Enerzair Breezhaler Dosage/Direction for Use

Posology: The recommended dose is one capsule to be inhaled once daily.
The maximum recommended dose is 114 mcg/46 mcg/136 mcg once daily.
Treatment should be administered at the same time of the day each day. It can be administered irrespective of the time of the 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.
Special populations: Elderly population: No dose adjustment is required in elderly patients (65 years of age or older) (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment. Caution should be observed in patients with severe renal impairment or end-stage renal disease requiring dialysis (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available for the use of the medicinal product in patients with severe hepatic impairment, therefore it should be used in these patients only if the expected benefit outweighs the potential risk (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Enerzair Breezhaler in paediatric patients below 18 years of age 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 inhaler provided (see Instructions for handling and use under Cautions for Usage) with each new prescription.
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.
The capsules must only be removed from the blister immediately before use.
After inhalation, patients should rinse their mouth with water without swallowing (see Precautions and Instructions for handling and use under Cautions for Usage).
For instructions on use of the medicinal product before administration, see Instructions for handling and use under Cautions for Usage.