Atectura Breezhaler

Atectura Breezhaler Dosage/Direction for Use

Manufacturer:

Novartis

Distributor:

Zuellig Pharma

Marketer:

A. Menarini
Full Prescribing Info
Dosage/Direction for Use
Posology: Adults and adolescents aged 12 years and over: The recommended dose is one capsule to be inhaled once daily.
Patients should be given the strength containing the appropriate mometasone furoate dosage for the severity of their disease and should be regularly reassessed by a healthcare professional.
The maximum recommended dose is 125 mcg/260 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 renal impairment (see 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 posology in patients 12 years of age and older is the same posology as in adults. The safety and efficacy in paediatric patients below 12 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 Special precautions for disposal and other handling 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 Special precautions for disposal and other handling under Cautions for Usage).
For instructions on use of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.
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