In this manual :
1. WHAT IS FLUODONTYL 1350 mg, toothpaste AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING FLUODONTYL 1350 mg, toothpaste?
3. HOW TO USE FLUODONTYL 1350 mg, toothpaste?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE FLUODONTYL 1350 mg, toothpaste?
6. ADDITIONAL INFORMATION
1. WHAT IS FLUODONTYL 1350 mg, toothpaste AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
PROPHYLACTIC ANTI-CARIES DRUGS
Prevention of dental caries, particularly in patients at risk of polycaries of any etiology.
2. WHAT DO YOU NEED TO KNOW BEFORE USING FLUODONTYL 1350 mg, toothpaste?
List of information needed before taking the medicine
Not applicable.
Do not take FLUODONTYL 1350 mg, toothpaste:
In case of allergy to any of the constituents.
Precautions for use; special warnings
Be careful with FLUODONTYL 1350 mg, 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/day for all fluoride intakes combined and not exceeding 1 mg/day), account must be taken of the possible doses of toothpaste ingestion (60 to 30% between 3 and 7 years of age), 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/100g). 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 to 1500 ppm (100 to 150 mg/100g).
Check the fluoride content on the toothpaste label.
Precautions for use
For good oral health, it is necessary that you consult a dental surgeon regularly.
Interactions with other medicines
Taking or using other medicines
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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).
3. HOW TO USE FLUODONTYL 1350 mg, toothpaste
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
For adult use only.
Method of administration/Frequency of administration
Brush thoroughly daily,
- 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.
Follow the advice of your doctor or dental surgeon.
Local use. Do not swallow.
Duration of treatment
Follow the advice of your doctor or dentist.
Symptoms and instructions in case of overdose
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, FLUODONTYL 1350 mg, toothpaste is likely to have undesirable effects, although not everyone is subject to them.
Due to the presence of methyl parahydroxybenzoate, there is a risk of eczema and exceptionally, allergic reactions with urticaria and respiratory discomfort.
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 CONSERVE FLUODONTYL 1350 mg, toothpaste?
Keep out of the reach and sight of children.
Do not use FLUODONTYL 1350 mg, toothpaste after the expiry date stated on the box.
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 FLUODONTYL 1350 mg toothpaste contain?
The active substance is:
Sodium fluoride ........................................................................................................................... 3,000 g
Per 100 g.
The other components are: sodium lauryl sulfate, sodium hexametaphosphate, disodium phosphate, hydrated silica, sodium carrageenan, 70 percent sorbitol, sodium saccharin, Italo-Mitcham peppermint essential oil, levomenthol, Chinese star anise essential oil, Ceylon cinnamon essential oil, eugenol, titanium dioxide, methyl parahydroxybenzoate, purified water
100 g of toothpaste contains 1.350 g of fluoride.
Pharmaceutical form and content
What is FLUODONTYL 1350 mg toothpaste and what does it contain?
Toothpaste, 6 ml and 75 ml tube.
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 Maréchal 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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