EGODERM

Main information

  • Trade name:
  • EGODERM Cream 1.0 %w/w
  • Dosage:
  • 1.0 %w/w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EGODERM Cream 1.0 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0863/003/001
  • Authorization date:
  • 07-07-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Egoderm1.0%w/wCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Ichthammol1%w/w.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Cream

Palefawncolouredcream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofitchingandinflammationassociatedwiththefollowingconditions:

Inflameddermatitisoreczema;

Persistentinfantileeczema;

Dry,crackedorfissuredskin;

Anadjuncttothetreatmentofpsoriasisorformaintenancetherapy.

4.2Posologyandmethodofadministration

RouteofAdministration

Forcutaneous(topical)useonly.

RecommendedDosageSchedules

Thecreamshouldbeappliedtotheaffectedskinarea3timesdailyorasneeded.

4.3Contraindications

Knownhypersensitivitytotheingredientsofthepreparation.

4.4Specialwarningsandprecautionsforuse

Thecreamisforexternaluseonly.

Avoidcontactwiththeeyes.Uponaccidentalcontact,flushwithcleanwater.Iftheconditiondoesnotimproveoris

aggravateddiscontinueuseandconsultthedoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

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Date Printed 18/07/2006 CRN 2025657 page number: 1

4.6Pregnancyandlactation

Useofthisproductinhumanpregnancyandlactationhasnotbeeninvestigated,butichthammolhasbeeninwideusefo

manyyearswithoutapparentillconsequences.Noadverseeffectshavebeenreportedinpublishedliterature.

4.7Effectsonabilitytodriveandusemachines

Notapplicable–notlikelytoproduceaneffectwhenusedasdirected.

4.8Undesirableeffects

Allergicreactionstoichthammolmayoccur.

4.9Overdose

Notapplicable(topicalpreparation).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:D04AX(otherantipruritics)

EgodermCreamcontains1%w/wichthammol(tumenolammonium).

Themodeofactionofichthammolhasnotbeenelucidated,however,ithasbeeninwidespreaduseformanyyearsandi

usedforthesymptomaticreliefofpruritusandinflammation.

5.2Pharmacokineticproperties

Forlocalapplicationonly.

5.3Preclinicalsafetydata

Ichthammolhasbeenusedintopicalapplicationsformanyyears.Oraltoxicityhasbeenreportedinhumanbeingsat

125mg/kgwithsymptomsofcoma,acutepulmonaryoedema,nauseaandvomiting.Theseeffectsareunlikelytobe

observedfromtheapplicationofthecream.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Allantoin

CetylAlcohol

Glycerol

Self-emulsifyingGlycerylMonostearate

LightLiquidParaffin

PropyleneGlycol

MethylParahydroxybenzoate(E218)

PropylParahydroxybenzoate(E216)

PurifiedWater

6.2Incompatibilities

Irish Medicines Board

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Date Printed 18/07/2006 CRN 2025657 page number: 2

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove30 o

6.5Natureandcontentsofcontainer

Pre-printedlaminatedtubesconsistingofa7layerLDPE,paper,aluminiumfoilandethylenecopolymerlaminatebody,

HDPEheadandpolypropylenescrewcappackedintopre-printedcartons.

Packsizes25and50g.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

EgoPharmaceuticals(UK)Ltd.

15WindsorPark

50WindsorAvenue

Merton

London,SW192TJ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA863/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:07July1999

Dateoflastrenewal:07July2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 18/07/2006 CRN 2025657 page number: 3