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BICALUTAMIDE TEVA-RATIOPHARM 50 mg FILM-COATED TABLETS

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About the medicine

How to use BICALUTAMIDE TEVA-RATIOPHARM 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 Teva-ratiopharm 50 mgfilm-coated tablets EFG

bicalutamide

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

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Bicalutamide Teva-ratiopharm is and what it is used for

Bicalutamide Teva-ratiopharm belongs to a group of antiandrogens. Antiandrogens act against the effects of male sex hormones (androgens).

Bicalutamide Teva-ratiopharm 50 mg is used for the treatment of advanced prostate cancer. It is taken together with another medicine known as a luteinizing hormone-releasing hormone (LHRH) analogue - an additional hormonal treatment - or accompanying surgical removal of the testicles.

It is also used in adult men for the treatment of non-metastatic prostate cancer, when castration or other types of treatments are not indicated or are unacceptable.

It should be used in combination with radiotherapy or prostate surgery at the beginning of treatment programs.

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 Teva-ratiopharm

Do not take Bicalutamide Teva-ratiopharm

  • if you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of this medicine (listed in section 6),
  • if you are taking terfenadine (for hay fever or allergy), astemizole (for hay fever or allergy), or cisapride (for stomach disorders).

Bicalutamide Teva-ratiopharm should not be given to women, children, and adolescents.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bicalutamide Teva-ratiopharm.

  • if you have moderate or severe liver function disorders. The medicine should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor must regularly perform liver function tests (bilirubin, transaminases, alkaline phosphatase). If severe liver function disorders occur, treatment with Bicalutamide Teva-ratiopharm must be discontinued. Fatal cases have been reported.
  • if you have diabetes and are taking an "LHRH analogue". These include goserelin, buserelin, leuprorelin, and triptorelin. You may need to check your blood sugar levels more often.
  • if you have severe kidney function disorders. The medicine should only be taken after your doctor has carefully considered the possible benefits and risks,
  • if you have heart disease. If this is the case, your doctor must regularly perform heart function tests.
  • If you have any heart or blood vessel problems, including heart rhythm problems (arrhythmia) or if you are being treated with medicines for these problems. It may increase the risk of heart rhythm problems when using Bicalutamide Teva-ratiopharm.

Use of Bicalutamide Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Bicalutamide Teva-ratiopharmshould not be taken with the following medicines:

  • terfenadine or astemizole (for hay fever or allergy).
  • cisapride (for stomach disorders).

If you take Bicalutamide Teva-ratiopharm with any of the following medicines, the effect of bicalutamide, as well as the other medicines, may be affected. Talk to your doctor before taking any of the following medicines with Bicalutamide Teva-ratiopharm:

  • warfarin or similar medicines to prevent blood clots.
  • ciclosporin (used to suppress the immune system to prevent and treat organ rejection in organ or bone marrow transplants).
  • cimetidine (to treat stomach ulcers).
  • ketoconazole (used to treat fungal infections of the skin and nails).
  • calcium channel blockers (to treat high blood pressure).

Bicalutamide Teva-ratiopharmmay interfere with some of the medicines used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medicines (e.g., methadone (used for pain relief and as part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy, breastfeeding, and fertility

Pregnancy

Bicalutamide is contraindicated in women and should not be taken by pregnant or breastfeeding women.

Fertility

Bicalutamide may induce a period of subfertility or infertility in men.

Driving and using machines

Bicalutamide is unlikely to affect your ability to drive or use any tools or machines. However, there is a possibility that the tablets may make you feel dizzy or sleepy. If you are affected by these symptoms, do not drive vehicles or operate machines.

Bicalutamide Teva-ratiopharm contains lactose

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

Bicalutamide Teva-ratiopharm contains sodium

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

3. How to take Bicalutamide Teva-ratiopharm

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

Your doctor will personally indicate the suitable dose for you.

The usual dose for the treatment of

  • advanced prostate cancer is 1 tablet once a day.
  • non-metastatic prostate cancer is 3 tablets once a day.

Read the instructions before taking the medicine.

The tablets should be swallowed whole with some liquid. Try to take your medicine at approximately the same time each day.

If you take more Bicalutamide Teva-ratiopharm than you should

If you have taken too many tablets, contact your doctor or the nearest hospital as soon as possible.

Take the remaining tablets or the package with you so that the doctor can identify what you have taken.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 5620420.

If you forget to take Bicalutamide Teva-ratiopharm

If you forget to take your daily dose, do not take it when you remember and wait until the next intake.

Do not take a double dose to make up for forgotten doses.

If you stop taking Bicalutamide Teva-ratiopharm

Do not stop taking this medicine even if you feel well, unless your doctor has told you to do so.

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.

Serious side effects:

Contact your doctor or pharmacist immediately if you experience any of the following serious side effects.

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

  • abdominal pain
  • blood in the urine

Common(may affect up to 1 in 10 people)

  • liver function disorders that can cause yellowing of the skin and the whites of the eyes (jaundice),

Uncommon(may affect up to 1 in 100 people)

  • severe allergic reactions that can cause swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing or breathing, 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 develop a lung inflammation called interstitial lung disease. Fatal cases have been reported.

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

  • liver failure (severe liver function disorders) that can be associated with the following symptoms (affecting less than 1 in 10 patients): jaundice, itching, nausea, loss of appetite, easy bruising, and somnolence. Fatal cases have been reported.

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

  • ECG changes (QT prolongation)

Other side effects:

Tell your doctor if any of the following side effects affect you:

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

  • reduction in the number of red blood cells that can make the skin pale and cause weakness or difficulty breathing,
  • dizziness,
  • abdominal pain
  • constipation,
  • nausea (discomfort),
  • feeling of weakness,
  • skin rash
  • breast enlargement and breast tenderness,
  • hot flashes,
  • edema,
  • chest pain

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

  • loss of appetite, decreased appetite
  • diabetes mellitus,
  • decreased sexual desire, erection problems,
  • depression,
  • sleepiness,
  • chest pain, muscle skeletal pain,
  • myocardial infarction (fatal cases have been reported), heart failure
  • diarrhea,
  • indigestion,
  • gas (flatulence),
  • changes in blood tests related to liver function.
  • hair loss,
  • excessive hair growth/re-growth of hair,
  • dry skin,
  • skin rash,
  • sweating,
  • weight gain.

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

  • high blood sugar levels
  • difficulty breathing

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

  • vomiting.
  • Increased sensitivity of the skin to sunlight.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. 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 Teva-ratiopharm

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 packaging after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use Bicalutamide Teva-ratiopharm if you notice any visible signs of deterioration in the tablets.

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

CompositionBicalutamide Teva-ratiopharm

  • The active substance is bicalutamide. One film-coated tablet contains 50 mg of bicalutamide.
  • The other ingredients are: lactose monohydrate, povidone (K-30), croscarmellose sodium, laurilsulfate sodium, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate. The film coating contains hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), and macrogol 4000.

Appearance and packaging

Bicalutamide Teva-ratiopharm is a white to off-white, round, biconvex film-coated tablet, engraved with "93" on one side and "220" on the other.

Transparent blister packs of 20, 28, 30, 30 x 1, 60, 90, 98, 100, 100 x 1 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Merckle GmbH

Ludwig Merckle Strasse, 3

89143 Blaubeuren (Germany)

TEVA Pharmaceutical Works Private Limited,

Pallagi út 13

4042 Debrecen, Hungary

Teva Nederland BV

Swensweg 5 , 2031 GA

Haarlem , Netherlands.

TEVA PHARMA B.V.

Swensweg 5 , 2031 GA

Haarlem , Netherlands.

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

Germany: Bicalutamid-ratiopharm 50 mg Filmtabletten

Spain: Bicalutamida Teva-ratiopharm 50 mg film-coated tablets EFG

Italy: Bicalutamide ratiopharm 50 mg film-coated tablets

Luxembourg: Bicalutamid-ratiopharm 50 mg Filmtabletten

Date of last revision of this leaflet October 2020

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

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Discuss questions about BICALUTAMIDE TEVA-RATIOPHARM 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 TEVA-RATIOPHARM 50 mg FILM-COATED TABLETS?
BICALUTAMIDE TEVA-RATIOPHARM 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 TEVA-RATIOPHARM 50 mg FILM-COATED TABLETS?
The active ingredient in BICALUTAMIDE TEVA-RATIOPHARM 50 mg FILM-COATED TABLETS is bicalutamide. This information helps identify medicines with the same composition but different brand names.
How much does BICALUTAMIDE TEVA-RATIOPHARM 50 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for BICALUTAMIDE TEVA-RATIOPHARM 50 mg FILM-COATED TABLETS is around 42.37 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures BICALUTAMIDE TEVA-RATIOPHARM 50 mg FILM-COATED TABLETS?
BICALUTAMIDE TEVA-RATIOPHARM 50 mg FILM-COATED TABLETS is manufactured by Teva Pharma S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of BICALUTAMIDE TEVA-RATIOPHARM 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 TEVA-RATIOPHARM 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 TEVA-RATIOPHARM 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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