EGODERM

Main information

  • Trade name:
  • EGODERM Ointment 1.0/ 15.0 %w/ w
  • Dosage:
  • 1.0/ 15.0 %w/ w
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EGODERM Ointment 1.0/ 15.0 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0863/003/002
  • Authorization date:
  • 16-10-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0863/003/002

CaseNo:2038246

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

EgoPharmaceuticals(UK)Limited

15WindsorPark,50WindsorAvenue,Merton,LondonSW192TJ,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

EgodermOintment

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom07/08/2007until15/10/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2038246 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EgodermOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Ointment

Palefawncolouredointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofitchingandinflammationassociatedwiththefollowingconditions:

Dermatitis,

Eczema,

Tender,itchy,scratchedorbrokenskinrashes,

Eruptionsinthenapkinarea,duetovariouscauses,

Analorgenitalitching,

Minorcoldsores.

4.2Posologyandmethodofadministration

Administration:

Forcutaneous(topical)administrationonly.

Dosage:

Theointmentshouldbeappliedtotheaffectedskinarea2to4timesdaily.

4.3Contraindications

Knownhypersensitivitytotheingredientsofthepreparation.

Oilyskin.

4.4Specialwarningsandprecautionsforuse

Avoidcontactwiththeeyes.Uponaccidentalcontact,flushwithclearwater.

Theointmentisforexternaluseonly.

Ichthammol 1 %w/w

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2038246 page number: 2

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noknowninteractions.

4.6Pregnancyandlactation

Useofthisproductinhumanpregnancyandlactationhasnotbeeninvestigated,butichthammolandzincoxidehave

beeninwideuseformanyyearswithoutapparentillconsequences.Noadverseeffectshavebeenreportedinpublished

literature.

4.7Effectsonabilitytodriveandusemachines

Notapplicable-notlikelytoproduceaneffectwhenusedasdirected.

4.8Undesirableeffects

Noknownundesirableeffects.

4.9Overdose

Notapplicable(topicalpreparation).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theointmentcontainstwoactiveingredientsichthammol1%w/wandzincoxide15%w/w.Themodeofactionofthe

ichthammolhasnotbeenelucidated,however,ithasbeeninwidespreaduseformanyyearsandisusedforthe

symptomaticreliefofpruritusandinflammation.Zincoxideisamildastringentandisoftenusedinconjunctionwith

ichthammolforthetreatmentofawidevarietyofskinconditionsincludingulcers,eczemaandpsoriasis.

5.2Pharmacokineticproperties

Forlocalapplicationonly.

5.3Preclinicalsafetydata

Bothdeclaredactiveingredientshavebeenusedintopicalapplicationsformanyyears.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Dimethicone

Lightliquidparaffin

Glycerol

Glycerylmonostearate

Isopropylmyristate

Methylhydroxybenzoate[E218]

Polyethylene

Propylhydroxybenzoate[E216]

Softwhiteparaffin

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2038246 page number: 3

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

Pre-printedlaminatetubesof25and50gpackedintopre-printedcartons.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

EgoPharmaceuticals(UK)Limited,

15WindsorPark

50WindsorAvenue

Merton

LondonSW192TJ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA863/3/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16October1998

Dateoflastrenewal:16October2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2038246 page number: 4