ALODONT S mouthwash Bottle glass/500ml

Cetylpyridinium chloride..................................................................................................................5,0000 mg

Chlorobutanol hemihydrate................................................................................................................50,0000 mg

Eugenol...................................................................................................................................................4,0000 mg

For 100 g of solution.

Alcohol content: 21 % v/v

Excipient with known effect : castor oil.

Alodont is indicated for the adjunctive local treatment of infections of the oral cavity, and for post-operative care in stomatology.

Dosage

RESERVED FOR ADULTS AND CHILDREN OVER 7 YEARS.

For adults: 3 mouthwashes per day with the undiluted product, keep the product in the mouth for one minute.

Paediatric population

For children aged 7 to 12 years: 3 mouthwashes per day with the product diluted to 50 % with water.

Method of administration

Local use as a mouthwash.

Do not swallow.

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

The indication does not justify prolonged treatment, especially as it could expose the patient to an imbalance of the normal microbial flora of the oral cavity with a risk of bacterial or fungal spread.

This medicine contains terpene derivatives which may cause neurological adverse events such as convulsions in infants and children at excessive doses. Observe the recommended dosages and duration of treatment.

This medicine contains castor oil and may cause skin reactions (for example: eczema).

If symptoms persist beyond 5 days and/or if associated fever occurs, the course of action should be re-evaluated.

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

Associations to be taken into account

Simultaneous or successive use of other antiseptics should be avoided given possible interferences (antagonism, inactivation...).

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.

Due to the presence of terpene derivatives and in case of failure to comply with recommended doses:

• risk of convulsions in children,

• possibility of agitation and confusion in elderly subjects.

Very rare: ≤ 0.01 %

Gastrointestinal disorders: Mouth irritation

Immune system disorders: Systemic allergic reaction

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

This product contains terpene derivatives, as excipients, which may lower the epileptogenic threshold and lead, at excessive doses, to neurological accidents in children (such as convulsions) and in elderly subjects (such as agitation and confusion). Respect the recommended dosages and duration of treatment. (see section Dosage and administration).

Paediatric population

This product contains terpene derivatives, as excipients, which may lower the epileptogenic threshold and lead, at excessive doses, to neurological accidents in children (such as convulsions). Respect the recommended dosages and duration of treatment. (see section Dosage and administration).

Pharmacotherapeutic class:

STOMATOLOGY/LOCAL TREATMENT WITH ANTISEPTIC AIM.

ATC code (A: alimentary tract and metabolism).

Clinical efficacy and safety

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

3 years

Store below 25°C.

No special requirements for disposal.

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