ACNECIDE WASH

Main information

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

Documents

Localization

  • Available in:
  • ACNECIDE WASH
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0590/007/004
  • Authorization date:
  • 31-10-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0590/007/004

CaseNo:2036964

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

Galderma(UK)Ltd

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

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AcnecideWash10%w/wGel

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom31/10/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 20/11/2007 CRN 2036964 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AcnecideWash10%w/wGel

2QUALITATIVEANDQUANTITATIVECOMPOSITION

HydrousBenzoylPeroxideequivalenttoBenzoylperoxide10%w/w.

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Gel.

Whitetooffwhitegel.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AcnecideWashisintendedforthecutaneoustreatmentofacnevulgarisoftheface,chestandback,wherecomedones,

papulespredominate.

4.2Posologyandmethodofadministration

Forcutaneous(topical)administrationonly.

Unlessotherwisedirected,AcnecideWashshouldbeappliedoncedailytocovertheaffectedskinareas.Wetthearea

tobetreated,applythepreparationtothehandsandwashtheaffectedareawiththegel.Contacttimewiththeskin

shouldbe1to5minutesfollowedbythoroughrinsingwithwateranddrying.

4.3Contraindications

Hypersensitivitytotheingredientsofthepreparation.

4.4Specialwarningsandprecautionsforuse

Innormaluse,amildburningsensationwillprobablybefeltonfirstapplicationandamoderatereddeningandpeeling

oftheskinwilloccurwithinafewdays.Duringthefirstweeksoftreatmentasuddenincreaseinpeelingwilloccurin

mostpatients,thisisnotharmfulandwillnormallysubsidewithinadayortwoiftreatmentistemporarily

discontinued.

Ifsevereirritationoccurs,patientsshouldbedirectedtousethemedicationlessfrequently,totemporarilydiscontinue

useortodiscontinueusealtogether.

AcnecideWashshouldnotcomeintocontactwiththeeyes,mouth,anglesofthenoseormucousmembranes.Ifthe

preparationenterstheeye,washthoroughlywithwater.CautionshouldbeexercisedwhenapplyingAcnecideWashto

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TherepeatedexposuretosunlightorUVirradiationshouldbeavoided.

Contactwithanycolouredmaterialincludinghairsanddyedfabricsmayresultinbleachingordiscoloration.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Therearenoknowninteractionswithothermedicationswhichmightbeusedcutaneouslyandconcurrentlywith

AcnecideWash.However,drugswithdesquamative,irritantanddryingeffectsshouldnotbeusedconcurrentlywith

AcnecideWash.

4.6Pregnancyandlactation

Therearenopublishedreportsrelatingtotheeffectsofbenzoylperoxideonreproductionfunction,fertility,

teratogenicity,embryotoxicity,orperi-andpost-nataldevelopmentinanimals.Inwidespreadclinicaluseforthe

cutaneoustreatmentofacnevulgaris,atconcentrationsupto10%w/wforseveraldecades,benzoylperoxidehasnever

beenassociatedwitheffectsontheseparametersinhumans.Althoughsafeforuseduringpregnancy,AcnecideWash

shouldonlybeusedbyapregnantwomanifclearlyneeded.

Itisnotknownwhetherbenzoylperoxideisexcretedinanimalorhumanmilk.Becausemanydrugsareexcretedin

humanmilk,cautionshouldbeexercisedwhenAcnecideisadministeredtoanursingwoman.Inthisevent,the

preparationshouldnotbeappliedonthechesttoavoidaccidentaltransfertotheinfant.

4.7Effectsonabilitytodriveandusemachines

Basedonthepharmacodynamicprofileandextensiveclinicalexperience,performancerelatedtodrivingandusing

machinesshouldnotbeaffectedduringtreatmentwithAcnecideWash.

4.8Undesirableeffects

Applicationofbenzoylperoxidemayproduceaninitialstingingeffect.

Aswithallkeratolyticsubstances,itching,reddening,burning,peelingofskinandafeelingofskintensionmayoccur.

Thismayberelievedbytheuseofamoisturisingcreamorbytemporaryinterruptionofuse.

Inrarecases,contactdermatitisincludingfaceoedemamayoccur,inwhicheventtreatmentshouldbestopped

immediately.

4.9Overdose

AcnecideWashisforcutaneoususeonly.Ifthemedicationisappliedexcessively,nomorerapidorbetterresultswill

beobtainedandsevereirritationmightdevelop.Inthisevent,treatmentmustbediscontinuedandappropriate

symptomatictherapyshouldbeinstituted.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Benzoylperoxidehasbeenshowntohavepotentbroadspectrumantimicrobialactivity,particularlyagainst

Propionibacteriumacneswhichisabnormallypresentinacneaffectedhairfollicles.Additionallybenzoylperoxidehas

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5.2Pharmacokineticproperties

Thepercutaneouspenetrationofbenzoylperoxideinrat,rabbit,monkeyandmanislow.Themajorityofthe

penetratedbenzoylperoxideisconvertedintobenzoicacidwhichafterabsorptionintothesystemiccirculationis

rapidlyeliminatedbythekidney.Thereisnoevidenceforanytissueaccumulation.Thereisnoevidencethat

cutaneousapplicationoftheproposedclinicaldosesofAcnecideWashshouldbeassociatedwithanysystemicadverse

reactionsinhumans.

5.3Preclinicalsafetydata

Inanimalstudiesbythecutaneousroute,benzoylperoxideisassociatedwithaminimaltomoderateskinirritation

potentialincludingerythemaandoedema.

Thelowsystemicexposuretobenzoylperoxideandtoitsmajordegradationproduct,benzoicacid,assuresthatno

acuteorchronicsystemictoxicityoccur.Phototoxicandphotoallergicreactionshavebeenreportedforbenzoyl

peroxidetherapy,althoughtherelevantscientificliteratureiscontradictory.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Acrylatescopolymer

Glycerol

Carbomer940(Carbopol980)

SodiumC

OlefinSulfonate

SodiumHydroxide

PurifiedWater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Whitehighdensitypolyethylenetube,fittedwithawhitepolypropylenescrewcap.

Whitehighdensitypolyethylenebottle,fittedwithawhitepolypropylenescrewcap.

Packsizes:tube100g,bottle200ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Squeezethetubeorbottlegentlytoplaceonthehandsaquantityofgelsufficienttowashtheareatobetreated.Wash

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7MARKETINGAUTHORISATIONHOLDER

Galderma(UK)Limited

MeridienHouse

69-71ClarendonRoad

Watford

Herts

WD171DS

8MARKETINGAUTHORISATIONNUMBER

PA590/7/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:31 st

October1997

Dateoflastrenewal:31 st

October2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 20/11/2007 CRN 2036964 page number: 5