For the rapid relief of pain caused by minor recurrent aphthous mouth ulcers.

For topical application to the mouth and gums.

Adults and children aged 5 months and over

A small quantity of gel to be applied to the sore area with a clean finger every three hours as necessary.

Babies under 5 months

Not suitable.

Hypersensitivity to the active ingredients or to any of the excipients listed in section 6.1)

Current or past history of methaemoglobinaemia.

Keep all medicines out of the reach of children.

If symptoms persist for more than seven days consult your doctor or dentist.

Not suitable for treatment of teething in children.

This medicine contains 350 mg of alcohol (ethanol) in each 1g of gel. The amount in 0.2g of this medicine is equivalent to less than 1.6 ml beer or 1.1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

No clinically significant drug interactions known.

The safety of this product during pregnancy and lactation has not been established. The product is, therefore, not recommended during pregnancy and lactation except under medical supervision.

No adverse effects known.

Hypersensitivity reactions due to lidocaine have been reported rarely and to cetylpyridinium chloride occasionally.

Methaemoglobinaemia has been reported with some local anaesthetics including lidocaine.

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/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store.

Overdosage with this product is unlikely to constitute a hazard as large amounts of lidocaine or cetylpyridinium chloride are required to produce clinically relevant toxic effects.

Very rarely, methaemoglobinaemia may occur with excessive exposure to some local anaesthetics. This is much more commonly seen with benzocaine and prilocaine than with lidocaine. Risk is increased in patients with hereditary methaemoglobinaemia and when used with other oxidising agents.

Lidocaine is a local anaesthetic of the amide type. Cetylpyridinium chloride is a cationic antiseptic.

Lidocaine is rapidly absorbed from mucous membranes. The plasma elimination half life is about two hours.

Lidocaine undergoes significant first pass metabolism in the liver and is rapidly de-ethylated to the active metabolite monoethylglycinexylidide and then hydrolysed to various metabolites including glycinexylidide. Less than 10% is excreted unchanged by the kidneys. The metabolites are also excreted in the urine.

Not applicable.

Refined sugar

Cetomacrogol 1000

Hypromellose

Alcohol 96%

Eucalyptol

Levomenthol synthetic or natural

Star anise oil

Purified water

None stated.

36 months.

Store below 25° C.

A collapsible aluminium tube, internally lacquered with a polyamide/polyimide lacquer system with a membrane seal fitted with a wadless polythene cap or polypropylene cap.

Pack size: 15 gm.

None stated.