Bicalutamide 150mg Film-Coated Tablets
S1500 LEAFLET Casodex 20160630
PACKAGE LEAFLET: INFORMATION FOR USER CASODEX® 150mg film-coated tablets (bicalutamide)
Your medicine is known as Casodex 150mg film-coated tablets but will be referred to as Casodex throughout the following leaflet.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CASODEX
Do not take Casodex:
• if you are a women.
• 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.
Warnings and precautions
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 go into hospital, tell the medical staff that you are taking Casodex.
Children and adolescents
Casodex must not be given to children or adolescents.
Tests and checks
Your doctor may do blood tests to check for any changes to your blood.
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-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 anticoagulants). 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). Pregnancy and breast-feeding
• Casodex must not be given to a woman.
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.
Sunlight or Ultraviolet (UV) light
Avoid direct exposure to excessive sunlight or UV-light while you are taking Casodex.
Casodex contains lactose. Lactose 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 this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose 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.
Use in children and adolescents
Casodex must not be given to children.
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 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.
Tell your doctor straight away if you notice any of the following side effects-you may need urgent medical treatment:
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).
Other possible side effects:
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 possible side effects. You may not get any of them.
5. HOW TO STORE CASODEX
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 30°C.
• If your doctor tells you to stop using the medicine, please take any leftover tablets back to the pharmacy for safe disposal.
• Do not take your tablets after the expiry date on the container. Take any tablets which are out of date back to the pharmacy.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Casodex contains
• Each film-coated tablet contains 150mg of the active ingredient bicalutamide
• Casodex tablets also contain the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, hypromellose, macrogol 300, carboxymethyl amidon sodium and titanium dioxide (E171).
What Casodex looks like and contents of the pack
Casodex tablets are round, white, film-coated and imprinted ‘Casodex 150' on one side and with a logo on the other side. Casodex Tablets are available as calendar blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1 DX.
Manufacturer
This product is manufactured by:
• Corden Pharma GmbH, Otto-Hahn-Strasse, 68723 Plankstadt, Germany or
• AstraZeneca Reims, Cedex, France or
• AstraZeneca UK Limited, Macclesfield, Cheshire, UK or
• CIT S.r.l., Via Primo Villa 17, 20040 Burago di Molgora (MB), Italy.
|POM | PL: 19488/1500 Leaflet revision date: 30 June 2016
Casodex® is a registered trademark of AstraZeneca UK Ltd, UK.
S1500 LEAFLET Casodex 20160630
Reporting of side effects
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.
By reporting side effects you can help provide more information on the safety of this medicine.
S1500 LEAFLET Bicalutamine 20160630
PACKAGE LEAFLET: INFORMATION FOR USER BICALUTAMIDE 150mg film-coated tablets (bicalutamide)
Your medicine is known as BICALUTAMIDE 150mg film-coated tablets but will be referred to as Bicalutamide 150mg throughout the following leaflet.
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 Bicalutamide 150mg is and what it is used for
2. What you need to know before you take Bicalutamide 150mg
3. How to take Bicalutamide 150mg
4. Possible side effects
5. How to store Bicalutamide 150mg
6. Contents of the pack and other information
1. WHAT BICALUTAMIDE 150MG IS AND WHAT IT IS USED
Bicalutamide 150mg contains a medicine called bicalutamide. This belongs to a group of medicines called ‘anti-androgens'.
• Bicalutamide 150mg is used to treat prostate cancer.
• It works by blocking the effects of male hormones such as testosterone.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BICALUTAMIDE 150MG
Do not take Bicalutamide 150mg:
• if you are a women.
• 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).
Bicalutamide 150mg must not be given to children.
Do not take Bicalutamide 150mg if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before taking
Bicalutamide 150mg.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide
150mg:
• if you have problems with your liver. Your doctor may do blood tests before and during your treatment with Bicalutamide 150mg.
• 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 Bicalutamide 150mg.
If you go into hospital, tell the medical staff that you are taking
Bicalutamide 150mg.
Children and adolescents
Bicalutamide 150mg must not be given to children or adolescents.
Tests and checks
Your doctor may do blood tests to check for any changes to your blood.
Other medicines and Bicalutamide 150mg
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 Bicalutamide 150mg can affect the way other medicines work. Also some other medicines can affect the way Bicalutamide 150mg works.
Do not take Bicalutamide 150mg if you are already taking any of the following medicines:
• Cisapride (used for some types of indigestion).
• Certain anti-histamines (terfenadine or astemizole). Bicalutamide 150mg 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 anticoagulants). Your doctor may do blood tests before and during your treatment with Bicalutamide 150mg.
• 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 and breast-feeding
• Bicalutamide 150mg must not be given to a woman.
Driving and using machines
Bicalutamide 150mg 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 150mg. If this happens to you, ask your doctor or pharmacist for advice.
Sunlight or Ultraviolet (UV) light
Avoid direct exposure to excessive sunlight or UV-light while you are taking Bicalutamide 150mg.
Bicalutamide 150mg contains lactose. Lactose 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 BICALUTAMIDE 150MG
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose 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.
Use in children and adolescents
Bicalutamide 150mg must not be given to children.
If you take more Bicalutamide 150mg than you should
If you take more Bicalutamide 150mg than you should, talk to a
doctor or go to a hospital straight away.
If you forget to take Bicalutamide 150mg
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following side effects-you may need urgent medical treatment:
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).
Other possible side effects:
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 possible 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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE BICALUTAMIDE 150MG
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 30°C.
• If your doctor tells you to stop using the medicine, please take any leftover tablets back to the pharmacy for safe disposal.
• Do not take your tablets after the expiry date on the container. Take any tablets which are out of date back to the pharmacy.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Bicalutamide 150mg contains
• Each film-coated tablet contains 150mg of the active ingredient bicalutamide
• Bicalutamide 150mg tablets also contain the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, hypromellose, macrogol 300, carboxymethyl amidon sodium and titanium dioxide (E171).
What Bicalutamide 150mg looks like and contents of the pack
Bicalutamide 150mg tablets are round, white, film-coated and imprinted ‘Casodex 150' on one side and with a logo on the other side.
Bicalutamide 150mg Tablets are available as calendar blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by:
• Corden Pharma GmbH, Otto-Hahn-Strasse, 68723 Plankstadt, Germany or
• AstraZeneca Reims, Cedex, France or
• AstraZeneca UK Limited, Macclesfield, Cheshire, UK or
• CIT S.r.l., Via Primo Villa 17, 20040 Burago di Molgora (MB), Italy.
|POM | PL: 19488/1500 Leaflet revision date: 30 June 2016
S1500 LEAFLET Bicalutamine 20160630