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The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler (see Instructions for Use under Patient Counselling Information).
Two puffs from the Respimat inhaler comprise one medicinal dose.
The recommended dose for adults is 5 microgram tiotropium given as two puffs from the Respimat inhaler once daily, at the same time of the day.
The recommended dose should not be exceeded.
In the treatment of asthma, the full benefit will be apparent after several doses of Spiriva Respimat.
Special Populations: Geriatric patients can use tiotropium bromide at the recommended dose.
Renally impaired patients can use tiotropium bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance ≤50 ml/min, see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatically impaired patients can use tiotropium bromide at the recommended dose (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: COPD: Spiriva Respimat is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Asthma: The recommended dosage of tiotropium using the SPIRIVA RESPIMAT in patients 6 to 17 years of age is 5 micrograms. This is administered as two puffs once daily from the RESPIMAT inhaler, at the same time each day (see RESPIMAT inhaler Instructions for Use under Patient Counselling Information). Tiotropium has not been studied in children less than 1 year.
