CALLOUS REMOVAL PADS

Main information

  • Trade name:
  • CALLOUS REMOVAL PADS
  • Dosage:
  • 40 %w/w
  • Pharmaceutical form:
  • Impregnated Dressing
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALLOUS REMOVAL PADS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0455/006/003
  • Authorization date:
  • 24-06-1987
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0455/006/003

CaseNo:2035470

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

SchollConsumerProductsLimited

Venus,1OldParkLane,TraffordPark,Manchester,M417HA,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CallousRemovalPads

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom24/06/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/04/2009 CRN 2035470 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CallusRemovalPads

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Medicatedplasters

Amedicatedplastermountedonasilicone-backedpaper.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofcallouses.

4.2Posologyandmethodofadministration

Adults

Forthebestresultsthefeetshouldbewashedanddriedbeforeuse.Onemedicateddiscshouldbeplacedonthecallous,

coveredwithacoverplaster.Thisshouldberepeateddailyuntilthecallouscanberemoved.Treatmentshouldnot

continueformorethantwoweeks,exceptundermedicaladvice.

Nodistinctionismadebetweendifferentcategoriesofpatient.

Children

Notrecommendedforchildrenunder16yearsofage,exceptfollowingadoctor’srecommendation.

4.3Contraindications

Nottobeusedbydiabeticsorthosewithseverecirculatorydisorders,exceptfollowingadoctor’spermissionand

recommendation.

Nottobeusedbythosesensitivetosalicylicacidoranyoftheotherconstituentsoftheproduct.

Nottobeusedifthecallousorsurroundingskinisbrokenorinflamed.

4.4Specialwarningsandprecautionsforuse

Discontinueuseandremoveplasterifexcessivediscomfortisexperienced.

Donotapplytonormalskin.

SalicylicAcid 40.00%w/w

Irish Medicines Board

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notrelevanttocutaneoususe.

4.6Pregnancyandlactation

Safetyforuseinpregnancyandduringlactationhasnotbeenestablished.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Localirritationordermatitismayoccur.

4.9Overdose

Nonestated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

PharmacotherapeuticGroup:

Keratolytic.

MechanismofAction

Themechanismofsalicylicacidhasnotbeenestablished.

PharmacodynamicEffects

Salicylateshaveanalgesic,anti-inflammatoryandantipyreticpropertiesmuchofwhichisascribedtoaninhibitionof

prostaglandinsynthesis.However,therelevantpharmacodynamiceffectofsalicylicacidforthisproductisits

“keratolytic”action.

Themechanismofthiseffecthasbeeninvestigatedinanimalsandinman,andappearstobeduetoalipidmodifying

effectinthelipidbilayersoftheskinratherthatakeratolyticaction.Itisthoughtthatthesalicylicacidincreaseslipid

structurefluiditysoallowingmoisturetopenetrateintoareassurroundingthecallous.Thisinturnleadstoapressure

buildupcausingthecalloustobepushedupwards.Ithasbeensuggestedthattheocclusivenatureoftheplaster

enhancesthiseffect.

5.2Pharmacokineticproperties

Salicylicacidcanbeabsorbedfollowingtopicalapplication.Plasmasalicylateislargelyprotein-boundandis

metabolisedbyoxidationandconjugationwithsomeexcretedunchanged.Theeliminationofsalicylatefollowsfirst

orderkineticswithahalflifeofaboutfourhoursexceptwithhighsystemicdoseswhichresultinsaturationofthe

eliminationmechanism.

5.3Preclinicalsafetydata

SalicylicacidhasalowacutetoxicitywithoralLD

valuesof480mg/kginthemouseand891mg/kgintherat.Itisa

dermalirritantbutsystemictoxicityfromapplicationof40%w/wsalicylicacidadhesivemassisextremelyunlikely

Irish Medicines Board

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

PolyvinylAlkylEther(LowMolecularWeight)

PolyvinylAlkylEther(HighMolecularWeight)

TitaniumDioxide

LiquidParaffin

4,4’Thio-Bis-2-Terbutyl-5-Methylphenol

RedIronOxide

BlackIronOxide

Backingmaterial

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened

3years.

Shelflifeafterfirstopeningthecontainer

6weeks.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Sachetcontents:2,4or6medicatedadhesiveplastersmountedontoasiliconebackedpaper.

Outercontainer:polypropyleneflowwraporcardboardcarton.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Notapplicable.

6.6Specialprecautionsfordisposalandotherhandling

Irish Medicines Board

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7MARKETINGAUTHORISATIONHOLDER

SchollConsumerProductsLtd

Venus

1OldParkLane

TraffordPark

Manchester

M417HA

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA455/6/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoflastrenewal:24June1987

Dateoflastrenewal:24June2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 08/04/2009 CRN 2035470 page number: 5