Bicalutamide Aurobindo Italia: detailed information

Package leaflet: Information for the user

Bicalutamide Aurobindo Italia 50 mg film-coated tablets

Equivalent medicine
Please read all of 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 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 reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Bicalutamide Aurobindo Italia is and what it is used for
What you need to know before taking Bicalutamide Aurobindo Italia
How to take Bicalutamide Aurobindo Italia
Possible side effects
How to store Bicalutamide Aurobindo Italia
Contents of the pack and other information

1. What Bicalutamide Aurobindo Italia is and what it is used for

Bicalutamide Aurobindo Italia belongs to a group of medicines called antiandrogens. It interferes with certain actions of male sex hormones.
Bicalutamide Aurobindo Italia is used to treat prostate cancer. It is used:
- as monotherapy in tumour stages described as "locally advanced", or
- in combination therapy in tumour stages described as "advanced", together with other treatments such as surgical castration or medicines that reduce androgen levels in the body.

2. What you need to know before taking Bicalutamide Aurobindo Italia

Do not take Bicalutamide Aurobindo Italia
if you are allergic (hypersensitive) to bicalutamide or to any of the other ingredients of this
medicine (listed in section 6);
if you are a woman or a child;
if you are taking any medicine containing terfenadine, astemizole or cisapride (see ‘Other
medicines and Bicalutamide Aurobindo Italia’ below).

Warnings and precautions
Talk to your doctor or pharmacist before taking bicalutamide:
if you have liver problems. Bicalutamide levels in the blood may increase. Your liver function may need to be checked periodically.
if you have diabetes.
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.
if you are taking Bicalutamide Aurobindo Italia, you and/or your partner must use contraception both during treatment with Bicalutamide Aurobindo Italia and for 130 days after stopping treatment with Bicalutamide Aurobindo Italia. Speak with your doctor if you have questions about contraceptive methods.

Other medicines and Bicalutamide Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is particularly important if you are taking any of the following medicines:
terfenadine or astemizole (for hay fever or allergies) or cisapride (for stomach disorders). See ‘Do not take Bicalutamide Aurobindo Italia’;
cyclosporine (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow);
calcium channel blockers (used to treat high blood pressure or certain heart conditions);
cimetidine (used to treat stomach ulcers);
ketoconazole (used to treat fungal skin and nail infections);
blood thinners or medicines to prevent blood clots such as warfarin. Your doctor may perform blood tests before and during treatment with bicalutamide.

Bicalutamide Aurobindo Italia may interfere with some 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 addiction detoxification programs), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy, breastfeeding and fertility
Bicalutamide must not be used by women.
In men, bicalutamide may cause reduced fertility or temporary infertility.

Driving and using machines
This medicine may cause confusion or drowsiness. If you experience such effects, do not drive or operate machinery.

Bicalutamide Aurobindo Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially ‘sodium-free’.

Bicalutamide Aurobindo Italia contains 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 Aurobindo Italia

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage:
Depending on your condition, the usual dose is one 50 mg tablet daily (in combination therapy) or three 50 mg tablets once daily (in monotherapy).
Method of administration:
Swallow the tablets whole with a glass of water.
You may take these tablets with or without food.
Frequency of administration:
The tablet may be taken at any time of day, but it is advisable to take it at the same time each day to help you remember.
Duration of treatment:
The duration of treatment is determined by your doctor.
Do not stop treatment without your doctor's approval.
If you take more Bicalutamide Aurobindo Italia than you should:
Contact your doctor immediately or go to the nearest hospital emergency department. If possible, bring the tablets or the pack with you to show the doctor what you have taken.
If you forget to take Bicalutamide Aurobindo Italia:
If you forget to take your medicine, take the missed dose as soon as you remember, then take the next dose at your usual time. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Bicalutamide Aurobindo Italia:
Do not stop taking the tablets even if you feel well, unless your doctor tells you to do so.
If you have any questions about the use of 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.
These side effects may occur with the following frequency, as defined below:
Very common: in more than 1 out of 10 people
Common: in 1 to 10 out of 100 people
Uncommon: in 1 to 10 out of 1,000 people
Rare: in 1 to 10 out of 10,000 people
Very rare: in less than 1 out of 10,000 people
Not known: frequency cannot be estimated from the available data.
Contact your doctor immediately if you experience any of the following side effects, as urgent medical treatment may be necessary:
- severe breathing problems, or sudden worsening of a breathing problem, possibly accompanied by cough or fever. This could be a sign of lung inflammation known as “interstitial lung disease”;
- severe itching accompanied by skin rash or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing or breathing. This could be a severe allergic reaction to bicalutamide;
- blood in the urine;
- abdominal pain;
- jaundice.

The following side effects may occur:

Very common side effects (may affect more than 1 in 10 people):
Anaemia (a condition affecting red blood cells)
Dizziness
Hot flushes
Abdominal pain, constipation, nausea
Haematuria (blood in the urine)
Breast tenderness or swelling
Asthenia (feeling of weakness)
Oedema
Rash

Common side effects (may affect up to 1 in 10 people):
Loss of appetite
Decreased libido
Depression
Somnolence
Myocardial infarction, heart failure
Dyspepsia (digestive discomfort), flatulence (gas)
Hepatotoxicity, jaundice, hypertransaminasaemia
Alopecia, hirsutism/regrowth of hair, dry skin, pruritus
Erectile dysfunction
Chest pain
Weight gain

Uncommon side effects (may affect up to 1 in 100 people):
Hypersensitivity, angioedema and urticaria
Lung inflammation called “interstitial lung disease”

Rare side effects (may affect up to 1 in 1,000 people):
Liver failure
Increased sensitivity of the skin to sunlight

Side effects with frequency not known:
Changes in ECG trace (prolongation of QT interval)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Bicalutamide Aurobindo Italia 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, Magnesium stearate.
Film coating: HPMC 2910/Hypromellose, Titanium dioxide (E171), Macrogol.

Description of the appearance of Bicalutamide Aurobindo Italia and package contents
Film-coated tablet.
Bicalutamide Aurobindo Italia 50 mg film-coated tablets:
Round, white, film-coated tablet, marked with "B" on one side and "l" on the other side.
Bicalutamide Aurobindo Italia film-coated tablets are available in blister packs containing 1, 10, 28,
30, 56, 60, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914, Malta

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua Joao De Deus, no 19,
Venda Nova, 2700487 Amadora
Portugal
Arrow Génériques,
26 Avenue Tony Garnier,
Lyon, 69007
France

This medicinal product is authorized in the European Economic Area countries under the following
names:
Belgium: Bicalutamide Eugia 50 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
France: Bicalutamide Arrow 50 mg, comprimé pelliculé
Germany: Bicalutamid Puren 50 mg Filmtabletten
Italy: Bicalutamide Aurobindo Italia
Netherlands: Bicalutamide Eugia 50 mg, filmomhulde tabletten
Portugal: Bicalutamida Generis
Spain: Bicalutamida Aurovitas 50 mg comprimidos recubiertos con película EFG

Package leaflet: information for the user

Bicalutamide Aurobindo Italia 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, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Bicalutamide Aurobindo Italia is and what it is used for
What you need to know before taking Bicalutamide Aurobindo Italia
How to take Bicalutamide Aurobindo Italia
Possible side effects
How to store Bicalutamide Aurobindo Italia
Contents of the pack and other information

1. What Bicalutamide Aurobindo Italia is and what it is used for

Bicalutamide Aurobindo Italia contains bicalutamide, which belongs to a group of medicines called 'antiandrogens'.

Bicalutamide Aurobindo Italia is indicated for the treatment of prostate cancer (a gland in men that produces seminal fluid), and works by reducing the amount of testosterone (a hormone) produced in your body.
Bicalutamide Aurobindo Italia may be prescribed alone or in combination with other medicines:
after surgical removal of the prostate;
following a course of radiotherapy (a medical technique that uses radiation to treat cancer).
Bicalutamide Aurobindo Italia may be prescribed alone:
if the cancer has spread to other organs and surgical removal is not possible, or if testicular function is suppressed.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Bicalutamide Aurobindo Italia

Do not take Bicalutamide Aurobindo Italia

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 taking a medicine called cisapride or certain antihistamines (terfenadine or astemizole).

Bicalutamide must not be administered to children.
Do not take bicalutamide if any of the conditions listed above apply to you. If you are unsure, speak with your
doctor or pharmacist before taking bicalutamide.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking bicalutamide.
- if you have liver problems. Your doctor may require blood tests before and during treatment
with bicalutamide.
- if you suffer from any of the following conditions: any heart or blood vessel disorders, including
heart rhythm problems (arrhythmia), or if you are being treated with medicines for these conditions. The risk
of heart rhythm problems may increase with the use of bicalutamide.
- if you are taking bicalutamide, you and/or your partner must use contraception both during treatment
with bicalutamide and for 130 days after stopping therapy with bicalutamide.
Talk to your doctor if you have questions about contraceptive methods.
If you need to go to hospital, inform the medical staff that you are taking bicalutamide.
Children and adolescents
Bicalutamide must not be administered to children or adolescents.
Tests and monitoring
Your doctor may prescribe blood tests to check for any changes in your blood.
Other medicines and Bicalutamide Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
This includes medicines obtained without a prescription and herbal medicines. This is because
bicalutamide may affect how other medicines work. Also, some other medicines may affect how bicalutamide works.
Do not take Bicalutamide Aurobindo Italia if you are already taking any of the following medicines:

cisapride (used for certain types of indigestion);
certain antihistamines (terfenadine or astemizole).

Bicalutamide 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).
Inform your doctor or pharmacist if you are taking any of the following medicines:
- Oral medicines used to prevent blood clots (oral anticoagulants).
Blood thinners or medicines to prevent blood clotting. Your doctor may perform blood tests before and during treatment with bicalutamide.
- Cyclosporine (used to suppress the immune system).
- Calcium channel blockers (for treating high blood pressure or certain heart conditions).
- Cimetidine (for stomach problems).
- Ketoconazole (to treat fungal infections).
Pregnancy and breastfeeding
Bicalutamide must not be administered to women.
In men, bicalutamide may cause reduced fertility or infertility for a transient period of time.
Driving and using machines
It is unlikely that bicalutamide will affect your ability to drive or operate tools or machinery. However,
some people may occasionally feel drowsy while taking bicalutamide. If this occurs, seek advice from your doctor or pharmacist.
Sunlight or ultraviolet (UV) light
Avoid direct exposure to excessive sunlight or UV light while taking bicalutamide.
Bicalutamide Aurobindo Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially ‘sodium-free’.
Bicalutamide Aurobindo Italia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Bicalutamide Aurobindo Italia

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, 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 the same time each day. Do not stop taking this medicine even if you feel well, unless your doctor tells you otherwise.
Use in children and adolescents
Bicalutamide must not be given to children.
If you take more Bicalutamide Aurobindo Italia than you should
If you have taken more bicalutamide than you should, contact a doctor immediately or go to hospital.
If you forget to take Bicalutamide Aurobindo Italia
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 forgotten dose.
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.
Immediately inform your doctor if you notice any of the following side effects: you may need urgent
medical treatment:
Allergic reactions (uncommon, may affect up to 1 in 100 people)
Symptoms may include sudden onset of:

Rash, itching or hives on the skin.
Swelling of the face, lips, tongue, throat or other parts of the body.
Shortness of breath, wheezing or difficulty breathing.

Also immediately inform your doctor if you notice any of the following side effects:
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 (less than 1 in 1,000 people), liver failure.
Abdominal pain.
Blood in the urine.

Uncommon (may affect up to 1 in 100 people):
Severe shortness of breath or sudden worsening of breathing difficulties. This may occur together with
cough or high body temperature (fever). These may be signs of lung inflammation called “interstitial lung disease”.
Not known (frequency cannot be estimated from available data):
Changes in ECG trace (prolongation of QT interval)
Other possible side effects:
Very common (may affect more than 1 in 10 people):

Rash.
Breast swelling and tenderness.
Feeling weak.

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

Hot flushes.
Feeling unwell (nausea).
Itching.
Dry skin.
Problems achieving an erection (erectile dysfunction).
Weight gain.
Reduced sex drive and fertility.
Hair loss.
Hair regrowth or increased hair growth.
Low levels of red blood cells in the blood (anaemia). This may make you feel tired or look pale.
Loss of appetite.
Depression.
Feeling sleepy.
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 carry out blood tests to check for any changes in the blood. Do not worry about this list of side effects. You may not experience any of them.
Reporting of side effects
If you get 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 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 Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and the blister after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Aurobindo Italia contains
The active substance is bicalutamide.
Each tablet contains 150 mg of bicalutamide.
The other components are:
Tablet core: Lactose monohydrate, Sodium starch glycolate (type A), Povidone, Magnesium stearate.
Film coating: HPMC 2910/Hypromellose, Titanium dioxide (E171), Macrogol.

Description of the appearance of Bicalutamide Aurobindo Italia and package contents
Film-coated tablet.
Bicalutamide Aurobindo Italia 150 mg film-coated tablets:
Round, white, film-coated tablet, marked “B2” on one side and plain on the other.
Bicalutamide Aurobindo Italia film-coated tablets are available in blister packs containing 1, 10, 28,
30, 56, 60, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914, Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Bicalutamide Eugia 150 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Germany: Bicalutamid Puren 150 mg Filmtabletten
Italy: Bicalutamide Aurobindo Italia
Netherlands: Bicalutamide Eugia 150 mg, filmomhulde tabletten
Portugal: Bicalutamida Generis
Spain: Bicalutamida Aurovitas 150 mg comprimidos recubiertos con película EFG