Leaflet DAXANLO 150mg capsules

Product code:
W69917003
Quantity:
60
Indicated for:
prevention and treatment of thromboembolism
Route of administration:
oral
Substance:
dabigatran etexilat (anticoagulant)
ATC
B01AE07 — Blood and blood forming organs | Antithrombotic agents | 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 DAXANLO 150mg

Substance:
dabigatran etexilat
Date of latest medicines list:
01-06-2026
Product code:
W69917003
Concentration:
150mg
Pharmaceutical form:
capsules
Quantity:
60
Product type:
Generic medicine
Price:
150.43 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
KRKA, D.D., NOVO MESTO - SLOVENIA
Holder:
KRKA, D.D., NOVO MESTO - SLOVENIA
Number:
15252/2023/03
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

Compensation lists for DAXANLO 150mg KRKA

B - Sublist B with 50% discount from the reference price

Price
150.43 RON
Copayment
75.21 RON
Patient
75.22 RON