Immune system disorders (frequency not known):
Hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions (see sections 4.3 and 4.4) manifested by cardiac arrest, circulatory collapse, hypotension, bronchospasm, tachycardia, rash, erythema and urticaria
Skin and subcutaneous tissue disorders (frequency not known):
Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.
Other Adverse Reactions:
The adverse events reported and/or observed with other chlorhexidine products include:
Fatal anaphylactic reactions
Chemical burns in neonates (See Section 4.4 Special Warnings and Precautions for Use).
Very occasionally the following reactions have been noted when chlorhexidine-containing irrigating solutions have been used intravesically, intravaginally or topically on traumatised skin: Hypotension, paraesthesia, dyspnoea, tachycardia, cold sweat, generalised erythema, urticaria and loss of consciousness. Other effects that have been noted include pain, haematuria and/or increased urge to urinate.
Idiosyncratic reactions to chlorhexidine acetate have been reported and are well documented.
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.
Website:
www.mhra.gov.uk/yellowcard