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BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS

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About the medicine

How to use BICALUTAMIDE AUROVITAS 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

Bicalutamide Aurovitas 150 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 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

This medicinal product contains the active substance bicalutamide, which belongs to a group of medicines called anti-androgens.

  • Bicalutamide is indicated for the treatment of prostate cancer (a gland that, in men, produces seminal fluid) and acts by reducing the amount of testosterone (a hormone) produced by your body.
  • This medicine will also be prescribed to you alone or in combination with other medicines:
    • after prostate removal.
    • after radiotherapy treatment (a medical technique that uses radiation to treat cancer).
  • This medicine will be prescribed to you as monotherapy:
    • if the tumor spreads to other organs and cannot be removed or if the action of agents in the testicles is inhibited.

Talk to your doctor if you do not feel better or if you feel worse.

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 a woman.
  • If you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
  • If you are already taking a medicine called cisapride or some antihistamines (terfenadine or astemizole).

Bicalutamide should not be given to children.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take bicalutamide:

  • If you have any liver problems. Your doctor may perform blood tests before and during your treatment with bicalutamide.
  • If you have any of the following: any heart or blood vessel disease, including heart rhythm problems (arrhythmia), or if you are being treated with medicines 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.

If you are hospitalized, inform the healthcare staff that you are taking bicalutamide.

Children and adolescents

Bicalutamide should not be given to children or adolescents.

Medical tests

Your doctor may perform blood tests to check if there are any changes in your blood.

Other medicines and Bicalutamide Aurovitas

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

This includes medicines that are not prescribed by a doctor and medicines that are based on plants. This is because bicalutamide may affect the way other medicines work. Also, some other medicines may affect the way bicalutamide works.

Do not take bicalutamide if you are already taking any of the following medicines:

  • Cisapride (used for some types of indigestion).
  • Some antihistamines (terfenadine or astemizole).

Bicalutamide 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 to relieve pain and for part of the treatment of drug addiction), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • Oral medicines to prevent blood clotting (oral anticoagulants). Anticoagulants or medicines to prevent blood clots. Your doctor may perform blood tests before and during your treatment with bicalutamide.
  • Cyclosporin (used to suppress the immune system).
  • Calcium channel blockers (to treat high blood pressure or some heart diseases).
  • Cimetidine (to treat stomach problems).
  • Ketoconazole (to treat fungal infections).

Pregnancy, breastfeeding, and fertility

Bicalutamide should not be used in women.

Bicalutamide may cause limited fertility or infertility in men for a temporary period.

Driving and using machines

Bicalutamide is unlikely to affect your ability to drive or use tools or machines. However, some people may feel drowsy occasionally while taking bicalutamide. If this happens, consult your doctor or pharmacist.

Sunlight or ultraviolet (UV) light

Avoid excessive direct sunlight or ultraviolet light while taking bicalutamide.

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 some sugars, consult them before taking this medicine.

3. How to take Bicalutamide Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. Swallow the tablet whole with a glass of water. Try to take the tablet at the same time every day. Do not stop taking this medicine, even if you feel well, unless your doctor tells you to.

Use in children and adolescents

Bicalutamide should not be given to children.

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, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you have any other 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 side effects, contact your doctor immediately – you may need urgent medical treatment:

Allergic reactions(uncommon, may affect up to 1 in 100 people):

The symptoms may include the sudden appearance of:

  • Rash, itching, or hives on the skin.
  • Swelling of the face, lips, tongue, throat, or other parts of the body.
  • Shortness of breath, wheezing, or difficulty breathing.

Also, inform your doctor immediately if you notice any of the following symptoms:

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

  • Yellowing of the skin or the whites of the eyes (jaundice). These may be signs of liver problems or, in rare cases, liver failure (may affect up to 1 in 1,000 patients).
  • Abdominal pain.
  • Blood in the urine.

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

  • Severe difficulty breathing or sudden worsening of breathing difficulties, possibly with cough or high fever. These may be signs of a lung disease called "interstitial lung disease".

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

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

Other side effects:

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

  • Skin rash.
  • Increased breast size and breast tenderness.
  • Weakness.

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

  • Hot flushes.
  • Feeling of discomfort (nausea).
  • Itching.
  • Dry skin.
  • Difficulty achieving an erection (erectile dysfunction).
  • Weight gain.
  • Decreased sexual desire and reduced fertility.
  • Hair loss.
  • Excessive hair growth/re-growth of hair.
  • Low red blood cell count (anemia). This may make you feel tired or look pale.
  • Decreased appetite.
  • Depression.
  • Drowsiness.
  • Indigestion.
  • Dizziness.
  • Constipation.
  • Gas (flatulence).
  • Chest pain.
  • Swelling.

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

  • Increased sensitivity of the skin to sunlight.

Your doctor may perform blood tests to check if there are any changes in your blood. Do not worry about this list of side effects. You may not get any of them.

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) at 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 150 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 and packaging

Film-coated tablet.

Bicalutamide Aurovitas 150 mg film-coated tablets EFG:

White, round, film-coated tablet with "B2" marked on one side and smooth 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 150 mg film-coated tablets

Belgium: Bicalutamide Eugia 150 mg film-coated tablets/comprimés pelliculés/Filmtabletten

Spain: Bicalutamida Aurovitas 150 mg film-coated tablets EFG

Italy: Bicalutamide Aurobindo Italia

Netherlands: Bicalutamide Eugia 150 mg, film-coated tablets

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 150 mg FILM-COATED TABLETS

Discuss questions about BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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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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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
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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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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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Frequently Asked Questions

Is a prescription required for BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS?
BICALUTAMIDE AUROVITAS 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 BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS?
The active ingredient in BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS is bicalutamide. This information helps identify medicines with the same composition but different brand names.
Who manufactures BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS?
BICALUTAMIDE AUROVITAS 150 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 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 BICALUTAMIDE AUROVITAS 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 BICALUTAMIDE AUROVITAS 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 50 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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