BREZTRI AEROSPHERE PRESSURISED INHALATION SUSPENSION 160 MCG/7.2 MCG/5 MCG per actuation

4.1 Therapeutic indications

Maintenance treatment to relieve symptoms and prevent exacerbations in adult patients with moderate to very severe chronic obstructive pulmonary disease (COPD) (see Section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Hypersensitivity to the active substances or any of the excipients.

4.2 Posology and method of administration

The recommended and maximum dose is two inhalations of BREZTRI AEROSPHERE 160/7.2/5.0 twice daily, in the morning and in the evening, by the orally inhaled route only.

Missed dose

If a dose is missed, it should be taken as soon as possible, and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose.

Children

There is no relevant use of BREZTRI AEROSPHERE in children and adolescents (under 18 years of age) in the indication of COPD.

Dosage in patients with renal impairment:

No dosage adjustment is necessary for patients with renal impairment (see section 4.4 and section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage in patients with hepatic impairment:

No dosage adjustment is necessary for patients with hepatic impairment (see section 4.4 and section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly:

No dosage adjustment is necessary for elderly patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

For oral inhalation use.

For detailed instructions, refer to the patient leaflet – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Patients should be instructed how to administer the product correctly and advised to read the instructions for use carefully.

Patients who find it difficult to co-ordinate actuation with inhalation may use BREZTRI AEROSPHERE with a spacer to ensure proper administration of the product. BREZTRI AEROSPHERE can be used with spacer devices including the Aerochamber Plus® Flow Vu®.