BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide Aurovitas 150 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

This medicinal product contains the active substance bicalutamide, which belongs to a group of medicines called anti-androgens.

• Bicalutamide is indicated for the treatment of prostate cancer (a gland that, in men, produces seminal fluid) and acts by reducing the amount of testosterone (a hormone) produced by your body.
• This medicine will also be prescribed to you alone or in combination with other medicines:
  • after prostate removal.
  • after radiotherapy treatment (a medical technique that uses radiation to treat cancer).
• This medicine will be prescribed to you as monotherapy:
  • if the tumor spreads to other organs and cannot be removed or if the action of agents in the testicles is inhibited.

Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Bicalutamide Aurovitas

Do not take Bicalutamide Aurovitas

• If you are a woman.
• If you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
• If you are already taking a medicine called cisapride or some antihistamines (terfenadine or astemizole).

Bicalutamide should not be given to children.

Do not take bicalutamide if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before taking bicalutamide.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take bicalutamide:

• If you have any liver problems. Your doctor may perform blood tests before and during your treatment with bicalutamide.
• If you have any of the following: any heart or blood vessel disease, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these diseases. The risk of heart rhythm problems may increase with bicalutamide treatment.
• If you are taking bicalutamide, you and/or your partner must use a contraceptive method while you are being treated with bicalutamide and for 130 days after the end of treatment. Consult your doctor if you have any questions about contraceptive methods.

If you are hospitalized, inform the healthcare staff that you are taking bicalutamide.

Children and adolescents

Bicalutamide should not be given to children or adolescents.

Medical tests

Your doctor may perform blood tests to check if there are any changes in your blood.

Other medicines and Bicalutamide Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This includes medicines that are not prescribed by a doctor and medicines that are based on plants. This is because bicalutamide may affect the way other medicines work. Also, some other medicines may affect the way bicalutamide works.

Do not take bicalutamide if you are already taking any of the following medicines:

• Cisapride (used for some types of indigestion).
• Some antihistamines (terfenadine or astemizole).

Bicalutamide 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 other medicines (e.g., methadone (used to relieve pain and for part of the treatment of drug addiction), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Oral medicines to prevent blood clotting (oral anticoagulants). Anticoagulants or medicines to prevent blood clots. Your doctor may perform blood tests before and during your treatment with bicalutamide.
• Cyclosporin (used to suppress the immune system).
• Calcium channel blockers (to treat high blood pressure or some heart diseases).
• Cimetidine (to treat stomach problems).
• Ketoconazole (to treat fungal infections).

Pregnancy, breastfeeding, and fertility

Bicalutamide should not be used in women.

Bicalutamide may cause limited fertility or infertility in men for a temporary period.

Driving and using machines

Bicalutamide is unlikely to affect your ability to drive or use tools or machines. However, some people may feel drowsy occasionally while taking bicalutamide. If this happens, consult your doctor or pharmacist.

Sunlight or ultraviolet (UV) light

Avoid excessive direct sunlight or ultraviolet light while taking bicalutamide.

Bicalutamide Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

Bicalutamide Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Bicalutamide Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. Swallow the tablet whole with a glass of water. Try to take the tablet at the same time every day. Do not stop taking this medicine, even if you feel well, unless your doctor tells you to.

Use in children and adolescents

Bicalutamide should not be given to children.

If you take more Bicalutamide Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bicalutamide Aurovitas

If you forget to take the medicine, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you have any other 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.

If you notice any of the following side effects, contact your doctor immediately – you may need urgent medical treatment:

Allergic reactions(uncommon, may affect up to 1 in 100 people):

The symptoms may include the sudden appearance 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, inform your doctor immediately if you notice any of the following symptoms:

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 liver problems or, in rare cases, liver failure (may affect up to 1 in 1,000 patients).
• Abdominal pain.
• Blood in the urine.

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

• Severe difficulty breathing or sudden worsening of breathing difficulties, possibly with cough or high fever. These may be signs of a lung disease called "interstitial lung disease".

Frequency not known(cannot be estimated from the available data):

• Changes in the electrocardiogram (prolongation of the QT interval).

Other side effects:

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

• Skin rash.
• Increased breast size and breast tenderness.
• Weakness.

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

• Hot flushes.
• Feeling of discomfort (nausea).
• Itching.
• Dry skin.
• Difficulty achieving an erection (erectile dysfunction).
• Weight gain.
• Decreased sexual desire and reduced fertility.
• Hair loss.
• Excessive hair growth/re-growth of hair.
• Low red blood cell count (anemia). This may make you feel tired or look pale.
• Decreased appetite.
• Depression.
• Drowsiness.
• Indigestion.
• Dizziness.
• Constipation.
• Gas (flatulence).
• Chest pain.
• Swelling.

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

• Increased sensitivity of the skin to sunlight.

Your doctor may perform blood tests to check if there are any changes in your blood. Do not worry about this list of side effects. You may not get any of them.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Aurovitas

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 carton and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Bicalutamide Aurovitas

• The active substance is bicalutamide. Each film-coated tablet contains 150 mg of bicalutamide.
  • The other ingredients (excipients) are:

Core of the tablet:lactose monohydrate, sodium carboxymethyl starch type A (potato), povidone, magnesium stearate.

Coating of the tablet:HPMC 2910/hypromellose, titanium dioxide (E171), macrogol.

Appearance and packaging

Film-coated tablet.

Bicalutamide Aurovitas 150 mg film-coated tablets EFG:

White, round, film-coated tablet with "B2" marked on one side and smooth on the other.

Bicalutamide Aurovitas film-coated tablets are available in blister packs of 1, 10, 28, 30, 56, 60, 90, and 100 film-coated 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

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Bicalutamid PUREN 150 mg film-coated tablets

Belgium: Bicalutamide Eugia 150 mg film-coated tablets/comprimés pelliculés/Filmtabletten

Spain: Bicalutamida Aurovitas 150 mg film-coated tablets EFG

Italy: Bicalutamide Aurobindo Italia

Netherlands: Bicalutamide Eugia 150 mg, film-coated tablets

Portugal: Bicalutamida Generis

Date of last revision of this leaflet: July 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).