Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Thornton & Ross Limited, Linthwaite, Huddersfield, West Yorkshire, HD7 5QH, United Kingdom
Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).
Acriflex contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Acriflex should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8).
Keep away from the eyes.
Avoid contact with the brain, meninges and middle ear. Not for use in body cavities.
None known.
No harmful effects in human pregnancy have been reported. Nevertheless, like all medicines, care should be exercised during pregnancy and lactation.
None known.
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).
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 Care Scheme at: www.mhra.gov.uk/yellowcard.
None known.
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