FLUODONTYL 1350 mg Toothpaste T/75ml

Toothpaste.
Tube of 75 ml.

Per 100 g:

Sodium fluoride: 3,00 g
100 g of toothpaste contains 1 350 mg or 13 500 ppm of fluoride.

Excipients with known effect: methyl parahydroxybenzoate (E218), cinnamal, eugenol, limonene, linalool.

Prevention of dental caries, in particular in patients at risk of multiple caries whatever the aetiology.

Dosage

Reserved for the adult.

Method of administration

For orodental use only. Do not swallow.

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

Careful brushing lasts approximately 3 minutes.

Hypersensitivity to the active substance or to any of the excipients mentioned in the section Composition

• Local use of fluoridated toothpastes or fluoridated mouthwashes is compatible with intake of fluoride by the general route; it reinforces protection of the tooth against caries.
• However, multiplication of potential sources of fluoride may be the origin of fluorosis. In order to avoid accumulations, it is essential to establish a personalised assessment of intakes (tap and mineral waters, fluoridated salt, medicinal products 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 ingestion of toothpaste (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 quantity to use must be the size of a pea and children must spit out the toothpaste well.
  From 6 years, children may use toothpastes dosed at 1 000 to 1 500 ppm (100 to 150 mg/100 g).
• This medicinal product contains methyl parahydroxybenzoate (E218) and may cause allergic reactions (possibly delayed).
• This medicinal product contains eugenol which may cause allergic reactions.
• This medicinal product contains essential oils of peppermint (Italo-Mitcham), star anise, and Ceylon cinnamon containing cinnamal, eugenol, limonene, linalool which may cause allergic reactions.

Have the teeth checked regularly by a dental surgeon.

No interaction study has been performed.

Pregnancy

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

As a precautionary measure, it is preferable not to use FLUODONTYL 1 350 mg in pregnant women.

Breast-feeding

Information on the excretion of sodium fluoride in human or animal milk being insufficient, FLUODONTYL 1 350 mg should be used with caution.

Fertility

Anomalies 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 (≥ 1/1 000, < 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.

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

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 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).

Pharmacotherapeutic group: ANTICARIES PROPHYLACTIC MEDICINAL PRODUCTS, 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 mineralisation, complemented by a topical effect after tooth eruption.

These two routes are interdependent and complementary. Indeed, upon ingestion of a fluoridated product, fluoride comes into contact with dental surfaces during its passage through the oral cavity, thereby exerting a topical action.

Conversely, topical fluoride may be partially ingested and then integrates into the systemic route.

The effects of fluoride are of three types:

• 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,
• a decrease in the solubility threshold of enamel in acidic medium,
• a remineralization of the initial carious lesions of the enamel.

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

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.

3 years.

Store at a temperature not exceeding +25 °C.

No special requirements.

Any unused medicine or waste must be disposed of in accordance with current regulations.