BICALUTAMIDE 50 mg Film-Coated Tablets

Зміст інструкції

1. Bicalutamide TecniGen 50 mg film-coated tablets
   1. What is Bicalutamide TecniGen 50 mg and what is it used for?
   2. What you need to know before you use 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
2. Bicalutamide TecniGen 150 mg film-coated tablets
   1. What is Bicalutamide TecniGen 150 mg and what is it used for
   2. What you need to know before you use 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

Bicalutamide TecniGen 50 mg film-coated tablets

Bicalutamide

Equivalent Medicinal Product

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those 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 you use 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 is Bicalutamide TecniGen 50 mg and what is it used for?

Bicalutamide TecniGen 50 mg contains a medicine called bicalutamide, which belongs to the class of
medicines called “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 you use Bicalutamide TecniGen 50 mg

Do not take Bicalutamide TecniGen 50 mg

• If you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
• If you are already taking a medicine such as cisapride or certain antihistamines (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 problems, including heart rhythm problems (arrhythmias), or if you are being treated for these conditions. The risk of heart rhythm problems may increase with the use of Bicalutamide TecniGen
• if you have problems with your liver. Your doctor may prescribe blood tests before or during treatment with Bicalutamide TecniGen
• if you go to hospital, tell the medical staff that you are taking Bicalutamide TecniGen 50 mg Children and adolescentsBicalutamide TecniGen 50 mg should not be given to children and adolescents.

Other medicines and Bicalutamide TecniGen 50 mg
Tell 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 some digestive disorders).
• Antihistamine medicines (terfenadine or astemizole) Bicalutamide TecniGen may interfere with some 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 with some other medicines (for example methadone (used to relieve pain and in drug detoxification programs), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses). Tell 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 some heart conditions)
• Cimetidine (to treat stomach problems)
• Ketoconazole (to treat fungal infections)

Pregnancy and breastfeeding
Bicalutamide TecniGen should 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, talk to your doctor or pharmacist for advice.

Bicalutamide TecniGen 50 mg contains lactose
Lactose is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, contact
them before taking this medicine.

3. How to take Bicalutamide TecniGen 50 mg

Take this medicine following exactly the instructions of 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 in a single administration, in accordance with 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 has been 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 it and take the next dose as usual. Do not take a double
dose to make up for a missed dose.
If you have any doubts about using this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

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

Allergic reactions

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

• Skin rash, itching, hives on the skin
• 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. Tell your doctor immediately if you also notice any of the following effects: Very common(may affect more than 1 in 10 people)
• Abdominal pain
• Blood in urine Common(may affect up to 1 in 10 people)
• Yellowing of the skin or the whites of the eyes (jaundice). These may be signs of problems with the liver or in rare cases (may affect up to 1 in 1,000) liver damage. Uncommon (may affect up to 1 in 100 people)
• Severe shortness of breath, or worsening shortness of breath, possibly with cough or high temperature (fever). These may be signs of inflammation of the lungs called ‘interstitial lung disease’. Not known (the frequency cannot be estimated based on available data)
• Changes in ECG tracing (QT prolongation). Other possible side effects Very common (may affect more than 1 in 10 people)
• Reduction in red blood cells (anemia). This may make you feel tired or look pale
• Dizziness
• Hot flushes
• Constipation
• Feeling sick (nausea)
• Skin rash
• Swelling and pain in the breasts
• Swelling Common (may affect up to 1 in 10 people)
• Loss of appetite
• Decreased sex drive (libido)
• Depression
• Drowsiness
• Heart attack or reduced heart function
• Indigestion
• Flatulence
• Increased liver enzyme levels (serum alanine aminotransferase)
• Hair loss
• Extra hair growth or regrowth
• Dry skin
• Itching
• Erectile dysfunction (impotence)
• Chest pain
• Weight gain Rare (may affect up to 1 in 1,000 patients)
• Increased sensitivity of the skin to sunlight. Your doctor may prescribe laboratory tests to check for any changes in the blood. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 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 particular storage conditions are required if packaged in OPA/Aluminum/PVC/Aluminum blisters.
Store in the original package.
Do not use this medicine after the expiry date which is reported on the package after “Exp.”. The expiry date refers to the last day of the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bicalutamide TecniGen 50 mg contains
The active ingredient is bicalutamide. Each tablet contains 50 mg of bicalutamide.
The other ingredients are:
Lactose monohydrate, 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 contents of the pack
The tablets are packaged in PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters.
Bicalutamide TecniGen 50 mg is available in packs of 20, 28, 30, 60 and 90 tablets.

Marketing Authorisation Holder and Manufacturer

MAH:
TECNIMEDE – Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra, Portugal
Marketing Authorisation Holder for sale:
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 authorised in the Member States of the European Economic Area with the following
names:
Germany: Bicalutamid Tecnimede 50 mg Filmtabletten
Italy: Bicalutamide TecniGen
Poland, Portugal: Bicalutamida Tecnimede

This leaflet was last updated on

Bicalutamide TecniGen 150 mg film-coated tablets

Bicalutamide

Generic Medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Bicalutamide TecniGen 150 mg and what is it 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 you use 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 should not be given to children. Do not take Bicalutamide TecniGen if you fall into any of the above conditions. If you have doubts, ask 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 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 the treatment of these disorders. The risk of heart rhythm problems may increase with the use of Bicalutamide TecniGen. If you go to hospital, tell the medical staff that you are taking Bicalutamide TecniGen. Children and adolescentsBicalutamide TecniGen should not be given to children and adolescents. Tests and checks Your doctor may prescribe laboratory tests to check for any changes in your blood.

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

• cisapride (for some digestive disorders).
• some antihistamines (terfenadine or astemizole) Bicalutamide TecniGen can interfere with some 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 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, tell your doctor or pharmacist if you are taking any of the following medicines:
• medicines taken by mouth to prevent blood clots (oral anticoagulants) Your doctor may prescribe blood tests before and during treatment with Bicalutamide TecniGen.
• cyclosporine (to suppress the immune system)
• calcium channel blockers (to treat high blood pressure or some heart conditions)
• cimetidine (to treat stomach problems)
• ketoconazole (to treat fungal infections)

Pregnancy and breastfeeding
Bicalutamide TecniGen should not be given to women.

Driving and using machines
Bicalutamide TecniGen does not appear to impair the ability to drive vehicles or operate machinery.
However, some people may occasionally feel drowsy while taking Bicalutamide
TecniGen. If this happens to you, ask your doctor or pharmacist for advice.

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

Bicalutamide TecniGen 150 mg contains lactose
Lactose is a type of sugar.
If you have told your doctor that you have an intolerance to some sugars, contact them 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
tells you to do. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is one tablet a day.
Swallow the tablet whole with a glass of water.
Try to take the tablet at about the same time each day.
Do not stop taking this medicine even if you feel better, unless your doctor tells you to.

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

If you take more Bicalutamide TecniGen 150 mg than you should
If you take more Bicalutamide 150 mg than you should, 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 a missed dose.
If you have any doubts about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

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, wheezing or worsening of breath 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 suddenly worsening shortness of breath, possibly with cough or fever. These may be signs of inflammation of the lungs called “interstitial lung disease”. Not known(frequency cannot be estimated based on available data)
• Changes in ECG tracing (QT prolongation). Other possible side effectsVery common(may affect more than 1 in 10 people)
• Skin rash
• Breast swelling and pain
• Feeling of weakness Common(may affect less than 1 in 10 people)
• Hot flushes
• Feeling unwell (nausea)
• Itching
• Dry skin
• Erectile dysfunction (erectile dysfunction)
• Weight gain
• Decreased libido and reduced fertility
• Hair loss
• Increased body and facial hair
• Reduced number of red blood cells (anemia). This can make you tired and pale
• Loss of appetite
• Depression
• Drowsiness
• Indigestion
• Dizziness
• Constipation
• Flatulence
• Chest pain
• Swelling Rare(may affect up to 1 in 1,000 patients)
• Increased sensitivity of the skin to sunlight. Your doctor may prescribe laboratory tests to check for any changes in the blood. The possible side effects listed above should not alarm you because they may also not occur. Reporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through 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 which is stated on the pack 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 package.
This medicine does not require any particular storage conditions if packaged in OPA/Aluminum/PVC/Aluminum blisters.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bicalutamide TecniGen 150 mg contains
The active ingredient is bicalutamide. Each tablet contains 150 mg of bicalutamide.
The other ingredients are:
Lactose monohydrate, 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 contents of the pack
The tablets are packaged in PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters.
Bicalutamide TecniGen 150 mg is available in packs of 20, 28, 30, 60 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

MAH:
TECNIMEDE – Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande, 2
Abrunheira
2710-089 Sintra, Portugal
Marketing Authorisation Holder for sale:
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 authorised in the Member States of the European Economic Area under the following
names:
Germany: Bicalutamid Tecnimede 150 mg Filmtabletten
Italy: Bicalutamide TecniGen
Portugal: Bicalutamida Tecnimede

This leaflet was last updated on