ACETOXYL 5

Main information

  • Trade name:
  • ACETOXYL 5
  • Dosage:
  • 5 %w/w
  • Pharmaceutical form:
  • Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACETOXYL 5
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0144/010/002
  • Authorization date:
  • 09-08-1979
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Acetoxyl5Gel

2QUALITATIVEANDQUANTITATIVECOMPOSITION

HydrousBenzoylPeroxideequivalenttoBenzoylperoxide5%w/w.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Awhitegel,freefromgrittyparticles.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Acetoxyl5Gelisindicatedforthetreatmentofmildtomoderateacnevulgaris.

4.2Posologyandmethodofadminstration

Adults

Applytothewholeoftheaffectedareaonceortwicedaily.Washwithsoapandwaterpriortoapplication.

Paediatricuse

ThesafetyandefficacyofAcetoxyl5Gelhasnotbeenestablishedinchildrensinceacnevulgarisrarelypresentsinthis

agegroup.

Elderlypatients

Therearenospecificrecommendations.Acnevulgarisdoesnotpresentintheelderly.

4.3Contraindications

Patientswithknownhypersensitivitytoanyoftheingredientsshouldnotusetheproduct.

4.4Specialwarningsandprecautionsforuse

Avoidcontactwiththeeyes,mouthandothermucousmembranes.Careshouldbetakenwhenapplyingtheproductto

theneckandothersensitiveareas.

Theproductmaybleachcolouredordyedfabrics.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

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Date Printed 05/07/2006 CRN 2025170 page number: 1

4.6Pregnancyandlactation

Thesafetyofbenzoylperoxideinhumanpregnancyisestablished.TherearenorestrictionsontheuseofAcetoxyl5

Gelduringpregnancyandlactation.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Innormaluse,amildburningsensationwillprobablybefeltonfirstapplicationandamoderatereddeningandpeeling

oftheskinwilloccurwithinafewdays.Duringthefirstfewweeksoftreatment,asuddenincreaseinpeelingwill

occurinmostpatients,thisisnotharmfulandwillnormallysubsideinadayortwoiftreatmentistemporarily

discontinued.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

BenzoylperoxidehasantibacterialactivityagainstPropionibacteriumacnes,theorganismimplicatedinacnevulgaris.

Ithaskeratolyticactivityandissebostatic,counteractingthehyperkeratinisationandexcessivesebumproduction

associatedwithacne.

5.2Pharmacokineticproperties

Aftertopicalapplication,benzoylperoxideisabsorbedinvaryingquantitiesthroughtheskinofmanandanimals.

Radio-labelledstudieshaveshownthattheabsorptionofbenzoylperoxidethroughtheskincanonlyoccurfollowing

itsconversiontobenzoicacid.Benzoicacidismostlyconjugatedtoformhippuricacidwhichisexcretedviathe

kidneys.

5.3Preclinicalsafetydata

Animaltoxicitystudiesofbenzoylperoxidehaveshownthatthecompoundisnon-toxicwhenappliedtopically.

Benzoicacid,towhichbenzoylperoxideisconvertedpriortoabsorption,hasawidemarginofsafety.Benzoicacidis

anapprovedfoodadditive.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Trolamine

Propyleneglycol(E1520)

Carbomer940

Sodiumlaurilsulfatesolution

Acetone

Irish Medicines Board

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Date Printed 05/07/2006 CRN 2025170 page number: 2

6.2Incompatibilities

Noneknown.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Storebelow25°C.

6.5Natureandcontentsofcontainer

Lacqueredaluminiumtubeswithwhitepolypropylenescrewcapscontaining40g.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

StiefelLaboratories(UK)Ltd

Holtspurlane

WooburnGreen

HighWycombe

Buckinghamshire

HP100AU

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA144/10/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:09August1979

Dateoflastrenewal:09August2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 05/07/2006 CRN 2025170 page number: 3