Leaflet ONBREZ BREEZHALER 300mcg capsules with inhalation powder

Indicated for: chronic obstructive pulmonary disease

Route of administration: inhalation

Substance: indacaterol (beta-2 adrenergic agonist)

ATC: R03AC18 (Respiratory system | Adrenergics, inhalants | Selective beta-2-adrenoreceptor agonists)

Precautions:
Hyperglycemia
Hyperglycemia

This medicine may increase blood sugar.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Indacaterol is a bronchodilator used to treat chronic obstructive pulmonary disease (COPD). It belongs to the class of long-acting beta-2 adrenergic agonists and helps relax the muscles of the airways, making breathing easier.

The medication is administered via inhalation, usually once daily, as directed by a doctor.

Side effects may include cough, headache, dizziness, or throat irritation. In rare cases, severe allergic reactions or palpitations may occur.

Patients should strictly follow the usage instructions and inform their doctor about any other medications they are taking. Pregnant or breastfeeding women should consult a specialist before use.

General data about ONBREZ BREEZHALER 300mcg

  • Substance: indacaterol
  • Date of latest medicines list: 01-06-2026
  • Product code: W64464002
  • Concentration: 300mcg
  • Pharmaceutical form: capsules with inhalation powder
  • Quantity: 30
  • Product type: Original
  • Price: 137.30 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: NOVARTIS PHARMA GMBH - GERMANIA
  • Holder: NOVARTIS EUROPHARM LIMITED - IRLANDA
  • Number: 593/2009/07
  • Shelf life: 30 months

Concentrations available for indacaterol

  • 150mcg
  • 300mcg
PDF icon EMA leaflet
Published: 05/01/2010
Updated: 18/11/2025

Compensation lists for ONBREZ BREEZHALER 300mcg Europharm

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

Price

Copayment

Patient

137.30 RON

68.65 RON

68.65 RON