EURAX HYDROCORTISONE CREAM

Main information

  • Trade name:
  • EURAX HYDROCORTISONE CREAM
  • Dosage:
  • 10/0.25 %w/w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EURAX HYDROCORTISONE CREAM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/014/001
  • Authorization date:
  • 12-05-1988
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0030/014/001

CaseNo:2057643

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NovartisConsumerHealthUKLimited

WimblehurstRoad,Horsham,WestSussexRH125AB,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

EuraxHydrocortisoneCreamCrotamiton10.0%w/wHydrocortisone0.25%w/w

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom08/02/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/02/2010 CRN 2057643 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EuraxHydrocortisoneCream

Crotamiton10.0%w/w

Hydrocortisone0.25%w/w

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Crotamiton10.0%w/w

Hydrocortisone0.25%w/w

Excipients:

3PHARMACEUTICALFORM

Cream

Awhitetocreamcolouredcreamgivingahomogeneoussmear,apartfromtrappedairbubbles;

odourcharacteristicofperfume.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Incorticosteroidsensitivedermatosesincludingintertrigoandininsectbitereactions.

4.2Posologyandmethodofadministration

Methodofapplication:

AthinlayerofEuraxHydrocortisoneCreamshouldbeappliedtotheaffectedarea2-3timesaday.Occlusivedressings

shouldnotbeused.Treatmentshouldbelimitedto10-14daysorupto7daysifappliedtotheface.

UseintheElderly

Clinicalevidencewouldindicatethatnospecialdosageregimeisnecessary.

Stearylalcohol

Propyleneglycol

Propylparahydroxybenzoate(E216)

Methylparahydroxybenzoate(E218)

Perfume(containingbenzylbenzoate)

Forafulllistofexcipients,seesection6.1. 25.00

20.00

0.015

0.025

<0.125 %w/w

%w/w

%w/w

%w/w

Irish Medicines Board

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Date Printed 08/02/2010 CRN 2057643 page number: 2

EuraxHydrocortisoneshouldbeusedwithcautionininfantsandfornotmorethan7days.EuraxHydrocortisone

shouldnotbeappliedformorethanonceadaytolargeareasofthebodysurfaceinyoungchildren.

Routeofadministration:Cutaneoususe.

4.3Contraindications

Bacterial,viralorfungalinfectionsoftheskin.

Hypersensitivitytoanycomponentoftheformulation.Acuteexudativedermatoses.

Applicationtoulceratedareas.

4.4Specialwarningsandprecautionsforuse

EuraxHydrocortisoneshouldbeusedwithcautionininfantsandfornotmorethan7days;long-termcontinuous

topicaltherapyshouldbeavoidedsincethiscanleadtoadrenalsuppressionevenwithoutocclusion.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Thereisinadequateevidenceofsafetyinhumanpregnancy.Topicaladministrationofcorticosteroidstopregnant

animalscancauseabnormalitiesoffoetaldevelopment,includingcleftpalateandintra-uterinegrowthretardation.

Theremaythereforebeaverysmallriskofsucheffectsinthehumanfoetus.

ItisnotknownwhethertheactivesubstancesofEuraxHydrocortisoneand/ortheirmetabolitespassintothebreast

milkaftertopicaladministration.Useinlactatingmothersshouldonlybeatthedoctor’sdiscretion.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Occasionallyatthesiteofapplicationsignsofirritationsuchasaburningsensation,itching,contactdermatitis/contact

allergymayoccur.Treatmentshouldbediscontinuedifpatientsexperiencesevereirritationorsensitisation.

4.9Overdose

EuraxHydrocortisoneisforapplicationtotheskinonly.Ifaccidentalingestionoflargequantitiesoccurs,thereisno

specificantidoteandgeneralmeasurestoeliminatethedrugandreduceitsabsorptionshouldbeundertaken.

Symptomatictreatmentshouldbeadministeredasappropriate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Irish Medicines Board

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5.2Pharmacokineticproperties

NopharmacokineticdataonEuraxHydrocortisoneCreamareavailable.

5.3Preclinicalsafetydata

Noadditionaldatagiven.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Stearylalcohol

Propyleneglycol

Whitesoftparaffin

Polyoxyl40stearate

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Sulphuricacid

PerfumeGivaudanno.45(containingbenzylbenzoate)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

30months.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

Collapsiblealuminiumtube.

Packsize:30g.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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Date Printed 08/02/2010 CRN 2057643 page number: 4

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerUKLimited

TradingasNovartisConsumerHealth

WimblehurstRoad

Horsham

WestSussex

RH125AB

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA30/14/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12May1988

Dateoflastrenewal:12May2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 08/02/2010 CRN 2057643 page number: 5