Leaflet MACITENTAN TEVA 10mg film-coated tablets


Indicated for: pulmonary arterial hypertension

Route of administration: oral

Substance: macitentan (vasodilator)

ATC: C02KX04 (Cardiovascular system | Other antihypertensives | Antihypertensives for pulmonary arterial hypertension)

Macitentan is a medication used for the treatment of pulmonary arterial hypertension (PAH). It acts as an endothelin receptor antagonist, reducing pressure in the pulmonary blood vessels and improving exercise capacity.

The medication is taken orally, usually once daily, and is intended for long-term use under the supervision of a specialist. It is important to follow the treatment regimen to achieve the best results.

Side effects may include headaches, fluid retention, or anemia. In rare cases, elevated liver enzymes or allergic reactions may occur.

Macitentan is not recommended for pregnant women or patients with severe liver impairment. Regular monitoring of liver function is required during treatment.

General data about MACITENTAN TEVA 10mg

  • Substance: macitentan
  • Date of last drug list: 01-05-2026
  • Commercial code: W71352001
  • Concentration: 10mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 30
  • Product type: generic
  • Price: 5741.84 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: BALKANPHARMA DUPNITSA AD - BULGARIA
  • Holder: TEVA PHARMACEUTICALS S.R.L. - ROMANIA
  • Number: 16212/2025/01
  • Shelf life: 3 years

Pharmaceutical forms available for macitentan

Concentrations available for macitentan

  • 10mg
  • 2.5mg

Compensation lists for MACITENTAN TEVA 10mg Teva

NHP 6.3 (C2) - Pulmonary hypertension

Price

Copayment

Patient

5741.84 RON

5741.84 RON

0.00 RON