Fluocaril Toothpaste Mint 75ml LOT OF 2

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?

PROPHYLACTIC ANTICARIES DRUGS

Prevention of dental caries.

2. WHAT YOU SHOULD KNOW BEFORE USING FLUOCARIL BIFLUORE 250 mg MINT, toothpaste

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Never use FLUOCARIL BIFLUORE 250 mg MINT, toothpaste:

- in case of allergy to any of the constituents.

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.

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.

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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?

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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.

If you have taken more FLUOCARIL BIFLUORE 250 mg MINT toothpaste than you should have, contact your doctor immediately:

Consult your doctor immediately.

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4. WHAT ARE THE POSSIBLE 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.

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

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.

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).

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

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The last date on which this package insert was approved was {date}.

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Detailed information on this medicinal product is available on the website of Afssaps (France).

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