Leaflet: information for the user

Bicalutamide 50 mg film-coated tablets EFG

bicalutamida

Read this 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, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isBicalutamideand what it is used for

2. What you need to know before starting to takeBicalutamide

3. How to takeBicalutamide

4. Possible side effects

5. Storage ofBicalutamide

6. Contents of the pack and additional information

Biobicabelongs to a group of medications known as anti-androgens, which means it interferes with some of the actions of androgens (male sex hormones) in the body.

This medicationis indicated for certain prostate pathologies in conjunction with other treatments, such as medications that reduce androgen levels in the body.

Do not take Biobica:

• If you are allergic to bicalutamide or any of the other components of this medication (listed in section 6).
• If you are a woman.
• If you are taking terfenadine or astemizol (used to treat seasonal allergic rhinitis or allergies) or cisapride, which is used to treat heartburn and acid reflux.

This medication should not be administered to children and adolescents under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you have any liver disorder or disease that may affect your liver. The medication should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor should regularly perform liver function tests. Fatal cases (severe liver changes and liver failure) have been reported.
• If you have a lung inflammation called interstitial lung disease. Symptoms of this condition may include severe difficulty breathing with cough or fever. Fatal cases have been reported.
• If you are taking any other medication, including those obtained without a prescription. In particular, if you are taking blood-thinning medications or medications to prevent blood clotting.
• If you have diabetes. The combined treatment of bicalutamide with LHRH analogs may alter your blood sugar levels. Your doctor should adjust your insulin and/or antidiabetic medication dosage.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in these cases.

Inform your doctor if you have any heart or blood vessel disorders or are being treated for them, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when bicalutamide is used.

If any of the above situations apply to you, inform your doctor, who will take this into account during your treatment with bicalutamide.

In case of hospital admission, inform the healthcare staff that you are taking bicalutamide.

If you are taking bicalutamide, you and/or your partner should use a contraceptive method while you are on treatment with bicalutamide and for 130 days after the end of treatment. Consult your doctor if you have any questions about contraceptive methods.

Children and adolescents

This medication should not be administered to children or adolescents under 18 years old.

Other medications and Biobica

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take bicalutamide with the following medications:

• Terfenadine or astemizol (for hay fever or allergy).
• Cisaprida (for stomach disturbances).

If you take bicalutamide with any of the following medications, the effect of this and the other medications may be affected. Consult your doctor before taking any of the following medications with bicalutamide:

• In particular, inform your doctor if you are taking blood-thinning medications such as warfarin.
• Ciclosporina (used to reduce the immune system to prevent and treat organ or bone marrow transplant rejection).
• Midazolam (a medication used to alleviate anxiety before surgery or certain procedures or as an anesthetic before and during surgery).
• Calcium channel blockers (e.g., diltiazem or verapamil. These medications are used to treat high blood pressure or certain heart diseases).
• Cimetidine (used to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamide may interfere with some medications used to treat heart rhythm problems (e.g., quinidina, procainamida, amiodarona, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g., metadona (used for pain relief and detoxification of other medications), moxifloxacino (an antibiotic), antipsychotics used for severe mental illnesses).

Please note that these warnings may also apply to medications you have used in the past.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using any medication.

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

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

Driving and operating machinery

Bicalutamide may make you feel drowsy, so you should be careful when driving or operating machinery.

Bicalutamide contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will inform you of the duration of your treatment. Do not discontinue treatment before your doctor tells you to.

The recommended dose for adult males is 1 tablet per day.

• Swallow the tablet whole with water.
• Try to take the tablet at the same time every day.

If you take more Biobica than you should:

If you ingest a dose higher than the normal dose, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 5620420.

If you forget to take Biobica:

Do not take a double dose to compensate for the missed doses.

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 go to the nearest hospital emergency service. These side effects are very serious.

• Skin rash, severe skin itching (with blisters), hives, skin peeling or formation of blisters or scabs.
• Swelling of the face or neck, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
• Difficulty breathing or sudden worsening of breathing difficulty, possibly with cough or fever. These may be signs of interstitial lung disease.
• Blood in the urine.
• Abdominal pain.
• Yellow discoloration of the skin and eyes (jaundice). These may be symptoms of liver damage.

Other possible side effects of this medicine are:

Very common: may affect more than 1 in 10 patients

• Anemia.
• Dizziness.
• Abdominal pain, constipation, nausea (urge to vomit).
• Confusion.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after treatment is stopped, particularly after prolonged treatment.

Common: may affect up to 1 in 10 patients

• Weight gain.
• Drowsiness.
• Myocardial infarction (fatalities have been reported), heart failure.
• Indigestion, flatulence (gas).
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Decreased appetite.
• Chest pain.
• Liver toxicity, elevated levels of liver enzymes, jaundice (yellow discoloration of skin and eyes).
• Erectile dysfunction.
• Decreased libido.
• Depression.

Uncommon: may affect up to 1 in 100 patients

• Interstitial lung disease (a lung inflammation). Fatalities have been reported.
• Allergic reactions (hypersensitivity), skin swelling, urticaria.

Rare: may affect up to 1 in 1,000 patients

• Liver failure. Fatalities have been reported,
• Increased sensitivity to sunlight.

Frequency not known: cannot be estimated from available data

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

Reporting of side effects

Ifyou experience any type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly to theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute toproviding more information on the safety of this medicine.

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

No special storage conditions are required.

Store in the original packaging.

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

Medications should not be disposed of through drains or in the trash.Deposit empty packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt,ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Biobica

• The active principle is bicalutamide. Each film-coated tablet contains 50 mg of bicalutamide.
• The other components are:
• • Core: Lactose monohydrate, povidone K-30, sodium starch glycolate, magnesium stearate of vegetable origin, purified water.
  • Coating: Ethanol, purified water, macrogol, hypromellose, and titanium dioxide.

Appearance of the product and contents of the packaging

Biobicaare film-coated tabletsof white color, round, and biconvex..

Each package contains 30 film-coated tablets conditioned in blister packs.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Islas Baleares (Spain)

Responsible for manufacturing:

Tecnimede – Sociedade Técnico-Medicinal, SA

Quinta da Cerca – Caixaria

2565-187 Dois Portos (Portugal)

Last review date of this leaflet:February 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es