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Active substance: BICALUTAMIDE

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Casodex 150 mg Film-coated Tablets

Read all of this leaflet carefully
before you start taking this
• 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. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
• 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
In this leaflet:
1.  hat Casodex is and what it is
used for
2. Before you take Casodex

3. How to take Casodex

4. Possible side effects

5.  ow to store Casodex
6. Further 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’.
•  asodex is used to treat prostate
• t works by blocking the effects
of male hormones such as
2. Before you take Casodex
Do not take Casodex if:
•  ou are allergic (hypersensitive) to
bicalutamide or any of the other
ingredients of this medicine (listed
in Section 6: Further information).
•  ou are already taking a medicine
called cisapride or certain antihistamine medicines (terfenadine
or astemizole).
•  ou 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
Take special care with Casodex
Check with your doctor before you
take Casodex if:
•  ou have problems with your liver.
Your doctor may do blood tests
before and during your treatment
with Casodex.
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.
Do not take Casodex if you are
already taking any of the following
•  isapride (used for some types of
• Certain anti-histamine medicines

(terfenadine or astemizole).
Also, tell your doctor 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.
•  iclosporin (to suppress your immune

•  alcium channel blockers (to treat
high blood pressure or some heart
• Cimetidine (for stomach problems).

• Ketoconazole (to treat infections

caused by a fungus).
Driving and using machines
• Casodex is not likely to affect your

ability to drive or use any tools or
• 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.
Important information about some
of the ingredients of Casodex
Casodex contains lactose, 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.
3. How to take Casodex
Always take Casodex exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure.
• The usual 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
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.
•  o not take a double dose (two
doses at the same time) to make up
for a forgotten dose.
4. Possible side effects
Like all medicines, Casodex can
cause side effects, although not
everybody gets them.
Allergic reactions (uncommon,
affects less than 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:
Common (affects less than 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 (affects less than 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’.
Other possible side effects:
Very common (affects more than
1 in 10 people)
• Skin rash.
• Swelling and tenderness of your

• Feeling weak.

Common (affects less than 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


• Hair loss.
•  air 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.
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:
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 your tablets in a safe place

where children cannot see or
reach them. Your tablets could
harm them.
• Do not use your tablets after the

expiry date on the container.
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 150 mg Film-coated
Tablets contain
The active substance is bicalutamide.
Each tablet contains 150 mg of
The other ingredients are lactose
monohydrate, carboxymethyl amidon
sodium, povidone, magnesium stearate,
hypromellose, macrogol 300 and
titanium dioxide.
What Casodex 150 mg Film-coated
Tablets look like and contents of
the pack
Casodex 150 mg Film-coated Tablets
are white and come in blister packs of
28 tablets.
Marketing Authorisation Holder and
The Marketing Authorisation for
Casodex 150 mg Film-coated
Tablets is held by AstraZeneca UK
Limited, 600 Capability Green, Luton,
LU1 3LU, UK.
Casodex 150 mg Film-coated
Tablets are manufactured by Corden
Pharma GmbH, Otto‑Hahn‑Strasse,
68723 Plankstadt, Germany.

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 150 mg
Film‑coated Tablets
Reference number
This is a service provided
by the Royal National
Institute of Blind People.

This leaflet was last revised in
September 2014
© AstraZeneca 2014
Casodex is a trade mark of the
AstraZeneca group of companies.
ONC 14 0004a


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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.