SPIOLTO® RESPIMAT® was generally well-tolerated with an adverse event profile similar to the profiles of the monotherapies.^1-3

Most adverse events were mild or moderate with no new safety risks seen beyond the known effects of the ingredients.^1-3

The proportion of patients who discontinued SPIOLTO® RESPIMAT® due to an adverse event was comparable to SPIRIVA® RESPIMAT® or STRIVERDI® RESPIMAT® (olodaterol).⁴

In the long term 52-weeks clinical trials with SPIOLTO® RESPIMAT®, the most frequently observed undesirable anticholinergic effect was dry mouth which occurred in approximately 1.3% of patients treated with SPIOLTO® RESPIMAT® and in 1.7% and 1% in the tiotropium 5 microgram and olodaterol 5 microgram arms, respectively. Dry mouth led to The proportion of patients who discontinued SPIOLTO® RESPIMAT®

Serious undesirable effects include anaphylactic reaction and consistent with anticholinergic effects: glaucoma, constipation, intestinal obstruction including ileus paralytic and urinary retention.¹

For full safety information, please refer to the SPIOLTO® RESPIMAT® Summary of Product Characteristics.