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BICALUTAMIDE AUROVITAS 50 mg FILM-COATED TABLETS

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About the medicine

How to use BICALUTAMIDE AUROVITAS 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

Bicalutamide Aurovitas 50 mg Film-Coated Tablets EFG

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 Package Leaflet

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

1. What is Bicalutamide Aurovitas and what is it used for

Bicalutamide Aurovitas belongs to a group of medicines called anti-androgens. It interferes with some of the actions of male sex hormones.

Bicalutamide is used to treat prostate cancer. It is used as:

  • monotherapy in tumor stages called "locally advanced", or as
  • combination therapy in tumor stages called "advanced", and is used together with other treatments such as surgical castration or medications that reduce the body's androgen levels.
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 Bicalutamide Aurovitas

Do not take Bicalutamide Aurovitas

  • If you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
  • If you are a woman or a child.
  • If you are taking other medicines that contain terfenadine, astemizole or cisapride (see "Other medicines and Bicalutamide Aurovitas" below).

Warnings and precautions

Consult your doctor or pharmacist before starting to take bicalutamide:

  • If you have any liver problems. Bicalutamide levels in your blood may increase. Your liver function may be monitored periodically.
  • If you have diabetes.
  • If you have any cardiovascular disease, including heart rhythm problems (arrhythmias), or are being treated with medications for these diseases. The risk of heart rhythm problems may increase with bicalutamide treatment.
  • 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.

Other medicines and Bicalutamide Aurovitas

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

If you are taking any of the following medicines, it is especially important to mention them:

  • Terfenadine or astemizole (for hay fever or allergies) or cisapride (for stomach disorders). See "Do not take Bicalutamide Aurovitas" above.
  • Ciclosporin (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection).
  • Calcium channel blockers (to treat high blood pressure or certain heart diseases).
  • Cimetidine (to treat stomach ulcers).
  • Ketoconazole (used to treat fungal infections of the skin and nails).
  • Anticoagulants or medications to prevent blood clots, such as warfarin. Your doctor may perform blood tests before and during your treatment with bicalutamide.

Bicalutamide may interfere with some medications 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 medications (e.g., methadone (used to relieve pain and as part of drug detoxification treatment), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy, breast-feeding and fertility

Bicalutamide is not used in women.

Bicalutamide may cause limited or reduced fertility in men during a temporary period.

Driving and using machines

These tablets may make you feel dizzy or drowsy. If you are affected, do not drive or use machines.

Bicalutamide Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

Bicalutamide Aurovitas contains lactose

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

3. How to take Bicalutamide Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dose

Depending on your disease, the usual dose is one 50 mg tablet per day (combination therapy), or three 50 mg tablets once a day (monotherapy).

Method of administration

  • Swallow the tablets whole with a glass of water.
  • You can take these tablets with or without food.

Frequency of administration

The tablet can be taken at any time of the day, but try to take it at the same time every day to avoid forgetting.

Duration of treatment

  • The duration of treatment is determined by your doctor.
  • Do not stop treatment without your doctor's consent.

If you take more Bicalutamide Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bicalutamide Aurovitas

If you forget to take the medicine, take the dose when you remember and then take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Bicalutamide Aurovitas

Do not stop taking the tablets, even if you feel well, unless your doctor tells you to.

If you have any further questions on 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.

These side effects may occur with certain frequencies, as defined below:

very common: may affect more than 1 in 10 people.

common: may affect up to 1 in 10 people.

uncommon: may affect up to 1 in 100 people.

rare: may affect up to 1 in 1,000 people.

very rare: may affect up to 1 in 10,000 people.

frequency not known: cannot be estimated from the available data.

If you notice any of the following side effects, contact your doctor immediately, as you may need urgent medical treatment.

  • Severe respiratory problems or sudden worsening of a respiratory problem, possibly with cough or fever. This may be a lung disease called "interstitial lung disease".
  • Severe itching of the skin with rash, or swelling of the face, lips, tongue and/or throat, which can cause difficulty swallowing or breathing. This may be a severe allergic reaction to bicalutamide.
  • Blood in the urine.
  • Abdominal pain.
  • Jaundice (yellowing of the skin and eyes).

The following side effects may occur:

Very common side effects (may affect more than 1 in 10 people):

  • Anaemia (a condition that affects red blood cells).
  • Dizziness.
  • Hot flushes.
  • Abdominal pain, constipation, nausea.
  • Haematuria (blood in the urine).
  • Breast tenderness or swelling.
  • Asthenia (feeling of weakness).
  • Oedema.
  • Rash.

Common side effects (may affect up to 1 in 10 people):

  • Decreased appetite.
  • Decreased libido.
  • Depression.
  • Somnolence.
  • Myocardial infarction, heart failure.
  • Dyspepsia (indigestion), flatulence (gas).
  • Hepatotoxicity (liver damage), jaundice (yellowing of the skin and eyes), hypertransaminasaemia (elevated transaminase levels).
  • Alopecia (hair loss), hirsutism (excessive hair growth)/hair regrowth, dry skin, itching.
  • Erectile dysfunction.
  • Chest pain.
  • Weight gain.

Uncommon side effects (may affect up to 1 in 100 people):

  • Hypersensitivity, angioedema (skin swelling) and urticaria.
  • Lung disease called "interstitial lung disease".

Rare side effects (may affect up to 1 in 1,000 people):

  • Liver failure.
  • Increased skin sensitivity to sunlight.

Side effects of unknown frequency (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 leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Aurovitas

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 carton and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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 other information

Composition of Bicalutamide Aurovitas

  • The active substance is bicalutamide. Each film-coated tablet contains 50 mg of bicalutamide.
    • The other ingredients (excipients) are:

Core of the tablet:lactose monohydrate, sodium carboxymethyl starch type A (potato), povidone, magnesium stearate.

Coating of the tablet:HPMC 2910/hypromellose, titanium dioxide (E171), macrogol.

Appearance of the product and contents of the pack

Film-coated tablet.

Bicalutamide Aurovitas 50 mg film-coated tablets EFG:

White, round, film-coated tablet with "B" marked on one side and "l" on the other.

Bicalutamide Aurovitas film-coated tablets are available in blister packs of 1, 10, 28, 30, 56, 60, 90 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Bicalutamid PUREN 50 mg Filmtabletten

Belgium: Bicalutamide Eugia 50 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Spain: Bicalutamida Aurovitas 50 mg comprimidos recubiertos con película EFG

France: BICALUTAMIDE ARROW 50 mg, comprimé pelliculé

Italy: Bicalutamide Aurobindo Italia

Netherlands: Bicalutamide Eugia 50 mg, filmomhulde tabletten

Portugal: Bicalutamida Generis

Date of last revision of this leaflet: July 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 BICALUTAMIDE AUROVITAS 50 mg FILM-COATED TABLETS

Discuss questions about BICALUTAMIDE AUROVITAS 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 BICALUTAMIDE AUROVITAS 50 mg FILM-COATED TABLETS?
BICALUTAMIDE AUROVITAS 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 BICALUTAMIDE AUROVITAS 50 mg FILM-COATED TABLETS?
The active ingredient in BICALUTAMIDE AUROVITAS 50 mg FILM-COATED TABLETS is bicalutamide. This information helps identify medicines with the same composition but different brand names.
Who manufactures BICALUTAMIDE AUROVITAS 50 mg FILM-COATED TABLETS?
BICALUTAMIDE AUROVITAS 50 mg FILM-COATED TABLETS is manufactured by Eugia Pharma (Malta) Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of BICALUTAMIDE AUROVITAS 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 BICALUTAMIDE AUROVITAS 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 BICALUTAMIDE AUROVITAS 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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