Medicine information ENERZAIR BREEZHALER 114mcg / 46mcg / 136mcg inhalation powder, capsules

Product code:
W66830005
Quantity:
150
Indicated for:
asthma
Route of administration:
inhalation
Substance:
indacaterol + glycopyrronium bromide + mometasone (beta-2 adrenergic agonist+bronchodilator+glucocorticoid)
ATC
R03AL12 — Respiratory system | Adrenergics, inhalants | Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
The combination of indacaterol, glycopyrronium bromide, and mometasone is used for the treatment of chronic obstructive pulmonary disease (COPD) and severe asthma. Indacaterol is a long-acting beta-2 adrenergic agonist, glycopyrronium is an anticholinergic, and mometasone is a corticosteroid that reduces inflammation.

The medication is administered via inhalation, usually once daily, as directed by a doctor. It is important to follow the treatment regimen to achieve the best results.

Side effects may include cough, dry mouth, headache, or throat irritation. In rare cases, severe allergic reactions or paradoxical bronchospasm may occur.

This combination is not recommended for patients with hypersensitivity to any of the components or severe cardiac conditions.

General data about ENERZAIR BREEZHALER 114mcg / 46mcg / 136mcg

Substance:
indacaterol + glycopyrronium bromide + mometasone
Date of latest medicines list:
01-10-2020
Product code:
W66830005
Strength:
114mcg / 46mcg / 136mcg
Pharmaceutical form:
inhalation powder, capsules
Quantity:
150
Product type:
Original
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:
1438/2020/05
Shelf life:
30 months

Strengths available for indacaterol + glycopyrronium bromide + mometasone

  • 114mcg+46mcg+136mcg
  • 114mcg/46mcg/136mcg

Official documents

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Source institution
EMA
Document language
English
Source record: first published
21/07/2020
Source record: last updated
20/11/2025

Warnings:

Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Anticholinergic effects

May cause dry mouth, constipation, urinary retention, or blurred vision.

Hyperglycemia

This medicine may increase blood sugar.

Immunosuppression / infection risk

This medicine may increase the risk of infections.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

Elderly warning

Older people may have an increased risk of side effects.

Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.