NOTICE
ANSM - Updated: 23/02/2017
Name of the drug
FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste
Sodium monofluorophosphate
Sodium fluoride
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your dentist or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If any of the side effects occur, talk to your 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.
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste and when is it used?
2. What you need to know before taking FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste?
3. How to take FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste?
4. What are the possible side effects?
5. How to store FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste?
6. Contents of the package and other information.
1. WHAT FLUOCARIL BI-FLUORATE 250 mg MINT, toothpaste AND WHAT IT IS USED FOR
Pharmacotherapeutic class
ANTICARIAN PROPHYLACTIC DRUGS
Therapeutic indications
FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste contains fluorine in the form of two salts: sodium fluoride and sodium monofluorophosphate. This medicine is recommended to prevent tooth decay.
You should talk to your doctor if you do not feel better or if you feel worse.
2. BEFORE YOU TAKE FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste?
Never use FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste:
If you are allergic (hypersensitive) to sodium fluoride, sodium monofluorophosphate or any of the other ingredients of this medicine, listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using FLUOCARIL BI FLUORE 250 mg MINT, toothpaste:
· The local use of fluoridated toothpastes or fluoridated mouthwashes is perfectly compatible with fluoride intake in general; it reinforces the protection of the tooth against decay.
· However, the multiplication of potential sources of fluoride may cause 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 of fluorine / kg / day, all fluoride intake combined and not exceeding 1 mg / day), it is necessary to take into account the possible doses of toothpaste ingestion (60 to 30 mg / day). % between 3 and 7 years), which will vary according to the age and concentration of the dough used.
· Children under 6 years old should use toothpastes with a fluorine 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.
· This medicine contains methyl parahydroxybenzoate (E218) and may cause allergic reactions.
· Due to the presence of sodium benzoate (E211), this medicine may cause irritation of the skin, eyes and mucous membranes.
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.
For good oral health, it is necessary that your child consults regularly with a dentist.
Children and adolescents
Not applicable.
Other medicines and FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste with food and drink 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.
FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste contains methyl parahydroxybenzoate (E218) and sodium benzoate (E211).
3. HOW TO TAKE FLUOCARIL BI-FLUORA 250 mg MINT, toothpaste?
Always use this medicine exactly as your pharmacist or dentist has told you.
Check with your pharmacist or dentist if in doubt.
Dosage
Oral way. Do not swallow.
It is recommended for adults and children over 10 years of age 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 FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste than you should:
See your doctor immediately. Symptoms of overdose may include vomiting, diarrhea, and stomach pain.
If you forget to take FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste:
Not applicable.
If you stop taking FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste:
Not applicable.
If you have any further questions about the use of this medicine, ask your 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.
The expected side effects are mainly due to the presence of methyl parahydroxybenzoate.
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.
· Gastrointestinal disorders:
Oral irritation
· Skin and subcutaneous disorders:
Allergic reactions and urticaria in exceptional cases.
Reporting of side effects
If you get any side effects, talk to your dentist, 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 on the safety of the medicine.
5. HOW TO STORE FLUOCARIL BI-FLUORE 250 mg MINT, 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 FLUOCARIL BI-FLUORE 250 mg MINT contains, toothpaste
· The active substances are:
Sodium monofluorophosphate ............................................... ........................................... 0.7600 g
Sodium fluoride ............................................... .................................................. ............ 0.3315 g
For 100 g.
100 g of toothpaste contains 250 mg or 2500 ppm of fluoride.
· The other excipients are:
Sodium benzoate (E211), sodium lauryl sulphate, disodium phosphate, sodium hexametaphosphate, Neuburg silica, silica for dental use (E551), carrageenan (E407), non-crystallizable 70% sorbitol (E420), sodium saccharin (E954) , peppermint essential oil (Italo-Mitcham), star anise essential oil, levomenthol, phenol, eugenol, Ceylon cinnamon essential oil, titanium dioxide (E171), methyl parahydroxybenzoate (E218), purified water.
What FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste looks like and contents of the pack
This medicament is in the form of a toothpaste in 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 dosing bottles of 112.50 g (90 ml) or 112.50 g (100 ml).
Not all presentations may be marketed.
Marketing Authorization Holder
PROCTER & GAMBLE PHARMACEUTICALS FRANCE
163-165 QUAI AULAGNIER
92600 ASNIERES SUR SEINE
Operator of the marketing authorization
PROCTER & GAMBLE PHARMACEUTICALS FRANCE
163-165 QUAI AULAGNIER
92600 ASNIERES SUR SEINE
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). www.ansm.sante.fr