EURAX

Main information

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

Documents

Localization

  • Available in:
  • EURAX Cream 10 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/023/001
  • Authorization date:
  • 11-04-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0030/023/001

CaseNo:2067331

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NovartisConsumerHealthUKLimited

WimblehurstRoad,Horsham,WestSussexRH125AB,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Eurax10%w/wCream

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom13/07/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/07/2010 CRN 2067331 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Eurax10%w/wCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Crotamiton10%w/w

Excipients:alsoinclude

MethylParahydroxybenzoate(E218) 0.150%w/w

StearylAlcohol 0.750%w/w

Perfume(containingbenzylbenzoate) <0.125%w/w

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Cream.

Awhitetocreamcolouredcream,givingahomogeneoussmear,apartfromtrappedairbubbles;

odourcharacteristicofperfume.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanantipruriticandsarcopticideforuseinthemanagementofpruritusofanyaetiologyandinthetreatmentof

scabies.

4.2Posologyandmethodofadministration

Pruritus

Applytotheaffectedarea2to3timesdaily.Euraxwillproviderelieffromirritationfor6-10hoursaftereach

application.Euraxcanbeusedinchildren.Therearenospecialdosagerecommendationsintheelderly.

Scabies

Afterathoroughbath,Euraxshouldbeappliedtoallareasbelowthechinwithparticularattentiontointerdigitalareas.

Itisadvisabletorepeatthetreatment24hourslater.Abathshouldbetakenadayafterwithachangeofclothesand

bedding.

Allcontactsshouldbetreatedsimultaneouslyinscabaticpatients.

Methodofadministration:Forcutaneoususe.

4.3Contraindications

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/07/2010 CRN 2067331 page number: 2

4.4Specialwarningsandprecautionsforuse

Ifsymptomspersistconsultthedoctor.

Euraxcanbeusedforchildren,althoughitisadvisedthatyouconsultyourdoctorbeforeuseoninfants.

Forexternaluseonly.

Euraxshouldnotbeusedneartheeyesoronbrokenskin,orforweepingskinconditions.

ConsultyourdoctorbeforeusingEuraxifyouarepregnantorbreastfeeding.

Ifyousufferfromgenitalitching,consultyourdoctororpharmacistbeforeusingEurax.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

Thereisnoevidenceofriskduringpregnancy.Whenbreastfeeding,applicationshouldnotbemadetothenipples.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Useneartheeyesmayproduceinflammationofconjunctiva.Localirritationofskinmayoccur.

4.9Overdose

Symptomatictreatment.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Nonestated.

5.2Pharmacokineticproperties

Nonestated.

5.3Preclinicalsafetydata

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/07/2010 CRN 2067331 page number: 3

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MethylParahydroxybenzoate(E218)

PhenylethylAlcohol

Glycerol

Trolamine(Triethanolamine)

SodiumLaurilsulfate

EthyleneGlycolMonopalmitostearate

StearylAlcohol

ConcentratedAmmoniaSolution

StearicAcid

HardParaffin

WhiteBeeswax

PerfumeGivaudanNo45(containingbenzylbenzoate)

PurifiedWater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

30months.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Internallylacqueredaluminiumtubes.

Packsizes:30gand100g

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLtd

WimblehurstRoad

Horsham

WestSussex

RH125AB

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/07/2010 CRN 2067331 page number: 4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1April1978

Dateoflastrenewal:11April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 13/07/2010 CRN 2067331 page number: 5