Leaflet MACITENTAN STADA 10mg film-coated tablets

Product code:
W71376001
Quantity:
15
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 STADA 10mg

Substance:
macitentan
Date of latest medicines list:
01-11-2025
Product code:
W71376001
Concentration:
10mg
Pharmaceutical form:
film-coated tablets
Quantity:
15
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:
STADA ARZNEIMIITEL AG - GERMANIA
Holder:
STADA ARZNEIMITTEL AG - GERMANIA
Number:
16228/2025/01
Shelf life:
4 years

Pharmaceutical forms available for macitentan

Concentrations available for macitentan

  • 10mg
  • 2.5mg