Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as:: very common (≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥ 1/1,000, <1/100); rare (≥ 1/10,000, <1/1,000); very rare (<1/10,000); or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Immune system disorders
Very rare: Anaphylactic reaction
Very rare: Angioedema, urticaria
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).
Skin and subcutaneous tissue disorders
Very rare: Skin irritation
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters
Paediatric population
No investigations in children have been performed. However, frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
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 Yellow Card Scheme at: www.mhra.gov.uk/yel1owcard.