XYLONOR

For professional use by dentists and stomatologists only. Posology For all populations, the lowest dose leading to effective anaesthesia should be used. The necessary dosage must be determined on an individual basis. Adults The recommended dose is one actuation which delivers approximately 10 mg of lidocaine and covers an area of about 1 cm2.

The maximum daily administration should not exceed 20 actuations, equivalent to 200 mg of lidocaine. Paediatric population (from 6 years of age) The recommended dose is one actuation which delivers approximately 10 mg of lidocaine and covers an area of about 1 cm².

The maximum daily administration in the paediatric population should not exceed 4 mg/kg of lidocaine. Elderly patients or patients with hepatic function disorders When liver activity is reduced, the minimum effective anaesthetic dose should be used when applied before anaesthetic injection.

Method of administration The medicinal product is for oromucosal use (local use). Prior to use, the area of administration should be thoroughly dried. The tip of the nozzle should be placed at 2 to 4 cm from the area to be anaesthetised.

This operation can be repeated in three different locations in the mouth during the same session.

Summary of the safety profile The adverse reactions following the administration of lidocaine/cetrimide are similar to those observed with other amide local anaesthetics. These adverse reactions are mainly local application site reactions and hypersensitivity reactions.

Systemic adverse reactions are extremely rare with topical lidocaine. 9) particularly when associated with injectable local anaesthetics. Such reactions may also result from hypersensitivity, idiosyncrasy, or diminished tolerance. Drowsiness following the administration of lidocaine is usually an early sign of high lidocaine plasma levels and may occur as a consequence of rapid absorption.

Serious adverse reactions are generally systemic. Tabulated list of adverse reactions The reported adverse reactions come from spontaneous reporting and the literature. The frequency classification follows the 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) and “not known” (cannot be estimated from the available data).

MedDRA System Organ Class Frequency Adverse Reactions Immune System disorders Rare Hypersensitivity including anaphylactic shock Nervous System disorders Not known Local hypoesthesia Respiratory, thoracic and mediastinal disorders Not known Bronchospasm Gastrointestinal disorders Not known Gingival ulceration Oral mucosal exfoliation Skin and subcutaneous tissue disorders Not known Angioedema Erythema Face oedema Rash Pruritus Urticaria General disorders and administration site conditions Not known Application site oedema Application site burn 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

Although the passage of lidocaine into systemic circulation is expected to be negligible, the medicinal product must be used with caution applied to an inflamed or infected area due to the risk of a rapid systemic absorption of lidocaine.

Precautions to be taken before and after handling or administering the medicinal product: • Saliva aspiration is required alongside isolation with a cotton bud of the site to be treated with the local anaesthetic. • The risk of biting trauma (lips, cheeks, tongue) does exist but it is expected to be very low with the medicinal product due to the limited application area.

When it is associated with injectable local anaesthetics, the patient should be told to avoid chewing gum or eating until sensation is restored. • The oropharyngeal use of local anaesthetics should be avoided, since this can interfere with swallowing capacities, particularly in children and consequently lead to choking.

The accidental orientation of the anaesthetic toward the uvula (soft palate) or the pharynx may trigger a transitory paralysis of these areas and temporary discomfort to the patient. This quickly disappears. To avoid choking and related issues, the product should not be applied to the back of the throat.

45% (w/w). It may cause a slight burning sensation when exposed to open wounds.

1. • Hypersensitivity to any amide local anaesthetics. • Children (under 6 years old), because of a risk of choking.