Leaflet RUNAPLAX 15mg film-coated tablets

Product code:
W70050019
Quantity:
100
Indicated for:
prevention and treatment of thromboembolism
Route of administration:
oral
Substance:
rivaroxaban (anticoagulant)
ATC
B01AF01 — 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.

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 RUNAPLAX 15mg

Substance:
rivaroxaban
Date of latest medicines list:
01-06-2026
Product code:
W70050019
Concentration:
15mg
Pharmaceutical form:
film-coated tablets
Quantity:
100
Product type:
Generic medicine
Price:
250.90 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
SALUTAS PHARMA GMBH - GERMANIA
Holder:
SANDOZ PHARMACEUTICALS S.R.L. - ROMANIA
Number:
14751/2022/19
Shelf life:
3 years

Pharmaceutical forms available for rivaroxaban

Concentrations available for rivaroxaban

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

Combinations with other substances

Compensation lists for RUNAPLAX 15mg Sanpha

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

Price
250.90 RON
Copayment
114.41 RON
Patient
136.49 RON