FLUOCARIL DENTIFRICE BI-FLUORE 250mg Menthe Gel 125ml
  • FLUOCARIL DENTIFRICE BI-FLUORE 250mg Menthe Gel 125ml
  • FLUOCARIL DENTIFRICE BI-FLUORE 250mg Menthe Gel 125ml

FLUOCARIL DENTIFRICE BI-FLUORE 250mg Mint Gel 125ml

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Pharmacotherapeutic class

ANTICARIES PROPHYLACTICS

Therapeutic indications

FLUOCARIL BI-FLUORE 250 mg MENTHE, gel dentifrice contains fluoride in the form of two salts: sodium fluoride and sodium monofluorophosphate. This medicine is recommended to prevent dental caries.

You should contact your doctor if you do not feel any improvement or if you feel less well.

Data sheet

Substances actives
Gels et pâtes dentaires

Specific References

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.

ANSM - Updated on : 10/02/2020

1. DRUG NAME Retour en haut de la page

FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste gel

2. QUALITATIVE AND QUANTITATIVE COMPOSITION Retour en haut de la page

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 Retour en haut de la page

Toothpaste gel.

4. CLINICAL DATA Retour en haut de la page

4.1. therapeutic indications Retour en haut de la page

Prevention of dental caries.

4.2. Dosage and administration Retour en haut de la page

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 Retour en haut de la page

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 Retour en haut de la page

- 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 Retour en haut de la page

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation Retour en haut de la page

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 Retour en haut de la page

Not applicable.

4.8. Undesirable effects Retour en haut de la page

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

.

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Anonymous customer published the 17/06/2021 following an order made on 07/06/2021

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