Active Ingredient and Strength	INDACATEROL ACETATE EQUIVALENT TO INDACATEROL - 150 MCG MOMETASONE FUROATE - 80 MCG
Dosage Form	POWDER, METERED
Manufacturer and Country	NOVARTIS PHARMA STEIN AG - SWITZERLAND SIEGFRIED BARBERA S.L. (PRIMARY AND SECONDARY PACKAGER) - SPAIN
Registration Number	SIN16149P
Licence Holder	NOVARTIS (SINGAPORE) PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	R03AK14

2 Indications

Atectura Breezhaler is indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older where use of a combination of long-acting beta₂-agonist and inhaled corticosteroid is appropriate.

3 Dosage regimen and administration

Dosage regimen

General target population

Inhalation of the content of one capsule of Atectura Breezhaler 150/80 micrograms once daily is recommended in patients who require a combination of a long-acting beta₂-agonist and a low dose of inhaled corticosteroid.

Inhalation of the content of one capsule of Atectura Breezhaler 150/160 micrograms or 150/320 micrograms once daily is recommended in patients who require a combination of a long-acting beta₂-agonist and a medium or high dose of inhaled corticosteroid.

Patients usually experience an improvement in lung function within 5 minutes of inhaling Atectura Breezhaler. However, the patient should be informed that regular daily use is necessary to maintain control of asthma symptoms and that use should be continued even when asymptomatic.

The maximum recommended dose is Atectura Breezhaler 150/320 micrograms once daily.

Special populations

Renal impairment

No dose adjustment is required in patients with renal impairment.

Hepatic impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available for Atectura Breezhaler in subjects with severe hepatic impairment, therefore Atectura Breezhaler should be used in these patients only if the expected benefit outweighs the potential risk (see section 10 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 12 years)

Atectura Breezhaler may be used in pediatric patients (12 years of age and older) at the same posology as in adults. The safety and efficacy of Atectura Breezhaler in pediatric patients below 12 years of age have not been established.

Geriatric patients (65 years or above)

No dose adjustment is required in elderly patients 65 years of age or older (see section 10 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

For inhalation use only. Atectura Breezhaler capsules must not be swallowed.

Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the capsule rather than inhaling it.

The capsules must be administered only using the Atectura Breezhaler inhaler. The inhaler provided with each new prescription should be used.

Atectura Breezhaler should be administered at the same time of the day each day. It can be administered irrespective of the time of the day.

The capsules must always be stored in the blister to protect from moisture and light, and only removed immediately before use (see section 13 Pharmaceutical information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

After inhalation, patients should rinse their mouth with water without swallowing.

If a dose is missed, it should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day.

4 Contraindications

Atectura Breezhaler is contraindicated in patients with hypersensitivity to any of the active substances or excipients.