Ultibro Breezhaler Dosage/Direction for Use

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: Elderly population: 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 Precautions and Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
Paediatric population: 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 Special precautions for disposal and other handling under Cautions for Usage). The inhaler provided with each new prescription should be used.
Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it.
For instructions on use of the medicinal product before administration, see Instructions for handling and use under Cautions for Usage.