NOTICE
ANSM - Updated on: January 26, 2023
Product Name
FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste
Sodium monofluorophosphate
Sodium fluoride
Box
Please read this package insert carefully before taking this medication, as it contains important information for you.
You should always use this medication exactly as described in this leaflet or as instructed by your dentist or pharmacist.
· Keep this leaflet. You may need to read it again.
· Ask your pharmacist for any advice or information.
· If you experience any side effects, tell your dentist or pharmacist. This also applies to any side effects not listed in this leaflet. See Section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse.
Keep this medication out of the reach of children.
What is in this package insert?
1. What is FLUOCARIL BI-FLUORE 250 mg MINT toothpaste, and what is it used for?
2. What should you know before using FLUOCARIL BI-FLUORE 250 mg MINT toothpaste?
3. How should you use FLUOCARIL BI-FLUORE 250 mg MINT toothpaste?
4. What are the possible side effects?
5. How should you store FLUOCARIL BI-FLUORE 250 mg MINT toothpaste?
6. Package contents and other information.
1. WHAT IS FLUOCARIL BI-FLUORE 250 mg MINT TOOTHPASTE AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
PROPHYLACTIC ANTI-CARIES MEDICATIONS
Therapeutic indications
FLUOCARIL BI-FLUORE 250 mg MINT toothpaste contains fluoride in the form of two salts: sodium fluoride and sodium monofluorophosphate.
This medication is recommended to prevent tooth decay. You should consult your doctor if you do not notice any improvement or if you feel worse.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE USING 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 in this medication listed in Section 6.
Warnings and Precautions
Consult your doctor or pharmacist before using FLUOCARIL BI-FLUORE 250 mg MINT toothpaste.
· The topical use of fluoride toothpaste or fluoride mouthwash is perfectly compatible with systemic fluoride intake; it enhances protection against tooth decay.
· However, an increase in the number of potential sources of fluoride may lead to fluorosis. To avoid cumulative exposure, it is essential to conduct a personalized assessment of fluoride intake (tap and mineral water, fluoridated salt, medications in the form of tablets, drops, chewing gum, or fluoride toothpaste) before prescribing any fluoride-containing products.
· In overall calculations of the recommended fluoride ion intake (0.05 mg of fluoride/kg/day for all fluoride sources combined, not to exceed 1 mg/day), one must take into account the potential amounts of toothpaste ingested (60 to 30% among children aged 3 to 7), which will vary depending on age and the concentration of the toothpaste 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 about the size of a pea, and children must be sure to spit out the toothpaste.
· This medication contains methyl parahydroxybenzoate (E218) and may cause allergic reactions.
· Due to the presence of sodium benzoate (E211), this product may cause irritation of the skin, eyes, and mucous membranes.
Children aged 6 and older may use toothpastes containing 1,000 to 1,500 ppm (100 to 150 mg/100 g).
Check the fluoride content on the toothpaste label.
For good oral health, it is important for your child to see a dentist regularly.
Children and Adolescents
Not applicable
Other medications 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 medications.
FLUOCARIL BI-FLUORE 250 mg MINT toothpaste with food, beverages, and alcohol
Not applicable.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, if you think you might be pregnant, or if you are planning to become pregnant, consult your doctor or pharmacist before taking this medication.
Athletes
Not applicable.
Driving and operating machinery
Not applicable.
FLUOCARIL BI-FLUORE 250 mg MINT toothpaste contains methyl parahydroxybenzoate (E218) and sodium benzoate (E211).
3. HOW SHOULD YOU USE FLUOCARIL BI-FLUORE 250 mg MINT TOOTHPASTE?
Be sure to always use this medication exactly as directed by your pharmacist or dentist.
Check with your pharmacist or dentist if you have any questions.
Dosage
For oral use. Do not swallow.
For adults and children over 10 years of age, it is recommended to brush thoroughly three times a day, after each meal, using vertical strokes from the gum line toward the tip of the tooth.
Thorough brushing takes about 3 minutes.
Duration of Treatment
Follow your doctor’s or dentist’s advice regarding the duration of treatment.
If you have used more FLUOCARIL BI-FLUORE 250 mg MINT toothpaste than you should have:
Consult your doctor immediately. Symptoms of an overdose may include vomiting, diarrhea, and stomach pain.
If you forget to use FLUOCARIL BI-FLUORE 250 mg MINT toothpaste
Not applicable.
If you stop using FLUOCARIL BI-FLUORE 250 mg MINT toothpaste
Not applicable.
If you have any other questions about the use of this medication, ask your pharmacist or dentist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, though not everyone experiences them.
The expected side effects are mainly due to the presence of methyl parahydroxybenzoate.
Very rare side effects (fewer than 1 in 10,000 patients)
· Immune system disorders:
Symptoms of hypersensitivity reactions, including hives and breathing difficulties in exceptional cases.
· Gastrointestinal disorders:
Oral irritation
· Skin and subcutaneous disorders:
Allergic reactions and hives in rare cases.
Reporting Side Effects
If you experience any side effects, tell your dentist or pharmacist. This also applies to any side effects not listed in this package insert. You can also report adverse effects directly through the national reporting system: the French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers—Website: www.signalement.social-sante.gouv.fr
By reporting side effects, you help provide more information on the safety of this medication.
5. HOW SHOULD FLUOCARIL BI-FLUORE 250 mg MINT TOOTHPASTE BE STORED?
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date printed on the package or tube. The expiration date refers to the last day of that month.
Store at a temperature not exceeding +25°C.
Do not dispose of any medication down the drain or with household trash . Ask your pharmacist how to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What FLUOCARIL BI-FLUORE 250 mg MINT Toothpaste Contains
· The active ingredients are:
Sodium monofluorophosphate ................................................................................. 0.7600 g
Sodium fluoride ...................................................................................................... 0.3315 g
Per 100 g.
100 g of toothpaste contains 250 mg, or 2,500 ppm, of fluoride.
· The other excipients are:
Sodium benzoate (E211), sodium lauryl sulfate, disodium phosphate, sodium hexametaphosphate, Neubourg silica, silica for dental use (E551), carrageenans (E407), 70% non-crystallizable 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 is FLUOCARIL BI-FLUORE 250 mg MINT, toothpaste, and outer packaging contents
This medication is available as a toothpaste in tubes containing 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 dispenser tubes containing 112.50 g (90 mL) or 112.50 g (100 mL).
Not all strengths may be marketed.
Marketing Authorization Holder
U-LABS
20 RUE DES DEUX GARES
92500 RUEIL-MALMAISON
Marketing Authorization Holder
U-LABS
20 Rue des Deux Gares
92500 RUEIL-MALMAISON
Manufacturer
DELPHARM ORLEANS
5 Avenue de Concyr
F 45071 ORLEANS
Drug Names in Member States of the European Economic Area
Not applicable.
The date this package insert was last revised is:
[to be completed later by the marketing authorization holder]
Other
Detailed information about this medication is available on the ANSM (France) website. www.ansm.sante.fr