ULTIBRO BREEZHALER INHALATION POWDER HARD CAPSULE 110/50 MCG

4.1 Therapeutic indications

Ultibro Breezhaler is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD) and for the reduction of exacerbations of COPD in patients with a history of exacerbations.

4.3 Contraindications

Hypersensitivity to indacaterol or glycopyrronium, which are components of Ultibro Breezhaler, or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2 Posology and method of administration

Posology

The recommended dose is the inhalation of the content of one capsule once daily using the Ultibro Breezhaler inhaler.

Ultibro Breezhaler is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day. Patients should be instructed not to take more than one dose in a day.

Special populations

Geriatric patients (75 years or above)

Ultibro Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older).

Renal impairment

Ultibro Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

Ultibro Breezhaler can be used at the recommended dose in patients with mild and moderate hepatic impairment. There are no data available for the use of Ultibro Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 18 years)

There is no relevant use of Ultibro Breezhaler in the paediatric population (under 18 years) in the indication COPD. The safety and efficacy of Ultibro Breezhaler in children have not been established. No data are available.

Method of administration

For inhalation use only. The capsules must not be swallowed.

The capsules must be administered only using the Ultibro Breezhaler inhaler (see section 6.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

For instructions on use of the medicinal product before administration, see section 6.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.