Skip to Content

BICALUTAMIDE 150MG FILM COATED TABLETS

Active substance(s): BICALUTAMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
®

Casodex 150mg 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.

Do not take Casodex if you are already taking any of
the following medicines:
Cisapride (used for some types of indigestion).
Certain anti-histamines (terfenadine or astemizole).

The name of your medicine is Casodex 150mg
Film-coated Tablets but will be referred to as Casodex
throughout this leaflet.

Tell your doctor or pharmacist 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.
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).

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 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 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.

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 illness).

Pregnancy and breast-feeding
Casodex must not be given to a woman.
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.
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 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.
Translation of the days of the week into English from
Italian as given on the blister pack is as follows:
LUN MAR MER GIO VEN SAB DOM
MON TUE WED THUR FRI SAT SUN

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 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.
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.
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,
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
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 label after ‘Exp’.
The expiry date refers to the last day of that month
If the tablet becomes discoloured or show any signs
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 no longer
required. These measures will help to protect the
environment.

6. Contents of the pack and other
information
What Casodex contains
The active ingredient in Casodex is bicalutamide.
Each tablet contains 150mg bicalutamide.
The other ingredients are lactose monohydrate,
carboxymethyl amidon sodium, povidone, magnesium
stearate, hypromellose, macrogol 300 and
titanium dioxide (E171).
What Casodex looks like and contents of the pack
Casodex is round, biconvex, white, film-coated tablet
marked with ‘casodex 150’ on one side and a 'logo' on
the other side.
Casodex is available 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, UK.
Casodex® 150mg Film-coated Tablets
PL 18799/1972
Leaflet date: 21.06.2016

POM

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 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.

Do not take Bicalutamide if you are already taking any
of the following medicines:
Cisapride (used for some types of indigestion).
Certain anti-histamines (terfenadine or astemizole).

The name of your medicine is Bicalutamide 150mg
Film-coated Tablets but will be referred to as
Bicalutamide throughout this leaflet.

Tell your doctor or pharmacist 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
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).

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 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).
Bicalutamide must not be given to children.
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Bicalutamide:
if you have problems with your liver. Your doctor
may do blood tests before and during your
treatment with 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 go into hospital, tell the medical staff that you are
taking Bicalutamide.
Children and adolescents
Bicalutamide 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 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.

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 illness).

Pregnancy and breast-feeding
Bicalutamide must not be given to a woman.
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.
Sunlight or Ultraviolet (UV) light
Avoid direct exposure to excessive sunlight or UV-light
while you are taking Bicalutamide.
Bicalutamide 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 Bicalutamide
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
Bicalutamide must not be given to children.
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
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.
Translation of the days of the week into English from
Italian as given on the blister pack is as follows:
LUN MAR MER GIO VEN SAB DOM
MON TUE WED THUR FRI SAT SUN

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 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.
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.
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,
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
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 blisters label after ‘Exp’.
The expiry date refers to the last day of that month
If the tablet becomes discoloured or show any signs
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 no longer
required. These measures will help to protect the
environment.

6. Contents of the pack and other
information
What Bicalutamide contains
The active ingredient in Bicalutamide is bicalutamide.
Each tablet contains 150mg bicalutamide.
The other ingredients are lactose monohydrate,
carboxymethyl amidon sodium, povidone, magnesium
stearate, hypromellose, macrogol 300 and
titanium dioxide (E171).
What Bicalutamide looks like and contents of the
pack
Bicalutamide is round, biconvex, white, film-coated
tablet marked with ‘casodex 150’ on one side and a
'logo' on the other side.
Bicalutamide is available in 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, UK.
Bicalutamide 150mg Film-coated Tablets
PL 18799/1972
Leaflet date: 21.06.2016

POM

Expand view ⇕

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.

Hide