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Dabigatran eteksilan Polpharma

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Doctor

Tomasz Grzelewski

Dermatology20 years of experience

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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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use Dabigatran eteksilan Polpharma

Package Leaflet: Information for the Patient

Dabigatran Etexilate Polpharma, 150 mg, Hard Capsules

Dabigatranum Etexilatum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

  • Keep this leaflet, as you may need to read it again.
  • In case of any doubts, consult a doctor or pharmacist.
  • This medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
  • If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

  • 1. What is Dabigatran Etexilate Polpharma and what is it used for
  • 2. Important information before taking Dabigatran Etexilate Polpharma
  • 3. How to take Dabigatran Etexilate Polpharma
  • 4. Possible side effects
  • 5. How to store Dabigatran Etexilate Polpharma
  • 6. Contents of the pack and other information

1. What is Dabigatran Etexilate Polpharma and what is it used for

Dabigatran Etexilate Polpharma contains dabigatran etexilate as the active substance and belongs to a group of medications called anticoagulants. Its action involves blocking a substance in the body responsible for blood clot formation.

Dabigatran Etexilate Polpharma is used in adults to:

  • prevent blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem and at least one additional risk factor.
  • treat blood clots in the veins of the legs and lungs and prevent the recurrence of blood clots in the veins of the legs and lungs.

Dabigatran Etexilate Polpharma is used in children to:

  • treat blood clots and prevent the recurrence of blood clots.

2. Important information before taking Dabigatran Etexilate Polpharma

When Not to Take Dabigatran Etexilate Polpharma

  • If the patient is allergic to dabigatran etexilate or any of the other ingredients of this medication (listed in section 6).
  • If the patient has severe kidney problems.
  • If the patient is currently bleeding.
  • If the patient has a disease of any internal organ that increases the risk of major bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
  • If the patient has an increased tendency to bleed. This may be inherited, of unknown cause, or caused by the use of other medications.
  • If the patient is taking anticoagulant medications (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment, introducing a venous or arterial catheter when heparin is administered to maintain its patency or when restoring normal heart function using a procedure called catheter ablation in atrial fibrillation.

...

Diagram showing a blister pack with capsules, number 1 in a circle, arrow indicating the removal of a single blister along the perforation

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Sketch of a folded paper with a curved edge and an arrow indicating the direction of folding, number 2 in the lower right corner

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4. Possible Side Effects

Like all medications, Dabigatran Etexilate Polpharma can cause side effects, although not everybody gets them.

...

Reporting Side Effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

5. How to Store Dabigatran Etexilate Polpharma

Keep the medication out of the sight and reach of children.

Do not use this medication after the expiry date stated on the blister and carton after EXP.

The expiry date refers to the last day of the month stated.

Store in the original package to protect from moisture.

Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Dabigatran Etexilate Polpharma Contains

  • The active substance is dabigatran. Each hard capsule contains 172.95 mg of dabigatran etexilate (as mesylate) equivalent to 150 mg of dabigatran etexilate.
  • The other ingredients are: tartaric acid, arabic gum, hypromellose 2910 (15 cps), dimethicone 350, talc, hydroxypropylcellulose (100 cps); The capsule shell contains: carrageenan, potassium chloride, titanium dioxide (E 171), hypromellose 2910 (6 cps), indigo carmine (E 132).

What Dabigatran Etexilate Polpharma Looks Like and Contents of the Pack

Dabigatran Etexilate Polpharma 150 mg is a hard capsule with a blue cap and a white to almost white body, size 0, filled with almost white to light yellow pellets.

This medication is available in packs containing 10 x 1, 30 x 1, or 60 x 1 hard capsules in perforated unit dose blisters of aluminum/OPA/aluminum/PVC.

A collective pack containing 3 packs of 60 x 1 hard capsules (180 hard capsules) or a collective pack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) in perforated unit dose blisters of aluminum/OPA/aluminum/PVC.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Galenicum Health, S.L.U.

Sant Gabriel 50

08950 Esplugues de Llobregat, Barcelona

Spain

SAG Manufacturing S.L.U.

Carretera Nacional 1, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

France: Dabigatran etexilate Galenicum Axium 150 mg, gélule

Spain: Dabigatrán etexilato Normon 150 mg cápsulas duras EFG

Malta: Dabigatran etexilate Galenicum Axium 150 mg hard capsule

Germany: Dabigatranetexilat Galenicum Axium 150 mg Hartkapseln

Date of Last Revision of the Leaflet:

  • Country of registration
  • Active substance
  • Prescription required
    Yes
  • Importer
    Galenicum Health S.L.U. SAG Manufacturing S.L.U.
  • Alternatives to Dabigatran eteksilan Polpharma
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Alternative to Dabigatran eteksilan Polpharma in Spain

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Dosage form: capsules, 75 mg capsules in blister
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Prescription required

Online doctors for Dabigatran eteksilan Polpharma

Discuss dosage, side effects, interactions, contraindications, and prescription renewal for Dabigatran eteksilan Polpharma – subject to medical assessment and local rules.

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Doctor

Tomasz Grzelewski

Dermatology20 years of experience

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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Dr Cayatte earned his degree from the University of Lisbon and taught internal medicine at Boston University School of Medicine. He holds active medical registrations in both Portugal and the UK and is a Fellow of the American Heart Association.

Consultations are available in English and Portuguese. Patients value his clarity, professionalism, and balanced approach to evidence-based care.

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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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