FLUORIGARD GEL-KAM

Main information

  • Trade name:
  • FLUORIGARD GEL-KAM
  • Dosage:
  • 0.4 %w/w
  • Pharmaceutical form:
  • Oromucosal Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLUORIGARD GEL-KAM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0320/004/001
  • Authorization date:
  • 03-04-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FluorigardGel-Kam

2QUALITATIVEANDQUANTITATIVECOMPOSITION

StannousFluoride0.4%w/w.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Oralgel

Agelforapplicationtotheteethandgingivaeofhumanbeings.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanaidintreatmentandpreventionofdentalcariesanddecalcificationoftheteeth.

FluorigardGel-Kamgelwillpreventcaries,decalcificationanddemineralisationoftheteethwhenusedonadaily

basis.

FluorigardGel-Kamwillalsotreatandarrestactivesurfacecariesinenamelanddentinepreventingfurthercarious

breakdownofthedentition.

4.2Posologyandmethodofadministration

Recommendedforadultsandchildrenoversixyearsofage.Thedosageforchildren,adultsandtheelderlyisthesame.

ApplyFluorigardGel-Kamtoacleantoothbrush,asyouwouldatoothpaste,onceadayatbedtimeoraspartofthelast

regulartoothbrushingregimebeforeretiringtobed.BrushFluorigardGel-Kamontoallthetoothsurfaces;swish

aroundforoneminute,similartoarinse,pushingthegelbetweentheteethwiththetongueandcheekmuscles,then

spitouttheexcess.Donotswalloworrinseout.

MethodofAdministration:Fordentaluse.

4.3Contraindications

Hypersensitivitytooneormoreoftheingredients.

4.4Specialwarningsandprecautionsforuse

Donotusemorethantherecommendeddose.

Donotswallowtheexcessgel.

Donotuseonchildrenundersixyears.

Keepoutofthereachofchildren.

Closebottleafteruse.

Irish Medicines Board

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Date Printed 24/07/2006 CRN 2025845 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

StannousFluoridemaypotentiatetheefficacyofsodiumfluorideandacidulatedphosphatepreparationsinreducing

enamelsolubility.

Noknowninteractionswithfoodandalcohol.

4.6Pregnancyandlactation

FluorigardGel-Kamcanbeusedduringpregnancyandlactation.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

FluorigardGel-Kamwillnotstainintactenamelbuttheremaybesuperficiallightbrownpigmentationofplaqueifthe

teetharenotcleanedproperly.Thisiseasilyremovedbyprofessionalscalingandprophylaxis.Itmaybeminimisedby

theuseofaconventionaltoothpastepriortousingFluorigardGel-Kam.

4.9Overdose

Nonereported.

Symptomsinacutefluoridepoisoningaregastralgia,nausea,vomiting,tetany,muscleweakening(twitchingoften

occurs)collapse.

Emergencytreatmentconsistsof:

Emesisandgastriclavage.

Givemilkforitscalciumcontentandforitsdemulcentaction.Limewatermayalsobeused.

Solublecalciumsaltsaregivenintravenously.

Procainamidehydrochloride0.5to1.0gorallyorhalfofthisamountintravenouslyevery4to6hoursuntilthe

patientimproves.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

0.4%StannousFluoridepreventsandtreatsdentalcariesanddecalcificationbyincreasingtheresistanceoftheenamel

androotsurfacesoftheteethtoacidattack.Ofthefluoridesavailablefortopicalapplication,stannousfluoridehas

provedtobethefluorideofchoiceduetothefactthatthestannousioncombineswiththenaturallyoccurring

phosphateintheenameltoformstannousfluorophosphatewhichservesasaprotectivecoatingtothetooth.

5.2Pharmacokineticproperties

0.4%StannousFluorideshouldbeuseddailyforthemostefficaciousresults.Studieshaveshownthatifitisnotused

dailythentheincidenceofcariesmayincrease.Whenuseddaily,0.169mgoffluorideionmaybeingestedwhenthe

excessisexpectorated.Shouldthetotaldosageonastandardtoothbrushbeswallowedthen1.08mgoffluoridemaybe

Irish Medicines Board

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5.3Preclinicalsafetydata

Fluorideshavebeeninwidespreaduseindentalpracticeformanyyears.Safetyinmaniswelldocumentedtherefore

nostatementsonPreclinicalSafetyaremade.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol

Hydroxyethylcellulose

Crèmedementhe/MintflavourF-1328

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

6.5Natureandcontentsofcontainer

WhiteLDPEbottlefittedwithaflip-topandchildresistantpolyethyleneclosure.

Packsizes:50mland100ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Colgate-Palmolive(UK)Limited

GuildfordBusinessPark

MiddletonRoad

Guildford

SurreyGU28JZ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA320/4/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:03April1998

Irish Medicines Board

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10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 24/07/2006 CRN 2025845 page number: 4