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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.
Two puffs from the Respimat inhaler comprise one medicinal dose.
Adults: The recommended dose is 5 microgram tiotropium and 5 microgram olodaterol given as two puffs from the Respimat inhaler once daily, at the same time of the day (see Instructions for Use under Cautions for Usage).
The recommended dose should not be exceeded.
Elderly population: Elderly patients can use SPIOLTO RESPIMAT at the recommended dose.
Hepatic impairment and renal impairment: SPIOLTO RESPIMAT contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver.
Hepatic impairment: Patients with mild and moderate hepatic impairment can use SPIOLTO RESPIMAT at the recommended dose.
There are no data available for use of olodaterol in patients with severe hepatic impairment.
Renal impairment: Renally impaired patients can use SPIOLTO RESPIMAT at the recommended dose.
SPIOLTO RESPIMAT contains tiotropium, which is a predominantly renally excreted drug. Therefore, SPIOLTO RESPIMAT use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance ≤50 ml/min).
SPIOLTO RESPIMAT contains olodaterol. There is limited experience with the use of olodaterol in patients with severe renal impairment.
Paediatric population: There is no relevant use of SPIOLTO RESPIMAT in the paediatric population (under 18 years) in COPD. The safety and effectiveness of SPIOLTO RESPIMAT in the paediatric population have not been established.
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 care professionals.
