spiolto_side_effects_safty_0

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.

References

  1. SPIOLTO® RESPIMAT® Summary of Product Characteristics.

  2. SPIRIVA® Respimat® Summary of Product Characteristics.

  3. STRIVERDI® Respimat® Summary of Product Characteristics.

  4. Buhl R et al. Eur Respir J 2015;45:969–79.

Please be aware that this website contains promotional information about Boehringer Ingelheim medicines and services. Some of this may not be directly relevant to your scope of practice and it is your own decision whether you choose to view this information.