BICALUTAMIDE AUROVITAS SPAIN 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide Aurovitas Spain 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 pack

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

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

Bicalutamide Aurovitas Spain is a medicine that contains the active substance called bicalutamide. It belongs to a group of medicines called anti-androgens.

• Bicalutamide is used in the treatment of prostate cancer.
• It works by blocking the effects of male sex hormones such as testosterone.

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

Do not take Bicalutamide Aurovitas Spain

• if you are allergic to bicalutamide or any of the other ingredientsof this medicine (listed in section 6),
• if you are already taking terfenadineor astemizole, which are used to treat allergies, or cisapride, for the treatment of heartburn and acid reflux,
• if you are a woman.

Bicalutamide must not be taken by children and adolescents.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bicalutamide Aurovitas Spain:

• if you have any heart or blood vessel disease, including heart rhythm problems (arrhythmias)or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when using bicalutamide,
• if you have liver disease. Your doctor may decide to perform blood tests to check that your liver is working 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 be necessary to adjust the dose of insulin and/or oral anti-diabetic medicines,
• if you are going to the hospital, tell the medical staff that you are taking Bicalutamide Aurovitas Spain,
• if you are taking bicalutamide, you and/or your partner must use a contraceptive method while you are being treated with this medicine 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 Spain

Tell 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 the way other medicines work. Other medicines may also affect the way bicalutamide works.

• Ciclosporin(used as an immunosuppressant 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 perform blood tests to monitor this.
• Midazolam(a medicine used to relieve anxiety before an operation or certain procedures, or as an anaesthetic before and during the operation). If you are going to have an operation or are experiencing a lot of anxiety in the hospital, you must inform your doctor or dentist that you are taking bicalutamide.
• Terfenadineor astemizole, which are used to treat allergies, and cisapride, which is used to treat heartburn and acid reflux (see section 2. Do not take Bicalutamide Aurovitas Spain).
• A type of medicine called calcium channel blocker, for example, diltiazemor verapamil, which are used to treat heart problems, angina, and high blood pressure.
• Medicines that are taken orally to prevent the formation of blood clots (oral anticoagulants) or so-called anticoagulants, for example, warfarin. Your doctor may perform blood tests before and during your treatment with bicalutamide.
• Cimetidinefor acid reflux or stomach ulcers.
• Ketoconazole, a medicine used to treat fungal infections.
• Bicalutamide may interfere with some medicines used to treat heart rhythm problems(for example, quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medicines (for example, methadone(used to relieve pain and as part of detoxification for drug addiction), moxifloxacin(an antibiotic), antipsychotics(used to treat serious mental illnesses)).

Taking Bicalutamide Aurovitas Spain with food and drinks

It is not necessary to take the tablets with food, but they should be swallowed whole with a glass of water.

Pregnancy, breastfeeding, and fertility

Bicalutamide must not be taken by women, including pregnant women or breastfeeding mothers.

Bicalutamide may have an effect on male fertility that can be reversible.

Driving and using machines

This medicine does not affect the ability to drive or use machines; however, some patients may feel drowsy while taking this medicine. If you think this is happening to you, you should inform your doctor or pharmacist before driving or using machines.

Sunlight or ultraviolet (UV) light

Avoid excessive direct sunlight or ultraviolet light while being treated with bicalutamide.

Bicalutamide Aurovitas Spain contains lactose

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

Bicalutamide Aurovitas Spain contains sodium

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

3. How to take Bicalutamide Aurovitas Spain

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

The recommended dose is one tablet once a day. The tablet should be swallowed whole with a glass of water. Try to take the medicine at approximately the same time each day.

You should start taking the tablets at least 3 days before starting treatment with LHRH analogues, e.g., gonadorelin, or at the same time as you undergo surgical castration.

If you take more Bicalutamide Aurovitas Spain than you should

If you think you may have taken more tablets than you should, contact your doctor or go to the nearest hospital as soon as possible. Bring the remaining tablets or the package so that the doctor can identify what you have been taking. They may decide to monitor your body's functions until the effects of bicalutamide have disappeared.

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

If you forget to take Bicalutamide Aurovitas Spain

If you think you may have forgotten to take a dose, inform your doctor or pharmacist. Do not take a double dose to make up for the forgotten dose. Take the next dose when it is due.

If you stop taking Bicalutamide Aurovitas Spain

Do not stop taking this medicine even if you feel better, 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.

If you notice any of the following symptoms, inform your doctor or go to the emergency department of the nearest hospital immediately.These side effects are very serious.

• Severe difficulty breathing or worsening of breathing. This may be with cough or high temperature (fever). These can be signs of a lung disease called “interstitial lung disease”. This side effect is uncommon.
• Severe skin rash, itching, hives, or swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing. These side effects are uncommon.

Other possible side effects:

Very commonside effects (may affect more than 1 in 10 people)

Dizziness, abdominal pain, constipation, feeling sick (nausea), blood in the urine (haematuria), breast tenderness or swelling, breast development in men, hot flushes, feeling weak, swelling (oedema), low red blood cell count (anaemia).

Commonside effects (may affect up to 1 in 10 people)

Lack of appetite, decreased sex drive, depression, drowsiness, indigestion, flatulence, changes in liver function, including yellowing of the skin and the whites of the eyes (jaundice), hair loss, increased hair growth, dry skin, itching, rash, difficulty getting an erection (erectile dysfunction), weight gain, chest pain, decreased heart function, heart attack.

Rareside effects (may affect up to 1 in 1,000 people)

Increased sensitivity of the skin to sunlight.

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

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

Your doctor may perform blood tests to detect any changes in your blood levels. Do not worry about this list of possible side effects. You may not get any of them.

Reporting of side effects

If you get 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 via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Aurovitas Spain

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 after EXP. The expiry date refers to the last day of the month shown.

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 further information

Composition of Bicalutamide Aurovitas Spain

• The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other ingredients (excipients) of the tablet core are: lactose monohydrate, povidone K-29/32, crospovidone, sodium lauryl sulfate, and magnesium stearate.

The ingredients (excipients) of the coating are: lactose monohydrate, hypromellose, titanium dioxide (E171), and macrogol 4000.

Appearance and packaging

Film-coated tablets, round, biconvex, white, with the marking BCM 50 on one side.

They are available in blister packs containing 5, 7, 10, 14, 20, 28, 30, 40, 50, 56, 80, 84, 90, 98, 100, 140, 200, and 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 Hispania

Castello 1

Polígono Las Salinas

08830 Sant Boi de Llobregat (Spain)

Or

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach (Austria)

You can request more information about 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:

Austria Androbloc 50 mg - Filmtabletten

Czech Republic Lanbica 50 mg film-coated tablets

Greece Bikalen 50 mg, film-coated tablets

Iceland Bicalutamide Medical 50 mg film-coated tablets

Italy Bicalutamide Ibigen 50 mg, film-coated tablets

Poland Bicalutamide Polpharma 50 mg film-coated tablets

Slovenia Bicalutamide Synthon 50 mg, film-coated tablets

Spain Bicalutamida Aurovitas Spain 50 mg film-coated tablets EFG

Netherlands Bicalutamide Actavis 50 mg, film-coated tablets

United Kingdom Bicalutamide 50 mg, film-coated tablets

Date of last revision of this leaflet:February 2024

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