Bicalutamide Ratiopharm

Patient Information Leaflet: Information for the User

Bicalutamide ratiopharm 50 mg film-coated tablets

Generic medicine
Please read this entire 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 they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Bicalutamide belongs to the group of anti-androgen medicines. Anti-androgens block the effects of androgens (male sex hormones).
Bicalutamide ratiopharm 50 mg is used for the treatment of advanced prostate cancer. It is taken in combination with a medicine known as an LHRH agonist (luteinizing hormone-releasing hormone agonist)—another form of hormonal treatment—or following surgical removal of the testes.
It is also 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 approaches.

2. What you need to know before taking Bicalutamide ratiopharm

Do not take Bicalutamide ratiopharm

• If you are allergic to bicalutamide or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking terfenadine (for hay fever or allergies), astemizole (for hay fever or allergies), or cisapride (for stomach disorders). Bicalutamide ratiopharm must not be administered to women, children, or adolescents.

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

• if you have moderate or severe liver impairment. In such cases, the medicine should only be taken if your doctor has carefully considered the potential benefits and risks. If used, your doctor will arrange regular blood tests to monitor liver function (bilirubin, transaminases, alkaline phosphatase). If serious liver dysfunction occurs, treatment with Bicalutamide ratiopharm must be discontinued. Fatal outcomes have been reported.
• if you have diabetes and are already taking an “LHRH analogue”. These medicines include goserelin, buserelin, leuprorelin, and triptorelin. More frequent monitoring of blood glucose levels may be required.
• if you have severe renal impairment. In such cases, the medicine should only be taken if your doctor has carefully considered the potential benefits and risks.
• if you have heart disease. In this case, your doctor must regularly monitor cardiac function.
• if you have any heart or blood vessel disorders, including heart rhythm problems (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 ratiopharm.

Other medicines and Bicalutamide ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Bicalutamide ratiopharm must not be used together with any of the following medicines:

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

If you take Bicalutamide ratiopharm together with any of the following medicines, the effect of bicalutamide or of the other medicines may be affected. Consult your doctor before taking any of the following medicines together with Bicalutamide ratiopharm:

• warfarin or similar medicines used to prevent blood clots
• cyclosporine (used to suppress the immune system, to prevent and treat rejection after organ or bone marrow transplantation)
• cimetidine (used to treat stomach ulcers)
• ketoconazole (used to treat fungal infections of the skin and nails)
• calcium channel blockers (used to treat hypertension)

Bicalutamide ratiopharm 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
Pregnancy
Bicalutamide is contraindicated in women and must not be taken during pregnancy or breastfeeding.
Fertility
Bicalutamide may cause a period of subfertility or infertility in men.

Driving and using machines
It is unlikely that bicalutamide will affect your ability to drive or operate tools or machinery. However, there is a possibility that this medicine may cause dizziness or drowsiness. If you experience these symptoms, do not drive or operate machinery.

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

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

3. How to take Bicalutamide ratiopharm

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will prescribe the dose most suitable for you.
The usual dose for the treatment of

• advanced prostate carcinoma is one tablet once daily.
• non-metastatic prostate carcinoma is three tablets once daily. Please read the instructions label on the packaging.

The tablets must be swallowed whole with liquid. Try to take the medicine at approximately the same time each day.
If you take more Bicalutamide ratiopharm than you should
If you have taken too many tablets, contact your doctor or the nearest hospital immediately. Take the remaining tablets or the packaging with you, so the doctor can identify the tablets you have taken.
If you forget to take Bicalutamide ratiopharm
If you forget to take your daily dose, skip it and wait for the next scheduled dose. Do not take a double dose to make up for the missed dose.
If you stop taking Bicalutamide ratiopharm
Do not stop taking the medicine even if you feel better, unless advised by your doctor.
If you have any questions 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 everyone gets them.
Serious side effects:
Contact your doctor immediately if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people):

• Abdominal pain
• Presence of blood in the urine

Common (may affect up to 1 in 10 people):

• Impaired liver function which may cause yellowing of the skin or the whites of the eyes (jaundice)

Uncommon (may affect up to 1 in 100 people):

• Severe allergic reaction causing swelling of the face, lips, tongue and/or throat, leading to difficulty in swallowing or breathing, or severe skin itching with swelling
• Severe breathlessness, or sudden worsening of breathlessness, possibly associated with cough or fever. Some patients taking Bicalutamide ratiopharm develop a lung inflammation called interstitial lung disease. Fatal cases have been reported.

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

• Liver failure (severe deterioration of liver function) which may be associated with the following symptoms (occurring in fewer than 1 in 10 people): jaundice, itching, nausea, loss of appetite, easy bruising and drowsiness. Fatal cases have been reported.

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

• Changes in ECG (QT prolongation)

Other side effects:
Inform your doctor if any of the following side effects occur:
Very common (may affect more than 1 in 10 people):

• Decrease in red blood cells which may make the skin look pale and cause weakness or breathlessness
• Dizziness
• Abdominal pain
• Constipation
• Nausea (feeling unwell)
• Weakness
• Skin rash
• Tenderness or enlargement of breast tissue
• Hot flushes
• Oedema
• Chest pain

Common (may affect up to 1 in 10 people):

• Loss of appetite, decreased appetite
• Diabetes mellitus
• Decreased sex drive, erection problems
• Depression
• Drowsiness
• Chest pain, musculoskeletal pain
• Myocardial infarction (fatal cases have been reported), heart failure
• Diarrhoea
• Indigestion
• Wind (flatulence)
• Changes in blood tests relating to liver function
• Hair loss
• Hair regrowth or growth of new hair
• Dry skin
• Itching
• Sweating
• Weight gain

Uncommon (may affect up to 1 in 100 people):

• High blood sugar levels
• Shortness of breath

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

• Vomiting
• Increased sensitivity of the skin to sunlight

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bicalutamide ratiopharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Bicalutamide ratiopharm if you notice any visible signs of deterioration in the appearance of the tablets.
Do not dispose of medicines via wastewater. 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 ratiopharm contains

• The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other ingredients are monohydrate lactose, povidone (K-30), sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, anhydrous colloidal silica and magnesium stearate. The tablet coating contains hypromellose (E464), polydextrose (E1200), titanium dioxide (E171) and macrogol 4000.

Description of the appearance of Bicalutamide ratiopharm and pack sizes
Bicalutamide ratiopharm 50 mg is a film-coated tablet, white to off-white in colour, round, biconvex, and marked "93" on one side and "220" on the other.
Available in blister packs containing 20, 28, 30, 30x1, 60, 90, 98, 100, 100x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Strasse, 3
89079 Ulm (Germany)

Manufacturers
TEVA Pharmaceutical Works Private Limited Company
H 4042, Debrecen
Pallagi Street 13
Hungary
TEVA UK Ltd
Brampton Road
Hampden Park
Eastbourne, East Sussex
BN22 9AG
United Kingdom
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
Teva Nederland B.V
Swensweg 5
2031 GA Haarlem
The Netherlands
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria Bicalutabene 50 mg Filmtabletten
Belgium Bicalutamide-ratiopharm 50 mg comprimés pelliculés
Germany Bicalutamid-ratiopharm 50 mg Filmtabletten
Denmark Bicalutamid ratiopharm (50 mg)
Spain Bicalutamida 50 mg comprimidos recubiertos con película EFG
Luxembourg Bicalutamid-ratiopharm 50 mg Filmtabletten
Netherlands Bicalutamide ratiopharm 50 mg
United Kingdom Bicalutamide 50 mg tablets

Package leaflet: information for the user

Bicalutamide ratiopharm 150 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before 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 effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Bicalutamide ratiopharm and what is it used for?

Bicalutamide belongs to the group of anti-androgen medicinal products. Anti-androgens counteract the effects of androgens (male sex hormones).
Bicalutamide ratiopharm 150 mg is used in adult males for the treatment of non-metastatic prostate carcinoma, 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 treatments.

2. What you need to know before taking Bicalutamide ratiopharm

Do not take Bicalutamide ratiopharm

• If you are allergic to bicalutamide or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking terfenadine (for hay fever or allergies), astemizole (for hay fever or allergies), or cisapride (for stomach disorders).

Bicalutamide ratiopharm must not be administered to women, children, or adolescents.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide ratiopharm

• if your liver function is moderately or severely impaired. In such cases, the medicine should only be taken after your doctor has carefully considered the potential benefits and risks. If used, your doctor will regularly perform blood tests to monitor your liver function (bilirubin, transaminases, alkaline phosphatase). Severe liver function disorders may require discontinuation of treatment with Bicalutamide ratiopharm. Fatal outcomes have been reported.
• if your kidney function is severely impaired. The medicine should only be taken after your doctor has evaluated the potential risks and benefits.
• if you have heart disease. In this case, your doctor must regularly monitor your cardiac function.
• if you have any heart or blood vessel disorders, including heart rhythm problems (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 ratiopharm.

Other medicines and Bicalutamide ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Bicalutamide ratiopharm must not be taken together with any of the following medicines:

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

If you take Bicalutamide ratiopharm together with any of the following medicines, the effect of bicalutamide, as well as the effect of the other medicine, may be altered. Consult your doctor before taking Bicalutamide ratiopharm with any of the following medicines:

• warfarin or any similar medicine used to prevent blood clots
• cyclosporine (used to suppress the immune system, to prevent and treat rejection after organ or bone marrow transplantation)
• cimetidine (for the treatment of stomach ulcers)
• ketoconazole (used to treat fungal skin and nail infections)
• calcium channel blockers (used to treat hypertension)
  Bicalutamide ratiopharm 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 in drug detoxification programs), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)).

Pregnancy, breast-feeding and fertility
Pregnancy
Bicalutamide is contraindicated in women and must not be taken during pregnancy or breast-feeding.
Fertility
Bicalutamide may cause a period of subfertility or infertility in men.
Driving and using machines
It is unlikely that bicalutamide will affect your ability to drive or operate tools or machinery. However, there is a possibility that this tablet may cause dizziness or drowsiness. Do not drive or operate machinery if you experience these symptoms.
Bicalutamide ratiopharm contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Bicalutamide ratiopharm contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Bicalutamide ratiopharm

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will prescribe the most appropriate dose for you. The usual dose is one tablet once daily. Read the instructions label on the package.
The tablets should be swallowed whole with liquid. Try to take the medicine at approximately the same time each day.
If you take more Bicalutamide ratiopharm than you should
If you have taken too many tablets, contact your doctor immediately or go to the nearest hospital.
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 ratiopharm
If you forget to take your daily dose, do not take it as soon as you remember, but wait until your next scheduled dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Bicalutamide ratiopharm
Do not stop taking this medicine even if you feel better, unless advised otherwise by your doctor.
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 experiences them.
Serious side effects:
Contact your doctor immediately if you notice any of the following side effects:
Common (may affect less than 1 in 10 people):

• Abdominal pain
• Blood in the urine
• Impaired liver function which may cause yellowing of the skin or the whites of the eyes (jaundice)
  Uncommon (may affect less than 1 in 100 people):
• Severe allergic reaction causing swelling of the face, lips, tongue and/or throat, which may lead to difficulty swallowing or breathing, or severe itching of the skin with swelling.
• Severe breathlessness or sudden worsening of breathlessness possibly accompanied by cough or fever. Some patients taking Bicalutamide ratiopharm develop a lung inflammation called interstitial lung disease. Fatal outcomes have been reported.

Rare (may affect less than 1 in 1,000 people):

• Liver failure (severe deterioration of liver function) which may be associated with the following symptoms (occurring in less than 1 in 10 people): jaundice, itching, nausea, loss of appetite, easy bruising and somnolence. Fatal outcomes have been reported.

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

• Changes in ECG (QT prolongation).

Other side effects:
Inform your doctor if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people):

• Weakness
• Rash
• Tenderness or enlargement of breast tissue

Common (may affect less than 1 in 10 people):

• Decrease in red blood cells which may make the skin appear pale and cause weakness or breathlessness
• Loss of appetite, decreased appetite
• Diabetes mellitus
• Decreased sex drive, erectile problems
• Depression
• Dizziness
• Somnolence
• Hot flushes
• Chest pain, musculoskeletal pain
• Diarrhoea or constipation
• Indigestion
• Gas (flatulence)
• Nausea (feeling unwell)
• Changes in blood tests relating to liver function
• Hair loss
• Regrowth of hair or growth of new hair
• Dry skin
• Itching
• Sweating
• Oedema
• Weight gain

Uncommon (may affect less than 1 in 100 people):

• High blood sugar levels
• Shortness of breath
  Rare (may affect less than 1 in 1,000 people):
• Vomiting
• Increased sensitivity of the skin to sunlight.

Reporting of side effects
If you experience any side effect, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bicalutamide ratiopharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Bicalutamide ratiopharm if you notice any visible signs of deterioration in the appearance of the tablets.
Do not dispose of medicines via wastewater. 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 ratiopharm contains

• The active substance is bicalutamide. Each tablet contains 150 mg of bicalutamide.
• The excipients are monohydrate lactose, povidone (K-30), sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate. The tablet coating contains hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), and macrogol 4000.

Description of the appearance of Bicalutamide ratiopharm and package contents
Bicalutamide ratiopharm 150 mg is a film-coated tablet, white to off-white in colour, round, biconvex, engraved with "BCL" on one side and smooth on the other.
20, 28, 30, 30x1, 60, 90, 98, 100, 100x1 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Strasse, 3
89079 Ulm (Germany)

Manufacturers
TEVA Pharmaceutical Works Private Limited Company
H 4042, Debrecen
Pallagi Street 13
Hungary
TEVA UK Ltd
Brampton Road
Hampden Park
Eastbourne, East Sussex
BN22 9AG
United Kingdom
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
Teva Nederland B.V
Swensweg 5
2031 GA Haarlem
The Netherlands
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Bicalutabene 150 mg Filmtabletten
Czech Republic Bicalutamid-ratiopharm 150 mg
Denmark Bicalutamid ratiopharm (150 mg)
Hungary Bicalutamid-ratiopharm 150 mg fimtabletta
United Kingdom Bicalutamide 150 mg tablets