BICALUTAMIDE 150MG FILM COATED TABLETS

Active substance: BICALUTAMIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Casodex® 150mg
Film-coated Tablets
(bicalutamide)

Read all of this leaflet
carefully before you start
taking this medicine.
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
pharmacist.
The name of your medicine is
Casodex 150mg Film-coated
Tablets but will be referred to as
Casodex throughout this leaflet.

Also, tell your doctor if you are
taking any of the following
medicines:
Medicines taken by mouth to
prevent blood clots (oral anticoagulants). Your doctor may do
blood tests before and during your
treatment with Casodex.
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 your
ability to drive or use any tools or
machines.
However, some people may
occasionally feel sleepy while
taking Casodex. If this happens to
you, ask your doctor or pharmacist
for advice.

In this leaflet:

Important information about
some of the ingredients of
Casodex

1. What Casodex is and what it is
used for
2. Before you take Casodex
3. How to take Casodex
4. Possible side effects
5. How to store Casodex
6. Further information

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.

1. What Casodex is and
what it is used for

3. How to take Casodex

Casodex contains a medicine called
bicalutamide. This belongs to a
group of medicines called ‘antiandrogens’.
Casodex is used to treat prostate
cancer.
It works by blocking the effects of
male hormones such as
testosterone.

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

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 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 (two
doses at the same time) to make
up for a forgotten dose.
Translation of the days of the week
into English from Italian as given on
the blister pack is as follows:

Take special care with
Casodex

LUN

Check with your doctor before you
take Casodex if:

MON

You 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
medicines:
Cisapride (used for some types of
indigestion).
Certain anti-histamine medicines
(terfenadine or astemizole).

MAR
VEN
TUE
FRI

MER
SAB
WED
SAT

GIO
DOM
THUR
SUN

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
breasts.
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
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.
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.
Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse.
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
Do not store above 30°C.
Keep your tablets in the original
pack.
If your doctor decides to stop your
treatment, return your unused
tablets to your pharmacist.
Do not take your tablets after the
expiry date on the pack.
Keep out of the sight and reach of
children. Your tablets could harm
them.
If your tablets become discoloured
or show any signs of deterioration,
seek the advice of your
pharmacist.

6. Further information
What Casodex contains
Each tablet contains 150mg of
bicalutamide.
Each tablet contains a number of
inactive ingredients which allow it to
be made. These are lactose
monohydrate, carboxymethyl
amidon sodium, povidone,
magnesium stearate, hypromellose,
macrogol 300 and titanium dioxide
(E171).
Warning: Lactose: If you have
been told by your doctor that you
have an intolerance to some sugars,
contact your doctor before taking
this medicinal product.

What Casodex looks like and
contents of the pack
Casodex comes as round, biconvex,
white, film-coated tablets marked
with ‘casodex 150’ on one side and
a 'logo' on the other side.
Casodex come in calendar blister
packs of 28 tablets.
Manufactured by: Corden Pharma
GmbH, Plankstadt, Germany.
Procured from within the EU and
repackaged by the Product
Licence holder:
B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU.
®

Casodex 150mg Film-coated
Tablets
PL No: 18799/1972
POM
Leaflet date: 09.04.2014
Casodex is a registered trademark
of the AstraZeneca Group of
companies.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Bicalutamide 150mg
Film-coated Tablets
Read all of this leaflet
carefully before you start
taking this medicine.
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
pharmacist.
The name of your medicine is
Bicalutamide 150mg Film-coated
Tablets but will be referred to as
Bicalutamide throughout this leaflet.

In this leaflet:
1. What Bicalutamide is and what it
is used for
2. Before you take Bicalutamide
3. How to take Bicalutamide
4. Possible side effects
5. How to store Bicalutamide
6. Further 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. Before you take
Bicalutamide
Do not take Bicalutamide if:
You are allergic (hypersensitive) to
bicalutamide or any of the other
ingredients of this medicine (listed
in Section 6: Further information).
You are already taking a medicine
called cisapride or certain antihistamine medicines (terfenadine
or astemizole).
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.

Also, tell your doctor if you are
taking any of the following
medicines:
Medicines taken by mouth to
prevent blood clots (oral anticoagulants). Your doctor may do
blood tests before and during your
treatment with Bicalutamide.
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
your ability to drive or use any
tools or machines.
However, some people may
occasionally feel sleepy while
taking Bicalutamide. If this
happens to you, ask your doctor or
pharmacist for advice.

Important information about
some of the ingredients of
Bicalutamide
Bicalutamide 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 Bicalutamide
Always take Bicalutamide 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 Bicalutamide
than you should
If you take more Bicalutamide than
you should, 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.

Bicalutamide must not be given to
children.

Translation of the days of the week
into English from Italian as given on
the blister pack is as follows:

Take special care with
Bicalutamide

LUN

Check with your doctor before you
take Bicalutamide if:

MON

You have problems with your liver.
Your doctor may do blood tests
before and during your treatment
with Bicalutamide.
If you go into hospital, tell the
medical staff that you are taking
Bicalutamide.

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 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).

MAR
VEN
TUE
FRI

MER
SAB
WED
SAT

GIO
DOM
THUR
SUN

4. Possible side effects
Like all medicines, Bicalutamide 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
breasts.
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
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.
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.
Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse.
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
Bicalutamide
Do not store above 30°C.
Keep your tablets in the original
pack.
If your doctor decides to stop your
treatment, return your unused
tablets to your pharmacist.
Do not take your tablets after the
expiry date on the pack.
Keep out of the sight and reach of
children. Your tablets could harm
them.
If your tablets become discoloured
or show any signs of deterioration,
seek the advice of your
pharmacist.

6. Further information
What Bicalutamide contains
Each tablet contains 150mg of
bicalutamide.
Each tablet contains a number of
inactive ingredients which allow it to
be made. These are lactose
monohydrate, carboxymethyl
amidon sodium, povidone,
magnesium stearate, hypromellose,
macrogol 300 and titanium dioxide
(E171).
Warning: Lactose: If you have
been told by your doctor that you
have an intolerance to some sugars,
contact your doctor before taking
this medicinal product.

What Bicalutamide looks like
and contents of the pack
Bicalutamide comes as round,
biconvex, white, film-coated tablets
marked with ‘casodex 150’ on one
side and a 'logo' on the other side.
Bicalutamide come in calendar
blister packs of 28 tablets.
Manufactured by: Corden Pharma
GmbH, Plankstadt, Germany.
Procured from within the EU and
repackaged by the Product
Licence holder:
B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU.
Bicalutamide 150mg Film-coated
Tablets
PL No: 18799/1972
POM
Leaflet date: 09.04.2014

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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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