Package Insert: Information for the User

Bicalutamide Aurovitas Spain 50 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Bicalutamida Aurovitas Spain is a medication that contains the active ingredient called bicalutamida. It belongs to a group of medications known as antiandrogens.

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

Do not take Bicalutamida Aurovitas Spain

• if you areallergic to bicalutamida or to any of the other componentsof this medication (listed in section 6),
• if you are already takingterfenadinaorastemizol, which are used for the treatment of allergies, orcisaprida, for the treatment of heartburn and acid reflux,
• if you are a woman.

Bicalutamida should not be administered to children and adolescents.

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

Warnings and precautions

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

• if you have anyheart or blood vessel disease, includingheart rhythm problems (arrhythmias)or if you are being treated with medications for these conditions. The risk of heart rhythm problems may increase when bicalutamida is used,
• if you have aliver disease. Your doctor may decide to perform blood tests to check that the liver is functioning properly while you are taking this medication,
• if you havediabetes. Treatment with bicalutamida in combination with luteinizing hormone-releasing hormone (LHRH) analogues may alter blood sugar levels. You may need to adjust your insulin and/or oral antidiabetic medication doses,
• if you are going to a hospital, inform the medical staff that you are taking Bicalutamida Aurovitas Spain,
• if you are taking bicalutamida, you and/or your partner must use a contraceptive method while you are on treatment with this medication and for 130 days after the end of treatment. Consult your doctor if you have any questions about contraceptive methods.

Other medications and Bicalutamida Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications obtained without a prescription and herbal remedies. This is because bicalutamida may affect the way other medications work. Other medications may also affect the way bicalutamida works.

• Ciclosporina(used as an immunosuppressant to prevent and treat organ or bone marrow transplant rejection). This is because bicalutamida may increase plasma concentrations of a substance called creatinine, and your doctor may perform blood tests to monitor it.
• Midazolam(a medication used to alleviate anxiety before a procedure or certain procedures, or as an anesthetic before and during the procedure). If you are to undergo a procedure or experience significant anxiety in the hospital, inform your doctor or dentist that you are taking bicalutamida.
• Terfenadinaorastemizol, which are used to treat allergies, andcisapridawhich is used to treat heartburn and acid reflux (see section 2. Do not take Bicalutamida Aurovitas Spain).
• A type of medication calledcalcium channel blocker, for example,diltiazemorverapamilo, which are used to treat heart problems, angina, and high blood pressure.
• Oral medications to prevent blood clot formation (oral anticoagulants) or the so-called anticoagulants, for example, warfarina. Your doctor may perform blood tests before and during your treatment with bicalutamida.
• Cimetidinafor acid reflux or stomach ulcers.
• Ketoconazol, a medication to treat fungal infections.
• Bicalutamida may interfere with somemedications used to treat heart rhythm problems(for example,quinidina,procainamida,amiodarona, andsotalol) or may increase the risk of heart rhythm problems when used with other medications (for example,metadona(used to alleviate pain and as part of drug addiction detoxification),moxifloxacino(an antibiotic),antipsicóticos(used to treat severe mental illnesses)).

Taking Bicalutamida Aurovitas Spain with food and drinks

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

Pregnancy, breastfeeding, and fertility

Bicalutamida should not be taken by women, including pregnant women or breastfeeding mothers.

Bicalutamida may have an effect on male fertility that may be reversible.

Driving and operating machinery

This medication does not affect the ability to drive or operate machinery; however, some patients may feel drowsy while taking this medication. If you think this happens to you, inform your doctor or pharmacist before driving or operating machinery.

Sunlight or ultraviolet (UV) light

Avoid direct exposure to excessive sunlight or ultraviolet light while taking bicalutamida.

Bicalutamida Aurovitas Spain contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Bicalutamida Aurovitas Spain contains sodium

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

Follow exactly the administration instructions for this medication as indicated 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 medication approximately at the same time every day.

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

If you take more Bicalutamida 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 packaging so that the doctor can identify what you have been taking. Your doctor may decide to monitor your body's function until the effects of bicalutamide have worn off.

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

If you forgot to take Bicalutamida Aurovitas Spain

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

If you interrupt treatment with Bicalutamida Aurovitas Spain

Do not stop taking this medication even if you feel better, unless your doctor tells you to.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you notice any of the following symptoms, inform your doctor immediately or visit the nearest hospital emergency department.These side effectsare very serious.

• Severe difficulty breathing or sudden worsening of breathing difficulty. This may be accompanied by cough or high temperature (fever). These may be signs of a lung inflammation called "interstitial lung disease". This side effect is rare.
• Severe skin rash, itching, urticaria, or swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing. These side effects are rare.

Other possible side effects:

Side effectsvery common(may affect more than 1 in 10 people)

Dizziness, abdominal pain, constipation, nausea, presence of blood in the urine (hematuria), breast swelling or tenderness, development of breast tissue in men, hot flushes, feeling weak, swelling (edema), low red blood cell count (anemia).

Side effectscommon(may affect up to 1 in 10 people)

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

Side effectsrare(may affect up to 1 in 1,000 people)

Increased skin sensitivity to sunlight.

Side effects ofunknown frequency(cannot be estimated from available data):

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Human Use Medicines:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Bicalutamida Aurovitas Spain Composition

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

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

Product Appearance and Packaging Contents

Film-coated, round, biconvex, white tablets with the mark BCM 50 on one face.

Available in blisters containing 5, 7, 10, 14, 20, 28, 30, 40, 50, 56, 80, 84, 90, 98, 100, 140, 200, and 280 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible 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 more information about this medication, please contact the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medication is authorized in the European Economic Area member states with the following names:

AustriaAndrobloc 50 mg - Filmtabletten

Czech RepublicLanbica 50 mg potahovaná tableta

GreeceBikalen 50 mg, film-coated tablets

IslandBicalutamide Medical 50 mg filmuhúðaðar töflur

ItalyBicalutamide Ibigen 50 mg, compresse rivestite con film

PolandBicalutamide Polpharma 50 mg tabletka powlekana

SloveniaBicalutamide Synthon 50 mg, filmsko obložena tableta

SpainBicalutamida Aurovitas Spain 50 mg comprimidos recubiertos con película EFG

NetherlandsBicalutamide Actavis 50 mg, filmomhulde tabletten

United KingdomBicalutamide 50 mg, film-coated tablets

Last reviewed date of this leaflet:February 2024

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/