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BIOBICA 50 mg FILM-COATED TABLETS

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About the medicine

How to use BIOBICA 50 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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

  1. What is Biobica and what is it used for
  2. What you need to know before you take Biobica
  3. How to take Biobica
  4. Possible side effects
  5. Storage of Biobica
  6. 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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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

Online doctors for BIOBICA 50 mg FILM-COATED TABLETS

Discuss questions about BIOBICA 50 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Doctor

Giorgi Eremeishvili

Urology 22 years exp.

Giorgi Eremeishvili is a top-category urologist, a Candidate of Medical Sciences, and a licensed physician in Spain. He provides expert assistance in the diagnosis and treatment of a wide range of urological conditions in both men and women, employing a comprehensive approach and evidence-based principles.

Key areas of expertise:

  • Erectile dysfunction, decreased libido, premature ejaculation.
  • Male infertility: comprehensive diagnosis and modern treatment methods.
  • Prostate gland diseases: acute and chronic prostatitis, prostatic adenoma (benign prostatic hyperplasia), prostate cancer.
  • Inflammatory diseases of the genitourinary system: acute and chronic cystitis, pyelonephritis, epididymitis, orchitis, urethritis.
  • Sexually transmitted infections (STIs): chlamydia, ureaplasmosis, mycoplasmosis, gardnerellosis, candidiasis, herpetic infections, HPV, CMV, trichomoniasis, and others.
  • Urination disorders: urinary retention, frequent urination, urinary incontinence, overactive bladder, neurogenic bladder.
  • Neoplasms: cysts, tumors of the kidneys, bladder, testicles, prostate gland (including prostate cancer).
  • Surgical interventions: determining indications and selecting optimal minimally invasive methods.

Dr. Eremeishvili applies an integrated approach to each case. This includes thorough preoperative preparation, postoperative observation, and regular dynamic follow-up during the treatment process to achieve the best possible outcomes. All diagnostic and therapeutic recommendations are based on current evidence-based medicine and comply with the recommendations of the European Association of Urology, guaranteeing high-quality and effective care.

If you are seeking qualified assistance in diagnosing or treating urological conditions, book an online consultation with Dr. Giorgi Eremeishvili. Get expert support, accurate diagnosis, and a personalized treatment plan from the comfort of your home.

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€60
5.0 (29)
Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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€60
5.0 (29)
Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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€60

Frequently Asked Questions

Is a prescription required for BIOBICA 50 mg FILM-COATED TABLETS?
BIOBICA 50 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in BIOBICA 50 mg FILM-COATED TABLETS?
The active ingredient in BIOBICA 50 mg FILM-COATED TABLETS is bicalutamide. This information helps identify medicines with the same composition but different brand names.
How much does BIOBICA 50 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for BIOBICA 50 mg FILM-COATED TABLETS is around 42.37 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures BIOBICA 50 mg FILM-COATED TABLETS?
BIOBICA 50 mg FILM-COATED TABLETS is manufactured by Biowise Pharmaceuticals, S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of BIOBICA 50 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether BIOBICA 50 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to BIOBICA 50 mg FILM-COATED TABLETS?
Other medicines with the same active substance (bicalutamide) include BICALUTAMIDE ACCORD 50 mg FILM-COATED TABLETS, BICALUTAMIDE ALMUS 50 mg FILM-COATED TABLETS, BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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