SPIRIVA® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM

SOLUTION

**4.2 Posology and method of administration** Posology The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler (see 4.2). 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 the medicinal product. 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 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Hepatically impaired patients can use tiotropium bromide at the recommended dose (see 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Paediatric population COPD SPIRIVA RESPIMAT re-usable is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy (see 5.1 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Asthma In asthma, the recommended dosage of tiotropium using the SPIRIVA RESPIMAT re-usable 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). SPIRIVA RESPIMAT re-usable has not been studied in children less than 1 year old. Method of administration To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health professionals.