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CASODEX 50 MG FILM-COATED TABLETS

Active substance: BICALUTAMIDE

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P035879

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.
•  eep this leaflet. You may need to
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read it again.
• f you have any further questions,
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ask your doctor or pharmacist.
•  his medicine has been prescribed
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for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same
as yours.
• f any of the side effects get
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serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1.  hat Casodex is and what it is
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used for
2.  efore you take Casodex
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3.  ow to take Casodex
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4.  ossible side effects
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5.  ow to store Casodex
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6. Further information
1. What Casodex is and what it is
used for

Do not take Casodex if:
•  ou are allergic (hypersensitive) to
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bicalutamide or any of the other
ingredients of this medicine (listed
in Section 6: Further information).
•  ou are already taking a medicine
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called cisapride or certain antihistamine medicines (terfenadine
or astemizole).
•  ou are a woman.
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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.

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:
•  ash, itching or hives on the skin.
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•  welling of the face, lips, tongue,
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throat or other parts of the body.
•  hortness of breath, wheezing or
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trouble breathing.
If this happens to you, see a doctor
straight away.

Casodex must not be given to
children.
Take special care with Casodex
Check with your doctor or pharmacist
before taking Casodex if:
•  ou have problems with your liver.
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•  ou have diabetes and are already
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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.

Driving and using machines
•  asodex is not likely to affect you
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being able to drive or use any
tools or machines.
•  owever, if you feel sleepy take
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care with these activities.

Always take Casodex exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure.
•  he usual dose for an adult is one
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tablet each day.
•  wallow the tablet whole with a
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drink of water.
•  ry to take your tablet at the same
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time each day.
•  o not stop taking this medicine
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even if you feel well, unless your
doctor tells you to.

If you forget to take Casodex
• f you forget to take a dose, skip
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the missed dose and take the next
dose as usual.
•  o not take a double dose (two
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doses at the same time) to make
up for a forgotten dose.

2. Before you take Casodex

Also, tell your doctor if you are taking
any of the following medicines:
•  edicines taken by mouth to
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prevent blood clots (oral anticoagulants).
•  iclosporin (to suppress your
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immune system).
•  alcium channel blockers (to treat
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high blood pressure or some heart
conditions).

3. How to take Casodex

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.

Casodex contains a medicine called
bicalutamide. This belongs to a group
of medicines called ‘anti-androgens’.
•  asodex is used to treat prostate
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cancer.
• t works by blocking the effects
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of male hormones such as
testosterone.

Do not take Casodex if you are
already taking any of the following
medicines:
•  isapride (used for some types of
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indigestion).
•  ertain anti-histamine medicines
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(terfenadine or astemizole).

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.

Also tell your doctor straight away
if you notice any of the following:
Very common (affects more than
1 in 10 people):
•  ain in your abdomen.
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•  lood in your urine.
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Common (affects less than 1 in
10 people):
•  ellowing of the skin or whites of
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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):
•  erious shortness of breath
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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)
• Dizziness.
• Constipation.
•  eeling sick (nausea).
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•  welling and tenderness of your
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breasts.
• Hot flushes.
• Feeling weak.
• Swelling.
•  ow levels of red blood cells
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(anaemia). This may make you feel
tired or look pale.

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Common (affects less than 1 in
10 people)
•  oss of appetite.
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•  educed sex drive.
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• Depression.
• Feeling sleepy.
• Indigestion.
• Wind (flatulence).
• Hair loss.
•  air re-growth or growth of
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extra hair.
• Dry skin.
• Itching.
• Skin rash.
•  eing unable to get an erection
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(impotence).
• Weight gain.
• Chest pain.
•  educed heart function.
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• 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
•  eep your tablets in the container
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they came in.
•  o not store above 30°C.
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•  eep your tablets in a safe place
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where children cannot see or
reach them. Your tablets could
harm them.
•  o not use your tablets after the
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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.
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
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

Leaflet updated: September 2013
© AstraZeneca 2013
Casodex is a trade mark of the
AstraZeneca group of companies.
ONC 13 0025

This is a service provided
by the Royal National
Institute of Blind People.

206982
UK
03
01 October 2013

13:30

Black

Profile

P035879
630170L4
1591

Technical
Info

Casodex Leaflet

FONT INFO
FONT FAMILY
NimbusSanL
TEXT SIZE
Body: 12.0 pt
(excluding component code)

P035879

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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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