Casodex 150 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
• The name of this medicine is Casodex 150 mg Tablets but will be referred to as Casodex 150 mg throughout the remainder of this leaflet.
What is in this leaflet
1) What Casodex 150 mg is and what it is used for
2) What you need to know before you take Casodex 150 mg
3) How to take Casodex 150 mg
4) Possible side effects
5) How to store Casodex 150 mg
6) Contents of the pack and other information
1) WHAT CASODEX 150 MG IS AND WHAT IT IS USED FOR
Casodex 150 mg contains a medicine called bicalutamide. This belongs to a group of medicines called ‘anti-androgens'.
• Casodex 150 mg 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 150 MG
Do not take Casodex 150 mg:
• 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 antihistamine medicines (terfenadine or astemizole).
Casodex 150 mg must not be given to children.
Do not take Casodex 150 mg if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Casodex 150 mg.
Warnings and precautions
Talk to your doctor or pharmacist before taking Casodex 150 mg:
• if you have problems with your liver. Your doctor may do blood tests before and during your treatment with Casodex 150 mg.
• 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 150 mg.
If you go into hospital, tell the medical staff that you are taking Casodex 150 mg.
Children and adolescents
Casodex 150 mg 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 150 mg
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 150 mg can affect the way other medicines work. Also some other medicines can affect the way Casodex 150 mg works.
Do not take Casodex 150 mg if you are already taking any of the following medicines:
• Cisapride (used for some types of indigestion).
• Certain anti-histamines (terfenadine or astemizole).
Casodex 150 mg 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). Your doctor may do blood tests before and during your treatment with Casodex 150 mg.
• 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 150 mg must not be given to a woman.
Driving and using machines
Casodex 150 mg 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 150 mg. 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 150 mg.
Casodex 150 mg 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 150 MG
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 150 mg must not be given to children.
If you take more Casodex 150 mg than you should
If you take more Casodex 150 mg than you should, talk to a doctor or go to a hospital straight away.
If you forget to take Casodex 150 mg
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).
• 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.
• Feeling sleepy.
• Wind (flatulence).
• Chest pain.
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.
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.
5) HOW TO STORE CASODEX 150 MG
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Casodex 150 mg Tablets contain
Casodex 150 mg comes as round white film-coated tablets, marked with a logo on one side and ‘Casodex 150' on the other side. Each tablet contains 150 mg 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).
Casodex 150 mg comes in calendar blister packs of 28 tablets. Manufactured by
Corden Pharma GmbH, Plankstadt, Germany
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by xxxxxxxxxxxxxxxxxxxxxxxxx PL: 33532/0082
Leaflet dated 10th March 2016 Leaflet coded xxxxxxxxx
Casodex® is a registered trade mark of the AstraZeneca group of companies
• Do not store above 30oC.
• Keep your tablets in the container they came in.
• 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.
• Do not take your tablets after the expiry date on the container.
• Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them.
• If your tablets become discoloured or show any sign of deterioration, return them to your pharmacist.