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CASODEX 150 MG FILM-COATED TABLETS

Active substance(s): BICALUTAMIDE / BICALUTAMIDE

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P044060

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
your doctor or pharmacist. This
you are taking any of the following
includes any possible side effects
medicines:
not listed in this leaflet. See
• Medicines taken by mouth to
section 4.
prevent blood clots (oral anticoagulants). Your doctor may do
What is in this leaflet
blood tests before and during your
1. What Casodex is and what it is
treatment with Casodex.
used for
2. What you need to know before you • Ciclosporin (to suppress your
take Casodex
immune system).
3. How to take Casodex
• Calcium channel blockers (to treat
4. Possible side effects
high blood pressure or some heart
5. How to store Casodex
conditions).
6. Contents of the pack and other
• Cimetidine (for stomach problems).
information
• Ketoconazole (to treat infections
caused by a fungus).
1. What Casodex is and what it is
Pregnancy and breast‑feeding
used for
• Casodex must not be given to a
Casodex contains a medicine called
woman.
bicalutamide. This belongs to a group
of medicines called ‘anti‑androgens’.
Driving and using machines
• Casodex is used to treat prostate
Casodex is not likely to affect your
cancer.
ability to drive or use any tools or
• It works by blocking the effects
machines. However, some people may
of male hormones such as
occasionally feel sleepy while taking
testosterone.
Casodex. If this happens to you, ask
your doctor or pharmacist for advice.
2. What you need to know before
you take Casodex
Do not take Casodex:
• if you are a woman.
• 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).
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.

Sunlight or Ultraviolet (UV) light
Avoid direct exposure to excessive
sunlight or UV light while you are
taking Casodex.
Casodex contains lactose. Lactose
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 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 go into hospital, tell the medical
staff that you are taking Casodex.

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.

Children and adolescents
Casodex must not be given to
children or adolescents.

If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist or nurse.

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

4. Possible side effects

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.

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
onset of:
Do not take Casodex if you are
• Rash, itching or hives on the skin.
already taking any of the following
• Swelling of the face, lips, tongue,
medicines:
throat or other parts of the body.
• Cisapride (used for some types of
• Shortness of breath, wheezing or
indigestion).
trouble breathing.
• Certain anti‑histamines (terfenadine
or astemizole).

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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.

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.

Other possible side effects:
Very common (may affect more than
1 in 10 people):
• Skin rash.
• Swelling and tenderness of your
breasts.
• Feeling weak.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder
and Manufacturer
The Marketing Authorisation for
Uncommon (may affect up to 1 in
Casodex 150 mg Film-coated
100 people):
Tablets is held by AstraZeneca UK
Serious shortness of breath or
Limited, 600 Capability Green, Luton,
shortness of breath which suddenly
LU1 3LU, UK.
gets worse. This may be with a cough Casodex 150 mg Film-coated
Tablets are manufactured
or high temperature (fever). These
may be signs of an inflammation of the by Corden Pharma GmbH,
Otto-Hahn-Strasse, 68723 Plankstadt,
lungs called ‘interstitial lung disease’.
Germany.
Not known (frequency cannot be
estimated from the available data):
To listen to or request a
Changes in ECG (QT prolongation).
copy of this leaflet in Braille,

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.

This is a service provided
by the Royal National
Institute of Blind People.
This leaflet was last revised in
February 2017.
© AstraZeneca 2017
Casodex is a trade mark of the
AstraZeneca group of companies.
ONC 17 0009

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.
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.

P044060

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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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