EPADERM

Main information

  • Trade name:
  • EPADERM Ointment 30%/30%w/w %w/w
  • Dosage:
  • 30%/30%w/w %w/w
  • Pharmaceutical form:
  • Ointment
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EPADERM Ointment 30%/30%w/w %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1175/004/001
  • Authorization date:
  • 11-02-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EpadermOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Apaleyellowtranslucentemulsifyingointment.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forgeneraluseasanemollienttomoisturiseandsoftendryskin.Epadermmaybeusedinsteadofsoap.

4.2Posologyandmethodofadministration

Topical.

Adults,theelderlyandchildren:

Epadermshouldbemassagedintotheskinasoftenasrequired.Epadermmayalsobeaddedtothebathbyfirst

producingadispersionwithhotwater.Whenusedasabathadditivecareshouldbetakenasitwillmakethesurface

slippery.

4.3Contraindications

TherearenospecificcontraindicationstotheuseofEpadermapartfromknownsensitivitytoanyofthecomponents.

4.4Specialwarningsandprecautionsforuse

Iftheconditiondoesnotimproveorisaggravated,discontinueuseandconsultyourdoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

TheeffectofEpadermduringpregnancyandlactationhasnotbeenstudied.Therefore,therearenorecommendations

Activesubstance

EmulsifyingWaxBP 30%w/w

Irish Medicines Board

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Date Printed 13/07/2006 CRN 2025506 page number: 1

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Nonestated.

4.9Overdose

Overdoseishighlyunlikely.Ifnecessary,medicationshouldberemovedbywashingwithwarmwater.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Epadermisanemollientpreparationfortopicalapplicationtotheskin.

5.2Pharmacokineticproperties

Notapplicableasthisisatopicalpreparation.

5.3Preclinicalsafetydata

Theactiveingredientsarewelldocumentedtherapeuticagentsandthereforepreclinicalortoxicologicaldataare

availablefromthepublicdomainandnotsubmittedinthisinstance.Emulsifyingwaxandyellowsoftparaffinareboth

subjectsofpharmacopoeiasmonographsbothbeingquotedintheBP.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

LiquidParaffinPh.Eur.

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Storebelow25 o

Cinadryplace.

Keepthetub/pottightlyclosed.

6.5Natureandcontentsofcontainer

500g:Whitepolypropylenesecuritubwithtamperevidentclosure.

125g:Whitepolypropylenesecuripotwithtamperevidentclosure.

Irish Medicines Board

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Date Printed 13/07/2006 CRN 2025506 page number: 2

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

MedlockMedicalLimited

TubitonHouse

MedlockStreet

Oldham

Lancashire

OL13HS

England

8MARKETINGAUTHORISATIONNUMBER

PA1175/4/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:6March1998

Dateoflastrenewal:6March2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 13/07/2006 CRN 2025506 page number: 3