ELUDRIL

Main information

  • Trade name:
  • ELUDRIL Mouth Wash 0.1 %w/ v
  • Dosage:
  • 0.1 %w/ v
  • Pharmaceutical form:
  • Mouth Wash
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ELUDRIL Mouth Wash 0.1 %w/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0329/001/001
  • Authorization date:
  • 25-06-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0329/001/001

CaseNo:2053168

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

PierreFabreMedicament

45PlaceAbelGance,92100Boulogne,Cedex,France

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

EludrilMouthwash1mg/ml

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom21/07/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 21/07/2010 CRN 2053168 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EludrilMouthwash1mg/ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1mlcontainschlorhexidinedigluconatesolution0.005ml(correspondingto1mgchlorhexidine

digluconate).

Thecontentofchlorhexidinedigluconatepermlwhendilutedasrecommendedis0.22mg/ml-0.33mg/ml

Excipients:containsCochinealRedA(E124)0.003g/100ml

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Mouthwash

Clear,pinkliquidwithanodourofmenthol.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanadjunctinthetopicalprophylaxisandmanagementofinflammationandminorinfectionsofthe

mouthandoralpharynx,includinguseafteroperativeordentalproceduresintheoropharynx.

4.2Posologyandmethodofadministration

Eludriliscontraindicatedininfantsandchildrenundersixyearsofage:seesection4.3.

Asamouthwash,dilute10to15mlinthemeasuring-cupprovidedforthispurposeandfillwithlukewarmwatertothe

upperlineanduseasamouthwashoragargletwoorthreetimesaday.

Routeofadministration

Oromucosaluse.(Thisproductisnotintendedtobeswallowed).

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Useininfantsandchildrenlessthan6yearsofage.

Usewithanionicagents:seesection4.5.

4.4Specialwarningsandprecautionsforuse

CochinealredAcancauseallergictypereactionsincludingasthma(allergyismorecommoninthosepeoplewho

areallergictoaspirin).

Irish Medicines Board

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Date Printed 21/07/2010 CRN 2053168 page number: 2

Keepoutoftheeyes.Ifthemouthwashcomesintocontactwiththeeyes,washoutpromptlyandthoroughlywith

water.

Donotswallow.

Ifthereisevidenceofirritationoraggravationofthecondition,thedoctorordentistshouldbeconsulted.

Discolorationofthetongue,teethandsilicateorcompositerestorationsmayoccur.Thisstainisnotpermanentandcan

largelybepreventedbybrushingwithaconventionaltoothpastedailybeforeusingthemouthwashor,inthecaseof

dentures,cleansingwithaconventionalcleanser.

Ifsymptomspersistformorethan5daysand/orintheeventofconcomitantfever,treatmentmustbere-assessed.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Chlorhexidineisincompatiblewithanionicagentswhichareusuallypresentinconventionaltoothpastes.

Therefore,thoroughrinsingofthemouth,aftertoothbrushingwithtoothpaste,shouldbedonebeforeusingEludril

mouthwash:seesection4.3.

4.6Pregnancyandlactation

Therearenoadequatedatafromtheuseofchlorhexidinedigluconateinpregnantorlactatingwomen.Therefore,use

duringpregnancyorlactationshouldbeavoidedunlessundertheguidanceofamedicalpractitioner.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.

4.8Undesirableeffects

4.9Overdose

Overdoseisnotexpectedundernormalconditionsofuseofthissolutionasamouthwash.

Shouldaccidentalingestionoccurchlorhexidinewhentakenorallyispoorlyabsorbed.Systemiceffectsareunlikely

eveniflargevolumesareingestedhowever,ifchlorhexidinepassesintothegeneralsystem,signsofneurological

toxicitymaydevelop.Thesemustbetreatedinaspecialisedenvironment.Gastriclavagemaybeadvisableusingmilk,

rawegg,gelatinormildsoap.Employsupportivemeasuresasappropriate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup: Anti-infectivesandantisepticsforlocaloraltreatment,

ATCcode:A01AB03

Broadspectrumantibacterial(gram+andgram-)andanti-fungalproductwithextendedbactericidalactivityonbuccal

Bodysystem Adversereactions(frequencynotknown)

Immunesystemdisorders Hypersensitivity

Nervoussystemdisorders Dysguesia:mayoccuroninitialuseofthemouthwash.This

disappearsaftertreatmentdiscontinuation

Gastrointestinaldisorders Tonguediscolouration(seesection4.4)

Toothdiscolouration(seesection4.4)

Irish Medicines Board

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5.2Pharmacokineticproperties

Veryweaksystemicabsorption,distributionmainlyvialiverandkidneys;littlemetabolism(nodegradationofthe

molecule).Eliminationmainlyinfaeces(99.5%oftheingesteddose)

5.3Preclinicalsafetydata

NoinformationfurthertothatcontainedinothersectionsoftheSPCisincluded.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Chlorobutanolhemihydrate

96%(v/v)ethanol

Glycerol

Docusatesodium

Alcoholicsolutionofmintessence

Levomenthol

CochinealredA(E124)

Purifiedwater

6.2Incompatibilities

Seesection4.5.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30 o

6.5Natureandcontentsofcontainer

TypeIIIglassbottleclosedwithanaluminiumscrewcaporPEcapfittedwithanLDPEsealingring,orPETbottle,

closedwithanaluminiumcaporPEcapfittedwithaLDPEsealingringandameasuringcupwitheitherprinted

measurementsorengravedmeasurements.

Packsizes:90ml,200ml,and500ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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Date Printed 21/07/2010 CRN 2053168 page number: 4

7MARKETINGAUTHORISATIONHOLDER

PierreFabreMedicament

45PlaceAbelGance

92100Boulogne

Cedex

France

8MARKETINGAUTHORISATIONNUMBER

PA329/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25June1999

Dateoflastrenewal:25June2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 21/07/2010 CRN 2053168 page number: 5