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BICALUTAMIDE 150 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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Patient leaflet - BICALUTAMIDE 150 MG FILM-COATED TABLETS

H What Bicalutamide is and what it is used for

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.

©

H 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 a woman
  • if you are already taking containing medicine called cisapride or certain antihistamine 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.

Warning 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 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 doctor if you have any questions about birth control.

  • If you go into hospital, tell the medical staff that you are taking Bicalutamide.

Sunlight or Ultraviolet (UV) light

Avoid direct exposure to excessive sunlight or UV light while 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 or 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-histamines (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).

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). Blood thinners or medicines to prevent blood clots. 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).

Pregnancy, breast-feeding and fertility

  • 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.

Bicalutamide contains lactose

If you have been told by your doctor that you have an intolerance to some sugars , contact your doctor before you take this medicinal product.

Bicalutamide contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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 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.

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Length:

Width:

Depth:


280 mm

160 mm


Colours Used:


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BLACK


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 stop taking Bicalutamide

Do not stop taking the medicine even if you feel absolutely healthy, unless your doctor tells you to.

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

r4

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 to1 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: 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 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: 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.

How to store Bicalutamide

Keep this medicine out of the sight and reach of children.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the blister and outer packaging. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

jg^ Contents of the pack and other information

What Bicalutamide contains

  • – The active substance is bicalutamide. Each film-coated tablet contains 150 mg bicalutamide.

  • – The other ingredients are:

Core : Microcrystalline cellulose, povidone, croscarmellose sodium, sodium lauryl sulfate, lactose monohydrate, anhydrous colloidal silica, magnesium stearate,

Coating : Hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), macrogol 4000.

What Bicalutamide looks like and contents of the pack

Bicalutamide 150 mg Film-coated Tablets are white to off-white biconvex film-coated tablets, debossed with “BCL” on one side and plain on the other.

Package sizes: 20, 28, 30, 40, 56, 60, 84, 90 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and Manufacturer Marketing Authorisation holder

TEVA UK Limited, Eastbourne, BN22 9AG.

Manufacturer

Teva Pharmaceutical Works Private Limited Company, 13 Pallagi H-4042, Debrecen, Hungary.

This leaflet was last revised in August 2020

PL 00289/0981

TFTTTI EAS5091a

ZINC Ref: EAS3550b LEA BICALUTAMIDE 150MG FC TAB TUK

Version: 1 15 September 2020

te«a

UK & Ireland Artwork Department

Length: 210 mm

Width: 160 mm

Colours Used: 1_______Template _______1

^^^BLAC^^M

■PANTONE®GREENd

PAGE 1: FRONT FACE (INSIDE OF REEL)

Bicalutamide 150 mg Film-coated Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

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 ‘anti-androgens’.

  • 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 a woman
  • if you are already taking containing medicine called cisapride or certain antihistamine 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.

Warning 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 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 doctor if you have any questions about birth control.

  • If you go into hospital, tell the medical staff that you are taking Bicalutamide.

Sunlight or Ultraviolet (UV) light

Avoid direct exposure to excessive sunlight or UV light while 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 or 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-histamines (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).

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). Blood thinners or medicines to prevent blood clots. 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).

Pregnancy, breast-feeding and fertility

  • 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.

Bicalutamide contains lactose

If you have been told by your doctor that you have an intolerance to some sugars , contact your doctor before you take this medicinal product.

Bicalutamide contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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 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.

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ZINC Ref: EAS3550b LEA BICALUTAMIDE 150MG FC TAB TUK

Version: 1 15 September 2020

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UK & Ireland Artwork Department

Length: 210 mm

Width: 160 mm

Colours Used: 1_______Template _______1

^^^BLAC^^M

■PANTONE®GREENd

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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 stop taking Bicalutamide

Do not stop taking the medicine even if you feel absolutely healthy, unless your doctor tells you to.

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

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 to1 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: 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 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: 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.

How to store Bicalutamide

Keep this medicine out of the sight and reach of children.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the blister and outer packaging. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Bicalutamide contains

  • – The active substance is bicalutamide. Each film-coated tablet contains 150 mg bicalutamide.

  • – The other ingredients are:

What Bicalutamide looks like and contents of the pack

Bicalutamide 150 mg Film-coated Tablets are white to off-white biconvex film-coated tablets, debossed with “BCL” on one side and plain on the other.

Package sizes: 20, 28, 30, 40, 56, 60, 84, 90 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and Manufacturer Marketing Authorisation holder

TEVA UK Limited, Eastbourne, BN22 9AG.

Manufacturer

Teva Pharmaceutical Works Private Limited Company, 13 Pallagi H-4042, Debrecen, Hungary.

This leaflet was last revised in August 2020

PL 00289/0981

TFTTTI EAS5091a

ZINC Ref: EAS3550b LEA BICALUTAMIDE 150MG FC TAB TUK

Version: 1 15 September 2020

te«a

UK & Ireland Artwork Department

Length: 210 mm

Width: 160 mm

Colours Used: 1_______Template _______1

^^^BLAC^^M

■PANTONE®GREENd

PAGE 1: FRONT FACE (INSIDE OF REEL)

Bicalutamide 150 mg Film-coated Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

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 ‘anti-androgens’.

  • 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 a woman
  • if you are already taking containing medicine called cisapride or certain antihistamine 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.

Warning 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 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 doctor if you have any questions about birth control.

  • If you go into hospital, tell the medical staff that you are taking Bicalutamide.

Sunlight or Ultraviolet (UV) light

Avoid direct exposure to excessive sunlight or UV light while 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 or 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-histamines (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).

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). Blood thinners or medicines to prevent blood clots. 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).

Pregnancy, breast-feeding and fertility

  • 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.

Bicalutamide contains lactose

If you have been told by your doctor that you have an intolerance to some sugars , contact your doctor before you take this medicinal product.

Bicalutamide contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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 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.

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M o B B

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ZINC Ref: EAS3550b LEA BICALUTAMIDE 150MG FC TAB TUK

Version: 1 15 September 2020

te«a

UK & Ireland Artwork Department

Length: 210 mm

Width: 160 mm

Colours Used: 1_______Template _______1

^^^BLAC^^M

■PANTONE®GREENd

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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 stop taking Bicalutamide

Do not stop taking the medicine even if you feel absolutely healthy, unless your doctor tells you to.

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

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 to1 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: 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 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: 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.

How to store Bicalutamide

Keep this medicine out of the sight and reach of children.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the blister and outer packaging. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Bicalutamide contains

  • – The active substance is bicalutamide. Each film-coated tablet contains 150 mg bicalutamide.

  • – The other ingredients are: