Leaflet EDOXABAN TEVA 60mg film-coated tablets

Product code:
W71149001
Quantity:
10
Indicated for:
prevention and treatment of thromboembolism
Route of administration:
oral
Substance:
edoxaban (anticoagulant)
ATC
B01AF03 — Blood and blood forming organs | Antithrombotic agents | Antithrombotic agents | Direct factor xa inhibitors

Precautions:

Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Major drug interactions

This medicine may have important interactions with other medicines.

Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

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 EDOXABAN TEVA 60mg

Substance:
edoxaban
Date of latest medicines list:
01-07-2025
Product code:
W71149001
Concentration:
60mg
Pharmaceutical form:
film-coated tablets
Quantity:
10
Product type:
Generic medicine
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
ACTAVIS LTD. - MALTA
Holder:
TEVA PHARMACEUTICALS S.R.L. - ROMANIA
Number:
16042/2025/01
Shelf life:
2 years

Concentrations available for edoxaban

  • 15mg
  • 30mg
  • 60mg