Spiolto Respimat Adverse Reactions

Summary of the safety profile: Many of the listed undesirable effects can be assigned to the anticholinergic properties of tiotropium bromide or to the β₂-adrenergic properties of olodaterol, the components of SPIOLTO RESPIMAT.
Tabulated summary of adverse reactions: The frequencies assigned to the undesirable effects listed as follows are based on the crude incidence rates of adverse drug reactions (i.e. events attributed to SPIOLTO RESPIMAT) observed in the tiotropium 5 microgram / olodaterol 5 microgram dose group (5646 patients), pooled from 8 active or placebo-controlled, parallel group clinical trials in COPD patients with treatment periods ranging between 4 and 52 weeks.
Adverse reactions reported in all clinical trials with SPIOLTO RESPIMAT are shown as follows according to system organ class.
These also include all adverse reactions previously reported with one of the individual components.
Frequency is defined using the following convention: Very common ( ≥ 1/10); common ( ≥ 1/100 to < 1/10); uncommon ( ≥ 1/1,000 to < 1/100); rare ( ≥ 1/10,000 to < 1/1,000); very rare ( < 1/10,000), not known (cannot be estimated from the available data). (See Table 4.)

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Description of selected adverse reactions: SPIOLTO RESPIMAT combines anticholinergic and β₂-adrenergic properties due to its components tiotropium and olodaterol.
Anticholinergic adverse reaction profile: 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 discontinuation in 2 of 4,968 patients (0.04 %) treated with SPIOLTO RESPIMAT.
Serious undesirable effects consistent with anticholinergic effects include glaucoma, constipation, intestinal obstruction including ileus paralytic and urinary retention.
β-adrenergic adverse reaction profile: Olodaterol, one component of SPIOLTO RESPIMAT is a member of the therapeutic class of long-acting beta₂-adrenergic agonists. Therefore the occurrence of other undesirable effects related to the beta-adrenergic agonist class, which are not listed previously, should be taken into consideration, such as, arrhythmia, myocardial ischaemia, angina pectoris, hypotension, tremor, nervousness, muscle spasms, fatigue, malaise, hypokalemia, hyperglycemia, and metabolic acidosis.
Other special populations: An increase in anticholinergic effect may occur with increasing age.