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BICALUTAMIDE SANDOZ 50 mg FILM-COATED TABLETS

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About the medicine

How to use BICALUTAMIDE SANDOZ 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

Leaflet: information for the patient

Bicalutamide Sandoz 50 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Bicalutamide Sandoz belongs to a group of medicines called antiandrogens. It interferes with some of the actions of male sex hormones.

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

  • monotherapy in tumor stages called "locally advanced" or as
  • combination therapy in tumor stages called "advanced", and is used in conjunction with other treatments such as surgical castration or medications that reduce the body's androgen levels.
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2. What you need to know before taking Bicalutamide Sandoz

Do not take Bicalutamide Sandoz

  • if you are allergic to bicalutamide or any of the other components of this medicine (listed in section 6),
    • if you are a woman, child, or adolescent,
    • if you are taking other medicines that contain terfenadine, astemizole, or cisapride (see "Taking Bicalutamide Sandoz with other medicines" 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 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 should 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.

Taking Bicalutamide Sandoz with other medicines

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 it:

  • terfenadine or astemizole (for hay fever or allergies) or cisapride (for stomach disorders). See the "Do not take Bicalutamide Sandoz" section,
  • oral medicines to prevent blood clotting (oral anticoagulants),
  • cyclosporine (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),
  • oral medicines to prevent blood clots (oral anticoagulants). Anticoagulants or medicines to prevent blood clots. Your doctor may perform blood tests before and during your treatment with bicalutamide.

Bicalutamide Sandoz 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 alleviate pain and as part of drug addiction detoxification treatment), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy, breastfeeding, and fertility

Bicalutamide is not used in women. Therefore, Bicalutamide Sandoz should not be taken by women, including pregnant or breastfeeding women.

Bicalutamide may lead to limited or impaired fertility for a period of time.

Driving and using machines

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

Bicalutamide Sandoz contains lactose

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

Bicalutamide Sandoz contains sodium

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

3. How to take Bicalutamide Sandoz

Follow the administration instructions for this medicine exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

  • Swallow the tablets whole with water.
  • You can take these tablets with or without food.
  • Try to take the tablets at the same time each day.

If you take more Bicalutamide Sandoz than you should

If you have taken more bicalutamide than you should, consult your doctor or go to the nearest hospital immediately, or call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Bicalutamide Sandoz

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 Sandoz

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

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

Medicine questions

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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.

Serious side effects:

You should contact your doctor immediately if you notice any of the following serious side effects.

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

  • yellowing of the skin or the whites of the eyes due to liver problems or liver failure in rare cases (may affect up to 1 in 1,000 patients).

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

  • severe allergic reactions that cause swelling of the face or throat or severe itching of the skin with the appearance of lumps,
  • severe difficulty breathing or sudden worsening of breathing difficulties, possibly with cough or fever. Some patients taking Bicalutamide Sandoz develop a lung disease called interstitial lung disease.

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

  • changes in the ECG (QT interval).

Other side effects:

The frequency of some side effects depends on whether bicalutamide is used in combination therapy or monotherapy.

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

  • breast tenderness or enlargement,
  • weakness,
  • skin rashes, very common in monotherapy although common (less than 1 in 10 patients) in combination therapy,
  • reduction of red blood cells that can lead to paleness of the skin and cause weakness or shortness of breath.

Very common in combination therapy although common in monotherapy, we can find:

  • hot flashes,
  • dizziness,
  • abdominal pain, constipation, nausea (feeling of discomfort),
  • edema,
  • presence of blood in the urine.

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

  • loss of appetite,
  • decreased libido,
  • erectile dysfunction,
  • depression,
  • drowsiness,
  • indigestion, flatulence (gas),
  • hair loss, excessive body hair,
  • dry skin, itching,
  • weight gain,
  • changes in blood tests related to liver function,
  • heart attack, heart failure,
  • chest pain.

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

  • increased sensitivity of the skin to sunlight.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through 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 Sandoz

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

Do not use this medicine after the expiration date stated on the packaging and blister after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you have any questions, ask your pharmacist. By doing so, you will help protect the environment.

6. Contents of the pack and further information

Composition of Bicalutamide Sandoz

  • The active substance is bicalutamide. Each film-coated tablet contains 50 mg of bicalutamide.
  • The other ingredients are:
  • Tablet core:lactose monohydrate, sodium carboxymethyl starch (type A) (derived from potato starch), povidone K 30 (E1201), corn starch, and magnesium stearate (E572).
  • Tablet coating:methylcellulose, titanium dioxide (E171), and glycerol triacetate (E1518).

Appearance of the product and pack contents

White, round, film-coated tablet with an approximate diameter of 7mm.

The cardboard boxes with PVC/Aclar/Al blisters may contain 10, 28, 30, 56, 84, 90, or 100 film-coated tablets.

The cardboard boxes with unit dose PVC/Aclar/Al blisters may contain 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

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

Austria: Bicalutamid "Hexal" 50 mg - Filmtabletten

Denmark: Bicalutamid HEXAL

Finland: Bicalutamid Hexal

France: BICALUTAMIDE GNR 50 mg, comprimé pelliculé

Germany: Bicalutamid HEXAL 50 mg Filmtabletten

Ireland: Biluta 50 mg Film-Coated Tablets

Italy: BICALUTAMIDE HEXAL 50 mg compresse rivestite con film

Luxembourg: Bicalutamid HEXAL 50 mg Filmtabletten

Netherlands: Bicalutamide 50 mg, filmomhulde tabletten

Poland: BicaHEXAL 50

Spain: Bicalutamida Sandoz 50 mg comprimidos recubiertos con película EFG

Date of last revision of this leaflet:February 2019

Detailed and updated 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 BICALUTAMIDE SANDOZ 50 mg FILM-COATED TABLETS

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

5.0 (3)
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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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5.0 (29)
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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 SANDOZ 50 mg FILM-COATED TABLETS?
BICALUTAMIDE SANDOZ 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 SANDOZ 50 mg FILM-COATED TABLETS?
The active ingredient in BICALUTAMIDE SANDOZ 50 mg FILM-COATED TABLETS is bicalutamide. This information helps identify medicines with the same composition but different brand names.
How much does BICALUTAMIDE SANDOZ 50 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for BICALUTAMIDE SANDOZ 50 mg FILM-COATED TABLETS is around 42.37 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures BICALUTAMIDE SANDOZ 50 mg FILM-COATED TABLETS?
BICALUTAMIDE SANDOZ 50 mg FILM-COATED TABLETS is manufactured by Sandoz Farmaceutica S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of BICALUTAMIDE SANDOZ 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 SANDOZ 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 SANDOZ 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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