Bicalutamide Aurobindo

Package leaflet: Information for the user

Bicalutamide Aurobindo 50 mg film-coated tablets

Generic 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 other people, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Bicalutamide Aurobindo is a medicine that contains the active substance called bicalutamide.
This belongs to a group of medicines known as "antiandrogens".

• Bicalutamide is used to treat prostate cancer.
• It works by blocking the effects of male hormones such as testosterone.

2. What you need to know before taking Bicalutamide Aurobindo

Do not take Bicalutamide Aurobindo

• 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 terfenadine or astemizole, used in allergy treatments, or cisapride, used in the treatment of stomach burning and gastro-oesophageal reflux;
• if you are a woman.

Bicalutamide Aurobindo must not be administered to children or adolescents.
Do not take Bicalutamide Aurobindo if any of the conditions listed above apply to you. If you are
unsure, consult your doctor or pharmacist before taking Bicalutamide Aurobindo.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide Aurobindo:

• if you have 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 Aurobindo;
• if you have liver disease. Your doctor may decide to perform blood tests to check whether your liver is functioning properly while you are taking this medicine;
• if you have diabetes. Treatment with bicalutamide in combination with luteinizing hormone-releasing hormone (LHRH) analogues may alter blood sugar levels. It may become necessary to adjust the dosage of insulin and/or oral anti-diabetic medicines.

If you go to hospital, inform the medical staff that you are taking Bicalutamide Aurobindo.
Children and adolescents
Bicalutamide Aurobindo must not be given to children or adolescents.
Other medicines and Bicalutamide Aurobindo
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 or herbal medicines. This is because
Bicalutamide Aurobindo may affect how other medicines work. Some other medicines may also affect
how Bicalutamide Aurobindo works.

• Cyclosporine (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow). This is because bicalutamide may increase the plasma concentration of a substance called creatinine, and your doctor may require blood tests to monitor it;
• Midazolam (a medicine used to relieve anxiety before surgical procedures or diagnostic tests, or as an anaesthetic before and during surgery). You must inform your doctor or dentist that you are taking bicalutamide if you are undergoing surgery or if you are particularly anxious in a hospital setting;
• Terfenadine or astemizole, used to treat allergies;
• Cisapride, used for heartburn and gastro-oesophageal reflux (see section 2, Do not take Bicalutamide Aurobindo);
• A type of medicine called calcium channel blockers, such as diltiazem or verapamil. These are used to treat heart conditions, angina, and hypertension;
• Medicines used to thin the blood, such as warfarin;
• Cimetidine for gastro-oesophageal reflux or gastric ulcers;
• Ketoconazole, an antifungal medicine.
• Bicalutamide Aurobindo 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 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).

Bicalutamide Aurobindo with food and drink
The tablets should not be taken with food, but should be swallowed whole with a glass of water.
Pregnancy and breastfeeding
Women must never take this medicine.
Driving and using machines
This medicine should not affect your ability to drive or operate machinery, although some individuals may experience drowsiness while taking this medicine. If you feel that this medicine causes drowsiness, consult your doctor or pharmacist before driving or operating machinery.
Sunlight or ultraviolet (UV) radiation
Avoid excessive exposure to sunlight or UV radiation while taking bicalutamide.
Bicalutamide Aurobindo contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Bicalutamide Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially ‘sodium-free’.

3. How to take Bicalutamide Aurobindo

Take this medicine exactly as directed by your doctor. 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 medicine at approximately the same time each day.
You must start taking the tablets at least 3 days before beginning therapy with LHRH analogues such as gonadorelin, or simultaneously with surgical castration.

If you take more Bicalutamide Aurobindo than you should
If you think you have taken more tablets than prescribed, contact your doctor or the nearest hospital immediately. Take the remaining tablets or the packaging with you so that the doctor can identify what you have taken. The doctor may decide to monitor your vital functions until the effects of bicalutamide have worn off.

If you forget to take Bicalutamide Aurobindo
If you think you have missed a dose of bicalutamide, speak to your doctor or pharmacist. Do not take a double dose to make up for the missed dose. Simply take your next dose at the usual time.

If you stop taking Bicalutamide Aurobindo
Do not stop taking this medicine even if you feel well, unless your doctor has advised you to do so.
If you have any questions 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 everybody gets them.
If you experience any of the following symptoms, contact your doctor immediately or go to the nearest hospital.

Allergic reactions
These are uncommon side effects (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, difficulty breathing, or trouble breathing.

If this affects you, seek medical attention immediately.
Also contact your doctor immediately if you notice any of the following side effects:
Very common side effects (may affect more than 1 in 10 people):

• Abdominal pain;
• Blood in the urine.

Common side effects (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 failure.

These are uncommon side effects (may affect up to 1 in 100 people):

• Severe shortness of breath or sudden worsening of breath. This may be accompanied by cough or high temperature (fever). These may be signs of lung inflammation known as “interstitial lung disease”.

Side effects with frequency not known (frequency cannot be estimated from the available data):

• Changes in ECG (prolongation of the QT interval)

Other possible side effects:
Very common side effects (may affect more than 1 in 10 people):
Dizziness • Constipation • Feeling unwell (nausea) • Breast swelling and tenderness • Breast development in males • Hot flushes • Feeling weak • Swelling • Low red blood cell count (anaemia). This may make you feel tired or look pale.

Common side effects (may affect up to 1 in 10 people):
Loss of appetite • Reduced sex drive • Depression • Feeling sleepy • Indigestion • Gas (flatulence) • Hair loss • Hair regrowth or increased hair growth • Dry skin • Itching • Rash • Inability to achieve an erection (impotence) • Weight gain • Chest pain • Reduced heart function • Heart attack

Rare side effects (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 your blood.
Do not be alarmed by this list of possible side effects. You may not experience any of them.

Reporting of side effects
If you get 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 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and container, following
“EXP”. The first two digits indicate the month and the last four digits indicate the year. 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 used. This will help protect the environment.

6. Package contents and other information

What Bicalutamide Aurobindo contains

• The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The excipients contained in the tablet core are: monohydrate lactose, magnesium stearate, crospovidone, povidone K-29/32, sodium lauryl sulfate. The excipients contained in the tablet coating are: monohydrate lactose, hypromellose, macrogol 4000, titanium dioxide (E171).

Description of the appearance of Bicalutamide Aurobindo and pack sizes
The tablets are white, round, biconvex, film-coated, marked with "BCM 50" on one side.
Available in blisters of 5, 7, 10, 14, 20, 28, 30, 40, 50, 56, 80, 84, 90, 98, 100, 140, 200 or 280 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2,
Valletta Waterfront,
Floriana FRN 1914, Malta
Manufacturer
Synthon BV - Microweg 22 - 6545 CM Nijmegen (The Netherlands)
Synthon Hispania - Castello 1 - Polígono Las Salinas - 08830 Sant Boi de Llobregat (Spain)

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Bicalutamid Puren Filmtabletten
Austria Bicalutamid Actavis 50 mg, Filmtabletten
Finland Bicavan 50 mg tabletti, kalvopäällysteinen
Italy Bicalutamide Aurobindo
Latvia Sapro 50 mg, apvalkotās tablets
Lithuania Sapro 50 mg, plevele dengtos tabletes
Netherlands Bicalutamide Mylan 50mg filmomhulde tabletten
Portugal Bicalutamida Aurovitas