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FLUOCARIL DENTIFRICE BI-FLUORE 250mg Mint Paste - Set of 2x125ml
ANTICARIES PROPHYLACTICS
Therapeutic indications
FLUOCARIL BI-FLUORE 250 mg MENTHE, toothpaste contains fluoride in the form of two salts: sodium fluoride and sodium monofluorophosphate.
This medicine is recommended to prevent dental caries. You should consult your doctor if you do not feel any improvement or if you feel less well.
Prix : €7.98
Tax included
8710604763479
Data sheet
- Substances actives
- Gels et pâtes dentaires
Specific References
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
FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste
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.
Notable excipients: sodium benzoate (E211), methyl parahydroxybenzoate (E218).
For full list of excipients, see section 6.1
.4.2. Dosage and administration
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
.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
- 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 the paste 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
.As systemic exposure to fluoride ions is low for toothpastes, this product may be used during breast-feeding
.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
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 and sodium benzoate
.
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Very rare |
