ENERZAIR BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /50 MCG /160 MCG

3 Indications

Enerzair Breezhaler is indicated as a once-daily maintenance treatment of asthma, and to reduce asthma exacerbations, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid.

5 Contraindications

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

4 Dosage regimen and administration

Dosage regimen

General target population

Inhalation of the content of one capsule of Enerzair Breezhaler 150/50/160 micrograms once-daily is recommended in patients not adequately controlled with a combination of a long-acting beta2-agonist and an inhaled corticosteroid.

Patients usually experience an improvement in lung function within 5 minutes of inhaling Enerzair 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 Enerzair Breezhaler 150/50/160 micrograms once daily.

Special populations

Renal impairment

No dose adjustment is required in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis, Enerzair Breezhaler should be used only if the expected benefit outweighs the potential risk (see sections 6 Warnings and precautions and 11 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available for Enerzair Breezhaler in subjects with severe hepatic impairment, therefore Enerzair Breezhaler should be used in these patients only if the expected benefit outweighs the potential risk (see section 11 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 18 years)

The safety and efficacy of Enerzair Breezhaler in pediatric patients below 18 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 11 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. Enerzair 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 Enerzair Breezhaler inhaler. The inhaler provided with each new prescription should be used.

Enerzair 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 14 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.