DUOFILM

Main information

  • Trade name:
  • DUOFILM Cutaneous Suspension 16.7/ 16.7 %w/ w
  • Dosage:
  • 16.7/ 16.7 %w/ w
  • Pharmaceutical form:
  • Cutaneous Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DUOFILM Cutaneous Suspension 16.7/16.7 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/121/001
  • Authorization date:
  • 03-12-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DUOFILMCutaneousSolution

SalicylicAcid16.7%w/w

LacticAcid16.7%w/w

2QUALITATIVEANDQUANTITATIVECOMPOSITION

SalicylicAcid 16.7 %w/w

LacticAcid 16.7 %w/w

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

CutaneousSolution.

Yellowtoambercoloured,slightlyviscousclearliquidhavinganetherodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DUOFILMisindicatedinthetreatmentofwarts.

4.2Posologyandmethodofadministration

DUOFILMshouldbeappliedtowartsoncedaily.

Childrenunder12yearsshouldonlyusetheproductundersupervision.

Treatmentofinfantsundertheageof2yearsisnotrecommended.

Thepatientshouldbeinstructedasfollows.Soakthewartsinwarmwaterfor5minutes.Rubsurfaceofwartscarefully

withpumicestoneoremeryboard.Apply,takingcaretoavoidnormalskin.Allowtodrythoroughly.Continue

treatmentuntilthewartiscompletelycleared.Ifwartspersistbeyond12weeksoftreatment,thepatientshouldbe

advisedtoconsulttheirdoctor.

4.3Contraindications

Hypersensitivitytotheactivesubstancesortoanyoftheexcipients.

Donotuseonopenskinwounds,moles,birthmarks,genitalwarts,wartsontheface,orwartswithhairgrowingfrom

them,rededges,orunusualcolour.

4.4Specialwarningsandprecautionsforuse

Thismedicinalproductisforexternaluseonly.

Avoidgettingtheproductintheeyes,nose,ormouth,oronthegenitalandanalareas.Ifcontactwiththeeyesoccurs,

flushwithwaterfor15minutes.Avoidinhalingvapour.

Ensurethisproductisstoredoutofthereachofchildrentoavoidaccidentalingestion.

Consideralternativetreatmentsifwartscoveralargeareaofthebody(morethan5cm 2

Irish Medicines Board

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Date Printed 30/01/2012 CRN 2108569 page number: 1

Patientswithdiabetesandpatientssufferingfromperipheralbloodcirculationconditionsshouldonlyusetheproduct

undermedicalsupervision.

Careshouldbetakentoapplytheproductonlytothewartandnottothenormalskinsurroundingthewart.Donot

applytoreddened,inflamedordamagedskin.

Althoughatheoreticalriskwithtopicalsalicylates,oralsalicylateshavebeenassociatedwithReye’ssyndrome.

Therefore,useisnotadvisedinchildrenorteenagersduringorimmediatelyafterchickenpox,influenza,orotherviral

infections.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Embryo-toxicityeffectsinhumanshavenotbeenstudiedbutstudiesinanimalsdemonstratedembryo-toxicityathigh

doses.

Thesystemicabsorptionfromusingthistopicalproductislimited.

Cautionshouldbeexercisedwhenprescribingtopregnantwomen.

ProlongeduseofDuofilmduringpregnancyandlactationshouldbeavoided.Theareaoftreatmentshouldnotexceed5

cm².

Ifusedduringlactation,itshouldnotbeappliedtothechesttoavoidaccidentalingestionbytheinfant.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Alocalisedirritantreactionwilloccurifappliedtothenormalskinsurroundingthewart.Theirritationwillnormally

becontrolledbytemporarilydiscontinuinguseandbyapplyingthemedicationonlytothewartsitewhentreatmentis

resumed.Reportedadversedrugreactionsfrompostmarketingexperienceincludeburningsensation,pain,erythema,

skindiscolouration,pruritis,exfoliation,bleeding,inflammation,contactdermatitisandswelling.

4.9Overdose

Excessiveusecouldcauseirritationoftheskin.Ifthisoccurs,usemoresparinglyorapplylessfrequently.Intheevent

ofaccidentaloralingestion,especiallyininfantsorchildren,monitorandprovideappropriatesupportivemeasures.

Symptomsmayincludeheadache,nausea,vomiting,diarrhoeaandhyperpnoea.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Wartandanti-cornpreparations,ATCCode:D11AF.

Salicylicacidisawidelyusedandeffectivekeratolytic,itproducesdesquamationanddestructionofthe

epitheliumbysolubilisingtheintercellularcementofthestratumcorneum.

Lacticacidaffectsthekeratinisationprocess,reducinghyperkeratosisandisalsocaustic,leadingtothedestruction

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5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Seesection4.6.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

FlexibleCollodionBP

(containspyroxylin,colophony,virgincastoroil,ethanolandether)

6.2Incompatibilities

Notapplicable

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Keepawayfromnakedflame.

6.5Natureandcontentsofcontainer

Duofilmissuppliedinamberbottlesof15mlfittedwithabrushapplicator.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Ltd

StonemasonsWay

Rathfarnham

Dublin16

Ireland

TradingasStiefel

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21 st

January1977

Dateoflastrenewal:21 st

January2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 30/01/2012 CRN 2108569 page number: 4