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Safety profile long term use  
Safety profile short term use

Dymista® (n=404); FP: fluticasone propionate (n=207)

Safety profile 52 weeks: Similar safety profile as standard therapy following 1 year of continuous use in patients with chronic rhinitis (i.e. perennial allergic rhinitis or non-allergic rhinitis). The most common treatment related adverse events were dysgeusia (2.5%) in the Dymista® group and headache (4.3%) in the fluticasone propionate group. None of these events were considered severe.

832 ≥ 12 years old, randomised into 4, 14 days placebo controlled SAR trials. Adapted from Price at al.

Safety profile 14 days: The proportion of seasonal allergic rhinitis patients treated with Dymista® who experienced a treatment related adverse event was very low, similar to standard therapies and placebo. The vast majority of these events were mild in nature.

UK/DYM/14/0070(1) Date of Prep: February 2017

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