Dosage: The recommended dosage of Ultibro Breezhaler is the once-daily inhalation of the content of one 110/50 microgram capsule using the BREEZHALER inhaler.
Patients with 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 Ultibro Breezhaler should be used only if the expected benefit outweighs the potential risk (see Precautions).
Patients with Hepatic Impairment: Ultibro Breezhaler can be used at the recommended dose in patients with mild and moderate hepatic impairment. No data are available for subjects with severe hepatic impairment.
Paediatric population: Ultibro Breezhaler should not be used in patients under 18 years of age.
Elderly population: Ultibro Breezhaler can be used at the recommended dose in elderly patients 75 years of age and older.
Method of administration: Ultibro Breezhaler capsules must be administered only by the oral inhalation route and only using the Ultibro Breezhaler inhaler. Ultibro Breezhaler capsules must not be swallowed (see Overdosage).
Ultibro Breezhaler should be administered at the same time of the day each day. 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.
Ultibro Breezhaler capsules must always be stored in the blister to protect from moisture, and only removed IMMEDIATELY BEFORE USE.
When prescribing Ultibro 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.