DYNEXAN 2 % Cr buccale T/10g

Oral cream.
Tube of 10 g. Box of 1.

For 1 g of cream:

Lidocaine hydrochloride: 20,00 mg

Excipient(s) with known effect: benzalkonium chloride.

Short-term symptomatic treatment of painful lesions of the oral cavity.

Topical contact local anaesthesia before instrumental examinations in odontology-stomatology.

Dosage

Reserved for adults and children over 6 years.

Method of administration

Strictly local use. Gingival and oral application

Adults and children over 6 years : Apply 0,5 g of cream, four times per day maximum, i.e. 40 mg of lidocaine.

Massage gently to spread the cream evenly over the area to be treated.

Do not exceed the maximum dose of 200 mg of lidocaine per day.

The indication does not justify prolonged treatment.

Hypersensitivity to the active substance, to local anaesthetics in general or to any of the excipients listed in section Composition.

Paediatric population: Do not use in children under 6 years of age.

Follow the administration and dosage advice.

Do not swallow after application to the mucosa.

Because of the local anaesthesia, take into account the risk of biting (lips, cheek, tongue).

If symptoms persist beyond 5 days, the course of action should be reassessed.

If the pain is related to wearing a denture, the advice of a dental specialist must always be sought.

Related to excipients

Because of the presence of benzalkonium chloride, this medicine may cause skin reactions.

Known interactions of lidocaine (antiarrhythmics, beta-blockers) in principle do not concern its local use on the mucosa of the oral cavity.

However, take into account a risk of systemic passage of lidocaine in case of damaged oral mucosa.

Pregnancy

Studies performed in animals have not demonstrated a teratogenic effect.

In the absence of a teratogenic effect in animals, a malformative effect in the human species is not expected.

In clinical practice, there are currently no sufficiently relevant data to assess a possible malformative or fetotoxic effect of lidocaine applied systemically during pregnancy. It is therefore preferable not to use lidocaine cream during pregnancy.

However, in cases of severe periodontitis that cannot be controlled by good oral hygiene, since trans-placental passage of lidocaine applied locally is unlikely, lidocaine cream may be used for a short period and without exceeding the recommended doses.

Breast-feeding

The use of lidocaine cream is possible during breastfeeding.

In case of intolerance to one of the components of the oral cream, allergic reactions are possible. However, these reactions occur very rarely.

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: https://signalement.social-sante.gouv.fr/.

An overdose is not expected under normal conditions of use of this oral cream in odontostomatology.

This specialty contains a small quantity of terpene derivatives in the excipients, which may cause, at excessive doses, neurological accidents such as convulsions, 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, headaches, nausea,
• respiratory system: tachypnoea then bradypnoea that may lead to apnoea,
• cardiovascular system: decrease in cardiac output and fall in blood pressure.

These must be treated in a specialised setting.

Pharmacotherapeutic class: Local anaesthetic, ATC code: N01BB02.

Mechanism of action

Lidocaine is a local anaesthetic of the amino-amide group, whose effect is rapid and long-lasting.

The mechanism of action is based on the inhibition of nerve impulse conduction by binding of the activated molecule to a specific receptor of the sodium channel in the membrane surrounding the nerve fibre.

The effect appears after one minute and persists for about one hour, as release from the excipients is slightly delayed.

The excipients contain terpene derivatives that may lower the epileptogenic threshold.

Absorption

After local application, absorption of lidocaine is limited. However, certain areas of the oral mucosa may be more permeable than others. The rate of absorption depends on the state of vascularisation of the mucosa.

Elimination

The metabolism of lidocaine is hepatic and its elimination is urinary.

The dose without toxic effect of lidocaine administered intramuscularly in mice is 4 mg/kg.

A mutagenic effect of an active metabolite (2,6-xylidine) has been demonstrated in rats from in vitro tests carried out with high doses at toxic concentrations.

In carcinogenicity studies with transplacental exposure and postnatal exposure to this same metabolite, administered at high doses for 2 years in rats, benign and malignant tumours were observed in the nasal cavity.

These data mean that treatment with lidocaine, even topical, must not be administered over a long period and beyond the recommended doses.

3 years.

After first opening : to be stored for a maximum of 3 months.

Store at a temperature not exceeding +25 °C.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.