DURAPHAT 2800 PPM FLUORIDE

Main information

  • Trade name:
  • DURAPHAT 2800 PPM FLUORIDE
  • Dosage:
  • 0.619 %w/ w
  • Pharmaceutical form:
  • Toothpaste
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DURAPHAT 2800 PPM FLUORIDE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0320/008/001
  • Authorization date:
  • 04-03-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Duraphat2800ppmFluorideToothpaste

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtubecontainssodiumfluoride0.619%w/w(2800ppmfluoride).

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Toothpaste

Smoothwhitepaste.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthepreventionandtreatmentofdentalcariesanddemineralisationinadultsandchildrenover16years,whoareat

highriskofdevelopingcaries.

4.2Posologyandmethodofadministration

Adultsandchildrenover16yearsold:Usedailyinsteadofthenormaltoothpaste.Theusualdosageistoapplyalineof

paste(about1g)acrosstheheadofatoothbrushandbrushtheteeththoroughlyforoneminutemorningandevening.

Spitoutafteruse;forbestresultsdonoteat,drinkorrinsefor30minutes.

Childrenunder16years:notrecommended.

Elderly:useasforadults.

4.3Contraindications

Noneknown.

Individualswithknownhypersensitivityshouldconsulttheirdentistbeforeusing.

Nottobeusedinchildrenunder16yearsold.

4.4Specialwarningsandprecautionsforuse

Nottobeswallowed.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

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Date Printed 24/07/2006 CRN 2025856 page number: 1

4.6Pregnancyandlactation

Notapplicable.

4.7Effectsonabilitytodriveandusemachines

Whenusedasrecommendedtherearenosideeffects.

4.8Undesirableeffects

Notapplicable.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ThisproductisatoothpasteinwhichtheactiveingredientisSodiumFluoridepresentatalevelof0.619%which

correspondsto280mgfluorideper100gpaste.

Sodiumfluorideappliedtopicallyaftertootheruptionreducescariesbyinhibitingdemineralisationandpromoting

remineralisationofthetoothsurface.

5.2Pharmacokineticproperties

Thisproductisnotintendedtobeswallowedandthereforeonlyminimalsystemicexposureisexpected.

5.3Preclinicalsafetydata

Thetotalamountofsodiumfluorideina75mltubeofDuraphat2800isabout620mgwhichequatesto280mg

fluoride.Thisiswithintheacceptablelimitsfortheamounttobesuppliedatonetimeforsafetypurposes.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol

Purifiedwater

Sorbitol

Hydratedsilicas

Macrogol600

Sodiumlaurilsulfate

Carmellosesodium

Flavour

Titaniumdioxide(E171)

Saccharinsodium

6.2Incompatibilities

Irish Medicines Board

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Date Printed 24/07/2006 CRN 2025856 page number: 2

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Aluminiumtubeswithanepoxy-phenoliclacquercoatingwhichisresistanttoacidandalkalinepH.Theclosureisa

whitepolypropylenescrewcap.

Tubescontain15ml,50mlor75mloftoothpaste.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Colgate-Palmolive(UK)Ltd

GuildfordBusinessPark

MiddletonRoad

Guildford

Surrey,GU25LZ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA320/8/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:04March1999

Dateoflastrenewal:04March2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 24/07/2006 CRN 2025856 page number: 3