The safety of SPIOLTO RESPIMAT has been evaluated in active-controlled, parallel-group and cross-over clinical trials in overall 7151 patients with COPD. A total of 1988 patients with COPD received the target dose of 5 microgram tiotropium and 5 microgram olodaterol.
Side effects of SPIOLTO RESPIMAT were primarily identified from data obtained in 2 active-controlled, parallel-group, long-term treatment (52 weeks) clinical trials in COPD patients.
In the pooled analysis of these long-term clinical trials the overall incidence of AEs in patients treated with SPIOLTO RESPIMAT was comparable to patients treated with the mono components tiotropium at a dose of 5 microgram or olodaterol at a dose of 5 microgram (74%, 73,3% and 76,6%, respectively). All undesirable effects previously reported with one of the individual components are considered undesirable effects with SPIOLTO RESPIMAT and are included in the adverse reactions listed as follows.
In addition undesirable effects reported with SPIOLTO RESPIMAT, but not with the individual components are included.
Tabulated list of adverse reactions: The adverse reactions are listed by absolute frequency. Frequencies are defined as 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), or very rare (<1/10,000), and not known (cannot be estimated from the available data). (See Table 10.)
Click on icon to see table/diagram/image
Many of the listed undesirable effects can be assigned to either the anticholinergic properties of tiotropium or to the β-adrenergic properties of olodaterol, the components of SPIOLTO RESPIMAT.
In addition the occurrence of other undesirable effects related to the beta-adrenergic agonist class, which are not previously listed, should be taken into consideration, such as arrhythmia, myocardial ischemia, angina pectoris, hypotension, tremor, headache, nervousness, nausea, muscle spasms, fatigue, malaise, hypokalemia, hyperglycemia, and metabolic acidosis.
Inform the doctor or pharmacist immediately about side effects that occur while taking the drug.