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SPIOLTO® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM / 2.5 MICROGRAM [SIN15890P]
Active ingredients: SPIOLTO® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM / 2.5 MICROGRAM
Last updated 26 October 2025
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Product Info
SPIOLTO® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM / 2.5 MICROGRAM
[SIN15890P]
Product information
Active Ingredient and Strength | OLODATEROL HYDROCHLORIDE EQV OLODATEROL - 0.0025 MG/ACTUATION |
Dosage Form | SOLUTION |
Manufacturer and Country | BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG - GERMANY |
Registration Number | SIN15890P |
Licence Holder | BOEHRINGER INGELHEIM SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | R03AL06 |
4.1 Therapeutic indications
SPIOLTO RESPIMAT re-usable is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
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 Handling Instructions – 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.
4.3 Contraindications
SPIOLTO RESPIMAT re-usable is contraindicated in patients with hypersensitivity to tiotropium or olodaterol or to any of the excipients.
SPIOLTO RESPIMAT re-usable is also contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium.