BICALUTAMIDE TEVA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bicalutamide Teva 50 mg film-coated tablets

Bicalutamide
Generic medicine
Please read this leaflet carefully before using 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, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Bicalutamide Teva belongs to the group of anti-androgen medicines. These medicines counteract
the effects of androgens (male sex hormones).
Bicalutamide Teva is used in adult males for the treatment of prostate cancer in combination with
other therapeutic methods capable of reducing levels of male sex hormones (chemical or surgical castration).

2. What you need to know before taking Bicalutamide Teva

Do not take Bicalutamide Teva

• If you are allergic to bicalutamide or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines containing terfenadine, astemizole or cisapride (see also section “Other medicines and Bicalutamide Teva” below).
• If you are a woman or a child.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide Teva.

• If you have moderate or severe impairment of liver function.
• If you have diabetes or if you are already taking LHRH agonists (such as goserelin, buserelin, leuprorelin and triptorelin).
• If you have any heart or blood vessel disorder, including problems with heart rhythm (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase with the use of Bicalutamide Teva.

Before starting this medicine, inform your doctor if you have any illness or condition affecting liver function.
Other medicines and Bicalutamide Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important to report the use of:

• terfenadine or astemizole (for hay fever or allergies) (see section 2 “Do not take Bicalutamide Teva” above).
• cisapride (for stomach disorders) (see section 2 “Do not take Bicalutamide Teva” above).
• warfarin or any similar medicine used to prevent blood clots.
• cyclosporine (used as an immunosuppressant to prevent and treat rejection after organ or bone marrow transplantation).
• calcium channel blockers, such as nifedipine or verapamil (used to treat high blood pressure or certain heart conditions).
• cimetidine (used to treat gastric ulcers).
• ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamide Teva 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 problems when used together with certain other medicines (e.g., methadone (used to relieve pain and in drug detoxification programs), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)).
Pregnancy, breast-feeding and fertility
Women must not take Bicalutamide Teva.
Driving and using machines
It is unlikely that Bicalutamide Teva will affect your ability to drive or operate machinery. However, some individuals may occasionally experience drowsiness or dizziness after taking the medicine. If you experience such effects, exercise caution when performing these activities.
Bicalutamide Teva contains lactose
Bicalutamide Teva tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, please contact him or her before taking this medicine.

3. How to take Bicalutamide Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once daily, unless otherwise prescribed by your doctor. It is important that you take the tablet every day at the same time.
The tablet must be swallowed whole with water.

Use in children and adolescents
Bicalutamide Teva must not be taken by children and adolescents under 18 years of age.

If you take more Bicalutamide Teva than you should
If you take an excessive dose of tablets or if a child accidentally swallows one or more tablets, contact your doctor or the nearest hospital emergency department immediately. Take this leaflet or some tablets with you so that the doctor can see what you have taken.

If you forget to take Bicalutamide Teva
If you forget to take a tablet at your usual time, skip it and do not take it later; wait for the correct time for the next tablet and continue taking the medicine regularly as before, following the original dosing schedule.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Bicalutamide Teva
Do not stop treatment even if you feel perfectly well, unless your doctor specifically advises you to do so.
If you have any questions about how to use this medicine, ask 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 or seek medical assistance if you experience any of the
following side effects:

• Severe breathing difficulties or sudden worsening of breathing difficulties, possibly accompanied by cough or fever. This could be a lung inflammation called "interstitial lung disease", which occurs in fewer than 1 in 100 patients treated with bicalutamide.
• Severe skin itching (with formation of swellings) or swelling of the face, lips, tongue and/or throat, which may cause difficulty swallowing or breathing. This could be a severe allergic reaction to bicalutamide, which occurs in fewer than 1 in 100 patients treated with this drug.

The following side effects may also occur:
Very common (may affect more than 1 in 10 people)

• Dizziness.
• Breast tenderness or enlargement.
• Hot flushes.
• Abdominal pain, constipation, feeling unwell (nausea).
• Haematuria (blood in urine).
• Feeling weak, swelling.
• Anaemia (reduction in red blood cell levels in the blood, which may be associated with tiredness, increased heart rate and breathing rate, paleness).

Common (may affect up to 1 in 10 people)

• Loss of appetite or weight gain.
• Reduced sex drive or erectile dysfunction.
• Depression.
• Drowsiness.
• Indigestion, flatulence (gas).
• Liver problems, including jaundice (yellowing of the skin or eyes) and elevated liver enzymes.
• Skin rash, itching, dry skin, hair loss (alopecia), excessive growth of body hair (hirsutism).
• Chest pain.
• Reduced heart function and heart attack.

Uncommon (may affect up to 1 in 100 people)

• Severe allergic reactions, including severe skin itching (with raised lumps) or swelling of the face, tongue and/or throat, which may cause difficulty in swallowing or breathing.
• Inflammation of the lungs called "interstitial lung disease".

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

• Liver failure.
• Increased sensitivity of the skin to sunlight.

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

• Changes in the ECG trace (QT prolongation).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bicalutamide Teva

Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the blister and outer packaging.
The expiry date refers to the last day of the 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 Teva contains

• The active substance is bicalutamide. Each film-coated tablet contains 50 mg of bicalutamide.
• The excipients are: Tablet core: microcrystalline cellulose, povidone, croscarmellose sodium, sodium lauryl sulfate, monohydrate lactose, colloidal anhydrous silica, magnesium stearate. Coating: hypromellose, polydextrose, titanium dioxide, macrogol 4000.

Description of the appearance of Bicalutamide Teva and contents of the pack
Bicalutamide Teva 50 mg film-coated tablets are white to off-white, biconvex, with "93" engraved on one side and "220" on the other side.
The product is available in packs containing 20, 28, 30, 40, 50, 56, 60, 84, 90 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l. – Via Messina, 38 – 20154 Milan, Italy

Manufacturers
Teva UK Ltd. - Brampton Road - Hampden Park – BN22 9AG Eastbourne – East Sussex (United Kingdom)
Pharmachemie B.V. - Swensweg 5 – P.O. Box 552 - 2003 RN Haarlem (The Netherlands)
Teva Santé SA – Rue Bellocier – BP 713 – 89107 Sens Cedex (France)
Teva Pharmaceutical Works Private Limited Company - Pallagi st. 13 - H-4042 Debrecen (Hungary)

This leaflet was last updated on:

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Bicalutamide Teva 150 mg film-coated tablets

Bicalutamide
Generic medicine
Please read this leaflet carefully before using 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Bicalutamide Teva belongs to the group of anti-androgen medicines. These medicines counteract the effects of androgens (male sex hormones).
Bicalutamide Teva is used in adult males for the treatment of non-metastatic prostate cancer in cases where castration or other types of therapy are not indicated or are unacceptable.
It may be used in combination with radiotherapy or surgical intervention on the prostate as part of early treatment programmes.

2. What you need to know before taking Bicalutamide Teva

Do not take Bicalutamide Teva

• If you are allergic to bicalutamide or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines containing terfenadine, astemizole, or cisapride (see section “Other medicines and Bicalutamide Teva” below).
• If you are a woman or a child.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide Teva.

• If you have moderate or severe impairment of liver function.
• If you have any heart or blood vessel disorder, including problems with heart rhythm (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase with the use of Bicalutamide Teva.

Before starting this medicine, inform your doctor if you have any illness or condition affecting liver function.
Other medicines and Bicalutamide Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to mention:

• terfenadine or astemizole (for hay fever or allergies) (see section 2 “Do not take Bicalutamide Teva” above).
• cisapride (for stomach problems) (see section 2 “Do not take Bicalutamide Teva” above).
• warfarin or any similar medicine used to prevent blood clots.
• cyclosporine (used as an immunosuppressant to prevent and treat rejection following organ or bone marrow transplantation).
• calcium channel blockers, such as nifedipine or verapamil (used to treat hypertension or certain heart conditions).
• cimetidine (used to treat gastric ulcers).
• ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamide Teva may interfere with certain medicines used to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol), or may increase the risk of heart rhythm problems when used together with certain other medicines (e.g., methadone (used to relieve pain and in drug detoxification programs), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)).
Pregnancy, breastfeeding and fertility
Women must not take Bicalutamide Teva.
Driving and using machines
It is unlikely that Bicalutamide Teva will affect your ability to drive or operate machinery. However, some individuals may occasionally experience drowsiness or dizziness after taking the medicine. If you experience these effects, exercise caution when performing such activities.
Bicalutamide Teva contains lactose
Bicalutamide Teva tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Bicalutamide Teva

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet once daily, unless otherwise prescribed by your doctor. It is important that you take the tablet every day at the same time.
The tablet must be swallowed whole with water.

Use in children and adolescents
Children and adolescents under 18 years of age must not take Bicalutamide Teva.

If you take more Bicalutamide Teva than you should
If you take an excessive dose of tablets or if a child accidentally swallows one or more tablets, contact your doctor or the nearest hospital emergency department immediately. Take this leaflet or some tablets with you so that the doctor can see what has been taken.

If you forget to take Bicalutamide Teva
If you forget to take a tablet at your usual time, skip the missed dose and do not take it later; wait until the correct time for your next tablet and continue taking the medicine regularly as before, following your original dosing schedule.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Bicalutamide Teva
Do not stop treatment even if you feel perfectly well, unless your doctor specifically advises you to do so.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately or seek medical assistance if you experience any of the
following side effects:

• Severe breathing difficulties or sudden worsening of breathing difficulties, possibly accompanied by cough or fever. This could be a lung inflammation called "interstitial lung disease", which occurs in less than 1 in 100 patients treated with bicalutamide.
• Severe skin itching (with formation of swellings) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing or breathing. This could be a serious allergic reaction to bicalutamide, occurring in less than 1 in 100 patients treated with this drug.

The following side effects may also occur:
Very common (may affect more than 1 in 10 people)

• Rash.
• Breast tenderness or enlargement.
• Feeling of weakness.

Common (may affect up to 1 in 10 people)

• Anaemia (reduced red blood cell levels, which may be associated with fatigue, rapid heartbeat, rapid breathing, paleness).
• Loss of appetite or weight gain.
• Haematuria (blood in the urine).
• Reduced sexual desire or erectile dysfunction.
• Depression.
• Dizziness, drowsiness.
• Hot flushes.
• Abdominal pain, constipation, feeling of discomfort (nausea), indigestion, flatulence (gas).
• Liver problems, including jaundice (yellowing of the skin or eyes) and elevated liver enzymes.
• Itching, dry skin, hair loss (alopecia), excessive hair growth (hirsutism).
• Chest pain, swelling.

Uncommon (may affect up to 1 in 100 people)

• Severe allergic reactions, including severe skin itching (with raised lumps) or swelling of the face, tongue and/or throat, which may cause difficulty in swallowing or breathing.
• Inflammation of the lungs called "interstitial lung disease".

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

• Liver failure.
• Increased sensitivity of the skin to sunlight.

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

• Changes in ECG trace (QT prolongation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bicalutamide Teva

Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the blister and outer packaging.
The expiry date refers to the last day of the 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 Teva contains

• The active substance is bicalutamide. Each film-coated tablet contains 150 mg of bicalutamide.
• The excipients are: Tablet core: microcrystalline cellulose, povidone, sodium croscarmellose, sodium lauryl sulfate, lactose monohydrate, anhydrous colloidal silicon dioxide, magnesium stearate. Coating: hypromellose, polydextrose, titanium dioxide, macrogol 4000.

Description of the appearance of Bicalutamide Teva and pack sizes
The film-coated tablets of Bicalutamide Teva 150 mg are white to off-white, biconvex, with "BCL" engraved on one side and smooth on the other.
The product is available in packs containing 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
Teva Italia S.r.l. – Via Messina, 38 – 20154 Milano
Teva UK Ltd. - Brampton Road - Hampden Park – BN 22 9AG Eastbourne – East Sussex (United Kingdom)
Pharmachemie B.V. - Swensweg 5 – P.O. Box 552 - 2003 RN Haarlem (The Netherlands)
Teva Santé SA – Rue Bellocier – BP 713 – 89107 Sens Cedex (France)
Teva Pharmaceutical Works Private Limited Company - Pallagi st. 13 - H-4042 Debrecen (Hungary)