NOTICE
ANSM - Updated: 19/07/2017
Name of the drug
FLUODONTYL 1350 mg, toothpaste
Sodium fluoride
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by a dentist or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor, dentist or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is FLUODONTYL 1350 mg toothpaste and what is it used for?
2. What information 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 store FLUODONTYL 1350 mg toothpaste?
6. Contents of the package and other information.
1. WHAT IS FLUODONTYL 1350 mg toothpaste AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: ANTICARCATED PROPHYLACTIC DRUGS - ATC code A01AA01.
FLUODONTYL 1350 mg toothpaste contains fluorine in the form of salt: sodium fluoride. This drug is recommended to prevent dental caries in patients at risk of polycaries.
You should talk to your doctor or dentist if you do not feel better or feel worse.
2. BEFORE YOU USE FLUODONTYL 1350 mg toothpaste?
Never use FLUODONTYL 1350 mg toothpaste:
· if you are allergic (hypersensitive) to sodium fluoride or any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using FLUODONTYL 1350 mg toothpaste .
• The local use of fluoridated toothpastes or fluoridated mouthwashes is perfectly compatible with general fluoride intake; it reinforces the protection of the tooth against decay.
• However, the multiplication of potential sources of fluoride can lead to fluorosis. In order to avoid cumulation, it is essential to draw up a personalized assessment of intake (drinking and mineral waters, fluoride salt, medicinal products in the form of tablets, drops, chewing gums or fluoridated toothpastes) before any fluoridated prescription. .
• In the overall calculations of the recommended intake of fluoride ion (0.05 mg fluorine / kg / day, all fluoride intake combined and not exceeding 1 mg / day), the possible doses of toothpaste ingestion (60 to 60 mg / day) should be taken into account. 30% between 3 and 7 years), which will vary according to the age and concentration of the dough used.
• Children under 6 years of age should use toothpastes with fluoride content less than or equal to 500 ppm fluorine (50 mg / 100 g). The amount to be used should be the size of a pea and children should spit the toothpaste well. From 6 years old, children can use toothpastes dosed from 1000 to 1500 ppm (100 to 150 mg / 100 g).
Check the fluoride level on toothpaste labeling.
• This medicine contains methyl parahydroxybenzoate (E218) and may cause allergic reactions.
For good oral health, it is necessary that you regularly consult a dentist.
Children and adolescents
Reserved for adults.
Other medicines and FLUODONTYL 1350 mg, toothpaste
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
FLUODONTYL 1350 mg, toothpaste with food, drinks and alcohol
Not applicable.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
FLUODONTYL 1350 mg toothpaste contains methyl parahydroxybenzoate (E218).
3. HOW TO USE FLUODONTYL 1350 mg, toothpaste?
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist or dentist. Check with your doctor, pharmacist or dentist if in doubt.
Dosage
Oral way. Do not swallow.
It is recommended to carry out a thorough daily brushing, 3 times a day, after each meal, in the vertical direction of the gum towards the end of the tooth.
Careful brushing takes about 3 minutes.
Duration of treatment
For the duration of the treatment, comply with the advice of your doctor or dentist.
If you have used more FLUODONTYL 1350 mg toothpaste than you should
Consult your doctor or your dentist immediately. Symptoms of overdose may be vomiting, diarrhea, and stomach pain.
If you forget to use FLUODONTYL 1350 mg, toothpaste
Not applicable.
If you stop using FLUODONTYL 1350 mg, toothpaste
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or dentist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects (Less than 1 in 10,000 patients)
• Immune system disorders:
Symptoms of hypersensitivity-type reactions, including symptoms of urticaria and difficulty breathing in exceptional cases.
• Skin and subcutaneous disorders:
Allergic reactions.
Reporting of side effects
If you get any side effects, talk to <<> your pharmacist> . This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE FLUODONTYL 1350 mg, toothpaste?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or tube. The expiry date refers to the last day of this month.
Store at a temperature not exceeding + 25 ° C.
Do not dispose of any medication at the sewer or with household waste. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What FLUODONTYL 1350 mg contains, toothpaste
· The active substance is:
Sodium fluoride ............................................... .................................................. ........ 3.00 g
For 100 g.
100 g of toothpaste contains 1350 mg or 13500 ppm of fluoride.
· The other components are:
Sodium Lauryl Sulfate, Sodium Hexametaphosphate, Disodium Phosphate, Silica for Dental Use (E551), Carrageenan (E407), Non-Crystalline 70% Sorbitol (E420), Sodium Saccharin (E954), Peppermint Essential Oil (Italo-Mitcham) , levomenthol, star anise essential oil, Ceylon cinnamon essential oil, eugenol, titanium dioxide (E171), methyl parahydroxybenzoate (E218), purified water.
What FLUODONTYL 1350 mg, toothpaste looks like and contents of the pack
This medicine is in the form of toothpaste, in tubes containing 6 ml and 75 ml.
Not all presentations may be marketed.
Marketing Authorization Holder
TRADIPHAR LABORATORY
176 ARBRISSEAU STREET
59000 LILLE
Operator of the marketing authorization
TRADIPHAR LABORATORY
176 ARBRISSEAU STREET
59000 LILLE
Maker
FAMAR ORLEANS
5 AVENUE OF CONCYR
F - 45071 ORLEANS
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).