BICALUTAMIDE 50 mg Film-Coated Tablets

Зміст інструкції

1. Bicalutamide SUN 50 mg film-coated tablets
   1. What is Bicalutamide SUN and what is it used for
   2. What you need to know before you take Bicalutamide SUN
   3. How to take Bicalutamide SUN
   4. Possible side effects
   5. How to store Bicalutamide SUN
   6. Package Contents and Other Information
2. Bicalutamide SUN 150 mg film-coated tablets
   1. What is Bicalutamide SUN and what it is used for
   2. What you need to know before taking Bicalutamide SUN
   3. How to take Bicalutamide SUN
   4. Possible side effects
   5. How to store Bicalutamide SUN
   6. Contents of the pack and other information

Bicalutamide SUN 50 mg film-coated tablets

bicalutamide

Generic Medicine

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Bicalutamide SUN is and what it is used for
• 2. What you need to know before you take Bicalutamide SUN
• 3. How to take Bicalutamide SUN
• 4. Possible side effects
• 5. How to store Bicalutamide SUN
• 6. Contents of the pack and other information

1. What is Bicalutamide SUN and what is it used for

Bicalutamide SUN belongs to a group of medicines known as anti-androgens.
It works by blocking the effects of male hormones such as testosterone.
Bicalutamide SUN is used to treat advanced prostate cancer.

2. What you need to know before you take Bicalutamide SUN

Do not take Bicalutamide SUN

• if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6)
• if you are already taking terfenadine or astemizole (to treat allergies) or cisapride (to treat stomach disorders). Bicalutamide SUN should not be given to women, children and adolescents (see sections “How to use Bicalutamide SUN” and “Pregnancy, breastfeeding and fertility”). Do not take Bicalutamide SUN if any of the above conditions apply to you. If you are not sure, ask your doctor or pharmacist before taking Bicalutamide SUN.

Warnings and precautions
Talk to your doctor or pharmacist before using Bicalutamide SUN.
In particular, tell your doctor if you have any of the following conditions:

• if you have heart rhythm problems or are being treated for these conditions. The risk of heart rhythm problems may be increased when using Bicalutamide SUN.
• if you have moderate or severe liver problems. Your doctor will prescribe you regular tests to assess your liver function

The doctor will inform you about the need for effective contraception: you and your partner must use
adequate contraceptive measures during treatment with Bicalutamide SUN and for 130 days after
stopping treatment (see “Pregnancy, breastfeeding and fertility”).
Bicalutamide SUN may cause a period of sub-fertility or infertility following changes
morphological in male reproductive cells (sperm) (see “Pregnancy, breastfeeding and
fertility”).
See your doctor if your condition worsens and the PSA (a blood test used to assess
prostate function) is increased, as it may happen that treatment with
Bicalutamide SUN needs to be stopped.
You must use Bicalutamide SUN as prescribed by your doctor and do not stop treatment unless
told to do so by your doctor. If you are admitted to hospital, inform the medical staff that you are being treated
with Bicalutamide SUN.

Other medicines and Bicalutamide SUN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines because Bicalutamide SUN can affect the mechanism of action of other
medicines. Also, other medicines can affect the mechanism of action of Bicalutamide SUN.
Do not take Bicalutamide SUN if you are already taking any of the following medicines:

• cisapride (used to treat stomach disorders)
• terfenadine or astemizole (used to treat allergies). Bicalutamide SUN may interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, disopyramide, amiodarone, dofetilide, ibutilide and sotalol) or may increase the risk of heart rhythm problems when used with other medicines, such as methadone (used to treat severe pain and to treat withdrawal symptoms in case of addiction), moxifloxacin (an antibiotic used to treat infections caused by bacteria), antipsychotics (used for mental disorders). Tell your doctor or pharmacist if you are taking any of the following medicines:
• oral anticoagulants (medicines taken by mouth to prevent blood clots e.g. warfarin). Your doctor may prescribe blood tests before and during treatment with Bicalutamide SUN.
• cyclosporine (used to prevent and treat rejection of a transplanted organ or bone marrow or to treat autoimmune diseases)
• calcium channel blockers (used to treat high blood pressure or in some heart diseases)
• cimetidine (used to cure stomach ulcers)
• ketoconazole (used to treat infections caused by a fungus).

Pregnancy, breastfeeding and fertility
If you are pregnant, if you suspect, are planning a pregnancy or if you are breastfeeding with breast
milk ask your doctor or pharmacist for advice before using this medicine.

Pregnancy and breastfeeding
Bicalutamide SUN should not be taken by women (see
"Do not take Bicalutamide SUN").

Fertility
Bicalutamide SUN may have an effect on male fertility which may be reversible (see
"Warnings and precautions").

Contraception in women and men
You and your partner must use adequate contraceptive measures while taking Bicalutamide
SUN and for 130 days after stopping treatment (see
"Warnings and precautions").

Driving and using machines
As drowsiness may occur, Bicalutamide SUN may impair the ability to drive
vehicles and use machines.

Sunlight or ultraviolet (UV) light
Avoid exposure to excessive sunlight or UV rays while taking Bicalutamide
SUN.

Bicalutamide SUN contains lactose
Lactose is a type of sugar.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.

Bicalutamide SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially
“sodium-free”.

3. How to take Bicalutamide SUN

Always take this medicine exactly as your doctor has instructed. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is one tablet once a day.
Swallow the tablet whole with water
Try to take the tablet every day at the same time.

Use in children and adolescents
Bicalutamide SUN must not be administered to children and adolescents (see
"Do not take Bicalutamide SUN").

If you take more Bicalutamide SUN than you should
If you have taken more Bicalutamide SUN than prescribed by your doctor, contact a doctor or go
immediately to hospital.
Bring with you the remaining tablets or the packaging so that the doctor can identify what you have
taken.

If you forget to take Bicalutamide SUN
If you forget to take a dose, skip the missed dose and take the next dose at the usual
time. Do not take a double dose to make up for a missed dose.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you notice any of the following side effects, as you may need urgent medical attention:
Allergic reactions
These are uncommon side effects (may affect up to 1 in 100 people). Symptoms may include sudden onset of:

• skin rash, itching or hives
• swelling of the face, lips, tongue, throat or other parts of the body
• shortness of breath, wheezing or difficulty breathing. Very common(may affect more than 1 in 10 people)
• abdominal pain
• hematuria (blood in the urine). Common(may affect up to 1 in 10 people)
• jaundice (yellowing of the skin or whites of the eyes), hypertransaminasemia (unusually high levels of liver enzymes in the blood, which may be an indicator of liver dysfunction). These may be signs of liver problems or, in rare cases, liver failure (may affect up to 1 in 1,000); fatal outcomes have been reported. Uncommon(may affect up to 1 in 100 people)
• severe shortness of breath or worsening shortness of breath. This may occur with cough or fever. These may be signs of inflammation of the lungs called “interstitial lung disease”; fatal outcomes have been reported. Not known(frequency cannot be estimated based on available data)
• Prolongation of the QT interval (a heart rhythm disorder), see sections “Warnings and precautions” and “Other medicines and Bicalutamide SUN”).

Other possible side effects:
Very common(may affect more than 1 in 10 people)

• dizziness (a sensation of falling or spinning)
• constipation
• nausea (feeling sick)
• breast enlargement and tenderness
• hot flushes
• asthenia (feeling of weakness)
• edema (accumulation of fluid in a specific part of the body)
• anemia (reduction in the number of red blood cells or reduction in the concentration of hemoglobin, a protein present in red blood cells that carries oxygen). This may make you feel tired or look pale. Common(may affect up to 1 in 10 people)
• decreased appetite
• decreased libido (reduced sexual desire)
• depression
• drowsiness
• dyspepsia (difficult digestion)
• flatulence (excessive gas production by the intestine)
• alopecia (hair loss)
• hirsutism (hair on parts of the body where it is normally absent or minimal) / hair regrowth
• dry skin
• erectile dysfunction (problems getting an erection)
• weight gain
• chest pain
• reduced heart function
• heart attack, fatal outcomes have been reported. Rare(may affect up to 1 in 1000)
• photosensitivity reaction (increased sensitivity of the skin to sunlight).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. You can also report side effects directly through the national reporting system at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bicalutamide SUN

Keep out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Bicalutamide SUN contains

• The active ingredient is bicalutamide. One film-coated tablet contains 50 mg of bicalutamide.
• The other ingredients are: Tablet core: lactose monohydrate, magnesium stearate, sodium starch glycolate type A, povidone. Film coating: opadry II white (33F28627) containing hypromellose 6CP (E464), titanium dioxide (E171), macrogol 3000.

Description of the appearance of Bicalutamide SUN and package contents
Bicalutamide SUN 50 mg film-coated tablets are white to off-white, round,
biconvex, film-coated tablets, with ‘485’ imprinted on one side and smooth on the other; tablet
content: 50 mg of bicalutamide.
Bicalutamide SUN 50 mg film-coated tablets are available in packs of 28, 30 and 84
tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Legal Representative in Italy:
Sun Pharma Italia Srl
Viale Giulio Richard 1
20143 Milano

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Italy Bicalutamide SUN 50 mg film-coated tablets
United Kingdom (Northern Ireland) Bicalutamide 50 mg film-coated tablets

Bicalutamide SUN 150 mg film-coated tablets

bicalutamide

Generic Medicine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Bicalutamide SUN is and what it is used for
• 2. What you need to know before you take Bicalutamide SUN
• 3. How to take Bicalutamide SUN
• 4. Possible side effects
• 5. How to store Bicalutamide SUN
• 6. Contents of the pack and other information

2. What is Bicalutamide SUN and what it is used for

Bicalutamide SUN belongs to a group of medicines known as antiandrogens.
It works by blocking the effects of male hormones such as testosterone and inhibits the growth of
cells in the prostate.
Bicalutamide SUN 150 mg can be used alone but also as part of a treatment in
combination with patients whose prostate has been removed. Furthermore, it is used in association with
radiotherapy in the treatment of prostate cancer, where the cancer has spread from the capsule of the
prostate gland to the nearby surrounding tissue. These patients are at high risk of
cancer spread.

4. What you need to know before taking Bicalutamide SUN

Do not take Bicalutamide SUN

• if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6)
• if you are already taking terfenadine or astemizole (to treat allergies) or cisapride (to treat stomach disorders). Bicalutamide SUN must not be administered to women, children and adolescents (see “How to take Bicalutamide SUN” and “Pregnancy, breastfeeding and fertility”). Do not take Bicalutamide SUN if any of the above conditions apply to you. If you are unsure, ask your doctor or pharmacist before taking Bicalutamide SUN.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide SUN.
In particular, tell your doctor if you have any of the following conditions:

• if you have heart rhythm problems or are being treated for these conditions. The risk of heart rhythm problems may be increased when using Bicalutamide SUN.
• if you have moderate or severe liver problems, your doctor will prescribe you regular tests to assess liver function. The doctor will inform you of the need for effective contraception: you and your partner must use adequate contraceptive measures during treatment with Bicalutamide SUN and for 130 days after stopping treatment (see "Pregnancy, breastfeeding and fertility"). Bicalutamide SUN may cause a period of sub-fertility or infertility due to morphological changes in male reproductive cells (sperm), see "Pregnancy, breastfeeding and fertility". Contact your doctor if your condition worsens and the PSA (a blood test used to assess prostate function) is increased, as it may happen that treatment with Bicalutamide SUN 150 mg may be interrupted. You must use Bicalutamide SUN 150 mg as prescribed by your doctor and do not stop treatment unless your doctor tells you to. If you are hospitalized, inform the medical staff that you are being treated with Bicalutamide SUN 150 mg.

Other medicines and Bicalutamide SUN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Do not take Bicalutamide SUN if you are already taking any of the following medicines:

• cisapride (used for the treatment of stomach disorders)
• terfenadine or astemizole (used to treat allergies). Bicalutamide SUN may interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or may increase the risk of heart rhythm problems when used with some other medicines, such as methadone (used to treat severe pain and to treat withdrawal symptoms in case of dependence), moxifloxacin (an antibiotic used to treat infections caused by bacteria), antipsychotics (used for mental disorders). Tell your doctor or pharmacist if you are taking any of the following medicines:
• oral anticoagulants (medicines taken by mouth to prevent blood clots, e.g. warfarin). Your doctor may prescribe blood tests before and during treatment with Bicalutamide SUN
• cyclosporine (used to prevent and treat rejection of a transplanted organ or bone marrow or to treat autoimmune diseases)
• calcium channel blockers (used for the treatment of high blood pressure or in some heart diseases)
• cimetidine (used to cure stomach ulcers)
• ketoconazole (used to treat infections caused by a fungus).

Pregnancy, breastfeeding and fertility
If you are pregnant, if you suspect you are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy and breastfeeding
Bicalutamide SUN should not be taken by women (see "Do not take Bicalutamide SUN").

Fertility
Bicalutamide SUN may have an effect on male fertility which may be reversible (see
"Warnings and precautions").

Contraception in women and men
You and your partner must use adequate contraceptive measures during the intake of Bicalutamide
SUN and for 130 days after stopping treatment (see "Warnings and precautions").

Driving and operating machinery
As drowsiness may occur, Bicalutamide SUN may impair the ability to drive
vehicles and operate machinery.

Sunlight or Ultraviolet (UV) light
Avoid direct exposure to excessive sunlight or UV light while taking
Bicalutamide SUN.

Bicalutamide SUN contains lactose
Lactose is a type of sugar
If your doctor has diagnosed you with an intolerance to some sugars, contact him/her before taking
this medicine.

Bicalutamide SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially
“sodium-free”.

5. How to take Bicalutamide SUN

Always take as your pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is one tablet once a day.
Swallow the tablet whole with water.
Try to take the tablet every day at the same time.

Use in children and adolescents
Bicalutamide SUN must not be given to children and adolescents (see
“Do not take Bicalutamide SUN”).

If you take more Bicalutamide SUN than you should
If you have taken more Bicalutamide SUN than prescribed by your doctor, contact a doctor or go to
hospital immediately. Bring with you any remaining tablets or the packaging so that the
doctor can identify what you have taken.

If you forget to take Bicalutamide SUN
If you forget to take a dose, skip the missed dose and take the next dose at the usual
time. Do not take a double dose to make up for a missed dose.
If you have further questions on the use of this medicine, ask your doctor or pharmacist.

If you stop taking Bicalutamide SUN
Do not stop taking the film-coated tablets even if you feel better, without
consulting your doctor. If you have any doubts about the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately inform your doctor if you notice any of the following side effects, as you may require urgent medical attention:
Allergic reactions
These are uncommon side effects (may affect up to 1 in 100 users). Symptoms may include sudden onset of:

• skin rash, itching or hives
• swelling of the face, lips, tongue, throat or other parts of the body
• shortness of breath, wheezing or difficulty breathing. Common(may affect more than 1 in 10 people)
• jaundice (yellowing of the skin or whites of the eyes), hypertransaminasemia (unusually high levels of liver enzymes in the blood, which may be an indicator of liver dysfunction). These may be signs of liver problems or, in rare cases, liver failure (may affect up to 1 in 1,000); fatal outcomes have been reported.
• abdominal pain
• hematuria (blood in the urine). Uncommon(may affect up to 1 in 100 people)
• severe shortness of breath or worsening shortness of breath. This may occur with cough or fever. These may be signs of lung inflammation called “interstitial lung disease”. Not known(frequency cannot be estimated based on available data)
• prolongation of the QT interval (a heart rhythm disorder), see “Warnings and precautions” and “Other medicines and Bicalutamide SUN)

Other possible side effects:
Very common(may affect more than 1 in 10 people)

• breast swelling and tenderness
• asthenia (feeling of weakness). Common(may affect up to 1 in 10 people)
• hot flushes
• nausea (feeling sick)
• dry skin
• erectile dysfunction (problems getting an erection)
• weight gain
• decreased libido (reduced sexual desire)
• alopecia (hair loss)
• hirsutism (hair on parts of the body where it is normally absent or minimal) / hair regrowth or increased hair growth
• anemia (reduction in the number of red blood cells or reduction in the concentration of hemoglobin, a protein present in red blood cells that carries oxygen). This may make you feel tired or look pale
• decreased appetite
• depression
• somnolence (feeling sleepy)
• dyspepsia (difficult digestion)
• dizziness (feeling of falling or spinning)
• constipation
• flatulence (excessive gas production by the intestine)
• chest pain
• edema (accumulation of fluid in a particular part of the body). Rare(may affect up to 1 in 1,000)
• photosensitivity reaction (increased sensitivity of the skin to sunlight).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bicalutamide SUN

Keep out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and the carton after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bicalutamide SUN contains

• The active substance is bicalutamide. One film-coated tablet contains 150 mg of bicalutamide.
• The other ingredients are: Tablet core: lactose monohydrate, magnesium stearate, sodium starch glycolate type A, povidone. Film coating: opadry II white (33F28627) containing hypromellose 6CP (E464), titanium dioxide (E171), macrogol 3000.

Description of the appearance of Bicalutamide SUN and contents of the pack
Bicalutamide SUN 150 mg film-coated tablets are white to off-white, round,
biconvex, film-coated tablets, with ‘507’ imprinted on one side and smooth on the other; tablet content:
150 mg of bicalutamide.
Bicalutamide SUN 150 mg film-coated tablets are available in packs of 28, 30 and 84
tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Legal Representative for Italy:
Sun Pharma Italia Srl
Viale Giulio Richard 1
20143 Milano

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Italy Bicalutamide SUN 150 mg film-coated tablets
United Kingdom (Northern Ireland) Bicalutamide 150 mg film-coated tablets