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CASODEX 50 MG FILM-COATED TABLETS

Active substance: BICALUTAMIDE

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P039717

Package leaflet: Information for the user

Casodex 50 mg Film-coated Tablets
Bicalutamide

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

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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.

The other ingredients are lactose
monohydrate (see section 2, Casodex
contains lactose), 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
Casodex 50 mg Film-coated Tablets
are white and come in packs of
28 tablets.
Marketing Authorisation Holder
and Manufacturer
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
Casodex 50 mg
Film-coated Tablets
Reference number
17901/0005
This is a service
provided by the Royal
National Institute of
Blind People.

Rare (may affect up to 1 in
1,000 people)
• Increased skin sensitivity to sunlight.

This leaflet was last revised in
November 2014

Your doctor may do blood tests to
check for any changes to your blood.

© AstraZeneca 2014
Casodex is a trade mark of the
AstraZeneca group of companies.

Do not be concerned by this list of
possible side effects. You may not
get any of them.

ONC 14 00046

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 your tablets in the container
they came in.
• Do not store above 30°C.
• Keep this medicine out of the sight
and reach of children.
• Do not use this medicine after the
expiry date which is stated on the
carton. The expiry date refers to
the last day of that month.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.
6. Contents of the pack and other
information
What Casodex 50 mg Film-coated
Tablets contains
The active substance is bicalutamide.
Each tablet contains 50 mg of
bicalutamide.

P039717

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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 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.

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