FLUOCARIL bi-fluoré 250 mg Mint toothpaste T/125ml

Sodium monofluorophosphate .............................................................................................................0,7600 g

Sodium fluoride .....................................................................................................................................0,3315 g

Per 100 g.

100 g of toothpaste contains 250 mg or 2500 ppm of fluoride.

Excipients with known effect: sodium benzoate (E211), methyl parahydroxybenzoate (E218).

Prevention of dental caries.

Dosage

Reserved for adults and children over 10 years.

This medicine may be used in children over 10 years after medical consultation.

Method of administration

For bucco-dental use only. Do not swallow.

Perform daily careful brushing, 3 times per day, after each meal, in the vertical direction from the gum to the tip of the tooth.

Careful brushing lasts approximately 3 minutes.

This medicine MUST NEVER BE USED:

• In case of hypersensitivity to sodium fluoride, to sodium monofluorophosphate or to any of the excipients mentioned in the section Composition.

• Local use of fluoridated toothpastes or fluoridated mouthwashes is compatible with the intake of fluoride by the general route; it reinforces the protection of the tooth against caries.
• However, the multiplication of potential sources of fluoride can be the origin of fluorosis. In order to avoid accumulations, it is essential to establish a personalized assessment of intakes (tap and mineral waters, fluoridated salt, medicines in the form of tablets, drops, chewing gums or fluoridated toothpastes) before any fluoridated prescription.
• In the overall calculations of the recommended intake of fluoride ion (0,05 mg of fluoride/kg/day all fluoridated intakes combined and without exceeding 1 mg/day), account must be taken of possible doses of toothpaste ingestion (60 to 30% between 3 and 7 years), which will vary according to age and the concentration of the paste used.
• The maximum recommended content for a toothpaste in children under 6 years is 500 ppm of fluoride (50 mg/100 g). The amount to be used must be the size of a pea and children must spit out the toothpaste well.
• This medicine contains methyl parahydroxybenzoate (E218) and may cause allergic reactions (possibly delayed).
• Due to the presence of sodium benzoate (E211), this medicine may cause irritation of the skin, eyes and mucous membranes.

From 6 years, children may use toothpastes dosed at 1000 to 1500 ppm (100 to 150 mg/100 g).

Have teeth checked regularly by a dental surgeon.

No interaction studies have been performed.

Pregnancy

The data on the use of sodium fluoride in pregnant women are limited. Animal data do not indicate direct or indirect deleterious effects with regard to reproductive toxicity.

Systemic exposure to fluoride ions being low for FLUOCARIL Bi-Fluoré 250 mg, this medicine may be used during pregnancy.

Breastfeeding

Systemic exposure to fluoride ions being low for toothpastes, this medicine may be used during breastfeeding.

Fertility

Abnormalities at the level of the reproductive system have been observed in animals at high doses and with chronic daily administration (see section Preclinical safety). However, at the doses to which treated patients are exposed, no effect on fertility is expected

The adverse effects listed below are classified by frequency and by system organ class (SOC). The frequency groups are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥1/10 000, <1/1 000), and very rare (<1/10 000), frequency not known (cannot be estimated from the available data).

The expected adverse effects are mainly due to the presence of methyl parahydroxybenzoate and sodium benzoate.

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: www.signalement.social-sante.gouv.fr.

Acute intoxication

In adults or children, the toxic dose is 5 mg of fluoride/kg (minimum dose that can induce symptoms of intoxication). It manifests as digestive disorders: vomiting, diarrhoea, abdominal pain and may exceptionally lead to death.

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

Chronic intoxication: fluorosis

Mottled or speckled appearance of dental enamel that may appear from a daily absorption of a dose of fluoride greater than 1.5 mg/day (0.10 mg of fluoride/kg/day in children up to 6 years), for several months or years depending on the extent of the overdose. It is accompanied by enamel fragility in severe forms.

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

ANTICARIES PROPHYLACTIC MEDICINES

ATC code: A01AA01.

Mechanism of action

Fluorides play an essential role in the prevention of dental caries.

They exert a systemic effect during the period of tooth mineralization, supplemented by a topical effect after tooth eruption.

These two pathways are interdependent and complementary. Indeed, during ingestion of a fluoridated product, fluoride is in contact with dental surfaces during its passage through the oral cavity, thus exerting a topical action.

Conversely, topical fluoride can be partially ingested and then integrates into the systemic pathway.

The effects of fluoride are of three types:

• a bactericidal effect on the germs of dental plaque. The consequences are an inhibition of bacterial proliferation of dental plaque and an inhibition of the formation of cariogenic acids,
• a decrease in the solubility threshold of enamel in acidic medium,
• a remineralization of the initial carious lesions of the enamel.

(Fluoride would not, however, suffice for the elimination of bacterial plaque or for the treatment of caries).

This medicine is a combination of two fluoride salts: sodium fluoride and sodium monofluorophosphate with a high fluoride concentration. The latter is released rapidly from sodium fluoride and with a delayed effect from sodium monofluorophosphates after enzymatic hydrolysis of bacterial or salivary origin. As with all fluoridated salts, the carioprotective action is dependent on the fluoride concentration.

Oral fluorides have shown genotoxic effects at high doses (approximately 20 mg/kg or more) and toxic effects on reproductive functions and on the fetus have been observed in mice, rats and rabbits, only at very high doses.

An equivocal carcinogenic effect was observed in the male rat but not in the female rat or in male and female mice.

2 years.

Store at a temperature not exceeding 25°C.

No special requirements.