BICALUTAMIDE 150MG FILM COATED TABLETS

Active substance: BICALUTAMIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

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 reach and sight 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

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.

Each tablet contains 150mg of bicalutamide.

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

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).

In this leaflet:

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

MAR
TUE

MER
WED

GIO
THUR

VEN
FRI

SAB
SAT

DOM
SUN

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.

Do not take Casodex if:

Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU.
PL No: 18799/1972

1. What Casodex is and what it is used for

2. Before you take Casodex

Manufactured by: AstraZeneca GmbH, Plankstadt, Germany.

Casodex® 150mg Film-coated Tablets

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

POM

Leaflet date: 11.05.2012
Casodex is a registered trademark of the AstraZeneca Group of companies.

• 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 anti-histamine 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.

Take special care with Casodex
Check with your doctor before you take Casodex if:
• 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

4. Possible side effects

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.

Like all medicines, Casodex can cause side effects, although not everybody gets them.

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).
Also, tell your doctor 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).

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.

Important information about some of the ingredients of Casodex
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.

3. How to take Casodex
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.

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):
• 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’.
• Yellowing of the skin or whites of your eyes (jaundice). These may be signs of liver
damage.

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.
Being unable to get an erection (impotence).
Weight gain.
Reduced sex drive and reduced fertility.
Hair loss.
Hair regrowth 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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 reach and sight 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
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 come in calendar blister packs of 28 tablets.
Translation of the days of the week into English from Italian as given on the blister pack is
as follows:
MER
WED

GIO
THUR

VEN
FRI

SAB
SAT

Leaflet date: 11.05.2012

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

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

Do not take Bicalutamide if:

Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU.
PL No: 18799/1972

In this leaflet:

2. Before you take Bicalutamide

DOM
SUN

Manufactured by: AstraZeneca GmbH, Plankstadt, Germany

Bicalutamide® 150mg Film-coated Tablets

• 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.

1. What Bicalutamide is and what it is used for

Bicalutamide comes as round, biconvex, white, film-coated tablets marked with
‘Bicalutamide 150’ on one side and a 'logo' on the other side.

MAR
TUE

Read all of this leaflet carefully before you start taking this medicine.

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

What Bicalutamide contains

LUN
MON

Bicalutamide® 150mg Film-coated Tablets

POM

• 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 anti-histamine 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.
Bicalutamide must not be given to children.

Take special care with Bicalutamide
Check with your doctor before you take Bicalutamide if:
• 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

4. Possible side effects

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.

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.

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).
Also, tell your doctor 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).

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.

Also tell your doctor straight away if you notice any of the following:
Common (affects less than 1 in 10 people):
• 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’.
• Yellowing of the skin or whites of your eyes (jaundice). These may be signs of liver
damage.

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)

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.

• Hot flushes.
• Feeling sick (nausea).
• Itching.
• Dry skin.
• Being unable to get an erection (impotence).
• Weight gain.
• Reduced sex drive and reduced fertility.
• Hair loss.
• Hair regrowth 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.

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
(web3)