Summary of the safety profile: The most frequently reported adverse reaction with umeclidinium/vilanterol was nasopharyngitis (9%).
Tabulated summary of adverse reactions: The safety profile of ANORO is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting. The clinical development programme included 2,354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1,296 patients received the recommended dose of 62.5/25 micrograms in 24-week studies, 832 patients received a higher dose of 125/25 micrograms in 24-week studies and 226 patients received 125/25 micrograms in a 12-month study.
The frequencies assigned to the adverse reactions identified in the table as follows include crude incidence rates observed in the integration of five 24-week studies and in the 12-month safety study.
The frequency of adverse reactions 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) and not known (cannot be estimated from available data). (See Table 2.)
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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.