CUPLEX

Main information

  • Trade name:
  • CUPLEX Gel 11+4 %w/w
  • Dosage:
  • 11+4 %w/w
  • Pharmaceutical form:
  • Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CUPLEX Gel 11+4 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0710/002/001
  • Authorization date:
  • 30-09-1991
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CuplexGel

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients,see6.1.

3PHARMACEUTICALFORM

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetopicaltreatmentofcommon,juvenile,plantarandmosaicwarts;cornsandcallouses.

4.2Posologyandmethodofadministration

Adults(includingtheelderly)andchildren:

1.Everynightsoakthewartinhotwaterfor5minutes.

2.Drythoroughly.

3.ApplyoneortwodropsofCuplexGeltothewartandallowtospread.

4.Inthemorning,removeelasticfilmandre-apply.

5.Twice,orthreetimesperweek,rubawaythewartsurfacecarefully(excessiverubbingwillcausestingingwhen

CuplexGelisapplied)withanemeryboardorpumicestone,thenapplyCuplexgel.

Suitableforallagesexceptininfants.

4.3Contraindications

Donotapplytofacialoranogenitalwarts.Avoidcontactwiththeeyes.Onlyapplytotheaffectedarea.Keepaway

fromnakedflames.

4.4Specialwarningsandprecautionsforuse

Wartsarecontagiousandanypersonsufferingfromwartsshouldalwaysusetheirowntowel.

Mostwartswilldisappearafter6-12weeksoftreatmentwithCuplexGel,providinginstructionsarecarefullyand

consistentlyfollowed.Where,however,thewartcontinuestoincreaseinsizeafter6weekstreatment,andthepatient

hasnotconsultedadoctor,thepatientshouldbeadvisedtodoso.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

SalicylicAcid11.0%w/w

Irish Medicines Board

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Date Printed 27/07/2006 CRN 2026067 page number: 1

4.6Pregnancyandlactation

Noeffectsonpregnancyandlactationareanticipated.

4.7Effectsonabilitytodriveandusemachines

Noeffectsareanticipatedintheabilitytodriveandtousemachinery.

4.8Undesirableeffects

Noneexpected.

4.9Overdose

Noneexpected.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

TheactiveingredientspresentinCuplexgelhavenosignificantsystemiceffects.Thereisalonghistoryofsafeuseof

theseactiveingredientsinthelocaltreatmentofwarts.

5.2Pharmacokineticproperties

SalicylicAcidisabsorbedpercutaneouslyinvaryingamountsdependantonseveralfactors,e.g.Vehicle,dosage,skin

area,skinconditionsetc.

Cuplexisusedonlyonverylimitedskinareassincecornsandcallousesareskindiseasesofaverylimitedextension.

TheamountofCuplexappliedwillthusamounttoamax.0.5-1.0g,correspondingto0.06-0.1gsalicylicacidapplied

onceortwicedaily.Usuallytheamountisevensmaller.Assuming100%absorption,theamountofsalicylicacid

absorbedwillbesosmallthatdetectableplasmaconcentrationscanhardlybefound.

5.3Preclinicalsafetydata

Nothingrelevanttoaddtotheprescribinginformation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Veniceturpentine

Colophony63NORD

Collodion

Ethanol

6.2Incompatibilities

Noneknown.

6.3ShelfLife

Irish Medicines Board

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Date Printed 27/07/2006 CRN 2026067 page number: 2

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.Donotfreeze.

6.5Natureandcontentsofcontainer

5gramaluminiumtube.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Avoidnakedflames.

7MARKETINGAUTHORISATIONHOLDER

Smith&NephewPharmaceuticalsLtd.

HessleRoad

HullHU32BN

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA710/2/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:30September1986

Dateoflastrenewal:30September2001

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 27/07/2006 CRN 2026067 page number: 3