Bicalutamide Aurovitas 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bicalutamida 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 symptoms 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 leaflet

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

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

This medicine contains an active substance called bicalutamide, which belongs to a group of medicines known as antiandrogens.

• Bicalutamide 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 by your body.
• This medicine will be prescribed to you alone or in combination with other medicines:
  • after removal of the prostate.
  • after radiotherapy treatment (a medical technique that uses radiation to treat cancer).
• This medicine will be prescribed to you as monotherapy:
  • if the tumour has spread to other organs and cannot be removed, or if the action of agents in the testicles is to be suppressed.

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

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

Do not take Bicalutamide Aurovitas

• 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 a medicine called cisapride or certain antihistamine medicines (terfenadine or astemizole).

Bicalutamide must not be given to children.

Do not take bicalutamide if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking bicalutamide.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting bicalutamide:

• If you have any liver problems. Your doctor may carry out blood tests before and during treatment with bicalutamide.
• If you have any of the following: a heart or blood vessel condition, 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 bicalutamide treatment.
• If you are taking bicalutamide, you and/or your partner must use an effective method of contraception during treatment and for 130 days after the end of treatment. Consult your doctor if you have any questions about contraceptive methods.

If you are admitted to hospital, inform healthcare staff that you are taking bicalutamide.

Children and adolescents

Bicalutamide must not be given to children or adolescents.

Medical tests

Your doctor may perform blood tests to check for changes in your blood.

Other medicines and Bicalutamide Aurovitas

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

This includes medicines that do not require a prescription and herbal medicines. This is because bicalutamide may affect how other medicines work. In addition, some other medicines may affect how bicalutamide works.

Do not take bicalutamide 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 with other medicines (e.g., methadone (used to relieve pain and as part of drug addiction treatment), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).

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

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

Pregnancy, breastfeeding, and fertility

Bicalutamide must not be used in women.

Bicalutamide may cause reduced fertility or temporary infertility in men.

Driving and using machines

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

Sunlight or ultraviolet (UV) light

Avoid excessive direct exposure to sunlight or ultraviolet (UV) light while taking bicalutamide.

Bicalutamide Aurovitas contains sodium

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

Bicalutamide Aurovitas contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Bicalutamide Aurovitas

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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 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 must not be given to children.

If you take more Bicalutamide Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating 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 forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following adverse effects, contact your doctor immediately – 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 inform your doctor immediately if you notice any of the following symptoms:

Frequent (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, 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 problems, possibly with cough or high fever. These may be signs of lung inflammation known as "interstitial lung disease".

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

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

Other adverse effects:

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

• Skin rash.
• Breast enlargement and breast tenderness.
• Weakness.

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

• Hot flushes.
• Feeling unwell (nausea).
• Itching.
• Dry skin.
• Problems achieving an erection (erectile dysfunction).
• Weight gain.
• Decreased sexual desire and reduced fertility.
• Hair loss.
• Excessive hair growth / regrowth of hair.
• Low levels of red blood cells (anaemia). This may make you feel tired or look pale.
• Loss of 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 for changes in your blood. Do not be alarmed by this list of side effects. You may not experience any of them.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This 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 components (excipients) are:

Tablet core: lactose monohydrate, sodium carboxymethyl starch type A (from potato), povidone, magnesium stearate.

Tablet coating: HPMC 2910/hypromellose, titanium dioxide (E171), macrogol.

Appearance of the product and contents of the pack

Film-coated tablet.

Bicalutamide Aurovitas 150 mg film-coated tablets EFG:

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

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

Only some pack sizes may be commercially available.

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

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

Germany: Bicalutamid PUREN 150 mg Filmtabletten
Belgium: Bicalutamide Eugia 150 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Spain: Bicalutamida Aurovitas 150 mg comprimidos recubiertos con película EFG
Italy: Bicalutamide Aurobindo Italia
Netherlands: Bicalutamide Eugia 150 mg, filmomhulde tabletten
Portugal: Bicalutamida Generis

Date of the most recent review of this leaflet: July 2024

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