Bicalutamide Doc Generici

PATIENT LEAFLET: INFORMATION FOR THE USER

BICALUTAMIDE DOC Generici 50 mg film-coated tablets

Generic medicinal product
Please read all of this leaflet carefully before you take 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 adverse reaction, including those not listed in this leaflet, contact your doctor. See section 4.
Contents of this leaflet:

1. What BICALUTAMIDE DOC Generici 50 mg film-coated tablets is and what it is used for

2. What you need to know before taking BICALUTAMIDE DOC Generics 50 mg film-coated tablets

3. How to take BICALUTAMIDE DOC Generics 50 mg film-coated tablets
4. Possible side effects
5. How to store BICALUTAMIDE DOC Generics 50 mg film-coated tablets
6. Contents of the pack and other information
1. WHAT BICALUTAMIDE DOC GENERICS 50 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
BICALUTAMIDE DOC Generics 50 mg film-coated tablets are used for the treatment of advanced prostate carcinoma. It is taken together with a medicine known as a luteinizing hormone-releasing hormone (LHRH) analogue—an additional hormonal treatment—or in addition to surgical removal of the testes.
BICALUTAMIDE DOC Generics 50 mg film-coated tablets belong to a group of medicines known as non-steroidal antiandrogens. The active substance, bicalutamide, blocks the unwanted effects of male sex hormones (androgens) and thereby inhibits cellular growth in the prostate.

2. WHAT YOU SHOULD KNOW BEFORE TAKING BICALUTAMIDE DOC GENERICS 50 MG FILM-COATED TABLETS

Do not take BICALUTAMIDE DOC Generics 50 mg film-coated tablets:

• If you are allergic (hypersensitive) to bicalutamide or to any of the other ingredients of BICALUTAMIDE DOC Generics 50 mg film-coated tablets.
• If you are taking terfenadine (for hay fever or allergies), astemizole (for hay fever or allergies), or cisapride (for stomach disorders).
  BICALUTAMIDE DOC Generics 50 mg film-coated tablets must not be given to women or to children and adolescents.

Warnings and precautions
Talk to your doctor or pharmacist before taking BICALUTAMIDE DOC Generics 50 mg film-coated tablets:

• If you have any heart or blood vessel disorder, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when using BICALUTAMIDE DOC Generics 50 mg film-coated tablets.
• If you have moderate or severe liver impairment. The medicine should only be taken after your doctor has carefully considered the potential risks and benefits. If this applies to you, your doctor will regularly perform liver function tests (bilirubin, transaminases, alkaline phosphatase). If severe liver problems develop, treatment with BICALUTAMIDE DOC Generics 50 mg film-coated tablets must be discontinued.
• If you have severe renal impairment. The medicine should only be taken after your doctor has carefully considered the potential risks and benefits.
• If you suffer from heart disorders. In such cases, your doctor must regularly monitor your cardiac function.

Other medicines and BICALUTAMIDE DOC Generics 50 mg film-coated tablets
Please inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
BICALUTAMIDE DOC Generics 50 mg film-coated tablets may interact with certain medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol) or may increase the risk of heart rhythm problems when used together with certain other drugs (e.g. methadone (used to relieve pain and as part of detoxification in drug addiction), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).
BICALUTAMIDE DOC Generics 50 mg film-coated tablets should not be used with any of the following medicines:

• terfenadine, astemizole (for hay fever or allergies)
• cisapride (for stomach disorders)

If you take BICALUTAMIDE DOC Generics 50 mg film-coated tablets together with any of the following medicines, the effect of bicalutamide and/or the other medicines may be altered. Please speak with your doctor before taking any of these medicines together with BICALUTAMIDE DOC Generics 50 mg film-coated tablets:

• warfarin or any other similar medicine used to prevent blood clotting
• ciclosporin (used to suppress the immune system to prevent and treat rejection of transplanted organs or bone marrow)
• cimetidine (to treat stomach ulcers)
• ketoconazole (used to treat fungal skin and nail infections)
• calcium channel blockers (to treat high blood pressure)

BICALUTAMIDE DOC Generics 50 mg film-coated tablets with food and drink:
Take one tablet of bicalutamide preferably at the same time each day, with or without food.

Pregnancy, breastfeeding and fertility:
Ask your doctor or pharmacist for advice before taking any medicine.
BICALUTAMIDE DOC Generics 50 mg film-coated tablets are contraindicated in women.
Women must not take BICALUTAMIDE DOC Generics 50 mg film-coated tablets.

Driving and using machines
These tablets may cause dizziness or make you feel weak. If this affects you, do not drive or operate machinery.

BICALUTAMIDE DOC Generics 50 mg film-coated tablets contain lactose monohydrate
This product contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE BICALUTAMIDE DOC Generici 50 mg FILM-COATED TABLETS

Always take BICALUTAMIDE DOC Generici 50 mg film-coated tablets exactly as directed by your doctor. If you are unsure, check with your doctor or pharmacist.
Your doctor will prescribe a dosage appropriate for you personally. The recommended dose is one tablet once daily. Read the instructions on the packaging.
Swallow the tablets whole with some liquid. Try to take the medicine at approximately the same time each day.

If you take more BICALUTAMIDE DOC Generici 50 mg film-coated tablets than you should:
If you have taken too many tablets, contact your doctor or the nearest hospital immediately.
Take the remaining tablets or the pack with you so that the doctor can identify what you have taken.

If you forget to take BICALUTAMIDE DOC Generici 50 mg film-coated tablets:
If you forget to take your daily dose, do not take it when you remember, but wait until the next scheduled dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking BICALUTAMIDE DOC Generici 50 mg film-coated tablets:
Do not stop taking this medicine if you feel better, unless advised by your doctor.
If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, BICALUTAMIDE DOC Generici 50 mg film-coated tablets can cause adverse reactions, although not everyone experiences them.
You must contact your doctor immediately if you notice any of the following serious adverse reactions:
Uncommon serious adverse reactions (affect fewer than 1 in 100 people):

• Severe allergic reaction causing swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing, or severe skin itching with appearance of lumps (hives).
• Severe breathlessness, or sudden worsening of breathlessness, possibly with cough or fever. Some patients taking BICALUTAMIDE DOC Generici 50 mg film-coated tablets develop lung inflammation known as interstitial lung disease.

Rare serious adverse reactions (affect fewer than 1 in 1,000 people):

• Yellowing of the skin or whites of the eyes due to liver problems (including liver failure).

Other adverse reactions:
Tell your doctor if any of the following adverse reactions cause you problems:
Very common adverse reactions (affect more than 1 in 10 people):

• Enlarged or tender breast tissue.
• Decreased sexual desire, erection problems, impotence.
• Hot flushes.

Common adverse reactions (affect fewer than 1 in 10 people):

• Nausea (feeling sick).
• Diarrhoea or constipation.
• Dizziness.
• Difficulty falling asleep.
• Hives, itching, excessive sweating, excessive body hair growth.
• Feeling of weakness.
• Weight gain.
• Diabetes mellitus.
• Oedema.
• General pain, pelvic pain.
• Chills.
• Blood tests showing changes in liver function.
• Reduction in red blood cells, which may cause pale skin, weakness, or breathlessness.

Uncommon adverse reactions (affect fewer than 1 in 100 people):

• Loss of appetite, weight loss.
• Depression.
• High blood sugar levels.
• Drowsiness.
• Shortness of breath.
• Dry mouth, indigestion, flatulence (gas).
• Hair loss.
• Need to urinate during the night, blood in the urine.
• Abdominal pain, chest pain, headache, back pain, neck pain.

Rare adverse reactions (affect fewer than 1 in 1,000 people):

• Vomiting.
• Dry skin.

Very rare adverse reactions (affect fewer than 1 in 10,000 people):

• Chest pain and heart failure (which may be associated with breathlessness, especially during exertion, rapid heartbeat, swelling of limbs, and mottled skin), irregular heartbeat, irregular ECG trace.
• Reduction in platelets, leading to increased risk of bleeding or bruising.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• Changes in ECG (QT prolongation).

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

5. HOW TO STORE BICALUTAMIDE DOC Generici 50 mg film-coated tablets

Keep out of the reach and sight of children.
Do not use BICALUTAMIDE DOC Generici 50 mg film-coated tablets after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
Do not use BICALUTAMIDE DOC Generici 50 mg film-coated tablets if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What BICALUTAMIDE DOC Generici 50 mg film-coated tablets contains
The active substance is bicalutamide.
Each tablet contains 50 mg of bicalutamide.
The other components are:
Tablet core: monohydrate lactose, sodium starch glycolate (Type A), povidone-K30, anhydrous colloidal silica, magnesium stearate.
Tablet coating: Opadry II 33G28523 white (hypromellose, titanium dioxide (E171), monohydrate lactose, macrogol 3350, triacetin).
What BICALUTAMIDE DOC Generici 50 mg film-coated tablets look like and contents of the pack
White or almost white, round, biconvex film-coated tablet, engraved with "L" on one side and "RG" on the other.
10, 14, 20, 28, 30, 40, 50, 56, 80, 84, 90, 100, 140, 200, 280 film-coated tablets are packed in blisters (PVC/PVDC/Aluminium).
Not all pack sizes may be marketed.
Marketing Authorization Holder:
DOC Generici S.r.l
Via Turati 40
20121 Milan, Italy
Name and address of the manufacturer responsible for batch release in the EEA:
Gedeon Richter Plc.
1103 Budapest Gyömrői út 19-21
Hungary
This leaflet was approved on
PATIENT LEAFLET

BICALUTAMIDE DOC Generics 150 mg film-coated tablets

Generic medicine
Please read all of 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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their
symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet,
contact your doctor. See section 4.
Contents of this leaflet:

7. What BICALUTAMIDE DOC Generici 150 mg film-coated tablets is and what it is used for

8. What you should know before taking BICALUTAMIDE DOC Generici 150 mg film-coated tablets

9. How to take BICALUTAMIDE DOC Generici 150 mg film-coated tablets
10. Possible side effects
11. How to store BICALUTAMIDE DOC Generici 150 mg film-coated tablets
12. Contents of the pack and other information
1. WHAT BICALUTAMIDE DOC GENERICI 150 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
BICALUTAMIDE DOC Generici 150 mg film-coated tablets are indicated alone or in combination with surgical removal of the prostate gland or radiotherapy in patients with locally advanced prostate carcinoma at high risk of disease progression.
Bicalutamide is a substance with antiandrogenic effects that binds to androgen receptors and thereby interferes with some of the actions of male sex hormones.

2. WHAT YOU SHOULD KNOW BEFORE TAKING BICALUTAMIDE DOC GENERICS 150 MG FILM-COATED TABLETS

Do not take BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets

• if you are allergic (hypersensitive) to bicalutamide or to any of the other ingredients.
• if you are taking terfenadine (for hay fever or allergies), astemizole (for hay fever or allergies), or cisapride (for stomach disorders).

Women and children must not take BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets:

• if you have any heart or blood vessel disorder, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when taking BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets.
• if you have moderate or severe liver impairment. The medicine should only be taken after your doctor has carefully considered the potential risks and benefits. If this applies to you, your doctor will regularly perform liver function tests (bilirubin, transaminases, alkaline phosphatase). If severe liver problems develop, treatment with BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets must be stopped.
• if you have severely impaired kidney function. The medicine should only be taken after your doctor has carefully considered the potential risks and benefits.
• if you suffer from heart disorders. If this applies to you, your doctor must regularly monitor your cardiac function.

Other medicines and BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets 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 drugs (e.g. methadone (used to relieve pain and as part of detoxification from drug addiction), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets must not be used with any of the following medicines:

• terfenadine or astemizole (for hay fever or allergies)
• cisapride (for stomach disorders)

If you take BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets together with any of the following medicines, the effect of bicalutamide and/or the other medicines may be affected. Please talk to your doctor before taking any of these medicines with BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets:

• warfarin or any other similar medicine used to prevent blood clotting
• ciclosporin (used to suppress the immune system to prevent and treat rejection of transplanted organs or bone marrow)
• cimetidine (for treating stomach ulcers)
• ketoconazole (used to treat fungal skin and nail infections)
• calcium channel blockers (for treating high blood pressure)

BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets with food and drink

Take one tablet of bicalutamide preferably at the same time each day, with or without food.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before taking any medicine.

BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets are contraindicated in women.

Women must not take BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets.

Driving and using machines

These tablets may cause dizziness or make you feel weak. If this affects you, do not drive or operate machinery.

BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets contain lactose monohydrate

This product contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE BICALUTAMIDE DOC GENERICS 150 MG FILM-COATED TABLETS

FILM-COATED TABLETS
Always take BICALUTAMIDE DOC Generics 150 mg film-coated tablets exactly as your doctor has told you. If you are unsure, check with your doctor or pharmacist.
Your doctor will prescribe a dosage appropriate for you personally. The recommended dose is one tablet once daily. Read the instructions on the package.
The tablets should be swallowed whole with some liquid. Try to take the medicine at approximately the same time each day.
If you take more BICALUTAMIDE DOC Generics 150 mg film-coated tablets than you should:
If you have taken too many tablets, contact your doctor or the nearest hospital as soon as possible. Take any remaining tablets or the package with you so that the doctor can identify what you have taken.
If you forget to take BICALUTAMIDE DOC Generics 150 mg film-coated tablets:
If you forget to take your daily dose, skip it when you remember and wait until the next scheduled dose. Do not take a double dose to make up for the missed dose.
If you stop taking BICALUTAMIDE DOC Generics 150 mg film-coated tablets:
Do not stop taking this medicine just because you feel better, unless your doctor advises you to do so.
If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, BICALUTAMIDE DOC Generici 150 mg film-coated tablets can cause adverse reactions, although not everyone experiences them.
You must contact your doctor immediately if you notice any of the following serious adverse reactions:
Uncommon serious adverse reactions (affect fewer than 1 in 100 people):

• severe allergic reaction causing swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing or breathing, or severe itching of the skin with appearance of lumps.

• severe breathlessness, or sudden worsening of breathlessness, possibly with cough or fever. Some patients taking BICALUTAMIDE DOC Generici 150 mg film-coated tablets develop lung inflammation known as interstitial lung disease.

Rare serious adverse reactions (affect fewer than 1 in 1,000 people):

• yellowing of the skin or whites of the eyes caused by liver problems (including liver failure).

Other adverse reactions:
Tell your doctor if any of the following adverse reactions cause you problems:
Very common adverse reactions (affect more than 1 in 10 people):

• breast tissue enlarged or tender
• decreased sexual desire, erection problems, impotence
• hot flushes

Common adverse reactions (affect fewer than 1 in 10 people):

• nausea (feeling sick)
• diarrhoea or constipation
• dizziness
• difficulty sleeping
• urticaria, itching, sweating, excessive body hair growth
• feeling of weakness
• weight gain
• diabetes mellitus
• oedema
• general pain, pelvic pain
• chills
• blood tests showing changes in liver function
• reduction in red blood cells which may cause pale skin, weakness or breathlessness

Uncommon adverse reactions (affect fewer than 1 in 100 people):

• loss of appetite, weight loss
• depression
• high blood sugar levels
• somnolence
• shortness of breath
• dry mouth, indigestion, flatulence (gas)
• hair loss
• need to urinate during the night, blood in the urine
• abdominal pain, chest pain, headache, back pain, neck pain

Rare adverse reactions (affect fewer than 1 in 1,000 people):

• vomiting
• dry skin

Very rare adverse reactions (affect fewer than 1 in 10,000 people):

• chest pain and heart failure (which may be associated with breathlessness, especially during exertion, rapid heartbeat, swelling of limbs and mottled skin), irregular heartbeat, irregular ECG trace.
• reduction in platelets causing increased risk of bleeding or bruising.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• changes in ECG (QT prolongation).

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

5. HOW TO STORE BICALUTAMIDE DOC GENERICS 150 MG FILM-COATED TABLETS

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not use BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
This medicinal product requires no special storage conditions.
Do not use BICALUTAMIDE DOC GENERICS 150 mg film-coated tablets if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What BICALUTAMIDE DOC Generici 150 mg film-coated tablets contains
The active substance is bicalutamide.
Each tablet contains 150 mg of bicalutamide.
The other components are:
Tablet core: monohydrate lactose, sodium carboxymethyl starch (Type A), Povidone-K30, anhydrous colloidal silica, magnesium stearate.
Tablet coating: Opadry II 33G28523 white (hypromellose, titanium dioxide (E171), monohydrate lactose, macrogol 3350, triacetin).
What BICALUTAMIDE DOC Generici 150 mg film-coated tablets look like and contents of the pack
White or almost white, round, biconvex, film-coated tablet, engraved with "XL" on one side and "RG" on the other.
Pack: 28 film-coated tablets in blister (PVC/PVDC/Aluminium).
Marketing Authorization Holder:
DOC Generici S.r.l
Via Turati 40
20121 Milan, Italy
Manufacturer responsible for batch release:
Gedeon Richter Plc.
1103 Budapest Gyömrői út 19-21
Hungary
This medicinal product is authorized in EEA Member States under the following names:
Italy: BICALUTAMIDE DOC Generici 150 mg film-coated tablets
United Kingdom: Bicalutamide 150 mg film-coated tablets
This leaflet was last approved in