Leaflet DABIGATRAN ETEXILAT VIATRIS 75mg capsules


Indicated for: prevention and treatment of thromboembolism

Route of administration: oral

Substance: dabigatran etexilat (anticoagulant)

ATC: B01AE07 (Blood and blood forming organs | Antithrombotic agents | Direct thrombin inhibitors)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Bleeding risk
Bleeding risk

This medicine may increase the risk of bleeding.

Dabigatran etexilate is an oral anticoagulant used for the prevention and treatment of blood clots. It is indicated for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Dabigatran etexilate works as a direct thrombin inhibitor, preventing the formation of blood clots. It is administered orally in capsule form, with the dosage adjusted based on the patient's condition and bleeding risk.

Side effects may include bleeding (nasal, gastrointestinal, or other types), dyspepsia (heartburn), nausea, or allergic reactions. It is contraindicated in patients with active bleeding, severe renal impairment, or hypersensitivity to the substance. It should also be used cautiously in patients with a high risk of bleeding.

General data about DABIGATRAN ETEXILAT VIATRIS 75mg

  • Substance: dabigatran etexilat
  • Date of last drug list: 01-05-2024
  • Commercial code: W70192001
  • Concentration: 75mg
  • Pharmaceutical form: capsules
  • Quantity: 10
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: MYLAN HUNGARY KFT. - UNGARIA
  • Holder: VIATRIS LIMITED - IRLANDA
  • Number: 15360/2024/01
  • Shelf life: 2 years

Pharmaceutical forms available for dabigatran etexilat

Concentrations available for dabigatran etexilat

  • 110mg
  • 150mg
  • 20mg
  • 30mg
  • 40mg
  • 50mg
  • 6.25mg/ml
  • 75mg