In this manual :
1. WHAT IS FLUOCARIL BIFLUORE 250 mg MINT, toothpaste AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING FLUOCARIL BIFLUORE 250 mg MINT, toothpaste
3. HOW TO USE FLUOCARIL BIFLUORE 250 mg MINT, toothpaste?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE FLUOCARIL BIFLUORE 250 mg MINT, toothpaste?
6. ADDITIONAL INFORMATION
1. WHAT IS FLUOCARIL BIFLUORE 250 mg MINT, toothpaste AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
PROPHYLACTIC ANTICARIES DRUGS
Prevention of dental caries.
2. WHAT YOU SHOULD KNOW BEFORE USING FLUOCARIL BIFLUORE 250 mg MINT, toothpaste
List of information needed before taking the medicine
Not applicable.
Never use FLUOCARIL BIFLUORE 250 mg MINT, toothpaste:
- in case of allergy to any of the constituents.
Precautions for use; special warnings
Take care with FLUOCARIL BIFLUORE 250 mg MINT, toothpaste:
Special warnings
- The topical use of fluoridated toothpastes or mouthwashes is perfectly compatible with systemic fluoride intake; it enhances the protection of the tooth against caries.
- However, the multiplication of potential sources of fluoride can lead to fluorosis. In order to avoid accumulation, it is essential to draw up a personalised assessment of intakes (tap and mineral water, fluoridated salt, medicines in the form of tablets, drops, chewing gum or fluoridated toothpaste) before any fluoride prescription.
- In the overall calculation of the recommended fluoride ion intake (0.05 mg fluorine/kg/d for all fluoride intakes combined and not exceeding 1 mg/d), the possible doses of toothpaste ingestion (60 to 30% between 3 and 7 years of age) must be taken into account, which will vary according to age and the concentration of the paste used.
- Children under 6 years of age should use toothpastes with a fluoride content of 500 ppm or less (50 mg/100 g). The amount to be used should be the size of a pea and children should spit out the toothpaste well.
From the age of 6 years, children can use toothpastes with a fluoride content of 1000-1500 ppm (100-150 mg/100 g).
Check the fluoride content on the toothpaste label.
Precautions for use
For good oral health, it is necessary for your child to consult a dental surgeon regularly.
Interactions with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Not applicable.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: Methyl parahydroxybenzoate (E 218), sodium benzoate (E 211).
3. HOW TO USE FLUOCARIL BIFLUORE 250 mg MINT, toothpaste?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
For use in adults and children over 10 years of age.
This medicine can be used in children over 10 years of age after medical consultation (dentist or physician).
In adults and children over 10 years of age:
Brush thoroughly every day,
- 3 times a day, after each meal,
- in a vertical direction from the gum to the tip of the tooth.
A thorough brushing takes about 3 minutes.
Follow the advice of your doctor or dentist.
How to use
Local use. Do not swallow.
Frequency of administration
As advised by your doctor or dentist.
Duration of treatment
As advised by your doctor or dentist.
Symptoms and instructions in case of overdose
If you have taken more FLUOCARIL BIFLUORE 250 mg MINT toothpaste than you should have, contact your doctor immediately:
Consult your doctor immediately.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, FLUOCARIL BIFLUORE 250 mg MINT, toothpaste is likely to have adverse effects, although not everyone is subject to them.
Due to the presence of methyl parahydroxybenzoate, risk of eczema and exceptionally, allergic reactions with urticaria and respiratory discomfort.
Due to the presence of sodium benzoate, risk of irritation of the mucous membranes.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.
5. HOW TO USE FLUOCARIL BIFLUORE 250 mg MINT, toothpaste
Keep out of the reach and sight of children.
Do not use FLUOCARIL BIFLUORE 250 mg MINT, toothpaste after the expiry date stated on the box or bottle.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does FLUOCARIL BIFLUORE 250 mg MINT toothpaste contain?
The active ingredients are:
Sodium monofluorophosphate ...................................................................................................... 0.7600 g
Sodium fluoride ......................................................................................................................... 0.3315 g
Per 100,000 g.
Other components are:
Sodium benzoate, sodium laurilsulfate, disodium phosphate, sodium hexametaphosphate, Neuburg silica, pure precipitated silica, sodium carrageenate, 70% non-crystallizable sorbitol, sodium saccharin, rectified peppermint essential oil (italo-micham), rectified star anise essential oil, menthol, officinal phenol, eugenol, Ceylon cinnamon essential oil, titanium dioxide, methyl parahydroxybenzoate, purified water.
Pharmaceutical form and content
What is FLUOCARIL BIFLUORE 250 mg MINT, toothpaste and what does it contain?
This medicine is in the form of a toothpaste.
Boxes of 1, 2, 8 or 10 tubes of 7.50 g (6 ml), 31.25 g (25 ml), 62.50 g (50 ml), 93.75 g (75 ml), 125.00 g (100 ml) or 156.25 g (125 ml).
Box of 1 or 2 measuring bottles of 112.50 g (90 ml) or 125.00 g (100 ml).
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
PROCTER & GAMBLE PHARMACEUTICALS FRANCE
163-165 QUAI AULAGNIER
92600 ASNIERES SUR SEINE
Operator
PROCTER & GAMBLE PHARMACEUTICALS FRANCE
163-165 QUAI AULAGNIER
92600 ASNIERES SUR SEINE
Manufacturer
SANOFI WINTHROP INDUSTRIE
196 AVENUE DU MARECHAL JUIN
45200 AMILLY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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