Leaflet SETIAPO 30mg film-coated tablets

Indicated for: prevention and treatment of thromboembolism

Route of administration: oral

Substance: edoxaban (anticoagulant)

ATC: B01AF03 (Blood and blood forming organs | Antithrombotic agents | Direct factor xa 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.

Edoxaban is an oral anticoagulant from the class of direct factor Xa inhibitors, used for the prevention and treatment of thrombosis and embolism. It works by inhibiting the activity of factor Xa, an enzyme essential for blood clotting, thereby preventing the formation of blood clots.

It is indicated for:

- Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
- Prevention of recurrence of these conditions.

Edoxaban is taken orally, once daily, with the dose adjusted based on the patient's weight, kidney function, and concomitant medications.

Side effects may include bleeding (nasal, gastrointestinal, or other types), anemia, nausea, skin rashes, or, rarely, severe allergic reactions. Patients should be monitored for signs of excessive bleeding.

Edoxaban is contraindicated in patients with active bleeding, severe liver impairment, severe coagulopathies, or those taking other anticoagulants. It is important to use it as prescribed by a doctor, and discontinuation should be done cautiously to avoid the risk of thrombosis.

General data about SETIAPO 30mg

  • Substance: edoxaban
  • Date of latest medicines list: 01-06-2026
  • Product code: W71052004
  • Concentration: 30mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 30
  • Product type: Generic medicine
  • Price: 164.85 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: ZENTIVA, K.S - REPUBLICA CEHA
  • Holder: ZENTIVA, K.S. - REPUBLICA CEHA
  • Number: 15964/2025/04
  • Shelf life: 2 years

Concentrations available for edoxaban

  • 15mg
  • 30mg
  • 60mg

Compensation lists for SETIAPO 30mg Zentiva

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

Price

Copayment

Patient

164.85 RON

41.21 RON

123.64 RON