Zymafluor 0.50 mg helps prevent cavities in children and adults. Its sodium fluoride strengthens teeth and protects against demineralization.
Zymafluor 0.50 mg, tablet is a sodium fluoride-based medication specifically designed to prevent tooth decay in children at high risk of caries. Its role is to strengthen tooth enamel, helping to reduce the risk of demineralization and caries. Children aged 2 to 4, with a history of cavities or eating habits conducive to decay, benefit particularly from this product.
In addition to protecting against dental caries, Zymafluor is also recommended for preventing root caries in adults, a condition often caused by receding gums. This treatment is particularly beneficial for adults at increased risk of root caries, enabling them to maintain optimal oral health.
Fluoride, the main ingredient in Zymafluor, acts by forming a protective barrier on the teeth. This not only strengthens teeth, but also reduces the appearance of white stains, a frequent consequence of fluoride deficiency. Zymafluor fits perfectly into an oral hygiene routine that includes regular brushing with fluoride toothpastes.
By using Zymafluor, users can ensure additional prevention against cavities, as a complement to good dietary habits. However, it is important to follow your healthcare professional's instructions to adapt the dose according to fluoride intake from water or other food sources.
For optimum protection of your child's dental health, or your own teeth, Zymafluor 0.50 mg is an essential ally to include in your daily dental care routine, ensuring enhanced defense against caries and the damaging effects of demineralization. As a complement to good oral hygiene, Zymafluor helps maintain a radiant smile and perfectly healthy teeth.
In addition, Zymafluor 0.50 mg acts as a preventive shield, strengthening tooth enamel against acidic aggression caused by food and oral bacteria. This protection not only strengthens teeth, but also limits the proliferation of cariogenic bacteria, often responsible for the formation of plaque and deep caries. Its balanced formulation makes it suitable for daily use to maintain robust dental health. By ensuring controlled fluoride administration, Zymafluor is an effective part of a comprehensive preventive strategy, particularly beneficial for growing children, where dental development is crucial.
We recommend that you combine Zymafluor 0.50 mg with a balanced diet for healthy teeth and gums.
We also offer Sterogyl Vitamin D Oral Solution 20ml at the best price in our online pharmacy.
In children, Zymafluor should be administered at the rate of 1 tablet a day, ideally after a fluoride intake assessment by a healthcare professional. For children under 6, we recommend dissolving the tablet in a little water before administration. For adults, the tablet should be allowed to melt slowly in the mouth for optimum fluoride absorption. Do not exceed the recommended daily dose.
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Precautions for use :
Sodium Fluoride, Magnesium Stearate, Sorbitol, Peppermint Essential Oil, Yellow Iron Oxide, Colloidal Silica, Colorant Mix (Red Iron Oxide, Yellow Iron Oxide, Black Iron Oxide, Titanium Dioxide).
Presentation
Zymafluor 0.50 mg is presented as tablets in a polyethylene tube. Each box contains 100 tablets, designed for long-term use.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on : 02/08/2024
Product name
ZYMAFLUOR 0.50 mg, tablet
Sodium fluoride
Sidebar
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any of the side effects, please tell 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 ZYMAFLUOR 0.50 mg, tablet and what is it used for?
2. What do I need to know before taking ZYMAFLUOR 0.50 mg, tablet?
3. How do I take ZYMAFLUOR 0.50 mg, Tablet?
4. What are the possible side effects?
5. How do I keep ZYMAFLUOR 0.50 mg, Tablet?
6. Package contents and other information.
1. WHAT IS ZYMAFLUOR 0.50 mg, tablet AND WHAT IS IT USED FOR?
Anti-caries prophylactics - ATC code: A01AA01
This medicine contains fluorine.
- Prevention of dental caries in children at high risk of caries, following a personalized assessment of fluoride intake.
NB: high caries risk means a history of caries (personal, parental or sibling), failure to comply with dietary or oral hygiene rules, or environmental risk factors.
This medication is particularly suitable for children aged 2 to 4.
- Prevention of root caries in adults (tooth root caries in the event of loosening)
2. WHAT DO I HAVE TO KNOW BEFORE TAKING ZYMAFLUOR 0.50 mg, tablet?
Never take ZYMAFLUOR 0.50 mg, tablet :
- if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine, as listed in section 6.
- in case of severe renal insufficiency.
- in regions where fluoride levels in tap water exceed 0.3 mg/L. In France, 85% of the population lives in regions where fluoride levels are less than or equal to 0.3 mg/L. In case of doubt, you can obtain the local fluoride level in the water supply from your town hall or the Direction Départementale des Affaires Sanitaires et Sociales (DDASS).
Warnings and precautions
Take special care with ZYMAFLUOR 0.50 mg, tablet
Advice to follow in addition to using this medicine
Taking this medicine does not exclude good oral and dietary hygiene. You should therefore follow the recommendations below:
- Limit your intake of sugars, especially snacking and sweetened drinks between meals.
- Brush your teeth after every meal with a toothpaste containing age-appropriate fluoride.
- Consult a dentist regularly.
Precautions to take to avoid fluoride overdose
For children
If you give your child too much fluoride for several months or years, you may develop a tooth disease called dental fluorosis (small white or opaque spots).
Children and adults
The use of fluoride-containing products such as ZYMAFLUOR must be adapted to other fluoride intakes, and in children to their age. Therefore, before taking this medicine, you should check the amount of fluoride you may have received from bottled water, tap water, fluoridated salt, medicines in tablet or drop form, fluoride chewing gum or fluoride-containing toothpaste.
Your doctor or dental surgeon should draw up a personalized fluoride intake report with you before giving you this medicine.
Information on drinking and bottle water consumption
- In some regions, tap water has a fluoride concentration in excess of 0.3 mg/l. If this is the case, you should not take or give your child fluoride-based medicines such as ZYMAFLUOR(see "Never take ZYMAFLUOR 0.50 mg, tablet").
- For infants, do not use mineral water containing more than 0.3 mg fluoride per liter of water for bottle preparation if you are giving your child a fluoride-containing medicine such as ZYMAFLUOR. Check the fluoride content on the bottle label.
Information on toothpaste use
- Using a toothpaste with an age-appropriate fluoride level is compatible with taking a fluoride-containing medication such as ZYMAFLUOR. This helps protect teeth against decay.
- Children under 6 years of age should use toothpastes with a fluoride content of less than or equal to 50 mg fluoride per 100 g toothpaste (i.e. 500 ppm). The amount to be used should be the size of a pea, and children should spit out the toothpaste well.
- Children aged 6 and over can use toothpastes with a fluoride content of between 100 and 150 mg fluoride per 100 g toothpaste (i.e. 1000 to 1500 ppm).
- Check the fluoride content indicated on the toothpaste.
Information on the use of fluoride salt
Fluoride-containing salt consumed with meals provides around 0.25 mg of fluorine per day. This salt is labelled "sel fluoré" (fluoride salt is sold with other cooking salts).
Children
Not applicable.
Other medicines and ZYMAFLUOR 0.50 mg, tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ZYMAFLUOR 0.50 mg, tablet with food and drink
Not applicable.
Pregnancy and breast-feeding
There is no benefit to your child's teeth from taking fluoride during pregnancy or while breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
ZYMAFLUOR 0.50 mg, tablet contains sorbitol (E420).
This medicine contains 47.205 mg sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has informed you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), please consult your doctor.ditary fructose intolerance (IHF), a rare genetic disorder characterized by the inability to break down fructose, talk to your doctor before you (or your child) take or receive this medication.
This medication contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".
3. HOW TO TAKE ZYMAFLUOR 0.50 mg, Tablet
Dosage
For children
Always follow the dose indicated by your doctor or dental surgeon.
The daily dose should take account of the patient's age and the fluoride concentration in drinking water and other sources (e.g. toothpaste).
If the fluoride concentration in drinking water is less than 0.3 mg/L: the usual daily dose is 1 tablet at 0.5 mg for children aged between 2 and 4 years.
If in doubt, consult your doctor or pharmacist.
For adults
Do not exceed the dose of 1.00 mg per day, i.e. 2 tablets of 0.50 mg.
Method and route of administration
This drug is taken orally.
For children
Avoid taking the tablet with a glass of milk, as the calcium contained in milk prevents fluoride from being properly absorbed.
From 6 months to at least 2 years of age, tablets must be dissolved in a little water before being given to your child.
As a general rule, tablets should not be used in children under the age of 6. However, given the small size of ZYMAFLUOR tablets, it is possible to give them to your child from the age of 2, provided he/she allows them to melt slowly in the mouth.
After 6 years, the tablets can be chewed or sucked.
For adults
Let the tablet melt slowly in the mouth, moving it regularly. Do not chew.
Directions for use :
Frequency of administration
In children, this medicine should generally be taken as a single dose per day.
In adults, tablets should be taken at intervals throughout the day.
Follow the advice of your doctor or dentist.
Duration of treatment
Your doctor or dentist will tell you how long to give your child this medicine.
If you have taken more ZYMAFLUOR 0.50 mg, tablet than you should have :
Consult your doctor or pharmacist immediately.
If you forget to take ZYMAFLUOR 0.50 mg, tablet :
Not applicable.
If you stop taking ZYMAFLUOR 0.50 mg, tablet :
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but these do not always occur in everyone.
- A few non-serious cases of agitation have been reported when taken in the evening (frequency unknown).
- A few cases of cutaneous reactions such as rash, urticaria or erythema have been reported (frequency unknown).
- A few cases of enamel discoloration have been reported after several years of treatment (frequency unknown).
- Hypersensitivity reactions including gastrointestinal symptoms (frequency unknown).
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 Centres Régionaux de Pharmacovigilance - Website: https: //signalement.social-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE ZYMAFLUOR 0.50 mg, tablet?
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.
This medicine must be stored in a dry place.
Do not dispose of any medicine in the sewage system or with household garbage. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ZYMAFLUOR 0.50 mg tablet contains
- The active substance is :
Sodium fluoride..................................................................................................... 1.105 mg
Quantity corresponding to fluorine................................................................................... 0.500 mg
For one tablet.
- Other components are: magnesium stearate, sorbitol (E420), peppermint essential oil, yellow iron oxide, colloidal silica, colorant mixture*.
*Composition of coloring agent: red iron oxide, yellow iron oxide, black iron oxide, titanium dioxide.
What ZYMAFLUOR 0.50 mg, tablet is and what it contains
Presented as a tablet in a polyethylene tube. Box of 100 tablets.
Not all presentations may be marketed.
Marketing authorization holder
ROTTAPHARM
1 BIS PLACE DE LA DEFENSE TOUR TRINITY
92400 COURBEVOIE
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Manufacturer
ROTTAPHARM LTD
DAMASTOWN INDUSTRIAL PARK
MULHUDDART
DUBLIN 15
IRELAND
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 subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
Ce médicament contient du fluor qui s'incorpore aux couches superficielles de l'émail dentaire et le rend plus résistant aux attaques des acides sécrétés par les bactéries de la plaque dentaire.
Les prix mentionnés ne tiennent pas compte des « honoraires de dispensation » du pharmacien.
La dernière mise à jour des informations contenues dans cette fiche médicament ne concerne que les présentations toujours commercialisées.
| p cp | p cp | p cp | |
| Fluorure de sodium | 0,55 mg | 1,10 mg | 2,21 mg |
| soit Fluor | 0,25 mg | 0,50 mg | 1 mg |
| Sorbitol | + | + | + |
Ce médicament ne doit pas être utilisé si la teneur en fluor de l'eau du robinet est supérieure à 0,3 mg/l.
L'utilisation de compléments fluorés sous forme de comprimé pour prévenir les caries chez les jeunes enfants, longtemps pratiquée, n'est plus recommandée, sauf risque de carie aggravé pour diverses raisons : antécédent de caries chez un enfant ou dans sa famille, non respect des règles d'hygiène alimentaire (grignotage ou consommation de boissons sucrées en dehors des repas, prise d'aliments au cours de la nuit...) ou buccodentaire (brossage des dents insuffisant ou inefficace...).
Certaines eaux de boissons ou sels de table sont riches en fluor. La dose optimale de fluor ne doit jamais dépasser 1 mg par jour, quel que soit le poids de l'enfant et tous apports confondus (sel, eau et dentifrice) pour éviter tout risque de coloration de l'émail dentaire (fluorose) ; l'utilité de ce médicament doit être réévaluée régulièrement par votre médecin ou votre dentiste.
Les enfants de moins de 6 ans doivent utiliser des dentifrices adaptés. Les jeunes enfants ont tendance à avaler une partie du dentifrice : il faut leur apprendre à ne pas utiliser trop de dentifrice (la grosseur d'un pois suffit).
Ce médicament n'a pas d'indication pendant la grossesse ou l'allaitement ; il n'y a pas de preuve que l'administration de fluor chez la mère pendant la grossesse ou l'allaitement comporte un bénéfice supplémentaire pour les dents de son enfant.
Les comprimés peuvent être croqués, sucés ou dissous dans un peu d'eau, en une seule prise quotidienne.
La meilleure prévention contre les caries reste le brossage après les repas avec un dentifrice fluoré adapté à l'âge, un suivi annuel par un dentiste, une limitation du grignotage de produits sucrés entre les repas, tout particulièrement sous forme de biscuits, de bonbons et de boissons sucrées (sodas...).
Fréquence indéterminée : agitation en cas de prise le soir, rougeur cutanée, urticaire, coloration de l'émail (après plusieurs années de traitement).
Affection guérie ou toujours en évolution. L'antécédent peut être personnel ou familial. Les antécédents constituent l'histoire de la santé d'une personne.
Organisme microscopique qui peut provoquer des infections. Contrairement aux virus, les bactéries sont généralement sensibles aux antibiotiques.
Pâte, poudre, gel ou liquide destiné à nettoyer les dents. Les dentifrices traitants, ou thérapeutiques, contiennent des substances qui renforcent l'action du brossage, protègent l'émail ou les gencives, dissolvent le tartre, etc.
Substance minérale qui possède la propriété de se fixer sur les os et sur les dents, et qui augmente leur dureté.
Consultez l'article : Fluor et Le fluor et la prévention des caries
La fréquence d'un effet indésirable est décrite dans les documents officiels de la manière suivante :
Enfant de un à 30 mois. Un enfant de moins de un mois est un nouveau-né.
Dépôt adhérent dans la bouche, élaboré par des bactéries qui sécrètent des acides et des enzymes toxiques pour les dents et les gencives.
Substance chimique dont la plus connue est le chlorure de sodium, ou sel de table. Le sel de régime ne contient pas de sodium ; celui-ci est remplacé généralement par du potassium.
Consultez l'article : Le sel, ami ou ennemi ?.
Substance minérale qui peut former des sels, notamment avec le chlore (chlorure de sodium, ou sel de table).
Le sorbitol est un sucre que l'on trouve dans certains fruits (les pruneaux par exemple). Parce qu'il est moins calorique que le sucre industriel (saccharose), il est utilisé comme édulcorant (sous le sigle E420) mais également comme stabilisateur, par exemple dans certains médicaments. Lors de la digestion, le sorbitol est transformé en fructose (sucre des fruits). Certaines personnes ont du mal à digérer le fructose et, de ce fait, présentent des troubles intestinaux (diarrhées) lorsqu'elles ingèrent un produit contenant du sorbitol.
Traitement destiné à prévenir une maladie (synonyme : prophylaxie), ou à limiter la fréquence des crises ou des poussées dans une maladie chronique.
Éruption de boutons sur la peau, dont l'origine est le plus souvent allergique. Les boutons ressemblent à des piqûres d'orties et leur couleur varie du rose pâle au rouge. L'urticaire peut apparaître ou disparaître en quelques minutes, et provoque d'intenses démangeaisons ; elle peut être localisée ou généralisée à la totalité de la surface cutanée.
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