DURAPHAT 500 mg/100 g Toothpaste T/51g

Elemental fluoride ................................................................................................................................................0,50 g

In the form of sodium fluoride ............................................................................................................1,10 g

Per 100 g.

1 g of toothpaste contains 5 mg of elemental fluoride corresponding to 5000 ppm of fluoride.

Excipients with known effect : 1 g of toothpaste contains 5 mg of sodium benzoate (E211).

1 g of toothpaste contains 10 mg of spearmint flavour with allergens.

Prevention of dental caries in adolescents and adults, in particular in patients at risk of multiple caries (coronal and/or root caries).

Reserved exclusively for adults and adolescents aged 16 years and over.

Dental route.

Do not swallow.

Perform thorough brushing daily:

• apply a 2 cm ribbon on your toothbrush at each brushing. 2 cm delivers between 3 mg and 5 mg of fluoride,

• 3 times per day, after each meal,

• in the vertical direction from the gum towards the tip of the tooth.

A thorough brushing lasts approximately 3 minutes.

Spit out the excess foam.

This medicine MUST NEVER BE USED:

• in case of hypersensitivity to the active substance or to any of the excipients.

The use of DURAPHAT 500 mg/100 g, toothpaste, is not indicated in adolescents and children under 16 years, see section Dosage and administration.

This toothpaste contains a high fluoride content.

Consequently, the advice of the qualified healthcare professional, such as a dentist, a pharmacist, an oral hygienist must be consulted before use of the product.

The multiplication of potential sources of fluoride can be the origin of fluorosis. Before using medicines containing fluoride such as DURAPHAT 500 mg/100 g, toothpaste, a review of total fluoride intakes must be established (drinking water, fluoridated salts, other medicines containing fluoride - tablets, drops, chewing gums or toothpaste). Fluoride in the form of tablets, drops, chewing gum, gels or varnishes, as well as fluoridated salt or water, must be avoided during use of DURAPHAT 500 mg/100 g, toothpaste.

In the overall calculations of the recommended fluoride ion intake, i.e. 0,05 mg/kg/day, all intakes combined and without exceeding 1 mg/day, possible doses of toothpaste ingestion must be taken into account (each tube of DURAPHAT 500 mg/100 g, toothpaste, contains 255 mg of fluoride ions).

This product contains sodium benzoate (E211). Sodium benzoate (E211) may cause local irritation.

This medicine also contains a spearmint flavour with allergens (limonene, linalool, citral, geraniol and citronellol). These allergens may cause allergic reactions.

There are no sufficient data on the use of DURAPHAT 500 mg/100 g, toothpaste, in pregnant women. Animal studies have shown toxicity of sodium fluoride administered at very high doses on reproductive functions. This toothpaste must therefore not be used during pregnancy and breastfeeding unless the benefit/risk ratio has been evaluated.

Gastrointestinal disorders

Frequency not known (cannot be estimated from the available data): oral burning sensation.

Immune system disorders

Rare (≥ 1/10 000, < 1/1 000): hypersensitivity reactions.

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 report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr

Acute intoxication: Fluoride

The toxic dose, i.e. the minimum dose that can induce symptoms of intoxication, is 5 mg of fluoride per kg of body weight.

It manifests itself by digestive disorders: vomiting, diarrhoea, abdominal pain and may exceptionally lead to death.

In the event of significant accidental ingestion, immediate treatment consists of gastric lavage or induced vomiting, ingestion of calcium (large quantity of milk) and medical monitoring for several hours.

Acute intoxication : Menthol

DURAPHAT 500 mg/100 g, toothpaste contains menthol, which may cause convulsions, particularly in infants and children, in the event that it is accidentally ingested in excessive quantities.

Chronic intoxication: fluorosis

Mottled or speckled appearance of the dental enamel that may appear from a daily absorption of a dose of fluoride greater than 1,5 mg/day for several months or years depending on the extent of the overdose. This appearance is accompanied by fragility of the enamel in severe forms.

Skeletal fluorosis (osteosclerosis) is only observed with strong chronic absorptions of fluoride (greater than 8 mg/day).

Pharmacotherapeutic group: anticaries prophylactic medicines

ATC code: A01AA01.

The main effect of fluoride in the prevention of dental caries is post-eruptive, i.e. topical. Systemic fluoride supplements are considered to act also mainly in a topical manner (for example during ingestion, via saliva).

The effects of fluoride are of three types:

• a decrease in demineralisation (decrease in the solubility threshold of enamel in an acidic medium);

• a remineralisation of initial carious lesions of the enamel;

• a bactericidal effect on the germs of dental plaque. The consequences are an inhibition of the bacterial proliferation of dental plaque and an inhibition of the formation of cariogenic acids.

Fluoride alone cannot suffice to eliminate dental plaque or constitute a complete treatment of caries.

DURAPHAT 500 mg/100 g, toothpaste, exerts a local and topical action at the level of the teeth, and therefore, the fate in the organism is not considered.

However, the following information has been included in the event that the toothpaste is accidentally ingested during treatment.

The ingested fluoride is converted to hydrofluoric acid. The peak concentration is obtained between 30 to 60 minutes after ingestion. The volume of distribution is 1 L/kg. Fluoride ions concentrate in the teeth and bones and are not bound to plasma proteins. The half-life is 2 to 9 hours. Fluoride ions are primarily eliminated via the urinary route, but small quantities may also be excreted in the faeces and sweat. The form of elimination is not known.

The preclinical data do not reveal any particular risk in humans beyond the information presented in the other sections of this summary of product characteristics.

After oral administration of sodium fluoride in the Mouse, the Rat and the Rabbit, toxic effects on reproductive functions and on the foetus were observed only at very high doses.

3 years.

Store at a temperature not exceeding + 25°C.