BICALUTAMIDE AUROVITAS 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide Aurovitas 50 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 Package Leaflet

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

Bicalutamide Aurovitas belongs to a group of medicines called anti-androgens. It interferes with some of the actions of male sex hormones.

Bicalutamide is used to treat prostate cancer. It is used as:

• monotherapy in tumor stages called "locally advanced", or as
• combination therapy in tumor stages called "advanced", and is used together with other treatments such as surgical castration or medications that reduce the body's androgen levels.

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

Do not take Bicalutamide Aurovitas

• If you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman or a child.
• If you are taking other medicines that contain terfenadine, astemizole or cisapride (see "Other medicines and Bicalutamide Aurovitas" below).

Warnings and precautions

Consult your doctor or pharmacist before starting to take bicalutamide:

• If you have any liver problems. Bicalutamide levels in your blood may increase. Your liver function may be monitored periodically.
• If you have diabetes.
• If you have any cardiovascular disease, including heart rhythm problems (arrhythmias), or are being treated with medications 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.

Other medicines and Bicalutamide Aurovitas

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

If you are taking any of the following medicines, it is especially important to mention them:

• Terfenadine or astemizole (for hay fever or allergies) or cisapride (for stomach disorders). See "Do not take Bicalutamide Aurovitas" above.
• Ciclosporin (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection).
• Calcium channel blockers (to treat high blood pressure or certain heart diseases).
• Cimetidine (to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).
• Anticoagulants or medications to prevent blood clots, such as warfarin. Your doctor may perform blood tests before and during your treatment with bicalutamide.

Bicalutamide may interfere with some medications 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 medications (e.g., methadone (used to relieve pain and as part of drug detoxification treatment), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy, breast-feeding and fertility

Bicalutamide is not used in women.

Bicalutamide may cause limited or reduced fertility in men during a temporary period.

Driving and using machines

These tablets may make you feel dizzy or drowsy. If you are affected, do not drive or use machines.

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 certain sugars, consult with them before taking this medicine.

3. How to take Bicalutamide Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dose

Depending on your disease, the usual dose is one 50 mg tablet per day (combination therapy), or three 50 mg tablets once a day (monotherapy).

Method of administration

• Swallow the tablets whole with a glass of water.
• You can take these tablets with or without food.

Frequency of administration

The tablet can be taken at any time of the day, but try to take it at the same time every day to avoid forgetting.

Duration of treatment

• The duration of treatment is determined by your doctor.
• Do not stop treatment without your doctor's consent.

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, take the dose when you remember and then take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Bicalutamide Aurovitas

Do not stop taking the tablets, even if you feel well, unless your doctor tells you to.

If you have any further questions on 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 certain frequencies, as defined below:

very common: may affect more than 1 in 10 people.

common: may affect up to 1 in 10 people.

uncommon: may affect up to 1 in 100 people.

rare: may affect up to 1 in 1,000 people.

very rare: may affect up to 1 in 10,000 people.

frequency not known: cannot be estimated from the available data.

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

• Severe respiratory problems or sudden worsening of a respiratory problem, possibly with cough or fever. This may be a lung disease called "interstitial lung disease".
• Severe itching of the skin with rash, or swelling of the face, lips, tongue and/or throat, which can cause difficulty swallowing or breathing. This may be a severe allergic reaction to bicalutamide.
• Blood in the urine.
• Abdominal pain.
• Jaundice (yellowing of the skin and eyes).

The following side effects may occur:

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

• Anaemia (a condition that affects 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):

• Decreased appetite.
• Decreased libido.
• Depression.
• Somnolence.
• Myocardial infarction, heart failure.
• Dyspepsia (indigestion), flatulence (gas).
• Hepatotoxicity (liver damage), jaundice (yellowing of the skin and eyes), hypertransaminasaemia (elevated transaminase levels).
• Alopecia (hair loss), hirsutism (excessive hair growth)/hair regrowth, dry skin, itching.
• Erectile dysfunction.
• Chest pain.
• Weight gain.

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

• Hypersensitivity, angioedema (skin swelling) and urticaria.
• Lung disease called "interstitial lung disease".

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

• Liver failure.
• Increased skin sensitivity to sunlight.

Side effects of unknown frequency (cannot be estimated from the available data):

• Changes in the electrocardiogram (QT interval prolongation).

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) through the website 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 50 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 of the product and contents of the pack

Film-coated tablet.

Bicalutamide Aurovitas 50 mg film-coated tablets EFG:

White, round, film-coated tablet with "B" marked on one side and "l" 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 50 mg Filmtabletten

Belgium: Bicalutamide Eugia 50 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Spain: Bicalutamida Aurovitas 50 mg comprimidos recubiertos con película EFG

France: BICALUTAMIDE ARROW 50 mg, comprimé pelliculé

Italy: Bicalutamide Aurobindo Italia

Netherlands: Bicalutamide Eugia 50 mg, filmomhulde tabletten

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/).