The presentation of the safety profile is based on the experience with Ultibro Breezhaler and the individual active substances.
Summary of the safety profile: The safety experience with Ultibro Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose.
Ultibro Breezhaler showed similar adverse reactions to the individual components. As it contains indacaterol and glycopyrronium, the type and severity of adverse reactions associated with each of these components may be expected in the combination.
The safety profile is characterised by typical anticholinergic and beta-adrenergic symptoms related to the individual components of the combination. Other most common adverse reactions related to the medicinal product (at least 3% of patients for Ultibro Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Tabulated summary of adverse reactions: Adverse reactions detected during clinical trials and from post-marketing sources are listed by MedDRA system organ class (Table 2). Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). (See Table 2.)
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Description of selected adverse reactions: Cough was common, but usually of mild intensity.