SORE MOUTH

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 and may be repeated after twenty minutes and then every three hours.

Adverse reactions have been ranked under headings of frequency using the following convention: Very common: ≥ 1/10 Common: ≥ 1/100 to < 1/10 Uncommon: ≥ 1/1,000 to < 1/100 Rare: ≥ 1/10,000 to <1/1,000 Very Rare: < 1/10,000 Not known: Frequency unable to be classified from available data.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Class Preferred Term Frequency Blood and lymphatic system disorders Methaemoglobinaemia Not known Immune System Disorders Hypersensitivity Not known Skin and subcutaneous tissue disorders Contact dermatitis Not known 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. uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store.

To be used with caution in patients with hepatic or cardiac dysfunction. Do not exceed the stated dose. Not recommended for infants under five months. Keep all medicines out of the reach of children. If symptoms persist consult your doctor or dentist.

Not suitable for treatment of teething in children. 9). This medicine contains 350 mg of alcohol (ethanol) in each 1g of gel. 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.

1) Known hypersensitivity to local anaesthetics of the amide type Current or past history of methaemoglobinaemia. Babies under 5 months