ANBESOL LIQUID

Route of administration: oromucosal Adults and the elderly:

Apply to the affected area, a small undiluted amount of Anbesol Liquid, by covering the bottle mouth with a clean fingertip, inverting once and returning the bottle to the upright position. Two applications immediately will normally be sufficient to obtain pain relief.

The application may be repeated if necessary after 3 hours. 25 ml of undiluted Anbesol Liquid, by covering the bottle mouth with a clean fingertip, inverting once and returning the bottle to the upright position. The application may be repeated if necessary after 3 hours, up to a maximum of 6 applications in 24 hours.

Treatment should be stopped once symptoms have resolved. Not to be used for more than 7 days. Parents or carers should seek medical attention if the child’s condition deteriorates during treatment. In case of vomiting, spitting or accidental ingestion, the dose should not be repeated immediately.

One application may be repeated if necessary after 3 hours.

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

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: cannot be estimated from the available data System Organ Class Undesirable Effect Frequency Immune system disorders Allergic reactions Not known Gastrointestinal disorders Non-specific ulceration Not known Skin and subcutaneous tissue disorders 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 search for MHRA Yellow Card in the Google Play or Apple App Store.

Do not use more than one product containing lidocaine at the same time. 9). Anbesol should be used with caution in patients with wounds or traumatised mucosa in the region of the proposed application. A damaged mucosa will permit increased systemic absorption resulting in systemic effects, such as convulsions, particularly if excessive quantities are used.

This medicinal product contains chlorocresol which may cause allergic reactions. 2 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 5 mg/100ml. For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml.

g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.

1. Lidocaine is considered to be unsafe in patients with porphyria because it has been shown to be porphyrinogenic in animals.