Skip to Content

CASODEX 50MG TABLETS

Active substance(s): BICALUTAMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Casodex® 50mg Tablets
(bicalutamide)
This medicine is known by the above name but will be referred to as
Casodex throughout this leaflet.
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.
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.





Calcium channel blockers (to treat high blood pressure or some heart
conditions).
Cimetidine (for stomach problems).
Ketoconazole (to treat infections caused by a fungus).

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.

3. HOW TO TAKE CASODEX
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
• The recommended 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 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.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist or nurse.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CASODEX

4. POSSIBLE SIDE EFFECTS

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 antihistamine 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.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

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 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.
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).
• Ciclosporin (to suppress your immune system).

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.

5. HOW TO STORE CASODEX








Keep the tablets in the container they came in.
Keep out of the sight and reach of children.
Do not store above 30°C.
The product should not be used after the expiry date. This is printed on
the container. The expiry date refers to the last day of that month.
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 the tablets become discoloured or show any signs of deterioration,
you should seek the advice of your pharmacist.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
The name of your medicine is Casodex 50mg Tablets. Each tablet
contains 50mg of the active ingredient bicalutamide. The tablet comes as
round, white, film-coated tablets, marked with ‘CDX 50’ and with a logo.
Your medicine also contains the following inactive ingredients: lactose
monohydrate, magnesium stearate, hypromellose, macrogol 300,
povidone, sodium starch glycolate and titanium dioxide.
Casodex is produced in packs of 28 tablets.
Casodex is manufactured by Corden Pharma GmbH, Plankstadt,
Germany. Repackaged by OPD Laboratories Ltd, Unit 6 Colonial Way,
Watford, Herts WD24 4PR. Procured from within the EU by the Product
Licence Holder: Caseview (PL) Limited, 20 Alliance Court, Alliance Road,
London W3 0RB.
PL 13826/1355

POM
Casodex® 50mg Tablets
Leaflet revision date (ref) 19/02/2015

Casodex is a trade mark of the AstraZeneca group of companies.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

Expand view ⇕

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide