BIOBICA 50 mg FILM-COATED TABLETS
Ask a doctor about a prescription for BIOBICA 50 mg FILM-COATED TABLETS
How to use BIOBICA 50 mg FILM-COATED TABLETS
Introduction
Package Leaflet: Information for the User
Biobica 50 mg film-coated tablets EFG
bicalutamide
Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this package 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 symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
Contents of the package leaflet
- What is Biobica and what is it used for
- What you need to know before you take Biobica
- How to take Biobica
- Possible side effects
- Storage of Biobica
- Contents of the pack and other information
1. What is Biobica and what is it 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 conditions, along with other treatments such as drugs that reduce androgen levels in the body.
2. What you need to know before you take Biobica
Do not take Biobica:
- If you are allergic to bicalutamide or 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.
Warnings and precautions
Talk to your doctor or pharmacist before you start taking this medicine:
- If you have any liver problems. This medicine should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor will need to regularly check your liver function. Serious liver damage and liver failure have been reported.
- If you have a lung disease called interstitial lung disease. Symptoms of this may include severe difficulty breathing with cough or fever. Fatal cases have been reported.
- If you are taking any other medicines, including those obtained without a prescription. In particular, if you are taking medicines that thin the blood or medicines to prevent blood clots.
- If you have diabetes. The combined treatment of bicalutamide with LHRH analogues may affect your blood sugar levels. Your doctor will need to adjust your insulin and/or anti-diabetic medication.
- If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in these cases.
Tell your doctor if you have any heart or blood vessel problems or are being treated for them, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when bicalutamide is used.
If any of the above applies to you, tell your doctor, he will take it into account during your treatment with bicalutamide.
If you are admitted to hospital, inform the medical 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. Ask 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.
Other medicines and Biobica
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take bicalutamide with the following medicines:
- Terfenadine or astemizole (for hay fever or allergy).
- Cisapride (for stomach problems).
If you take bicalutamide with any of the following medicines, the effect of this and the other medicines may be affected. Talk to your doctor before taking any of the following medicines with bicalutamide:
- In particular, tell your doctor if you are taking blood-thinning medicines such as warfarin.
- Ciclosporin (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection).
- 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 diseases).
- Cimetidine (for 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, procainamide, 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 for detoxification from other medicines), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).
Please note that these warnings may also apply to medicines that you have used some time ago.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Bicalutamide must not be taken by women, including pregnant women or breast-feeding mothers.
Bicalutamide may have an effect on male fertility, which may be reversible.
Driving and using machines
Biobica may make you feel drowsy, so be careful when driving or using machines.
Biobica contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.
3. How to take Biobica
Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will tell you how long you should take this medicine. Do not stop treatment unless your doctor tells you to.
The recommended dose in adult men is one tablet per day.
- 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 have taken more than the prescribed dose, contact your doctor or the nearest hospital.
In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 5620420.
If you forget to take Biobica:
Do not take a double dose to make up for forgotten doses.
If you have any further questions about 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, tell your doctor immediately or go to the casualty department of your nearest hospital. These side effects are very serious.
- Skin rash, severe itching of the skin (with lumps), hives, skin peeling or blistering.
- Swelling of the face or neck, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing.
- Difficulty breathing or sudden worsening of breathing difficulties, 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 side effects of this medicine are:
Very common: may affect more than 1 in 10 people
- Anaemia.
- Dizziness.
- Abdominal pain, constipation, nausea (feeling sick).
- Flushing.
- Blood in the urine.
- Skin rash.
- Weakness, swelling.
- Enlargement of the breasts 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 people
- Weight gain.
- Drowsiness.
- Heart attack (fatal cases have been reported), heart failure.
- Indigestion, flatulence (wind).
- Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
- Loss of appetite.
- Chest pain.
- Liver toxicity, elevated liver enzymes, jaundice (yellowing of the skin and eyes).
- Erectile dysfunction.
- Decreased sex drive.
- Depression.
Uncommon: may affect up to 1 in 100 people
- Interstitial lung disease (a lung inflammation). Fatal cases have been reported.
- Allergic reactions (hypersensitivity), skin swelling, urticaria.
Rare: may affect up to 1 in 1,000 people
- Liver failure. Fatal cases have been reported.
- Increased sensitivity to sunlight.
Frequency not known: cannot be estimated from the available data
- Changes in the electrocardiogram (QT interval prolongation)
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Biobica
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Store in the original package.
Do not use this medicine after the expiry date which is stated on the packaging (after EXP.). The expiry date refers to the last day of the month shown.
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 to 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 ingredients are:
- Core: Lactose monohydrate, povidone K-30, sodium starch glycolate, vegetable magnesium stearate, purified water.
- Coating: Ethanol, purified water, macrogol, hypromellose and titanium dioxide.
Appearance of the product and pack contents
Biobica are white, round, biconvex film-coated tablets.
Each pack contains 30 film-coated tablets in blisters.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Biowise Pharmaceuticals, S.L.
C/Teixidors 22,
Polígono Can Rubiol
07141-Marratxí
Balearic Islands (Spain)
Manufacturer:
Tecnimede – Sociedade Técnico-Medicinal, SA
Quinta da Cerca – Caixaria
2565-187 Dois Portos (Portugal)
Date of last revision of this package leaflet:February 2024
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es
How much does BIOBICA 50 mg FILM-COATED TABLETS cost in Spain ( 2025)?
The average price of BIOBICA 50 mg FILM-COATED TABLETS in December, 2025 is around 42.37 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
- Country of registration
- Average pharmacy price42.37 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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