ACNECIDE

Main information

  • Trade name:
  • ACNECIDE Gel 10 %w/ w
  • Dosage:
  • 10 %w/ w
  • Pharmaceutical form:
  • Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACNECIDE Gel 10 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0590/007/002
  • Authorization date:
  • 17-12-1992
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0590/007/002

CaseNo:2047174

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

Galderma(UK)Ltd

MeridienHouse,69-71ClarendonRoad,Watford,HertsWD171DS,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Acnecide10%w/wGel

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom11/03/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 12/03/2008 CRN 2047174 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Acnecide10%w/wGel

2QUALITATIVEANDQUANTITATIVECOMPOSITION

HydrousbenzoylperoxideequivalenttoBenzoylPeroxide10%w/w.

Excipient:Propyleneglycol40mg/g

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Gel.

White,smoothgel.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Acnecideisindicatedinthemanagementofacnevulgaris.

4.2Posologyandmethodofadministration

Topicaladministrationonly.

Adultsandchildren:

Afterwashingwithamildcleanserandwater,applyonceortwicedailyorasdirectedtotheaffectedareas.Thedegree

ofdryingandpeelingcanbeadjustedbymodificationofthedosageschedule.Itisrecommendedtoinitiatethe

treatmentwithAcnecideGel5%.Incaseadequateresultsarenotachievedwiththe5%gel,treatmentwiththe10%gel

maybestarted.Personswithsensitiveskinshouldbedirectedtoapplythegeloncedailybeforegoingtobed.

4.3Contraindications

Useinpatientshypersensitivetobenzoylperoxide.

4.4Specialwarningsandprecautionsforuse

Forexternaluseonly.

Ifnoresponseoccurswithinfourweekstheuseoftheproductshouldbediscontinuedandadoctorconsulted.In

anyeventasinglecourseoftreatmentshouldnotextendbeyondthreemonths.

Thisproductshouldbekeptfromcontactwitheyes,mouth,anglesofthenoseormucousmembranes.If

accidentalcontactoccurs,rinsewithwater.

Irish Medicines Board

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Fair-skinnedindividualsarelikelytobeparticularlysusceptibletoirritation.

Ifunduerednessordiscomfortoccurstheproductshouldnotbeuseduntilthedoctorhasbeenconsulted.

Acnecidemaybleachhairandcolouredfabrics.

ConcurrentusewithPABA-containingsunscreensmayresultintransientdiscolorationoftheskin.

DuetotheriskofsensitisationAcnecidegelshouldnotbeappliedtodamagedskin.

CautionshouldbeexercisedwhenapplyingAcnecideGeltotheneckandothersensitiveareas.

Duringthefirstweeksoftreatment,asuddenincreaseinpeelingwilloccurinmostpatients,thisisnotharmful

andwillnormallysubsidewithinadayortwoiftreatmentistemporarilydiscontinued.Ifsevereirritationoccurs,

patientsshouldbedirectedtousethemedicationlessfrequently,totemporarilydiscontinueuseortodiscontinue

usealtogether.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Therearenoknowninteractionswithothermedicationswhichmightbeusedcutaneouslyandconcurrentlywith

AcnecideGel.However,drugswithdesquamative,irritantanddryingeffectsshouldnotbeusedconcurrentlywith

AcnecideGel.

4.6Pregnancyandlactation

Thereisalackoftherapeuticexperienceofbenzoylperoxideinpregnancyandlactationandassuchitshouldnotbe

usedunlessconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Basedonthepharmacodynamicprofileandextensiveclinicalexperience,performancerelatedtodrivingandusing

machinesshouldnotbeaffectedduringtreatmentwithAcnecideGel.

4.8Undesirableeffects

Applicationofbenzoylperoxidemayproduceaninitialstingingeffect.

Aswithallkeratolyticsubstances,itching,reddening,burning,peelingofskinandafeelingofskintensionmayoccur.

Thismayberelievedbytheuseofamoisturisingcreamorbytemporaryinterruptionofuse.

Inrarecases,acontactdermatitisincludingfaceoedemamayoccur,inwhicheventtreatmentshouldbestopped

immediately.

4.9Overdose

Overdosagemaycausetheskintobecomeexcessivelyredandsoreduringthefirstfewdaysoftreatment.Acnecide

Gelshouldbeappliedlessoftenuntilthisphasehaspassed.Ifexcessiveirritationdevelops,discontinuetreatmentand

consultthephysician.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Irish Medicines Board

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IthasbeenshowntobeeffectiveinreducingthelocalpopulationofPropionibacteriumacnes,leadingtoareductionin

theproductionofirritantfattyacidsinthesebaceousglands.

5.2Pharmacokineticproperties

Thepharmacokineticcharacteristicsforbenzoylperoxidehavenotbeenestablishedandlittleisknownaboutthe

percutaneouspenetration,metabolismandexcretionofbenzoylperoxide,althoughitislikelythatbenzoicacidisa

majormetabolite.

5.3Preclinicalsafetydata

Thereisnoevidenceofsystemictoxicitycausedbybenzoylperoxideinhumans.Inanimalstudiesbythecutaneous

route,benzoylperoxideisassociatedwithaminimaltomoderateskinirritationpotentialincludingerythemaand

oedema.Phototoxicandphotoallergicreactionshavebeenreportedforbenzoylperoxidetherapy.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Docusatesodium

Disodiumedetate

Poloxamer182

Carbomer

Propyleneglycol

Acrylatescopolymer

Glycerol

Colloidalanhydroussilica

PurifiedWater

SodiumhydroxidetoadjustthepH

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Donotfreeze.

6.5Natureandcontentsofcontainer

Whitelowdensitypolyethylenetubeswithwhitepolypropylenescrewcapscontaining60ggel.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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7MARKETINGAUTHORISATIONHOLDER

Galderma(UK)Limited

MeridienHouse

69-71ClarendonRoad

Watford

Herts

WD171DS

8MARKETINGAUTHORISATIONNUMBER

PA590/7/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:17 th

April1984

Dateoflastrenewal:31 st

October2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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