EURAX HC

Main information

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

Documents

Localization

  • Available in:
  • EURAX HC
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/018/001
  • Authorization date:
  • 05-09-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0030/018/001

CaseNo:2061350

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NovartisConsumerHealthUKLtd

WimblehurstRoad,Horsham,WestSussexRH125AB,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

EuraxHCCream

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom12/06/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 12/06/2009 CRN 2061350 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EuraxHcCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Crotamiton10%w/wandHydrocortisone0.25%w/w.

Excipients:alsoincludesstearylalcohol25%w/w;propyleneglycol20%w/w;methylhydroxybenzoate(E218)

0.025%w/wandpropylhydroxybenzoate(E216)0.015%w/w.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream

Awhitetocreamcolouredcreamwithanodourcharacteristicoftheperfume.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Irritantcontactdermatitis,allergiccontactdermatitis,insectbitereactions,mildtomoderateeczema.

4.2Posologyandmethodofadministration

Forexternalapplication.

Adultsandchildrenover10:

Applysparinglyoverasmallareatwiceadayforamaximumperiodofsevendays.

Occlusivedressingshouldnotbeused.

Notrecommendedforchildrenunder10withoutmedicaladvice.

4.3Contraindications

Hypersensitivitytoanycomponentoftheformulation.Bacterial,viralorfungalinfectionsoftheskin.Acuteexudative

dermatoses.Applicationtoulceratedareas.Useoneyes/face,anogenitalregion,brokenorinfectedskinincludingcold

sores,acneandathletesfoot.

4.4Specialwarningsandprecautionsforuse

Productlabellingtoincludethefollowing:

Donotuseinpregnancyorbreastfeedingwithoutmedicaladvice.

Donotuseontheeyesorface,theano-genitalregion,oronbroken,infectedorweepingskin,includingcoldsores,

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 12/06/2009 CRN 2061350 page number: 2

Iftheconditiondoesnotimprovewithin7days,consultyourdoctor.

Forexternaluseonly.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Thereisinadequateevidenceofsafetyinhumanpregnancy.Topicaladministrationofcorticosteroidstopregnant

animalscancauseabnormalitiesoffoetaldevelopment,includingcleftpalateandintra-uterinegrowthretardation.

Theremaythereforebeaverysmallriskofsucheffectsinthehumanfoetus.

ItisnotknownwhethertheactivesubstancesofEuraxHccreamand/ortheirmetabolitespassintothebreastmilkafter

topicaladministration.Useinlactatingmothersshouldonlybeatthedoctor’sdiscretion.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Occasionallyatthesiteofapplicationsignsofirritationsuchasaburningsensation,itching,contactdermatitis/contact

allergymayoccur.Treatmentshouldbediscontinuedifpatientsexperiencesevereirritationorsensitisation.

4.9Overdose

EuraxHccreamisforapplicationtotheskinonly.Ifaccidentalingestionoflargequantitiesoccurs,thereisnospecific

antidoteandgeneralmeasurestoeliminatethedrugandreduceitsabsorptionshouldbetaken.Symptomatictreatment

shouldbeadministeredasappropriate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theproductcombinestheanti-pruriticactionofcrotamitonwiththeanti-inflammatoryandanti-allergicpropertiesof

hydrocortisone.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Stearylalcohol

Propyleneglycol

Irish Medicines Board

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Date Printed 12/06/2009 CRN 2061350 page number: 3

Polyoxyl40stearate

Methylhydroxybenzoate(E218)

Propylhydroxybenzoate(E216)

Perfumegivaudan

Sulphuricacid

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

30months.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Internallylacqueredaluminiumtubes,eachcontaining15gofcream.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLtd

WimblehurstRoad

Horsham

WestSussex

RH125AB

England

8MARKETINGAUTHORISATIONNUMBER

PA30/18/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:5 th

September1997

Dateoflastrenewal:5 th

September2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 12/06/2009 CRN 2061350 page number: 4