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BICALUTAMIDE KERN PHARMA 50 mg FILM-COATED TABLETS

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About the medicine

How to use BICALUTAMIDE KERN PHARMA 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 Kern Pharma 50 mg film-coated tablets EFG

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

  • Keep this package 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 package leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Bicalutamide Kern Pharma and what is it used for

Bicalutamide belongs to a group of medicines called anti-androgens, which means it interferes with some of the actions of androgens (male sex hormones) in the body.

This medicine is indicated for certain prostate conditions, along with other treatments such as drugs that reduce the body's androgen levels.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Bicalutamide Kern Pharma

Do not take Bicalutamide Kern Pharma

  • If you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of the medicine listed in section 6 of this package leaflet.

Bicalutamide should not be taken by women or males under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking Bicalutamide Kern Pharma.

  • If you have any liver problems. The medicine should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor will regularly perform liver function tests on you.
  • If you have diabetes. Combination treatment of bicalutamide with luteinizing hormone-releasing hormone (LHRH) analogues may affect your blood sugar levels. Your doctor will adjust your insulin dose and/or anti-diabetic medicines.
  • Tell your doctor if you have any heart or blood vessel disorders or are being treated for them, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Bicalutamide Kern Pharma.

If you are admitted to hospital, inform the medical staff that you are taking Bicalutamide.

Taking Bicalutamide Kern Pharma with other medicines

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

Bicalutamide should not be taken with the following medicines:

  • Terfenadine or astemizole (for hay fever or allergy).
  • Cisapride (for stomach disorders).

If you take bicalutamide with any of the following medicines, the effect of bicalutamide and the other medicines may be affected. Consult your doctor before taking any of the following medicines with bicalutamide:

  • Warfarin or any similar medicine to prevent blood clotting.
  • Ciclosporin (used to reduce 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 skin and nail infections).

Bicalutamide Kern Pharma 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 for pain relief and for detoxification of other medicines), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

There is a possibility that bicalutamide may make you feel dizzy or drowsy. If you are affected by these symptoms, do not drive or operate machinery.

Bicalutamide Kern Pharma contains lactose

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

3. How to take Bicalutamide Kern Pharma

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

Remember to take your medicine.

Your doctor will tell you how long your treatment will last. Do not stop treatment before your doctor tells you to.

Recommended dose:

  • In adults, the usual dose is 1 tablet per day.
  • Swallow the tablet whole with water.
  • Try to take the tablet at the same time each day.

If you take more Bicalutamide Kern Pharma than you should

If you ingest a higher dose than normal, contact your doctor or the nearest hospital.

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 Kern Pharma

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

If you forget a dose, do not take an extra tablet, simply continue with your usual treatment.

If you have any other questions about the use of this product, 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, bicalutamide 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:

Rare but serious side effects(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 bumps.
  • Severe breathing difficulties, sudden worsening of breathing difficulties, possibly with cough or fever. Some patients taking Bicalutamide develop a lung condition called interstitial lung disease.

Very rare but serious side effects(may affect up to 1 in 1,000 people):

Yellowing of the skin and eyes due to a liver problem (including very rare liver failure).

Other side effects:

Tell your doctor if you are concerned about any of the following side effects:

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

  • Breast tenderness or enlargement.
  • Decreased sex drive, erection problems, impotence.
  • Hot flashes.

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

  • Nausea (feeling sick).
  • Diarrhea or constipation.
  • Dizziness.
  • Difficulty sleeping.
  • Skin rash, itching, sweating, excess body hair.
  • Feeling weak.
  • Weight gain.
  • Diabetes mellitus.
  • Edema.
  • General pain, pelvic pain.
  • Chills.
  • Blood tests may be affected according to liver function.
  • Decrease in red blood cells, which can cause paleness and weakness or difficulty breathing.

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

  • Loss of appetite, weight loss.
  • Depression.
  • Increased blood sugar levels.
  • Drowsiness.
  • Shortness of breath.
  • Dry mouth, indigestion, flatulence (gas).
  • Hair loss.
  • Need to urinate at night, blood in the urine.
  • Abdominal pain, chest pain, headache, back pain, neck pain.

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

  • Vomiting.
  • Dry skin.

Very rare side effects(may affect up to 1 in 10,000 people):

  • Chest pain and heart failure (which may be associated with difficulty breathing, especially when making an effort, resulting in a rapid heartbeat, swelling of the arms and legs, and skin spots), irregular heartbeat, and abnormal electrocardiogram results.
  • Decrease in blood platelets, which can increase the risk of bleeding or bruising.

Unknown side effects:

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them 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 Kern Pharma

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

No special storage conditions are required. Store in the original package.

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date is the last day of the month shown.

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 Kern Pharma

  • The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
  • The other ingredients are: lactose monohydrate, povidone K-30, sodium starch glycolate (potato starch) and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E-171), and macrogol 400 in the film coating.

Appearance of the product and pack contents

Bicalutamide Kern Pharma is presented as white, round, and biconvex film-coated tablets. Each pack contains 30 film-coated tablets in PVC/Aluminum blisters.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

TECNIMEDE Sociedade Técnico-Medicinal, S.A.

Quinta da Cerca, Caixaria, Dois Portos, 2565-187, Portugal

Date of the last revision of this package leaflet: December 2014.

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/.

Online doctors for BICALUTAMIDE KERN PHARMA 50 mg FILM-COATED TABLETS

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

5.0 (3)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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5.0 (21)
Doctor

Giorgi Eremeishvili

Urology 22 years exp.

Giorgi Eremeishvili is a top-category urologist, a Candidate of Medical Sciences, and a licensed physician in Spain. He provides expert assistance in the diagnosis and treatment of a wide range of urological conditions in both men and women, employing a comprehensive approach and evidence-based principles.

Key areas of expertise:

  • Erectile dysfunction, decreased libido, premature ejaculation.
  • Male infertility: comprehensive diagnosis and modern treatment methods.
  • Prostate gland diseases: acute and chronic prostatitis, prostatic adenoma (benign prostatic hyperplasia), prostate cancer.
  • Inflammatory diseases of the genitourinary system: acute and chronic cystitis, pyelonephritis, epididymitis, orchitis, urethritis.
  • Sexually transmitted infections (STIs): chlamydia, ureaplasmosis, mycoplasmosis, gardnerellosis, candidiasis, herpetic infections, HPV, CMV, trichomoniasis, and others.
  • Urination disorders: urinary retention, frequent urination, urinary incontinence, overactive bladder, neurogenic bladder.
  • Neoplasms: cysts, tumors of the kidneys, bladder, testicles, prostate gland (including prostate cancer).
  • Surgical interventions: determining indications and selecting optimal minimally invasive methods.

Dr. Eremeishvili applies an integrated approach to each case. This includes thorough preoperative preparation, postoperative observation, and regular dynamic follow-up during the treatment process to achieve the best possible outcomes. All diagnostic and therapeutic recommendations are based on current evidence-based medicine and comply with the recommendations of the European Association of Urology, guaranteeing high-quality and effective care.

If you are seeking qualified assistance in diagnosing or treating urological conditions, book an online consultation with Dr. Giorgi Eremeishvili. Get expert support, accurate diagnosis, and a personalized treatment plan from the comfort of your home.

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€60
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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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€60
5.0 (29)
Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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€60

Frequently Asked Questions

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