AFTAGEL Buccal gel Tube/15ml

Lidocaine hydrochloride......................................................................................................................0,60000 g

Zinc sulfate.........................................................................................................................................0,50000 g

For 100 ml of buccal gel

Short-term symptomatic treatment of painful lesions of the oral or gingival mucosa (for example aphthous ulcers)

Reserved for adults

After thoroughly washing your hands, apply the equivalent of a small pea of gel on the finger and gently massage the painful area of the mouth. Wash your hands after application.

Adults: the application may be repeated 4 to 6 times a day.

The duration of treatment must not exceed 5 days.

History of allergy to local anaesthetics.

Due to the numbness caused by local anaesthesia, take into account the possible risk of biting (lips, cheek, tongue).

Close monitoring after application in dependent patients may in particular be necessary to verify the absence of biting.

Due to the risk of aspiration, do not eat or drink immediately after application.

The indication does not justify prolonged treatment.

Athletes should be made aware that this product contains an active substance that may induce a positive reaction in tests carried out during anti-doping controls.

The data available to date do not suggest the existence of clinically significant interactions.

Use with caution in pregnant or breastfeeding women, due to a lack of usable clinical data.

Adverse effects are classified by system organ class and by frequency as follows: very common (>1/100, < 1/10); uncommon (> 1/1 000, < 1/100); rare (> 1/10 000, < 1/1 000); very rare (< 1/10 000) and frequency not known (cannot be estimated from the available data).

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 national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-sante.gouv.fr.

An overdose is not expected under the normal conditions of use of this oral gel.

This specialty contains a small quantity of terpene derivatives in the excipients (clove essential oil). Ingestion of excessive doses of lidocaine and terpene derivatives may lead to neurological accidents of the convulsion type, in particular in case of a history of epilepsy.

With local application, systemic effects are very rare. However, in case of overdose and systemic absorption, toxic reactions cannot be excluded:

• Nervous system: nervousness, agitation, tremors, nystagmus, headache, nausea
• Respiratory system: tachypnoea then bradypnoea which may lead to apnoea,
• Cardiovascular system: decrease in cardiac output and fall in blood pressure.

They must be treated in a specialised setting.

Pharmacotherapeutic class: LOCAL ANAESTHETIC, ATC code: N01BB52

Combination of:

Lidocaine: local anaesthetic,

Zinc sulfate: astringent action

2 years.

To be stored at a temperature not exceeding + 25°C

No special requirements.