SPIOLTO® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM / 2.5 MICROGRAM

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

SOLUTION

**4.2 Posology and method of administration** The recommended dose for adults 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Elderly Elderly patients can use SPIOLTO RESPIMAT re-usable at the recommended dose. Hepatic impairment and renal impairment SPIOLTO RESPIMAT re-usable 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 re-usable 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 re-usable at the recommended dose. SPIOLTO RESPIMAT re-usable contains tiotropium, which is a predominantly renally excreted drug. For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min, see Special warnings and precautions for use and Pharmacokinetic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Paediatric population There is no relevant use of SPIOLTO RESPIMAT re-usable in the paediatric population in COPD. The safety and effectiveness of SPIOLTO RESPIMAT re-usable in the paediatric population have not been established.