SEEBRI BREEZHALER INHALATION POWDER, HARD CAPSULE 50MCG

INDICATIONS

Seebri Breezhaler is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).

CONTRAINDICATIONS

Seebri Breezhaler is contraindicated in patients with hypersensitivity to glycopyrronium or to any of the excipients of the preparations (see sections DESCRIPTION AND COMPOSITION and WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

DOSAGE REGIMEN AND ADMINISTRATION

Dosage regimen

General target population

The recommended dosage of Seebri Breezhaler is the once-daily inhalation of the content of one 50 microgram capsule using the Seebri Breezhaler inhaler.

Special Population

Renal impairment

Seebri 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, Seebri Breezhaler should be used only if the expected benefit outweighs the potential risk. See sections WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Hepatic impairment

No specific studies have been conducted in patients with hepatic impairment. Seebri Breezhaler is predominantly cleared by renal excretion and therefore no major increase in exposure is expected in patients with hepatic impairment. No dose adjustment is required in patients with hepatic impairment.

Pediatric patients (below 18 years)

Seebri Breezhaler should not be used in patients under 18 years of age.

Geriatric patients (75 years of age or above)

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

Method of administration

Seebri Breezhaler capsules must be administered only by the oral inhalation route and only using the Seebri Breezhaler inhaler. Seebri Breezhaler capsules must not be swallowed (see section OVERDOSAGE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

Seebri Breezhaler capsules must always be stored in the blister to protect from moisture, and only removed IMMEDIATELY BEFORE USE.

When prescribing Seebri Breezhaler patients should be instructed on correct use of the inhaler. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.