FLUOCARIL DENTIFRICE BI-FLUORE 250mg Mint Gel 75ml

ANSM - Updated on : 10/02/2020

1. DRUG NAME

FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste gel

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium monofluorophosphate ....................................................................................... 0.7600 g

Sodium fluoride ............................................................................................................ 0.3315 g

Per 100 g.

100 g toothpaste contains 250 mg or 2500 ppm fluoride.

Excipients: sodium benzoate (E211), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Toothpaste gel.

4. CLINICAL DATA

4.1. therapeutic indications

Prevention of dental caries.

4.2. Dosage and administration

Dosage

For adults and children over 10 years of age.

This drug may be used in children over 10 years of age after medical consultation

Method of administration

For oral use only. Do not swallow.

Brush carefully, 3 times a day, after each meal, in a vertical direction from the gum to the tip of the tooth

Thorough brushing takes about 3 minutes

4.3. Contraindications

This medicine must NEVER BE USED :

If you

are hypersensitive to sodium fluoride, sodium monofluorophosphate or any of the excipients listed in section 6.1

4.4 Special warnings and precautions for use

- The topical use of fluoride toothpastes or fluoride mouthwashes is compatible with systemic fluoride intake, and enhances tooth protection against caries.

- However, the multiplication of potential sources of fluoride can lead to fluorosis. To avoid accumulation, it is essential to draw up a personalized intake assessment (tap and mineral water, fluoridated salt, drugs in the form of tablets, drops, chewing gum or fluoride toothpaste) prior to any fluoride prescription

When calculating the overall recommended fluoride ion intake (0.05 mg fluorine/kg/d for all fluoride intakes, but not exceeding 1 mg/d), it is important to take into account possible toothpaste ingestion doses (60 to 30% between 3 and 7 years of age), which will vary according to age and the concentration of gel used

- The maximum recommended fluoride content of toothpaste for children under 6 is 500 ppm (50 mg/100 g). The amount to be used should be the size of a pea, and children should spit the toothpaste out 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

Children aged 6 and over may use toothpastes containing 1000 to 1500 ppm (100 to 150 mg/100 g)

Have your teeth checked regularly by a dental surgeon

4.5. Interactions with other drugs and other forms of interaction

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation

Pregnancy

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

As systemic exposure to fluoride ions is low for FLUOCARIL Bi-Fluoride 250 mg, this drug may be used during pregnancy

Breast-feeding

As systemic exposure to fluoride ions is low for toothpaste gels, this product may be used during breastfeeding

Fertility

Reproductive abnormalities have been observed in animals at high doses and with chronic daily administration (see section 5.3). However, at the doses to which treated patients are exposed, no effect on fertility is expected

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

The adverse reactions listed below are classified by frequency and by organ system class (OSC). 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 unknown (cannot be estimated from available data).

Expected side effects are mainly due to the presence of methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium benzoate

See notice

Very rare

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