Bicalutamide Tecnigen

Package leaflet: Information for the user

Bicalutamide TecniGen 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Bicalutamide TecniGen 50 mg is and what it is used for
2. What you need to know before taking Bicalutamide TecniGen 50 mg
3. How to take Bicalutamide TecniGen 50 mg
4. Possible side effects
5. How to store Bicalutamide TecniGen 50 mg
6. Contents of the pack and other information

1. What Bicalutamide TecniGen 50 mg is and what it is used for

Bicalutamide TecniGen 50 mg contains a medicine called bicalutamide, which belongs to a class of
medicines known as "antiandrogens".

• Bicalutamide TecniGen 50 mg is indicated for the treatment of prostate cancer
• It works by blocking the effects of male hormones, such as testosterone.

2. What you need to know before taking Bicalutamide TecniGen 50 mg

Do not take Bicalutamide TecniGen 50 mg

• If you are allergic (hypersensitive) to bicalutamide or to any of the excipients of this medicine (listed in section 6).
• If you are already taking a medicine such as cisapride or certain antihistamine medicines (terfenadine or astemizole).
• If you are a woman.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Bicalutamide TecniGen 50 mg:

• If you have any of the following conditions: any heart or blood vessel disorder, 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 TecniGen.
• If you have liver problems. Your doctor may order blood tests before or during treatment with Bicalutamide TecniGen.
• If you are admitted to hospital, inform the medical staff that you are taking Bicalutamide TecniGen 50 mg.

Children and adolescents
Bicalutamide TecniGen 50 mg must not be given to children or adolescents.

Other medicines and Bicalutamide TecniGen 50 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Bicalutamide TecniGen if you are already taking the following medicines:

• Cisapride (used for certain digestive disorders).
• Antihistamine medicines (terfenadine or astemizole).

Bicalutamide TecniGen could interfere with certain medicines used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol) or could increase the risk of heart rhythm problems when used together with certain other medicines (for example, methadone (used to relieve pain and in drug detoxification programs), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)). Inform your doctor or pharmacist if you are taking any of the following medicines:

• Oral anticoagulants (to prevent blood clots)
• Cyclosporine (to suppress the immune system)
• Calcium channel blockers (to treat high blood pressure or certain heart conditions)
• Cimetidine (to treat stomach problems)
• Ketoconazole (to treat fungal infections)

Pregnancy and breastfeeding
Bicalutamide TecniGen must not be given to women, including pregnant women or women who are breastfeeding.

Driving and using machines
It is unlikely that Bicalutamide TecniGen 50 mg will affect your ability to drive or operate machinery.
However, some people may occasionally experience drowsiness while taking bicalutamide.
If this happens to you, consult your doctor or pharmacist for advice.

Bicalutamide TecniGen 50 mg contains lactose
Lactose is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Bicalutamide TecniGen 50 mg

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose is one tablet (50 mg) daily or three tablets (150 mg) taken as a single dose, according to your doctor's instructions.
• Swallow the tablet whole with a glass of water.
• Try to take the tablet at approximately the same time each day.
• Do not stop taking this medicine if you feel better, unless your doctor tells you to.

If you take more Bicalutamide TecniGen 50 mg than you should
If you take more Bicalutamide TecniGen 50 mg than prescribed by your doctor, contact your doctor immediately or go to the nearest hospital.

If you forget to take Bicalutamide TecniGen 50 mg
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 the forgotten dose.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Allergic reactions
Uncommon ( may affect up to 1 in 100 people). Symptoms may include sudden onset of:

• Skin rash, itching, hives
• Swelling of the face, lips, tongue and/or throat or other parts of the body
• Shortness of breath, wheezing or breathing problems

If this happens to you, contact your doctor immediately. Inform your doctor immediately if you notice any of the following effects:

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

• Abdominal pain
• Blood in the urine

Common (may affect up to 1 in 10 people)

• Yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver problems or, in rare cases (may affect up to 1 in 1,000 people), liver damage.

Uncommon (may affect up to 1 in 100 people)

• Severe shortness of breath, or shortness of breath that suddenly worsens, possibly with cough or high temperature (fever). These may be signs of lung inflammation known as 'interstitial lung disease'.

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

• Changes in ECG (QT prolongation).

Other possible side effects

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

• Reduction in red blood cells (anaemia). This may make you feel tired or look pale
• Dizziness
• Hot flushes
• Constipation
• Malaise (nausea)
• Skin rash
• Swelling and pain in the breasts
• Swelling

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Decreased sexual desire (libido)
• Depression
• Drowsiness
• Heart attack or reduced heart function
• Indigestion
• Flatulence
• Increased liver enzyme levels (serum alanine aminotransferase)
• Hair loss
• Growth or regrowth of extra hair
• Dry skin
• Itching
• Erectile dysfunction (impotence)
• Chest pain
• Weight gain

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

• Increased sensitivity of the skin to sunlight.

Your doctor may prescribe laboratory tests to monitor for possible changes in the blood.

Reporting of side effects
If you get any side effects, including any 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:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Bicalutamide TecniGen 50 mg

Keep this medicine out of the sight and reach of children.
Do not store above 30°C if packaged in PVC/PVDC/Aluminum blisters.
No special storage conditions required if packaged in OPA/Aluminum/PVC/Aluminum blisters.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Bicalutamide TecniGen 50 mg contains
The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
The other components are:
Monohydrate lactose, crospovidone, povidone, magnesium stearate, OPADRY II 85F28751 (polyvinyl alcohol,
macrogol 3000, titanium dioxide (E171), talc).
Description of the appearance of Bicalutamide TecniGen 50 mg and package contents
The tablets are packaged in PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters.
Bicalutamide TecniGen 50 mg is available in packages containing 20, 28, 30, 60 and 90 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
TECNIMEDE – Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra, Portugal
Sales Licensee:
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº11, Venda Nova, 2700 Amadora, Portugal
This medicinal product is authorized in the European Economic Area countries with the following
names:
Germany: Bicalutamid Tecnimede 50 mg Filmtabletten
Italy: Bicalutamide TecniGen
Poland, Portugal: Bicalutamida Tecnimede
This leaflet was last updated on

Package leaflet: Information for the user

Bicalutamide TecniGen 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, pharmacist, or nurse.
• 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 effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Bicalutamide TecniGen 150 mg is and what it is used for
2. What you need to know before taking Bicalutamide TecniGen 150 mg
3. How to take Bicalutamide TecniGen 150 mg
4. Possible side effects
5. How to store Bicalutamide TecniGen 150 mg
6. Contents of the pack and other information

1. What Bicalutamide TecniGen 150 mg is and what it is used for

Bicalutamide TecniGen contains a medicine called bicalutamide, which belongs to a group of medicines
called "antiandrogens".

• Bicalutamide TecniGen is used for the treatment of prostate cancer
• It works by blocking the effects of male hormones such as testosterone.

2. What you need to know before taking Bicalutamide TecniGen 150 mg

Do not take Bicalutamide TecniGen 150 mg

• If you are a woman
• 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 medicines such as cisapride or other antihistamines (terfenadine or astemizole). Bicalutamide TecniGen must not be given to children. Do not take Bicalutamide TecniGen if any of the above conditions apply to you. If you have any doubts, consult your doctor or pharmacist before taking Bicalutamide TecniGen.

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

• if you have problems with your liver. Your doctor may request blood tests before starting and during treatment with Bicalutamide TecniGen.
• if you have any of the following conditions: any heart or blood vessel disorder, 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 TecniGen. If you go to hospital, inform the medical staff that you are taking Bicalutamide TecniGen.

Children and adolescents
Bicalutamide TecniGen must not be administered to children and adolescents.

Tests and monitoring
Your doctor may prescribe laboratory tests to monitor for possible changes in your blood.

Other medicines and Bicalutamide TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, herbal medicines, because Bicalutamide TecniGen may affect the action of other medicines. Other medicines may also affect the action of Bicalutamide TecniGen.
Do not use Bicalutamide TecniGen if you are already taking any of the following medicines:

• cisapride (for certain digestive disorders)
• certain antihistamines (terfenadine or astemizole)

Bicalutamide TecniGen 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 other medicines (e.g., methadone (used to relieve pain and in drug detoxification programs), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)). In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• oral medicines to prevent blood clots (oral anticoagulants). Your doctor may prescribe blood tests before and during treatment with Bicalutamide TecniGen.
• ciclosporin (to suppress the immune system)
• calcium channel blockers (to treat high blood pressure or certain heart conditions)
• cimetidine (to treat stomach problems)
• ketoconazole (to treat fungal infections)

Pregnancy and breastfeeding
Bicalutamide TecniGen must not be administered to women.

Driving and using machines
Bicalutamide TecniGen does not appear to affect the ability to drive or use machinery.
However, some people may occasionally feel drowsy while taking Bicalutamide TecniGen. If this happens to you, consult your doctor or pharmacist.

Sunlight or UV rays
Avoid excessive direct exposure to sunlight or UV rays while taking Bicalutamide TecniGen.

Bicalutamide TecniGen 150 mg contains lactose
Lactose is a type of sugar.
If you have previously informed your doctor of an intolerance to certain sugars, please contact your doctor before taking this medicine.

3. How to take Bicalutamide TecniGen 150 mg

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily.
Swallow the tablet whole with a glass of water.
Try to take the tablet at approximately the same time each day.
Do not stop taking this medicine even if you feel better, unless instructed by your doctor.

Use in children and adolescents
Bicalutamide TecniGen must not be given to children.

If you take more Bicalutamide TecniGen 150 mg than you should
If you take more than the prescribed amount of Bicalutamide 150 mg, contact your doctor or the nearest hospital immediately.

If you forget to take Bicalutamide TecniGen 150 mg
If you forget to take a dose, skip the missed dose and take the next dose as usual.
Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience any of the following serious side effects. You may
need urgent medical treatment:
Allergic reactions
Uncommon ( may affect less than 1 in 100 people)

• Rash, itching or skin eruptions
• Swelling of the face, lips, tongue and/or throat or other parts of the body
• Shortness of breath, difficulty breathing or worsening breathing Contact your doctor immediately if you notice any of the following effects: Common (may affect less than 1 in 10 people)
• Yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver problems or, in rare cases (may affect less than 1 in 1,000), liver damage.
• Abdominal pain
• Blood in the urine Uncommon ( may affect less than 1 in 100 people)
• Severe shortness of breath or sudden worsening of breathing, possibly with cough or fever. These may be signs of lung inflammation called "interstitial lung disease". Not known (frequency cannot be estimated from the available data)
• Changes in ECG trace (QT prolongation). Other possible side effects Very common (may affect more than 1 in 10 people)
• Skin rash
• Swelling and pain in the breasts
• Feeling weak Common (may affect less than 1 in 10 people)
• Hot flushes
• Malaise (nausea)
• Itching
• Dry skin
• Erectile problems (erectile dysfunction)
• Weight gain
• Decreased sexual desire and reduced fertility
• Hair loss
• Increased body and facial hair
• Decrease in red blood cell count (anaemia). This may cause tiredness and paleness
• Loss of appetite
• Depression
• Drowsiness
• Indigestion
• Dizziness
• Constipation
• Flatulence
• Chest pain
• Swelling Rare (may affect up to 1 in 1,000 people)
• Increased sensitivity of the skin to sunlight. Your doctor may order laboratory tests to monitor for possible blood changes. The possible side effects listed above should not alarm you, as they may not occur at all. Reporting of side effects If you get any side effects, including any 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 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 TecniGen 150 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of the month.
Do not store above 30°C if packaged in PVC/PVDC/Aluminum blisters.
Store in the original packaging.
This medicine does not require any special storage conditions if packaged in OPA/Aluminum/PVC/Aluminum blisters.
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 TecniGen 150 mg contains
The active substance is bicalutamide. Each tablet contains 150 mg of bicalutamide.
The other components are:
Monohydrate lactose, crospovidone, povidone, magnesium stearate, OPADRY II 85F28751 (polyvinyl alcohol,
macrogol 3000, titanium dioxide (E171), talc).
Description of the appearance of Bicalutamide TecniGen 150 mg and package contents
The tablets are packaged in PVC/PVDC/Aluminium or OPA/Aluminium/PVC/Aluminium blisters.
Bicalutamide TecniGen 150 mg is available in pack sizes of 20, 28, 30, 60 and 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
TECNIMEDE – Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra, Portugal
Marketing Authorisation Holder's representative in Italy:
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy
Manufacturer:
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº11, Venda Nova, 2700 Amadora, Portugal
This medicinal product is authorised in the European Economic Area countries under the following
names:
Germany: Bicalutamid Tecnimede 150 mg Filmtabletten
Italy: Bicalutamide TecniGen
Portugal: Bicalutamida Tecnimede
This leaflet was last updated on