Leaflet XANIRVA DUO 2.5mg / 50mg capsules

Indicated for: cardiovascular prevention

Route of administration: oral

Substance: rivaroxaban + acetylsalicylic acid (anticoagulant + antiplatelet agent)

ATC: B01AF51 (Blood and blood forming organs | Antithrombotic agents | Direct factor xa inhibitors)

Precautions:
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.

Nephrotoxicity
Nephrotoxicity

This medicine may affect the kidneys.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Pediatric warning
Pediatric warning

Use in children only as recommended in the leaflet or by a doctor.

Bleeding risk
Bleeding risk

This medicine may increase the risk of bleeding.

Ulcer / gastrointestinal bleeding
Ulcer / gastrointestinal bleeding

This medicine may increase the risk of ulcer or gastrointestinal bleeding.

Rivaroxaban with acetylsalicylic acid is a combination used in adults to reduce the risk of atherothrombotic events such as heart attack, stroke or complications of peripheral artery disease. Rivaroxaban is an anticoagulant that blocks factor Xa, while acetylsalicylic acid, also known as aspirin, reduces platelet clumping. Together they lower harmful clot formation.

This treatment must be used only when prescribed by a doctor, often as low-dose rivaroxaban twice daily plus acetylsalicylic acid once daily. The exact regimen depends on your diagnosis, bleeding risk, kidney and liver function and other conditions. Take doses at the same times each day and do not stop suddenly without medical advice.

The most important side effect is bleeding. Bruising, nosebleeds, bleeding gums, heavier periods, anaemia, abdominal pain or gastrointestinal bleeding may occur. Seek urgent medical help if you notice black stools, blood in urine, vomiting blood, severe headache, sudden weakness, a fall with head injury, unusual confusion or any bleeding that does not stop.

Tell your doctor if you have kidney or liver disease, stomach ulcer, recent bleeding, planned surgery or dental work. Mention all medicines, especially anti-inflammatory painkillers, other anticoagulants, antiplatelet drugs, antidepressants and herbal products such as St John’s wort. Careful follow-up balances cardiovascular protection against bleeding risk.

General data about XANIRVA DUO 2.5mg / 50mg

  • Substance: rivaroxaban + acetylsalicylic acid
  • Date of latest medicines list: 01-05-2026
  • Product code: W71839001
  • Concentration: 2.5mg / 50mg
  • Pharmaceutical form: capsules
  • Quantity: 56
  • 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: PHAROS MT LIMITED - MALTA
  • Holder: ZENIVA, K.S. - REPUBLICA CEHA
  • Number: 16552/2026/01
  • Shelf life: 18 months