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CASODEX 150 MG FILM-COATED TABLETS

Active substance(s): BICALUTAMIDE

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P044964

Package leaflet: Information for the user

Casodex 150 mg film‑coated tablets

Bicalutamide
Read all of this leaflet carefully
Casodex might interfere with some
before you start taking this
medicines used to treat heart
medicine because it contains
rhythm problems (e.g. quinidine,
important information for you.
procainamide, amiodarone and
• Keep this leaflet. You may need to
sotalol) or might increase the
read it again.
risk of heart rhythm problems
• If you have any further questions,
when used with some other drugs
ask your doctor or pharmacist.
(e.g. methadone, (used for pain
• This medicine has been prescribed relief and part of drug addiction
for you only. Do not pass it on to
detoxification), moxifloxacin
others. It may harm them, even if
(an antibiotic), antipsychotics used
their signs of illness are the same
for serious mental illness).
as yours.
Tell your doctor or pharmacist if
• If you get any side effects talk to
you are taking any of the following
your doctor or pharmacist. This
medicines:
includes any possible side effects
not listed in this leaflet. See
• Medicines taken by mouth to
section 4.
prevent blood clots (oral anticoagulants). Blood thinners or
What is in this leaflet
medicines to prevent blood clots.
1. What Casodex is and what it is
Your doctor may do blood tests
used for
before and during your treatment
2. What you need to know before you
with Casodex.
take Casodex
• Ciclosporin (to suppress your
3. How to take Casodex
immune system).
4. Possible side effects
• Calcium channel blockers (to treat
5. How to store Casodex
6. Contents of the pack and other
high blood pressure or some heart
information
conditions).
• Cimetidine (for stomach problems).
1. What Casodex is and what it is
• Ketoconazole (to treat infections
used for
caused by a fungus).
Casodex contains a medicine called
Pregnancy and breast‑feeding
bicalutamide. This belongs to a group
• Casodex must not be given to a
of medicines called ‘anti‑androgens’.
woman.
• Casodex is used to treat prostate
cancer.
Driving and using machines
• It works by blocking the effects
Casodex is not likely to affect your
of male hormones such as
ability to drive or use any tools or
testosterone.
machines. However, some people may
occasionally feel sleepy while taking
2. What you need to know before
Casodex. If this happens to you, ask
you take Casodex
your doctor or pharmacist for advice.
Do not take Casodex:
Sunlight or Ultraviolet (UV) light
• if you are a woman.
Avoid direct exposure to excessive
• if you are allergic to bicalutamide
sunlight or UV light while you are
or any of the other ingredients of
taking Casodex.
this medicine (listed in section 6).
• if you are already taking a
Casodex contains lactose. Lactose
medicine called cisapride or
is a type of sugar. If you have been
certain anti‑histamine medicines
told by your doctor that you cannot
(terfenadine or astemizole).
tolerate or digest some sugars (have
Casodex must not be given to
children.
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.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Casodex:
• if you have problems with your
liver. Your doctor may do blood
tests before and during your
treatment with 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 are taking Casodex, you
and/or your partner should use
birth control while you are taking
Casodex and for 130 days after
stopping Casodex. Talk to your
doctor if you have any questions
about birth control.
If you go into hospital, tell the medical
staff that you are taking Casodex.
Children and adolescents
Casodex 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
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.

an intolerance to some sugars),
talk to your doctor before taking this
medicine.
3. How to take Casodex
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 must not be given to
children.
If you take more Casodex than you
should
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. 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
Do not take Casodex if you are
onset of:
already taking any of the following
• Rash, itching or hives on the skin.
medicines:
• Swelling of the face, lips, tongue,
• Cisapride (used for some types of
throat or other parts of the body.
indigestion).
• Certain anti‑histamines (terfenadine • Shortness of breath, wheezing or
trouble breathing.
or astemizole).

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).
• Itching.
• 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.
• Depression.
• Feeling sleepy.
• Indigestion.
• Dizziness.
• Constipation.
• Wind (flatulence).
• Chest pain.
• Swelling.

What Casodex looks like and
contents of the pack
Casodex 150 mg film‑coated tablets
are white and are provided in blister
packs of 10, 20, 30, 40, 50, 80, 90,
100, 200, or 14, 28, 56, 84, 140 and
280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
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
17901/0006
This is a service provided
by the Royal National
Institute of Blind People.
This leaflet was last revised in
December 2017.
© AstraZeneca 2017
Casodex is a trade mark of the
AstraZeneca group of companies.
ONC 17 0045

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 or
search for MHRA Yellow Card in the
Google Play or Apple App Store. By
reporting side effects you can help
provide more information on the
safety of this medicine.
5. How to store Casodex
Keep this medicine out of the sight
and reach of children.
Keep your tablets in the container
they came in.
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 store above 30°C.
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 contains
The active substance is bicalutamide
150 mg. Each tablet contains 150 mg
bicalutamide.
The other ingredients (excipients) are:
• Tablet core: lactose monohydrate,
magnesium stearate, povidone,
carboxymethyl amidon sodium.
• Film‑coating material:
hypromellose, macrogol 300,
titanium dioxide.
P044964

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