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).
A superficial discolouration of the dorsum of the tongue may occur which disappears after discontinuation of treatment. Discolouration of the teeth and silicate or composite restorations may also occur. The discolouration is not permanent and may be prevented by brushing daily with conventional toothpaste prior to using the mouthwash and avoiding tannin-containing food and drinks. In some cases a professional prophylaxis (scaling and polishing) may be necessary to completely remove the stain.
Transient disturbances of taste and a burning sensation of the tongue may occur on initial use of the mouthwash but usually diminishes with continued use.
In cases where oral desquamation occurs it may be necessary to discontinue treatment.
Very occasionally, swelling of the parotid glands during use has been reported. If this happens stop using the product and the effect should go away.
In all cases spontaneous resolution has occurred on discontinuation of treatment.
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 Care Scheme at: www.mhra.gov.uk/yellowcard.