CHLORHEXIDINE VIATRIS 0,12 % mouthwash Bottle/300ml

Chlorhexidine digluconate ….............................................................................................................0,1200 g

As a chlorhexidine digluconate solution...................................................................0,6360 g

For 100 mL of mouthwash solution.

Excipients with known effect: azorubine (E122), ethanol, macrogolglycerol ricinoleate, propylene glycol.

100 mL of solution contain: 1,40 mg of azorubine (E122), 4,70 mg of ethanol (alcohol), 1,00 g of macrogolglycerol ricinoleate and 2,00 g of propylene glycol.

Adjunctive treatment of oral infections and post-operative care in stomatology.

This medicine is indicated in adults and children over 6 years of age.

KEEP OUT OF REACH OF ADULTS AND CHILDREN OVER 6 YEARS.

This medicine is contraindicated in children under 6 years of age (see section Contraindications).

Method of administration

For each mouthwash, use the contents of one cup (15 mL).

The number of mouthwashes is 1 to 3 per day, lasting about one minute each (after meals and preferably after brushing the teeth).

Brush teeth before each use and rinse the mouth thoroughly with water before using CHLORHEXIDINE VIATRIS.

This solution must be used neat, undiluted.

Local use as a mouthwash.

Do not swallow.

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

• Children under 6 years of age.

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 (candidiasis). If symptoms persist beyond 5 days and/or if fever is associated, the course of action should be reassessed and systemic antibiotic therapy considered.

This medicine may cause hypersensitivity reactions including generalised allergic reactions and anaphylactic shock.

Discontinue treatment in case of parotid swelling.

Do not put the product in contact with the eyes or nose.

Do not introduce the product into the ear canal.

Excipients

This medicine contains azorubine (E122) which may cause allergic reactions.

This medicine contains 0,7 mg of alcohol (ethanol) per dose of 15 mL of solution, equivalent to 0,04 mg/mL. The amount in a dose of 15 mL of this medicine equals less than 1 mL of beer or less than 1 mL of wine. The small amount of alcohol contained in this medicine is not likely to cause any noticeable effect.

This medicine contains macrogolglycerol ricinoleate which may cause stomach upset and diarrhoea.

This medicine contains 300 mg of propylene glycol per dose of 15 mL.

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

Chlorhexidine is incompatible with anionic agents generally present in conventional toothpastes. Therefore, a thorough rinsing of the mouth with water, after brushing the teeth with a toothpaste, must be carried out before using this medicine. A short interval must be observed between the use of the 2 products.

Pregnancy

There are no data or there are limited data (fewer than 300 pregnancies) on the use of chlorhexidine in pregnant women.

Studies performed in animals have not demonstrated any direct or indirect harmful effects (under normal conditions of use) on reproduction.

As a precaution, it is preferable to avoid using CHLORHEXIDINE VIATRIS during pregnancy.

Breast-feeding

It is not known whether chlorhexidine is excreted in breast milk.

A risk to newborns / infants cannot be excluded.

CHLORHEXIDINE VIATRIS must not be used during breast-feeding.

Fertility

Studies performed in animals have not demonstrated any effect on fertility (under normal conditions of use).

The effects on the ability to drive vehicles and use machines have not been studied. No effect is expected.

• Brown discolouration of the tongue and teeth, reversible on stopping treatment (particularly in tea and coffee drinkers).

• Risk of sensitisation to one of the constituents of the solution (parotitis, mucocutaneous irritation, skin allergic reaction or even a generalised reaction which may lead to anaphylactic shock, swelling of the salivary glands), requiring discontinuation of treatment.

• Occasionally dysgeusia or burning sensation of the tongue at the start of treatment.

• Occasionally desquamation of the oral mucosa.

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 should 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/.

In case of oral ingestion of chlorhexidine, the following effects have been reported: atrophic gastritis, oesophageal and hepatic lesions in case of very high doses.

In addition, this specialty 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).

Accidental eye exposure to a chlorhexidine solution may cause corneal damage requiring specialist management.

Pharmacotherapeutic class: ANTI-INFECTIVES AND ANTISEPTICS FOR ORAL LOCAL TREATMENT; ATC code: A01AB03

Chlorhexidine is a broad-spectrum bactericidal antiseptic belonging to the bisdiguanide family.

Its bactericidal activity is exerted on Gram-positive organisms and, to a lesser degree, on Gram-negative organisms.

Route oral

Absorption

Chlorhexidine is poorly absorbed through the digestive tract, and very low circulating concentrations are detected in the blood.

Distribution

Mainly in the liver and kidneys.

Biotransformation and Elimination

Chlorhexidine undergoes limited metabolism and is excreted essentially unchanged in the faeces (99,5% of the ingested dose).

Oral route

When used locally, chlorhexidine is adsorbed onto dental enamel, dentine, cementum, mucous membranes and dental prostheses, with slow desorption. Chlorhexidine remains detectable in saliva for 8 to 12 hours.

Due to its cationic nature, chlorhexidine digluconate binds strongly to the skin, mucous membranes and other tissues. It is therefore very poorly absorbed.

After contact with mucous membranes, chlorhexidine is absorbed by organic structures, which results in a local residual effect and limits passage into the systemic circulation.

The currently available non-clinical data add no further relevant information for the prescriber beyond that already mentioned in the other sections of the SmPC.

Before opening the bottle: 3 years.

After first opening of the bottle: 30 days.

This medicine does not require any particular storage precautions.

No special requirements for disposal.

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

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

Detailed information on this medicinal product is available on the ANSM website.

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree