DENTOBAUME S gingivale Fl/4ml

Gingival solution.
Bottle of 4 ml.

For 100 g:

Amylocaine hydrochloride: 0,80 g
Levomenthol: 0,80 g

Excipients with known effect: eugenol, isoeugenol.

Symptomatic treatment of acute gingival-dental pain.

Dosage

RESERVED FOR ADULTS AND CHILDREN OVER 10 YEARS.

Paediatric population

DENTOBAUME, gingival solution is contraindicated in children under 10 years of age.

Method of administration

Place a swab soaked in the solution in contact with the painful gum or tooth.

To be repeated if necessary.

Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

History of allergy to local anaesthetics.

Children under 10 years of age.

This medicine provides rapid cessation of pain, but it is only an emergency measure while awaiting a visit to a dental specialist, which is always essential; indeed, the disappearance of pain does not in any way correspond to a cure.

Special warnings

This specialty contains terpene derivatives which may cause, at excessive doses, neurological accidents of the convulsion type in infants and children (see section Contraindications). Observe the recommended dosages and duration of treatment.

This medicine contains clove essential oil containing eugenol and isoeugenol which may cause allergic reactions.

Precautions for use

In case of a history of epilepsy, take into account the presence of terpene derivatives.

No interaction studies have been performed.

Pregnancy

In the absence of data, it is preferable not to use this medicine during pregnancy.

Breast-feeding

During breastfeeding, it is preferable not to use this medicine due to:

• the absence of kinetic data on the passage of terpene derivatives into milk,
• and their potential neurological toxicity in infants.

Local reactions (irritation or sensitisation) are possible.

Due to the presence of terpene derivatives and in case of non-compliance with the recommended doses:

• risk of convulsions in children and infants,
• possibility of agitation and confusion in elderly subjects.

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

Overdose is not expected under normal conditions of use.

Pharmacotherapeutic class: Local anaesthetic, ATC code: A (alimentary tract and metabolism).

Amyléine: local anaesthetic.

This medicine contains terpene derivatives which may lower the epileptogenic threshold.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

3 years

No special storage requirements.

No special requirements.

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