Bicalutamide Aurovitas Spain 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bicalutamida Aurovitas Spain 50 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Bicalutamida Aurovitas Spain is a medicine that contains the active substance called bicalutamide. It belongs to a group of medicines known as antiandrogens.

• 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 taking Bicalutamida Aurovitas Spain

Do not take Bicalutamida Aurovitas Spain

• 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 to treat allergies, or cisapride, used to treat heartburn and acid reflux,
• if you are a woman.

Bicalutamide must not be given to children and adolescents.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Bicalutamida 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 bicalutamide is used,
• if you have liver disease. Your doctor may decide to carry out blood tests to check that 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 be necessary to adjust the dose of insulin and/or oral antidiabetic medicines,
• if you go to hospital, tell the medical staff that you are taking Bicalutamida 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 Bicalutamida Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because bicalutamide may affect how other medicines work. Other medicines may also affect how bicalutamide works.

• Cyclosporine (used as an immunosuppressant to prevent and treat rejection reactions following organ or bone marrow transplantation). This is because bicalutamide may increase plasma levels of a substance called creatinine, and your doctor may carry out blood tests to monitor this.
• Midazolam (a medicine used to relieve anxiety before surgery or certain procedures, or as an anaesthetic before and during surgery). If you are undergoing surgery or experience significant anxiety in hospital, you must inform your doctor or dentist that you are taking bicalutamide.
• Terfenadine or astemizole, used to treat allergies, and cisapride, used to treat heartburn and acid reflux (see section 2. Do not take Bicalutamida Aurovitas Spain).
• A type of medicine called calcium channel blockers, for example, diltiazem or verapamil, used to treat heart problems, angina, and high blood pressure.
• Oral medicines used to prevent blood clotting (oral anticoagulants), or so-called anticoagulants, for example, warfarin. Your doctor may carry out blood tests before and during your treatment with bicalutamide.
• Cimetidine for acid reflux or stomach ulcers.
• Ketoconazole, a medicine used to treat fungal infections.
• Bicalutamide may interfere with certain 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 drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used to treat serious mental illnesses)).

Taking Bicalutamida Aurovitas Spain with food and drink

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

Pregnancy, breast-feeding and fertility

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

Bicalutamide may have an effect on male fertility, which may be reversible.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery; however, some patients may experience drowsiness while taking this medicine. If you think this applies to you, you should inform your doctor or pharmacist before driving or operating machinery.

Sunlight or ultraviolet (UV) light

Avoid excessive direct exposure to sunlight or ultraviolet (UV) light while being treated with bicalutamide.

Bicalutamida Aurovitas Spain contains lactose

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

Bicalutamida Aurovitas Spain contains sodium

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

3. How to take Bicalutamide Aurovitas Spain

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

The recommended dose is one tablet once daily. 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 beginning treatment with LHRH analogues, e.g., gonadorelin, or at the same time as 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. Take any remaining tablets or the packaging so the doctor can identify what you have taken. Your doctor may decide to monitor your body's functions until the effects of bicalutamide have passed.

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

If you forget to take Bicalutamide Aurovitas Spain

If you think you have missed a dose, inform your doctor or pharmacist. Do not take a double dose to make up for the missed dose. Take the next dose at the scheduled time.

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 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 symptoms, inform your doctor immediately or go to the nearest hospital emergency department. These adverse effects are very serious.

• Severe difficulty breathing or breathing problems that suddenly worsen. This may occur with cough or high temperature (fever). These may be signs of lung inflammation known as “interstitial lung disease.” This side effect is uncommon.
• Severe skin rash, itching, hives, or swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing. These side effects are uncommon.

Other possible adverse effects:

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

Dizziness, abdominal pain, constipation, feeling unwell (nausea), presence of blood in the urine (haematuria), swelling or tenderness of the breasts, breast development in men, hot flushes, feeling weak, swelling (oedema), low number of red blood cells (anaemia).

Common adverse effects (may affect up to 1 in 10 people)

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

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

Increased sensitivity of the skin to sunlight.

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

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

Your doctor may carry out a blood test to detect any changes in your blood levels. Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the container after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bicalutamide Aurovitas Spain

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

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

Appearance of the product and pack contents

Film-coated tablets, round, biconvex, white in colour, marked "BCM 50" on one side.

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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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)

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

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

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria Androbloc 50 mg - Filmtabletten
Czech Republic Lanbica 50 mg potahovaná tableta
Greece Bikalen 50 mg, film-coated tablets
Iceland Bicalutamide Medical 50 mg filmuhúðaðar töflur
Italy Bicalutamide Ibigen 50 mg, compresse rivestite con film
Poland Bicalutamide Polpharma 50 mg tabletka powlekana
Slovenia Bicalutamide Synthon 50 mg, filmsko obložena tableta
Spain Bicalutamida Aurovitas Spain 50 mg comprimidos recubiertos con película EFG
Netherlands Bicalutamide Actavis 50 mg, filmomhulde tabletten
United Kingdom Bicalutamide 50 mg, film-coated tablets

Date of the most recent review of this leaflet: February 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/