ANBESOL ANAESTHETIC ANTISEPTIC

Main information

  • Trade name:
  • ANBESOL ANAESTHETIC ANTISEPTIC
  • Dosage:
  • 0.9/0.1/0. Unknown
  • Pharmaceutical form:
  • Oromucosal Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANBESOL ANAESTHETIC ANTISEPTIC
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1138/025/001
  • Authorization date:
  • 13-04-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AnbesolAnaestheticAntisepticOromucosalSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Excipients:Each1mloftheproductcontains2.76microgramsofamaranth(E123)and2.58microgramsofsunset

yellow(E110)and68.239%w/wofethanol96%w/v.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

OromucosalSolution

Aclearyellowliquid.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Properties:

Alocalanaesthetic/antisepticcombination.

Indicationsforuse:

Inthesymptomaticreliefofmouthulcersandsoregums.

4.2Posologyandmethodofadministration

Forpatientsof10yearsandover:

Applytotheaffectedarea3-4timesdailyorasdirectedbythephysicianordentist.

4.3Contraindications

Patientswithaknownhistoryofhypersensitivityorallergictypereactionstoanyoftheconstituentsoftheproduct.

4.4Specialwarningsandprecautionsforuse

LidocaineHydrochloride 0.90 %w/w

Chlorocresol 0.10 %w/w

CetylpyridiniumChloride 0.02 %w/w

1.Ifthereisnoimprovementin3days,consultyourdoctorordentist.

2.Donotpersistwithanymedicationifresultsseemunsatisfactory,exceptondoctor’sadvice.

3.Donotexceedthestateddose.

Keepallmedicinesoutofthereachofchildren.

Thisproductcontainstheazodyes;amaranth(E123)andsunsetyellow(E110)whichmaycauseallergic

reactionsinsensitiveindividuals.

Thismedicinalproductcontains68vol%ethanol(alcohol)i.e.upto546mgpermlequivalentto10.9mlbeeror

4.6mlwineperml.Tobetakenintoaccountinpregnantorbreast-feedingwomen,children,andhighriskgroups

Irish Medicines Board

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Date Printed 13/04/2012 CRN 2094740 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Noneknown.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Therehavebeenreportsofnon-specificulcerationfollowingoralcetylpyridiniumchloridetherapy.

4.9Overdose

Ingestionofthecompletecontentsofthemarketpackshouldnotbeexpectedtocauseanyadverseeffects.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Lidocainehydrochloride:

Whitecrystallinepowdersolubleinwaterandalcohol.

Mechanismofaction/effect:

Lidocaineisalocalanaestheticoftheamidetypewhichactsbyreversibleinhibitionofnerveimpulsegenerationand

transmission.

Chlorocresol:

Colourlesscrystalsorawhitecrystallinepowderslightlysolubleinwaterandalcohol.

Mechanismofaction/effect:

Chlorocresolhasadisinfectantaction.

Cetylpyridiniumchloride:

Awhiteunctuouspowdersolubleinwaterandalcohol.

Mechanismofaction/effect:

Cetylpyridiniumchloridehasadisinfectantaction.

5.2Pharmacokineticproperties

Lidocainehydrochloride:

Lidocaineisreadilyabsorbedfrommucousmembranesandthroughdamagedskin.Lidocaineundergoesfirst-pass

metabolismintheliverandabout90%isdealkylatedtoformmonoethylglycinexylidideandglycinexylidide.Further

metabolismoccursandthemetabolitesareexcretedintheurinewithlessthan10%asunchangedlidocaine.

Chlorocresolandcetylpyridiniumchloride:

Absorption:Thereisnosignificantabsorptionofchlorocresolorcetylpyridiniumchloridethroughtheskinormucous

Irish Medicines Board

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Date Printed 13/04/2012 CRN 2094740 page number: 2

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethanol

Levomenthol

Glycerol

CaramelColour[ComprisedofQuinolineYellow(E104),Amaranth(E123),Sunsetyellow(E110)&GreenS(E142)]

PurifiedWater

6.2Incompatibilities

Noneknown.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Glassbottlewithscrewthreadedwaddedplasticcapscontaining6.5mlor15mlofproduct.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

SSLInternationalplc

Venus

1OldParkLane

TraffordPark

Manchester

M417HA

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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Date Printed 13/04/2012 CRN 2094740 page number: 3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

Dateoflastrenewal:01April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 13/04/2012 CRN 2094740 page number: 4