Leaflet MACITENTAN ZENTIVA 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)

Precautions:
Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Hypotension / fall risk
Hypotension / fall risk

May lower blood pressure and increase the risk of falls.

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 ZENTIVA 10mg

  • Substance: macitentan
  • Date of latest medicines list: 01-06-2026
  • Product code: W71847001
  • Concentration: 10mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 30
  • 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: PHARMADOX HEALTHCARE LIMITED - MALTA
  • Holder: ZENTIVA, K.S. - REPUBLICA CEHA
  • Number: 16558/2026/01
  • Shelf life: 3 years

Pharmaceutical forms available for macitentan

Concentrations available for macitentan

  • 10mg
  • 2.5mg