Summary of the safety profile: Many of the listed undesirable effects can be assigned to the anticholinergic properties of tiotropium bromide.
Tabulated summary of adverse reactions: The frequencies assigned to the undesirable effects listed as follows are based on crude incidence rates of adverse drug reactions (i.e. events attributed to tiotropium) observed in the tiotropium group pooled from 7 placebo-controlled clinical trials in COPD (3,282 patients) and 12 placebo-controlled clinical trials in asthma (1,930 patients) with treatment periods ranging from four weeks to one year.
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: In controlled clinical studies in COPD, the commonly observed undesirable effects were anticholinergic undesirable effects such as dry mouth which occurred in approximately 2.9% of patients. In asthma the incidence of dry mouth was 1.2%.
In 7 clinical trials in COPD, dry mouth led to discontinuation in 3 of 3,282 tiotropium treated patients (0.1%). No discontinuations due to dry mouth were reported in 6 clinical trials in asthma (1,256 patients).
Serious undesirable effects consistent with anticholinergic effects include glaucoma, constipation, intestinal obstruction including ileus paralytic and urinary retention.
Paedriatic population: The frequency, type and severity of adverse reactions in the paediatric population are similar as in adults.
Other special population: An increase in anticholinergic effects may occur with increasing age.