Biobica 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Biobica 50 mg film-coated tablets EFG

bicalutamide

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet

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

1. What Biobica is and what it is used for

Biobica belongs to a group of medicines called anti-androgens, which means that it interferes with some of the actions of androgens (male sex hormones) in the body.

This medicine is indicated for certain prostate disorders, in combination with other treatments, such as drugs that reduce the levels of androgens in the body.

2. What you need to know before taking Biobica

Do not take Biobica:

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

This medicine must not be given to children and adolescents under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• If you have any liver disorder or liver disease. This medicine should only be taken after your doctor has carefully considered the potential benefits and risks. If this applies to you, your doctor should regularly perform liver function tests. Deaths due to severe liver changes and liver failure have been reported.
• If you have a lung inflammation called interstitial lung disease. Symptoms may include severe shortness of breath with cough or fever. Deaths have been reported.
• If you are taking any other medicine, including those obtained without a prescription. In particular, if you are taking blood-thinning medicines or medicines used to prevent blood clots.
• If you have diabetes. Combined treatment with bicalutamide and LHRH analogues may alter your blood sugar levels. Your doctor must adjust your insulin dose and/or antidiabetic medicines accordingly.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in such cases.

Inform your doctor if you have any heart or blood vessel condition or are being treated for one, including medicines 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 them into account during your treatment with bicalutamide.

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

If you are taking bicalutamide, you and/or your partner must use a contraceptive method while you are being treated 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 medicine must not be given to children or adolescents under 18 years of age.

Other medicines and Biobica

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

Do not take bicalutamide together with the following medicines:

• Terfenadine or astemizole (for hay fever or allergies).
• Cisapride (for stomach disorders).

If you take bicalutamide together with any of the following medicines, the effect of these medicines and/or bicalutamide may be affected. Consult your doctor before taking any of the following medicines together with bicalutamide:

• In particular, inform your doctor if you are taking blood-thinning medicines such as warfarin.
• Cyclosporine (used to suppress the immune system to prevent and treat rejection of organ or bone marrow transplants).
• Midazolam (a medicine used to relieve anxiety before surgery or certain procedures, or as an anaesthetic before and during surgery).
• Calcium channel blockers (e.g., diltiazem or verapamil). These medicines are used to treat high blood pressure or certain heart conditions.
• Cimetidine (to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Biobica may interfere with some medicines used to treat heart rhythm problems (e.g., quinidine, procainamida, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medicines (e.g., methadone (used for pain relief and detoxification from other drugs), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Please note that these warnings may also apply to medicines you have taken some time ago.

Pregnancy, breast-feeding and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medicine.

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

Biobica may make you feel drowsy, so you should be cautious when driving or operating machinery.

Biobica contains lactose

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

3. How to take Biobica

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will advise you on the duration of your treatment. Do not stop treatment before your doctor tells you to.

The recommended dose for adult males is 1 tablet daily.

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

If you take more Biobica than you should:

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420.

If you forget to take Biobica:

Do not take a double dose to make up for missed 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 may cause adverse effects, although not everyone experiences 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.

• Skin rash, severe skin itching (with lumps), hives, skin peeling, or formation of blisters or crusts.
• 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 problems, possibly with cough or fever. These may be signs of interstitial lung disease.
• Blood in the urine.
• Abdominal pain.
• Yellowing of the skin and eyes (jaundice). These may be symptoms of liver damage.

Other possible adverse effects of this medicine are:

Very common: may affect more than 1 in 10 patients

• Anaemia.
• Dizziness.
• Abdominal pain, constipation, nausea (feeling sick).
• Hot flush.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after stopping treatment, particularly after prolonged therapy.

Common: may affect up to 1 in 10 patients

• Weight gain.
• Drowsiness.
• Heart attack (fatal cases have been reported), heart failure.
• Indigestion, flatulence (gas).
• Hair loss (alopecia), excessive hair growth/regrowth of hair, dry skin, itching.
• Decreased appetite.
• Chest pain.
• Liver toxicity, elevated transaminase levels (liver enzymes), jaundice (yellowing of skin and eyes).
• Erectile dysfunction.
• Decreased sexual desire.
• Depression.

Uncommon: may affect up to 1 in 100 patients

• Interstitial lung disease (an inflammation of the lungs). Fatal cases have been reported.
• Allergic reactions (hypersensitivity), skin swelling, urticaria.

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

• Liver failure. Fatal cases have been reported.
• Increased sensitivity to sunlight.

Frequency not known: cannot be estimated from available data

• Changes in electrocardiogram (prolongation of QT interval)

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 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 Biobica

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging (after EXP.). The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Biobica

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

Appearance of the medicine and contents of the pack

Biobica are white, round, biconvex film-coated tablets.

Each pack contains 30 film-coated tablets packed in blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Biowise Pharmaceuticals, S.L.

C/Teixidors 22,

Polígono Can Rubiol

07141-Marratxí

Islas Baleares (Spain)

Manufacturer:

Tecnimede – Sociedade Técnico-Medicinal, SA

Quinta da Cerca – Caixaria

2565-187 Dois Portos (Portugal)

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

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