Leaflet XILTESS 10mg film-coated tablets

Indicated for: prevention and treatment of thromboembolism

Route of administration: oral

Substance: rivaroxaban (anticoagulant)

ATC: B01AF01 (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.

Rivaroxaban is a direct oral anticoagulant that inhibits factor Xa, an essential enzyme in the coagulation cascade. It is used for the prevention and treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and to reduce the risk of stroke in patients with non-valvular atrial fibrillation.

Rivaroxaban is administered orally, usually once daily, and has the advantage of not requiring regular INR (international normalized ratio) monitoring, unlike traditional anticoagulants such as warfarin. It is also indicated for the prevention of thromboembolic events following major orthopedic surgeries, such as hip or knee replacement.

Common side effects include bleeding, anemia, nausea, and dizziness. In rare cases, severe bleeding or allergic reactions may occur. It is important for patients to inform their healthcare provider about any other medications or supplements they are taking, as interactions may increase the risk of bleeding.

Rivaroxaban is a modern and effective option for the prevention and treatment of thromboembolic events, offering improved safety and convenience for patients.

General data about XILTESS 10mg

  • Substance: rivaroxaban
  • Date of latest medicines list: 01-06-2026
  • Product code: W69431002
  • Concentration: 10mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 28
  • Product type: Generic medicine
  • Price: 40.54 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: EGIS PHARMACEUTICALS PLC. - UNGARIA
  • Holder: EGIS PHARMACEUTICALS PLC - UNGARIA
  • Number: 14881/2023/02
  • Shelf life: 30 months

Pharmaceutical forms available for rivaroxaban

Concentrations available for rivaroxaban

  • 10mg
  • 15mg
  • 15mg+20mg
  • 2.5mg
  • 20mg

Combinations with other substances

Compensation lists for XILTESS 10mg Egis

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

Price

Copayment

Patient

40.54 RON

20.27 RON

20.27 RON