BENZAMYCIN

Main information

  • Trade name:
  • BENZAMYCIN Gel 3/5 %w/w
  • Dosage:
  • 3/5 %w/w
  • Pharmaceutical form:
  • Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BENZAMYCIN Gel 3/5 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0271/012/001
  • Authorization date:
  • 23-09-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Benzamycin3%/5%w/wGel.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramofreconstitutedgelcontains75mgbenzoylperoxide,hydrousequivalentto5%w/wbenzoylperoxide,

anhydrousand30mgerythromycinequivalentto3%w/werythromycin.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Theproductisathreecomponentsystem:

White,viscousgel.

Whitetooff-whiteerythromycinpowder.

Clear,colourlessdiluent.

Afterreconstitution,thefinalproductisawhite,viscousgel.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetopicaltreatmentofacnevulgaris.

4.2Posologyandmethodofadministration

BenzamycinGelshouldbeappliedtwicedaily,morningandevening,toareasusuallyaffectedbyacneorasdirected

bythephysician.Theseareasshouldfirstbegentlywashed,rinsedwithlukewarmwater,andgentlypatteddry.

Benzamycinshouldbeappliedinathinlayerwiththefingertipsuntildryandthehandswashedafterapplication.

Itisnotrecommendedforchildrenunder12yearsofage.

4.3Contraindications

Benzamyciniscontraindicatedinpersonswhohaveshownhypersensitivitytobenzoylperoxidehydrous,erythromycin

oranyoftheotheringredients.

4.4Specialwarningsandprecautionsforuse

Forexternaluseonly.Keepawayfromtheeyes,nose,mouthandothermucousmembranes.

Veryfairskinnedindividualsshouldbeginwithasingleapplicationatbedtimeallowingovernightmedication.

Irish Medicines Board

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Date Printed 19/09/2007 CRN 2041418 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitanttopicalacnetherapyshouldbeusedwithcautiontoavoidapossiblecumulativeirritancyeffect.

Antagonismhasbeendemonstratedbetweenclindamycinanderythromycin.

4.6Pregnancyandlactation

ThesafeuseofBenzamycinGelduringpregnancyorlactationhasnotbeenestablishedandshouldonlybeusedif

consideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Reportedadversereactionshavebeendrynessoftheskin,urticariaandfaceoedema.

4.9Overdose

Duetothetopicaladministrationofthisproductoverdoseisunlikelytooccur.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

BenzamycinGelprovidesananti-microbialagentwithmildkeratolyticpropertiesplusantibioticeffects.

Erythromycininhibitslipaseproductionwhilstbenzoylperoxide,hydrousreducesthecomedonecountandhasanti-

bacterialaction.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Therearenopre-clinicalsafetydataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Carbomer

Sodiumhydroxide

Ethanol

Lemonfragranceoil

Methylsalicylate

Docusatesodium75%solution

Purifiedwater

Ethanol70%*

Irish Medicines Board

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Date Printed 19/09/2007 CRN 2041418 page number: 2

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unreconstituted:2years.

Reconstituted:3months.

6.4Specialprecautionsforstorage

Unreconstituted:Donotstoreabove25°C.

Reconstituted:Storeinarefrigerator(2°Cto8°C).Donotfreeze.

6.5Natureandcontentsofcontainer

BenzamycinGelBase:40ginawhitepolypropylenejar.

Erythro-pak:1.6ginawhitepolypropylenevial.

Ethanol70%:6mlinaglass,plastic-cappedbottle.

BenzamycinGelisdispensedinaplasticjarcontaining46.6gofgel.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

InstructionsforthePharmacist:

Priortodispensing,taptheerythromycinvialtoloosenthepowder.Add6mloftheethanol70%providedtothe

powder.Shaketofullydissolvetheerythromycin.Dispersethesolutionintothebenzoylperoxidegelbystirringfor

60to90seconds.Coldstorageofthegelpriortoreconstitutionmaycausethegeltothickenandhindermixing.

Placea3monthexpirydateonthejar.

7MARKETINGAUTHORISATIONHOLDER

SCHWARZPHARMALimited

5HerculesWay

LeavesdenPark

Watford

WD257GS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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Date Printed 19/09/2007 CRN 2041418 page number: 3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23 rd

September1996

Dateoflastrenewal:23 rd

September2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 19/09/2007 CRN 2041418 page number: 4