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BICALUTAMIDE AUROVITAS SPAIN 50 mg FILM-COATED TABLETS

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About the medicine

How to use BICALUTAMIDE AUROVITAS SPAIN 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 Spain 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 pack

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

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

Bicalutamide Aurovitas Spain is a medicine that contains the active substance called bicalutamide. It belongs to a group of medicines called anti-androgens.

  • Bicalutamide is used in the treatment of prostate cancer.
  • It works by blocking the effects of male sex hormones such as testosterone.
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 Spain

Do not take Bicalutamide Aurovitas Spain

  • if you are allergic to bicalutamide or any of the other ingredientsof this medicine (listed in section 6),
  • if you are already taking terfenadineor astemizole, which are used to treat allergies, or cisapride, for the treatment of heartburn and acid reflux,
  • if you are a woman.

Bicalutamide must not be taken by children and adolescents.

Do not take bicalutamide if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking bicalutamide.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bicalutamide Aurovitas Spain:

  • if you have any heart or blood vessel disease, including heart rhythm problems (arrhythmias)or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when using bicalutamide,
  • if you have liver disease. Your doctor may decide to perform blood tests to check that your liver is working properly while you are taking this medicine,
  • if you have diabetes. Treatment with bicalutamide in combination with luteinizing hormone-releasing hormone (LHRH) analogues may alter blood sugar levels. It may be necessary to adjust the dose of insulin and/or oral anti-diabetic medicines,
  • if you are going to the hospital, tell the medical staff that you are taking Bicalutamide Aurovitas Spain,
  • if you are taking bicalutamide, you and/or your partner must use a contraceptive method while you are being treated with this medicine 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 Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because bicalutamide may affect the way other medicines work. Other medicines may also affect the way bicalutamide works.

  • Ciclosporin(used as an immunosuppressant to prevent and treat rejection of a transplanted organ or bone marrow). This is because bicalutamide may increase the plasma concentration of a substance called creatinine, and your doctor may perform blood tests to monitor this.
  • Midazolam(a medicine used to relieve anxiety before an operation or certain procedures, or as an anaesthetic before and during the operation). If you are going to have an operation or are experiencing a lot of anxiety in the hospital, you must inform your doctor or dentist that you are taking bicalutamide.
  • Terfenadineor astemizole, which are used to treat allergies, and cisapride, which is used to treat heartburn and acid reflux (see section 2. Do not take Bicalutamide Aurovitas Spain).
  • A type of medicine called calcium channel blocker, for example, diltiazemor verapamil, which are used to treat heart problems, angina, and high blood pressure.
  • Medicines that are taken orally to prevent the formation of blood clots (oral anticoagulants) or so-called anticoagulants, for example, warfarin. Your doctor may perform blood tests before and during your treatment with bicalutamide.
  • Cimetidinefor acid reflux or stomach ulcers.
  • Ketoconazole, a medicine used to treat fungal infections.
  • Bicalutamide may interfere with some medicines used to treat heart rhythm problems(for example, quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medicines (for example, methadone(used to relieve pain and as part of detoxification for drug addiction), moxifloxacin(an antibiotic), antipsychotics(used to treat serious mental illnesses)).

Taking Bicalutamide Aurovitas Spain with food and drinks

It is not necessary to take the tablets with food, but they should be swallowed whole with a glass of water.

Pregnancy, breastfeeding, and fertility

Bicalutamide must not be taken by women, including pregnant women or breastfeeding mothers.

Bicalutamide may have an effect on male fertility that can be reversible.

Driving and using machines

This medicine does not affect the ability to drive or use machines; however, some patients may feel drowsy while taking this medicine. If you think this is happening to you, you should inform your doctor or pharmacist before driving or using machines.

Sunlight or ultraviolet (UV) light

Avoid excessive direct sunlight or ultraviolet light while being treated with bicalutamide.

Bicalutamide Aurovitas Spain contains lactose

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

Bicalutamide Aurovitas Spain contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially, “sodium-free”.

3. How to take Bicalutamide Aurovitas Spain

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

The recommended dose is one tablet once a day. The tablet should be swallowed whole with a glass of water. Try to take the medicine at approximately the same time each day.

You should start taking the tablets at least 3 days before starting treatment with LHRH analogues, e.g., gonadorelin, or at the same time as you undergo surgical castration.

If you take more Bicalutamide Aurovitas Spain than you should

If you think you may have taken more tablets than you should, contact your doctor or go to the nearest hospital as soon as possible. Bring the remaining tablets or the package so that the doctor can identify what you have been taking. They may decide to monitor your body's functions until the effects of bicalutamide have disappeared.

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

If you forget to take Bicalutamide Aurovitas Spain

If you think you may have forgotten to take a dose, inform your doctor or pharmacist. Do not take a double dose to make up for the forgotten dose. Take the next dose when it is due.

If you stop taking Bicalutamide Aurovitas Spain

Do not stop taking this medicine even if you feel better, 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.

If you notice any of the following symptoms, inform your doctor or go to the emergency department of the nearest hospital immediately.These side effects are very serious.

  • Severe difficulty breathing or worsening of breathing. This may be with cough or high temperature (fever). These can be signs of a lung disease called “interstitial lung disease”. This side effect is uncommon.
  • Severe skin rash, itching, hives, or swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing. These side effects are uncommon.

Other possible side effects:

Very commonside effects (may affect more than 1 in 10 people)

Dizziness, abdominal pain, constipation, feeling sick (nausea), blood in the urine (haematuria), breast tenderness or swelling, breast development in men, hot flushes, feeling weak, swelling (oedema), low red blood cell count (anaemia).

Commonside effects (may affect up to 1 in 10 people)

Lack of appetite, decreased sex drive, depression, drowsiness, indigestion, flatulence, changes in liver function, including yellowing of the skin and the whites of the eyes (jaundice), hair loss, increased hair growth, dry skin, itching, rash, difficulty getting an erection (erectile dysfunction), weight gain, chest pain, decreased heart function, heart attack.

Rareside effects (may affect up to 1 in 1,000 people)

Increased sensitivity of the skin to sunlight.

Frequency not knownside effects (cannot be estimated from the available data):

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

Your doctor may perform blood tests to detect any changes in your blood levels. Do not worry about this list of possible side effects. You may not get any of them.

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 Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Aurovitas Spain

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 after EXP. The expiry date refers to the last day of the month shown.

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 further information

Composition of Bicalutamide Aurovitas Spain

  • The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
  • The other ingredients (excipients) of the tablet core are: lactose monohydrate, povidone K-29/32, crospovidone, sodium lauryl sulfate, and magnesium stearate.

The ingredients (excipients) of the coating are: lactose monohydrate, hypromellose, titanium dioxide (E171), and macrogol 4000.

Appearance and packaging

Film-coated tablets, round, biconvex, white, with the marking BCM 50 on one side.

They are available in blister packs containing 5, 7, 10, 14, 20, 28, 30, 40, 50, 56, 80, 84, 90, 98, 100, 140, 200, and 280 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

Synthon Hispania

Castello 1

Polígono Las Salinas

08830 Sant Boi de Llobregat (Spain)

Or

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach (Austria)

You can request more information about 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:

Austria Androbloc 50 mg - Filmtabletten

Czech Republic Lanbica 50 mg film-coated tablets

Greece Bikalen 50 mg, film-coated tablets

Iceland Bicalutamide Medical 50 mg film-coated tablets

Italy Bicalutamide Ibigen 50 mg, film-coated tablets

Poland Bicalutamide Polpharma 50 mg film-coated tablets

Slovenia Bicalutamide Synthon 50 mg, film-coated tablets

Spain Bicalutamida Aurovitas Spain 50 mg film-coated tablets EFG

Netherlands Bicalutamide Actavis 50 mg, film-coated tablets

United Kingdom Bicalutamide 50 mg, film-coated tablets

Date of last revision of this leaflet:February 2024

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

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

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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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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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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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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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Frequently Asked Questions

Is a prescription required for BICALUTAMIDE AUROVITAS SPAIN 50 mg FILM-COATED TABLETS?
BICALUTAMIDE AUROVITAS SPAIN 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 SPAIN 50 mg FILM-COATED TABLETS?
The active ingredient in BICALUTAMIDE AUROVITAS SPAIN 50 mg FILM-COATED TABLETS is bicalutamide. This information helps identify medicines with the same composition but different brand names.
How much does BICALUTAMIDE AUROVITAS SPAIN 50 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for BICALUTAMIDE AUROVITAS SPAIN 50 mg FILM-COATED TABLETS is around 42.37 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures BICALUTAMIDE AUROVITAS SPAIN 50 mg FILM-COATED TABLETS?
BICALUTAMIDE AUROVITAS SPAIN 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 SPAIN 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 SPAIN 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 SPAIN 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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