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NUBEQA 300 mg FILM-COATED TABLETS

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About the medicine

How to use NUBEQA 300 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

Patient Information: Summary of Product Characteristics

NUBEQA 300mg film-coated tablets

darolutamida

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

1. What is NUBEQA and what is it used for

NUBEQA contains the active substance darolutamida.

It is used to treat adult men with prostate cancerthat:

  • has not spread to other parts of the body and no longer responds to any medical or surgical treatment that lowers testosterone (also called non-metastatic castration-resistant prostate cancer)

or

  • has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone (also called metastatic hormone-sensitive prostate cancer).

Your doctor may also give you docetaxel.

How NUBEQA works

NUBEQA blocks the activity of male sex hormones called androgens, such as testosterone. Androgens can cause prostate cancer to grow. By blocking these hormones, darolutamida prevents prostate cancer cells from growing and dividing.

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 NUBEQA

Do not take NUBEQA if

  • you are allergic to darolutamida or any of the other ingredients of this medicine (listed in section 6);
  • you are a woman and are or may become pregnant.

Warnings and precautions

Tell your doctor or pharmacist before you start taking NUBEQA if

  • you have kidney problems;
  • you have liver problems;
  • you have heart problems, including heart rhythm problems, or if you are taking medicines for these conditions;
  • you have had surgery to treat blood vessel problems.

Taking this medicine may affect your liver function. If your blood tests show abnormal liver function results, your doctor may decide to stop your treatment with NUBEQA permanently.

Children and adolescents

This medicine is not for use in children and adolescents under 18 years. Prostate cancer does not occur in this age group.

Other medicines and NUBEQA

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

The following medicines may affect the effect of NUBEQA, or NUBEQA may affect the effect of these medicines. These medicines are commonly used to treat:

  • bacterial infections, such as rifampicin
  • epilepsy, such as carbamazepine, phenobarbital, phenytoin
  • mildly depressed mood and mild anxiety: St. John's Wort(a herbal medicine)
  • high cholesterol, such as rosuvastatin, fluvastatin, atorvastatin, pitavastatin
  • severe joint inflammation, severe skin disease psoriasis and cancer: methotrexate
  • inflammatory bowel disease: sulfasalazine

Therefore, your doctor may change the dose of the medicines you are taking.

Pregnancy, breast-feeding and fertility

NUBEQA is not for use in women.

This medicine may reduce male fertility.

Follow these tips during and up to one week after finishing treatment:

  • Use a condom or other highly effective contraceptive method to prevent pregnancy if you have sex with a woman of childbearing age. Ask your doctor which contraceptive method is best for you.
  • Use a condom to protect the fetus if you have sex with a pregnant woman.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines.

NUBEQA 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 NUBEQA

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is

2 tablets 2 times a day. Do not take more than 4 tablets per day.

Your doctor may reduce your dose to 1 tablet 2 times a day if you have liver or kidney problems.

Method of administration

Swallow the tablets whole, do not split or crush them. Take the tablets with food and a glass of water.

Your doctor may also prescribe you other medicines while you are taking NUBEQA.

If you take more NUBEQA than you should

Continue treatment with the next scheduled dose.

If you forget to take NUBEQA

Take the missed dose as soon as you remember before the next scheduled dose. Do not take a double dose to make up for 1 or more missed doses.

If you stop taking NUBEQA

Do not stop taking your medicine unless your doctor tells you to.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects of NUBEQA are as follows:

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

  • fatigue
  • reduction in the number of a type of white blood cell called neutrophils in the blood test
  • increase in liver substances: bilirubin, alanine transaminase and aspartate transaminase in the blood test

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

  • blockage of the heart arteries
  • heart failure
  • skin rash
  • pain in arms and legs
  • bone fractures

The side effects of NUBEQA when used in combination with docetaxelare as follows:

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

  • high blood pressure
  • skin rash
  • reduction in the number of a type of white blood cell called neutrophils in the blood test
  • increase in liver substances: bilirubin, alanine transaminase and aspartate transaminase in the blood test

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

  • bone fractures
  • breast enlargement in men

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 via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of NUBEQA

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 on each blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What NUBEQA contains

The active substance is darolutamida. Each film-coated tablet contains 300 mg of darolutamida.

The other ingredients are:

  • calcium hydrogen phosphate (E 341)
  • croscarmellose sodium
  • hypromellose
  • macrogol (E 1521)
  • magnesium stearate (E 470b)
  • povidone (E 1201)
  • titanium dioxide (E 171)

For more information, see “NUBEQA contains lactose” in section 2.

Appearance and packaging

The film-coated tablets (tablets) are white or almost white, oval, 16 mm long and 8 mm wide. They are engraved with “300” on one side and with “BAYER” on the other.

Each carton contains 112 film-coated tablets, which consist of 7 blisters, each with 16 film-coated tablets.

Marketing authorisation holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

The manufacturer can be identified by the batch number printed on the carton and on each blister:

  • If the characters are only numbers, the manufacturer is

Orion Corporation, Orion Pharma

24100 Salo

Finland

  • If the first and second characters are BX, the manufacturer is

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

You can get more information on this medicine by contacting the local representative of the marketing authorisation holder:

België/Belgique/Belgien

Bayer SA-NV

Tel: +32-(0)2-5356311

Lietuva

UAB Bayer

Tel: +37 05 23 36 868

Text in Bulgarian language including the name of a company Bayer Bulgaria EOOD and a phone number with country code

Luxembourg/Luxemburg

Bayer SA-NV

Tel: +32-(0)2-535 63 11

Ceská republika

Bayer s.r.o.

Tel: +420 266 101 111

Magyarország

Bayer Hungária KFT

Tel: +36 14 87-41 00

Danmark

Bayer A/S

Tlf: +45 45 23 50 00

Malta

Alfred Gera and Sons Ltd.

Tel: +35 621 44 62 05

Deutschland

Bayer Vital GmbH

Tel: +49 (0)214-30 513 48

Nederland

Bayer B.V.

Tel: +31-23-799 1000

Eesti

Bayer OÜ

Tel: +372 655 8565

Norge

Bayer AS

Tlf: +47 24 11 18 00

Ελλáδα

Bayer Ελλáς ΑΒΕΕ

Τηλ: +30 210-618 75 00

Österreich

Bayer Austria Ges.m.b.H.

Tel: +43-(0)1-711 46-0

España

Bayer Hispania S.L.

Tel: +34-93-495 65 00

Polska

Bayer Sp. z.o.o.

Tel: +48 22 572 35 00

France

Bayer HealthCare

Tél (N° vert): +33-(0)800 87 54 54

Portugal

Bayer Portugal, Lda.

Tel: +351 21 416 42 00

Hrvatska

Bayer d.o.o.

Tel: +385-(0)1-6599 900

România

SC Bayer s.r.l.

Tel: +40 21 529 59 00

Ireland

Bayer Limited

Tel: +353 1 216 3300

Slovenija

Bayer d. o. o.

Tel: +386 1 58 14 400

Ísland

Icepharma hf.

Sími: +354 540 8000

Slovenská republika

Bayer spol. s r.o.

Tel. +421 2 59 21 31 11

Italia

Bayer S.p.A.

Tel: +39 02 397 81

Suomi/Finland

Bayer Oy

Puh/Tel: +358 20 785 21

Κúπρος

NOVAGEM Limited

Τηλ: +357 22 48 38 58

Sverige

Bayer AB

Tel: +46 (0) 8 580 223 00

Latvija

SIA Bayer

Tel: +371 67 84 55 63

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.

Online doctors for NUBEQA 300 mg FILM-COATED TABLETS

Discuss questions about NUBEQA 300 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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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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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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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 NUBEQA 300 mg FILM-COATED TABLETS?
NUBEQA 300 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 NUBEQA 300 mg FILM-COATED TABLETS?
The active ingredient in NUBEQA 300 mg FILM-COATED TABLETS is darolutamide. This information helps identify medicines with the same composition but different brand names.
Who manufactures NUBEQA 300 mg FILM-COATED TABLETS?
NUBEQA 300 mg FILM-COATED TABLETS is manufactured by Bayer Ag. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of NUBEQA 300 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 NUBEQA 300 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 NUBEQA 300 mg FILM-COATED TABLETS?
Other medicines with the same active substance (darolutamide) 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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