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WIBICAL 150 mg FILM-COATED TABLETS

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About the medicine

How to use WIBICAL 150 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

Wibical 150 mg film-coated tablets EFG

Bicalutamide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this 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 signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

Contents of the pack and further information

1. What is Wibical and what is it used for

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

This medicine is used in adult men to treat prostate cancer that has not spread to other parts of the body, in cases where there is a high risk of the cancer spreading. It can be used alone or in combination with other treatments such as surgical removal of the prostate gland or radiotherapy.

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 Wibical

Do not take Wibical:

  • 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, which are used to treat allergies, or cisapride, which is used to treat heartburn and acid reflux.

Bicalutamide should not be given to children and adolescents under 18 years.

Warnings and precautions

Consult your doctor or pharmacist before taking Wibical.

  • If you have any liver problems. The 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. The symptoms of this may include severe difficulty breathing with cough or fever. Serious cases, including death, 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 severe kidney problems. Caution is needed as there is no experience with the use of bicalutamide in these cases.
  • If you have heart disease. Your doctor may decide to check your heart function regularly.

Tell your doctor if you have any heart or blood vessel disease, or if you are being treated for this, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Bicalutamide 150 mg.

If any of the above applies to you, tell your doctor, who 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 150 mg.

If you are taking Wibical, you and/or your partner must use a contraceptive method while you are being treated with Wibical and for 130 days after finishing treatment. Ask your doctor if you have any questions about contraceptive methods.

Children and adolescents

Wibical should not be given to children and adolescents under 18 years.

Other medicines and Wibical

Tell your doctor if you are using or have recently used other medicines or if you might take any other medicines, including those obtained without a prescription and herbal products.

Do not take bicalutamide with the following medicines:

  • Terfenadine or astemizole (for hay fever or allergy).
  • Cisapride (for stomach problems).

If you take Wibical with any of the following medicines, the effect of this and the other medicines may be affected. Consult 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 rejection or bone marrow transplantation).
  • 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).

Wibical 150 mg 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 detoxification), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

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

Wibical may have an effect on male fertility, which may be reversible.

Driving and using machines

Wibical may make you feel drowsy, so be careful when driving or using machines.

Wibical contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Wibical contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to take Wibical

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

  • The recommended dose is one tablet, once a day.
  • Swallow the tablet whole with a glass of water.
  • Try to take the tablet at the same time each day.

If you take more Wibical than you should

If you take more than you should, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicology Information Service immediately, telephone: 91 562 04 20.

If you forget to take Wibical

Do not take a double dose to make up for a forgotten dose, simply continue with your normal treatment schedule.

If you stop taking Wibical

Do not stop taking this medicine unless your doctor tells you to. If you have any further questions on the use of this product, 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 serious side effects, tell your doctor immediately or go to the casualty department of your nearest hospital. These serious side effects are very rare.

  • Skin rash, severe itching of the skin (with lumps), hives, skin peeling or blistering.
  • Swelling of the face or neck, lips, tongue or throat, which may cause difficulty breathing or swallowing.
  • Breathing difficulties 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 or eyes (jaundice). These may be symptoms of liver damage.

Other possible side effects of this medicine include:

Very common: more than 1 in 10 patients

  • Skin rash.
  • Weakness.
  • Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after stopping therapy, particularly after prolonged treatment.

Common: between 1 and 10 in 100 patients

  • Weight gain.
  • Anaemia.
  • Dizziness, drowsiness.
  • Abdominal pain, constipation, indigestion, flatulence (gas), nausea (feeling sick).
  • Blood in the urine.
  • Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
  • Decreased appetite.
  • Hot flushes.
  • Chest pain, swelling.
  • Liver toxicity, elevated liver enzymes, jaundice (yellowing of the skin and eyes).
  • Erectile dysfunction.
  • Decreased libido.
  • Depression.

Uncommon: between 1 and 10 in 1,000 patients

  • Interstitial lung disease (inflammation of the lungs). Serious cases, including death, have been reported.
  • Allergic reactions (hypersensitivity), skin swelling, hives.

Rare: between 1 and 10 in 10,000 patients

  • Liver failure. Serious cases, including death, have been reported.
  • Increased sensitivity to sunlight.

Cannot be estimated from the available data

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

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Wibical

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date is the last day of the month stated.

No special storage conditions are required.

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 protect the environment.

6. Contents of the pack and further information

Composition of Wibical 150 mg film-coated tablets EFG

  • The active substance is bicalutamide. Each tablet contains 150 mg of bicalutamide.
  • The other ingredients of the tablet core are: lactose monohydrate, magnesium stearate, crospovidone, povidone K-29/32, sodium lauryl sulfate

The ingredients of the tablet coating are: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E 171).

Appearance and packaging

White, round, biconvex film-coated tablets with the text BCM 150 engraved on one side.

Available in packs of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

GP-Pharm, S.A.

Polígono Industrial Els Vinyets – Els Fogars, sector 2

Carretera Comarcal C244, Km 22,

08777 – Sant Quintí de Mediona (Barcelona)

SPAIN

Manufacturer(s):

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Or

Synthon Hispania

Castello 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

Date of last revision of this leaflet:February 2021.

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Online doctors for WIBICAL 150 mg FILM-COATED TABLETS

Discuss questions about WIBICAL 150 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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€80
5.0 (21)
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 WIBICAL 150 mg FILM-COATED TABLETS?
WIBICAL 150 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 WIBICAL 150 mg FILM-COATED TABLETS?
The active ingredient in WIBICAL 150 mg FILM-COATED TABLETS is bicalutamide. This information helps identify medicines with the same composition but different brand names.
How much does WIBICAL 150 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for WIBICAL 150 mg FILM-COATED TABLETS is around 127.09 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures WIBICAL 150 mg FILM-COATED TABLETS?
WIBICAL 150 mg FILM-COATED TABLETS is manufactured by Gp Pharm S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of WIBICAL 150 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 WIBICAL 150 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 WIBICAL 150 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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