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CASODEX 50MG FILM-COATED TABLETS

Active substance(s): BICALUTAMIDE

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Package leaflet: Information for the user

Casodex® 50mg 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.
The name of your medicine is Casodex
50mg film-coated tablets but it will be
referred as Casodex throughout this
leaflet.
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 antihistamine 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.
 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.

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 anticoagulants).
 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, 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.
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.
Rare (may affect up to 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:
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 out of the sight and reach of
children.
Do not store above 30°C.
Store in the original package.
Do not take the tablets after the expiry
date which is stated on the carton and
blister labels after ‘Exp’. The expiry
date refers to the last day of that month.
If the tablet becomes discoloured or
shows any kind of deterioration, seek
the advice of your pharmacist.
Remember if your doctor tells you to
stop taking this medicine, return any
unused medicine to your pharmacist for
safe disposal. Only keep this medicine
if your doctor tells you to.
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. Contents of the pack and other
information
What Casodex contains
Each film-coated tablet contains 50mg
of the active ingredient bicalutamide.
The other ingredients are: lactose
monohydrate, carboxymethyl amide
sodium A, magnesium stearate,
hypromellose, macrogol 300, povidone,
and titanium dioxide (E171).
What Casodex looks like and
contents of the pack
Casodex is round, biconvex, white,
film-coated tablets embossed with
'CDX 50' on one side and a logo on the
other side.
Casodex are supplied in calendar
packs of 28 tablets.
Manufactured by: Corden Pharma
GmbH, Plankstadt, Germany.
OR
AstraZeneca, Reims, Cedex, France.
OR
CIT S.r.l., via Primo Villa 17, 20040
Burago di Molgora (MB), Italy.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Casodex® 50mg film-coated tablets;
PL 18799/0624
POM
Leaflet date: 30.11.2017
Casodex is a registered trademark of
the AstraZeneca UK Limited.

Blind or partially
sighted?
Is this leaflet hard to see
or read?
Call 0208 515 3763 to
obtain the leaflet in a
format suitable for you.

if you
Package leaflet: Informationdoctor
for the
userhave any questions
about birth
control.
Bicalutamide 50mg film-coated
tablets
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.
The name of your medicine is
Bicalutamide 50mg film-coated tablets
but it will be referred as Bicalutamide
throughout this leaflet.
What is in this leaflet:
1. What Bicalutamide is and what it is
used for
2. What you need to know before you
take Bicalutamide
3. How to take Bicalutamide
4. Possible side effects
5. How to store Bicalutamide
6. Contents of the pack and other
information
1. What Bicalutamide is and what it
is used for
Bicalutamide contains a medicine
called bicalutamide. This belongs to a
group of medicines called ‘antiandrogens’.
 Bicalutamide 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 Bicalutamide
Do not take Bicalutamide:
 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 antihistamine medicines (terfenadine or
astemizole).
 if you are a woman.
Do not take Bicalutamide if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
taking Bicalutamide.
Bicalutamide must not be given to
children.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Bicalutamide:
 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
Bicalutamide.
 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
Bicalutamide.
 if you are taking Bicalutamide, you
and/or your partner should use birth
control while you are taking
Bicalutamide and for 130 days after
stopping Bicalutamide. Talk to your

Other medicines and Bicalutamide
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 Bicalutamide can affect the
way other medicines work. Also some
other medicines can affect the way
Bicalutamide works.
Do not take Bicalutamide if you are
already taking any of the following
medicines:
 Cisapride (used for some types of
indigestion).
 Certain anti-histamine medicines
(terfenadine or astemizole).
Bicalutamide 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 anticoagulants).
 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
Bicalutamide 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.
Bicalutamide contains lactose
Bicalutamide contains lactose, 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 Bicalutamide
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 Bicalutamide than
you should
If you take more Bicalutamide than
prescribed by your doctor, talk to a
doctor or go to a hospital straight away.
If you forget to take Bicalutamide
 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.
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.
Rare (may affect up to 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:
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 Bicalutamide
Keep out of the sight and reach of
children.
Do not store above 30°C.
Store in the original package.
Do not take the tablets after the expiry
date which is stated on the carton and
blister labels after ‘Exp’. The expiry
date refers to the last day of that month.
If the tablet becomes discoloured or
shows any kind of deterioration, seek
the advice of your pharmacist.
Remember if your doctor tells you to
stop taking this medicine, return any
unused medicine to your pharmacist for
safe disposal. Only keep this medicine
if your doctor tells you to.
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. Contents of the pack and other
information
What Bicalutamide contains
Each film-coated tablet contains 50mg
of the active ingredient bicalutamide.
The other ingredients are: lactose
monohydrate, carboxymethyl amide
sodium A, magnesium stearate,
hypromellose, macrogol 300, povidone,
and titanium dioxide (E171).
What Bicalutamide looks like and
contents of the pack
Bicalutamide is round, biconvex, white,
film-coated tablets embossed with
'CDX 50' on one side and a logo on the
other side.
Bicalutamide are supplied in calendar
packs of 28 tablets.
Manufactured by: Corden Pharma
GmbH, Plankstadt, Germany.
OR
AstraZeneca, Reims, Cedex, France.
OR
CIT S.r.l., via Primo Villa 17, 20040
Burago di Molgora (MB), Italy.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Bicalutamide 50mg film-coated
tablets; PL 18799/0624
POM
Leaflet date: 30.11.2017

Blind or partially
sighted?
Is this leaflet hard to see
or read?
Call 0208 515 3763 to
obtain the leaflet in a
format suitable for you.

+ Expand Transcript

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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