Onbrez Breezhaler Dosage/Direction for Use

Posology: The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Onbrez Breezhaler inhaler. The dose should only be increased on medical advice.
The inhalation of the content of one 300 microgram capsule once a day, using the Onbrez Breezhaler inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly for patients with severe COPD. The maximum dose is 300 microgram once daily.
Onbrez Breezhaler should be administered at the same time of the day each day. If a dose is missed the next dose should be taken at the usual time the next day.
Special populations: Elderly population: Maximum plasma concentration and overall systemic exposure increase with age but no dose adjustment is required in elderly patients.
Hepatic impairment: No dose adjustment is required for patients with mild and moderate hepatic impairment. There are no data available for use of Onbrez Breezhaler in patients with severe hepatic impairment.
Renal impairment: No dose adjustment is required for patients with renal impairment.
Paediatric population: There is no relevant use of Onbrez Breezhaler in the paediatric population (under 18 years).
Method of administration: For inhalation use only. Onbrez Breezhaler capsules must not be swallowed.
The capsules must only be removed from the blister immediately before use.
The capsules must be administered only using the Onbrez Breezhaler inhaler (see Special precautions for disposal and other handling under Cautions for Usage). The Onbrez Breezhaler inhaler provided with each new prescription should be used.
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 Special precautions for disposal and other handling under Cautions for Usage.