Bicalutamide Sun: detailed information

Package leaflet: Information for the user

Bicalutamide SUN 50 mg film-coated tablets

bicalutamide
Generic Medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Bicalutamide SUN is and what it is used for
What you need to know before taking Bicalutamide SUN
How to take Bicalutamide SUN
Possible side effects
How to store Bicalutamide SUN
Contents of the pack and other information

1. What Bicalutamide SUN is and what it is 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 taking Bicalutamide SUN

Do not take Bicalutamide SUN

if you are allergic to bicalutamide or to any of the other ingredients of this medicine (listed in section 6)
if you are already taking terfenadine or astemizole (for treating allergies) or cisapride (for treating stomach disorders). Bicalutamide SUN must not be administered to women, children or 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 unsure, consult your doctor or pharmacist before taking Bicalutamide SUN.

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

if you have heart rhythm problems or are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when using Bicalutamide SUN.
if you have moderate or severe liver problems. Your doctor will regularly prescribe tests to assess liver function.

Your doctor will advise you on 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 subfertility or infertility due to morphological changes in male reproductive cells (sperm) (see “Pregnancy, breastfeeding and fertility”).
Contact your doctor if your condition worsens and your PSA (a blood test used to evaluate prostate function) increases, as it may be necessary to discontinue treatment with Bicalutamide SUN.
You must take Bicalutamide SUN exactly as prescribed by your doctor and must not stop treatment unless instructed 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, because Bicalutamide SUN may affect the way other medicines work. Other medicines may also affect the 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 withdrawal symptoms in addiction), moxifloxacin (an antibiotic used to treat bacterial infections), antipsychotics (used for mental disorders). Inform 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 transplanted organs or bone marrow or to treat autoimmune diseases)
calcium channel blockers (used to treat high blood pressure or certain heart conditions)
cimetidine (used to treat stomach ulcers)
ketoconazole (used to treat fungal infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy and breastfeeding
Bicalutamide SUN must not be taken by women (see "Do not take Bicalutamide SUN").
Fertility
Bicalutamide SUN may affect 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 treatment with 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 your ability to drive or operate machinery.

Sunlight or ultraviolet (UV) light
Avoid excessive direct exposure to 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 him or 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”.

3. How to take Bicalutamide SUN

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

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 to hospital immediately.
Take the remaining tablets or the packaging with you so that the doctor can identify what has been 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 your usual time. Do not take a double dose to make up for the forgotten dose.

If you have further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately tell your doctor if you notice any of the following side effects – you may need urgent
medical treatment:
Allergic reactions
These are uncommon side effects (may affect up to 1 in 100 people). Symptoms may 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 difficulty breathing

Very common (may affect more than 1 in 10 people)

abdominal pain
haematuria (blood in the urine)

Common (may affect up to 1 in 10 people)

jaundice (yellowing of the skin or whites of the eyes), hypertransaminasaemia (unusually high levels of liver enzymes in the blood which may indicate liver dysfunction). These may be signs of liver problems or, in rare cases, liver failure (may affect up to 1 in 1,000 people); fatal outcomes have been reported.

Uncommon (may affect up to 1 in 100 people)

severe shortness of breath or worsening breathlessness that suddenly worsens. This may occur with cough or fever. These may be signs of a lung inflammation called "interstitial lung disease"; fatal outcomes have been reported.

Not known (frequency cannot be estimated from the available data)

QT interval prolongation (a disturbance in heart rhythm) – 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 (feeling of falling or movement)
constipation
nausea (feeling unwell)
breast swelling and tenderness
hot flushes
asthenia (feeling of weakness)
oedema (fluid accumulation in a specific part of the body)
anaemia (reduction in the number of red blood cells or reduction in haemoglobin concentration, a protein 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
somnolence (sleepiness)
dyspepsia (indigestion)
flatulence (excessive intestinal gas production)
alopecia (hair loss)
hirsutism (excessive hair growth in areas where hair is normally minimal or absent) / hair regrowth
dry skin
erectile dysfunction (problems achieving an erection)
weight gain
chest pain
reduced heart function
heart attack; fatal outcomes have been reported.

Rare (may affect up to 1 in 1,000 people)

photosensitivity reaction (increased skin sensitivity to sunlight).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via 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 this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater 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 substance is bicalutamide. One film-coated tablet contains 50 mg of bicalutamide.
The other components 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 pack contents
Bicalutamide SUN 50 mg film-coated tablets are white to off-white, round, biconvex, film-coated tablets, marked with '485' on one side and plain on the other; tablet content: 50 mg of bicalutamide.
Bicalutamide SUN 50 mg film-coated tablets are available in packs containing 28, 30 or 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Legal representative in Italy:
Sun Pharma Italia Srl
Viale Giulio Richard 1
20143 Milano
This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Italy: Bicalutamide SUN 50 mg film-coated tablets
United Kingdom (Northern Ireland): Bicalutamide 50 mg film-coated tablets

Package leaflet: Information for the user

Bicalutamide SUN 150 mg film-coated tablets

bicalutamide
Generic Medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Bicalutamide SUN is and what it is used for
What you need to know before taking Bicalutamide SUN
How to take Bicalutamide SUN
Possible side effects
How to store Bicalutamide SUN
Contents of the pack and other information

2. What Bicalutamide SUN is 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
prostate cells.
Bicalutamide SUN 150 mg can be used alone or as part of a combined treatment in patients who have had their prostate removed. It is also used in combination with radiotherapy for the treatment of prostate cancer that has spread from the prostate gland capsule to nearby surrounding tissue. These patients are at high risk of cancer progression.

4. What you need to know before taking Bicalutamide SUN

Do not take Bicalutamide SUN

if you are allergic to bicalutamide or to any of the other ingredients of this medicine (listed in section 6)
if you are already taking terfenadine or astemizole (for treating allergies) or cisapride (for treating stomach disorders). Bicalutamide SUN must not be administered to women, children, or 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, consult your doctor or pharmacist before taking Bicalutamide SUN.

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

if you have heart rhythm problems or are being treated with medicines for such conditions. The risk of heart rhythm disturbances may be increased when using Bicalutamide SUN.
if you have moderate or severe liver problems, your doctor will regularly prescribe tests to assess liver function. Your doctor will advise 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 subfertility or infertility due to morphological changes in male reproductive cells (sperm); see "Pregnancy, breastfeeding and fertility". Contact your doctor if your condition worsens and your PSA (a blood test used to evaluate prostate function) increases, as treatment with Bicalutamide SUN 150 mg may need to be discontinued. You must take Bicalutamide SUN 150 mg exactly as prescribed by your doctor and must not stop treatment unless instructed by your doctor. If you are admitted to hospital, inform medical staff that you are being treated with Bicalutamide SUN 150 mg.

Other medicines and Bicalutamide SUN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 certain medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disturbances when used with certain other medicines, such as methadone (used to treat severe pain and withdrawal symptoms in addiction), moxifloxacin (an antibiotic used to treat bacterial infections), or antipsychotics (used for mental disorders). Inform 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 transplanted organs or bone marrow or to treat autoimmune diseases)
calcium channel blockers (used to treat high blood pressure or certain heart conditions)
cimetidine (used to treat stomach ulcers)
ketoconazole (used to treat fungal infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy and breastfeeding
Bicalutamide SUN must 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 men and women
You and your partner must use adequate contraceptive measures during treatment with Bicalutamide SUN and for 130 days after stopping treatment (see "Warnings and precautions").
Driving and using machines
Since drowsiness may occur, Bicalutamide SUN may impair your ability to drive or operate machinery.
Sunlight or Ultraviolet (UV) light
Avoid excessive direct exposure to 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 certain sugars, contact him or 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 this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once daily.
Swallow the tablet whole with water.
Try to take the tablet at the same time each day.
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.
Take the remaining tablets or the packaging with you 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 your usual time. Do not take a double dose to make up for the forgotten dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
If you stop treatment with Bicalutamide SUN
Do not stop treatment with the film-coated tablets even if you feel better, without first consulting your doctor. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice any of the following side effects, as you may
need urgent medical treatment:
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 indicate liver dysfunction). These may be signs of liver problems or, in rare cases, liver failure (may affect up to 1 in 1,000 people); fatal outcomes have been reported.
abdominal pain
haematuria (blood in the urine). Uncommon (may affect up to 1 in 100 people)
severe or suddenly worsening shortness of breath. This may occur with cough or fever. These may be signs of lung inflammation known as "interstitial lung disease". Not known (frequency cannot be estimated from the available data)
QT interval prolongation (a disturbance in heart rhythm), 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 unwell)
dry skin
erectile dysfunction (problems achieving an erection)
weight gain
decreased libido (reduced sexual desire)
alopecia (hair loss)
hirsutism (excessive hair growth in areas where hair is normally absent or minimal) / increased hair growth or new hair growth
anaemia (reduction in the number of red blood cells or in haemoglobin concentration, a protein in red blood cells that carries oxygen). This may make you feel tired or look pale
loss of appetite
depression
somnolence (feeling sleepy)
dyspepsia (indigestion)
dizziness (sensation of spinning or falling)
constipation
flatulence (excessive intestinal gas production)
chest pain
oedema (fluid accumulation in a particular part of the body). Rare (may affect up to 1 in 1,000 people)
photosensitivity reaction (increased skin sensitivity to sunlight).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via 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 the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater 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 substance is bicalutamide. One film-coated tablet contains 150 mg of bicalutamide.
The other components 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 pack contents
Bicalutamide SUN 150 mg film-coated tablets are white to off-white, round, biconvex, film-coated tablets, marked with '507' 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 containing 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
The Netherlands

Legal Representative in Italy:
Sun Pharma Italia Srl
Viale Giulio Richard 1
20143 Milano
Italy

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