your tablets in the container they came in. Do not store above 30C. Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them. Do not use your tablets after the expiry date which is stated on the carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
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.
4. Possible side effects
Like all medicines, Casodex can cause side effects, although not everybody gets them.
Allergic reactions:
These are uncommon (affect 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:
6. Further information
What Casodex 50 mg Film-coated Tablets contain
The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide. The other ingredients are lactose monohydrate, 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 Marketing Authorisation Holder and Manufacturer
Very common (affects more than 1 in 10 people): Pain in your abdomen. Blood in your urine. Common (affects less than 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. 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.
Other possible side effects: Very common (affects more than 1 in 10 people)
Casodex 50 mg Film-coated Tablets are white and come in packs of 28 tablets. 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 Reference number Casodex 50 mg Film-coated Tablets 17901/0005
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.
2
This is a service provided by the Royal National Institute of Blind People.
3
3/12/10 12:00:12
P029830-1 Leaflet.indd 2
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.
