Adverse events are listed by System Organ Class:
Frequencies are defined using the following convention:
Very common (>1/10), Common (>1/100, <1/10), Uncommon (>1/1000, <1/100), Rare (>1/10000, <1/1000), Very rare (<1/10000), Not known (cannot be estimated from available data).
The most common side effects are numbness and a stinging feeling in the mouth.
System organ class | Frequency | Undesirable effects |
Immune system disorders | Not known | Anaphylactic reaction which can be potentially life-threatening and hypersensitivity reactionsi |
Respiratory, thoracic and mediastinal disorders | Very rare | Laryngospasm or bronchospasm |
Gastrointestinal disorders | Uncommon | Oral numbness (hypothesia) and a stinging feeling in the mouth (oral pain) |
Skin and subcutaneous tissue disorders | Very rare | Hypersensitivity reactions which may be associated with pruritus, urticaria, photosensitivity reaction and rash |
Not known | Angiodema |
i) Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisations 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 Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.