FLUODONTYL 1350mg toothpaste 75 ml

Pharmacotherapeutic class - ATC code: ANTICARIES PROPHYLACTIC DRUGS ATC code A01AA01

FLUODONTYL 1350 mg, toothpaste contains fluoride in salt form: sodium fluoride. This medicine is recommended for the prevention of dental caries in patients at risk of polycaries. You should consult your doctor if you do not feel any improvement or if you feel less well.

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Réf. 3400932913923

Data sheet

Substances actives: Gels et pâtes dentaires

Specific References

Prevention of dental caries, especially in patients at risk of polycaries of any etiology.

Dosage

For adults only.

Method of administration

For oral use only. Do not swallow.

Carefully brush daily, 3 times a day, after each meal, in a vertical direction, from gum to tooth tip.

Thorough brushing takes about 3 minutes.

ANSM - Updated on : 20/02/2020

1. DRUG NAME

FLUODONTYL 1350 mg, toothpaste

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium fluoride............................................................................................................... 3.00 g

Per 100 g.

100 g toothpaste contains 1350 mg or 13500 ppm fluoride.

Notable excipients: methyl parahydroxybenzoate (E218).

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Toothpaste.

4. CLINICAL DATA

4.1. therapeutic indications

Prevention of dental caries, particularly in patients at risk of polycaries of any etiology.

4.2. Dosage and administration

Dosage

For adults only.

Method of administration

For oral use only. Do not swallow.

Carefully brush 3 times a day, after each meal, in a vertical direction, from gum to tooth tip

Thorough brushing takes about 3 minutes

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

- The local use of fluoride toothpastes or fluoride mouthwashes is compatible with systemic fluoride intake, and enhances the tooth's 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, fluoride salt, fluoride tablets, drops, chewing gum or 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), we need 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 the paste used

- The maximum recommended fluoride content of toothpaste for children under 6 is 500 ppm (50 mg/100g). The amount 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)

From the age of 6, children may use toothpastes containing 1000 to 1500 ppm (100 to 150 mg/100g)

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 a

precautionary measure, FLUODONTYL 1350 mg should not be used in pregnant

women.

Lactation

Since there is insufficient information on the excretion of sodium fluoride in breast milk or animal milk, FLUODONTYL 1350 mg should be used with caution

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

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4.9 /5

Based on 41 customer reviews

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Juliette D. published the 11/04/2024 following an order made on 12/03/2024

le rapport qualité/prix est très attractif par rapport aux autres vendeurs

5/5

Daniele S. published the 29/03/2024 following an order made on 07/03/2024

très bien comme d habitude

5/5

Jacqueline G. published the 29/03/2024 following an order made on 06/03/2024

Recommandé par mon dentiste prix intéressant

5/5

Christophe L. published the 14/01/2024 following an order made on 09/01/2024

Parfait !

5/5

GERARD T. published the 03/01/2024 following an order made on 22/12/2023

j utilise depuis tres longtemps

5/5

Fabienne M. published the 01/01/2024 following an order made on 27/12/2023

Bien

5/5

Dominique S. published the 27/10/2023 following an order made on 15/10/2023

Bon produit

5/5

Celine C. published the 27/10/2023 following an order made on 04/10/2023

Rien

4/5

Christophe R. published the 10/10/2023 following an order made on 21/09/2023

Excellent rapport qualité prix

5/5

Brigitte F. published the 30/09/2023 following an order made on 07/09/2023

Dentifrice tres bonne qualite

5/5

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