NOTICE
ANSM - Updated on : 01/08/2023
Product name
FLUOR OLIGOSOL, drinkable solution in ampoule
Sodium fluoride
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is FLUOR OLIGOSOL, drinkable solution in ampoule and what is it used for?
2. What do I need to know before taking FLUOR OLIGOSOL, solution for drinking in phials?
3. How should FLUOR OLIGOSOL be taken?
4. What are the possible side effects?
5. How should FLUOR OLIGOSOL be stored?
6. Package contents and other information.
1. WHAT IS FLUOR OLIGOSOL, drinkable solution in ampoule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OLIGOTHERAPY (V: miscellaneous).
This medicine contains fluorine. It is used in adults as a ground modifier, particularly for minor ligament injuries.
2. WHAT DO I HAVE TO KNOW BEFORE taking FLUOR OLIGOSOL, oral solution in ampoule?
Never take FLUOR OLIGOSOL, solution for drinking in phials:
- if you are allergic (hypersensitive) to sodium fluoride or to any of the other ingredients of this medicine, as listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking FLUOR OLIGOSOL, solution buvable en ampoule.
Children
Not applicable.
Other medicinal products and FLUOR OLIGOSOL, solution for drinking in phials
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
FLUOR OLIGOSOL, solution for drinking in phials with food and drink
Not applicable.
Pregnancy and breast-feeding
As a precautionary measure, this drug should not be used during pregnancy or while breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and use of machinery
Not applicable.
FLUOR OLIGOSOL, solution for drinking in phials contains glucose.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
3. HOW SHOULD FLUOR OLIGOSOL be taken?
FOR ADULTS ONLY.
The recommended dose is 1 to 2 phials per day.
Oral route.
Sublingual administration is recommended: keep the contents of the ampoule under the tongue for 1 to 2 minutes before swallowing.
Ampoules should be taken :
- preferably in the morning on an empty stomach,
- 15 minutes before a meal or in the evening at bedtime.
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Instructions for opening the ampoule :
Break off the 2 tips at the coloured ring.
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If you have taken more FLUOR OLIGOSOL, solution for drinking in phials than you should have :
Consult your doctor or pharmacist immediately.
Doses in excess of 1 mg per day (i.e. 5 ampoules) may cause yellowish or brownish spots to appear on dental enamel.
If you forget to take FLUOR OLIGOSOL, oral solution in phials
Not applicable.
If you stop taking FLUOR OLIGOSOL, solution for drinking in phials
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE FLUOR OLIGOSOL, oral solution in ampoule?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
Store at temperatures not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What FLUOR OLIGOSOL ampoule solution contains
- The active substance is :
Sodium fluoride............................................................................................................ 0.442 mg
(Corresponding fluoride quantity...................................................................................... 0.200 mg)
For one 2-ml ampoule.
- Other components are: glucose and purified water.
What FLUOR OLIGOSOL, solution buvable en ampoule is and what it contains
FLUOR OLIGOSOL is available as a 2 ml solution in ampoules, in boxes of 14 or 28 ampoules.
Marketing authorization holder
LABCATAL
1198 AVENUE DU DOCTEUR MAURICE DONAT
ZAC DU FONT DE LORME
06250 MOUGINS
Marketing authorization holder
LABORATOIRE DES GRANIONS
LE PARADOR II
5 ALLEE CROVETTO FRERES
98000 MONACO
Manufacturer
LABCATAL
ZONE INDUSTRIELLE DU MONT-BLANC
1, RUE DE LINDUSTRIE
74106 ANNEMASSE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed later by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.