ASCABIOL

Main information

  • Trade name:
  • ASCABIOL Cutaneous Emulsion 25 %w/ v
  • Dosage:
  • 25 %w/ v
  • Pharmaceutical form:
  • Cutaneous Emulsion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASCABIOL Cutaneous Emulsion 25 %w/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0040/062/001
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AscabiolEmulsion25%w/v

2QUALITATIVEANDQUANTITATIVECOMPOSITION

BenzylBenzoate25%w/v.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Acutaneousemulsion

Ahomogeneouswhiteemulsionwithacharacteristicodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofscabiesandpediculosis.

4.2Posologyandmethodofadministration

Scabies: Aftertotalbathing‘Ascabiol’emulsionshouldbeappliedtothewholebodyexcepttheheadandface.A

secondapplicationmayberepeatedwithin5daysoralternativelyitmaybeappliedonthreeoccasionsat12hourly

intervals.

Pediculosis: Theaffectedregionshouldbecoatedwith‘Ascabiol’emulsionfollowedbyawash24hourslater.This

mayberepeatedtwoorthreetimesinseverecases.

Foruseinchildrentheemulsionshouldbedilutedwithanequalvolumeofwater.Forinfantstheproportionof

emulsiontowatershouldbe1:3.

4.3Contraindications

Useinpatientswithaknownhypersensitivitytobenzylbenzoate.

4.4Specialwarningsandprecautionsforuse

Benzylbenzoatemustnotbeallowedtocomeintocontactwiththeeyes.

‘Ascabiol’causeslittleskinirritation,butmaycauseatransientburningsensation.Thisisusuallymild,butcan

occasionallybesevereinsensitiveindividuals.Intheeventofasevereskinreactionthepreparationshouldbewashed

offusingsoapandwater.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Ifthispreparationisaccidentallytakenbymouth,treatmentshouldconsistofgastriclavageortheadministrationofan

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/09/2006 CRN 2027924 page number: 1

4.6Pregnancyandlactation

Thereisaninadequateevidenceofthesafetyof‘Ascabiol’inhumanpregnancy,butithasbeeninwidespreadusefor

manyyearswithoutapparentillconsequences.Nevertheless‘Ascabiol’shouldnotbeusedduringpregnancyunless

consideredessential.Breastfeedingshouldbesuspendedduringtreatmentwith‘Ascabiol’.Feedingmayberestarted

aftertheemulsionhasbeenwashedoffthebody.

4.7Effectsonabilitytodriveandusemachines

Nonewhenusedasrecommended.

4.8Undesirableeffects

Ascabiolcauseslittleskinirritation,maycauseatransientburringsensation.Thisisusuallymildbutcanoccasionally

besevereinsensitiveindividuals.Intheeventofasevereskinreactionthepreparationshouldbewashedoffusingsoap

andwarmwater.Ascabiolisalsoirritatingtotheeyesthereforetheseshouldbeprotectedifitisappliedtothescalp.

4.9Overdose

IfAscabiolisaccidentallytakenbymouth,treatmentshouldconsistofgastriclavageortheadministrationofan

emetic.Ananticonvulsantshouldbegivenifnecessary,otherwisetreatmentissymptomatic.

Urinaryretentioninadultsandconvulsionsininfants,havebeenreportedfollowingexcessiveuseoftopicalbenzyl

benzoate.Thebodyshouldbewashedtoremoveexcessbenzylbenzoate.Otherwisetreatmentissymptomatic.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Benzylbenzoateisanacaricide,whicheliminatesAcarusscabiei,andisusedinthetreatmentofscabiesand

pediculosisinman.

5.2Pharmacokineticproperties

Nodataavailable.

5.3Preclinicalsafetydata

Noanimaldataareavailablerelatingto‘Ascabiol’.Theactiveingredienthasbeenusedwidelyformanyyears,without

apparentilleffects.Wheningested,benzylbenzoatemaycausestimulationoftheCNSandconvulsions.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Stearicacid

Trolamine

Terpineol

OilcinnamonleafCeylon

SiliconeMSantifoamA

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/09/2006 CRN 2027924 page number: 2

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Storebelow25°C.

6.5Natureandcontentsofcontainer

100mlTypeIIIamberglassbottlewithaluminiumpilfer-proof,screwcap.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Shakethebottlewellbeforeuse.

7MARKETINGAUTHORISATIONHOLDER

May&Baker

RPRHouse

50KingsHillAvenue

WestMalling

KentME194AH

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA40/62/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

Dateoflastrenewal:01April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/09/2006 CRN 2027924 page number: 3