Spiolto Respimat

Spiolto Respimat Side Effects

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Full Prescribing Info
Side Effects
The clinical development program of SPIOLTO RESPIMAT encompassed more than 19000 patients with COPD, of which more than 5900 COPD patients received a 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 comparing SPIOLTO RESPIMAT with tiotropium and olodaterol. Additionally, a third active-controlled, parallel-group, long-term treatment (52 weeks) clinical trial in COPD patients comparing SPIOLTO RESPIMAT with tiotropium was conducted (Trial 9).
In the two pivotal trials (Trials 1 and 2) the overall incidence of AEs in patients treated with SPIOLTO RESPIMAT was comparable to patients treated with the mono compound olodaterol at a dose of 5 microgram (74% and 76.6%, respectively). In the pooled analysis of all three long-term clinical trials (Trial 1, 2 and Trial 9) 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 (74.1% and 74.3% 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 Trial 9, no new side effects were identified contributing more than 3900 COPD patients treated with SPIOLTO RESPIMAT; furthermore the safety profile was consistent with that documented in the pivotal trials.
In addition undesirable effects reported with SPIOLTO RESPIMAT, but not with the individual components are included.
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 5.)

Click on icon to see table/diagram/image

In addition 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 ischemia, angina pectoris, hypotension, tremor, headache, nervousness, nausea, muscle spasms, fatigue, malaise, hypokalaemia, hyperglycaemia, and metabolic acidosis.
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