Leaflet RIVAROXABAN GEMAX PHARMA 15mg 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 RIVAROXABAN GEMAX PHARMA 15mg

  • Substance: rivaroxaban
  • Date of last drug list: 01-04-2024
  • Commercial code: W70126001
  • Concentration: 15mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 10
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: DELORBIS PHARMACEUTICALS LTD. - CIPRU
  • Holder: GEMAX PHARMA S.R.O. - REPUBLICA CEHA
  • Number: 15059/2023/01
  • Shelf life: 3 years

Pharmaceutical forms available for rivaroxaban

Concentrations available for rivaroxaban

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

Combinations with other substances