Leaflet LEFLUNOMIDE ARENA 20mg film-coated tablets

Indicated for: rheumatoid arthritis

Route of administration: oral

Substance: leflunomide (immunomodulator)

ATC: L04AA13 (Antineoplastic and immunomodulating agents | Immunosuppressants | Selective immunosuppressants)

Precautions:
Avoid live vaccines
Avoid live vaccines

Avoid live vaccines during treatment if contraindicated.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Immunosuppression / infection risk
Immunosuppression / infection risk

This medicine may increase the risk of infections.

Leflunomide is a medication used for the treatment of rheumatoid arthritis and psoriatic arthritis. It works by inhibiting pyrimidine synthesis, thereby reducing inflammation and autoimmune responses.

The medication is taken orally, usually once daily, and the dose is adjusted based on the patient's response. Monitoring of liver and hematologic function is important during treatment.

Side effects may include nausea, diarrhea, hair loss, or elevated liver enzymes. In rare cases, severe reactions such as hepatotoxicity or pancytopenia may occur.

Leflunomide is not recommended for pregnant women or those planning to become pregnant, as well as patients with severe liver impairment or hypersensitivity to this medication.

General data about LEFLUNOMIDE ARENA 20mg

  • Substance: leflunomide
  • Date of latest medicines list: 01-06-2026
  • Product code: W62664004
  • Concentration: 20mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 100
  • Product type: Generic medicine
  • Price: 389.00 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: ARENA GROUP S.A. - ROMANIA
  • Holder: ARENA GROUP S.A. - ROMANIA
  • Number: 14061/2021/01
  • Shelf life: 3 years

Concentrations available for leflunomide

  • 100mg
  • 10mg
  • 20mg

Compensation lists for LEFLUNOMIDE ARENA 20mg Arena

G18 (C1) - Rheumatoid arthritis, psoriatic arthropathy, severe chronic psoriasis and juvenile arthritis

Price

Copayment

Patient

389.00 RON

348.32 RON

40.68 RON

GX (C1) - GENERIC (used in compensation list, C1, for another diagnosis)

Price

Copayment

Patient

389.00 RON

348.32 RON

40.68 RON