EURAX

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/023/002
  • Authorization date:
  • 11-04-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Eurax10%w/wLotion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Crotamiton10%w/w

Excipients:alsoincludes

CetostearylAlcohol 3.0%w/w

SorbicAcid 0.1%w/w

PropyleneGlycol 10.0%w/w

Perfume(containingbenzylbenzoate) <0.1%w/w

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Cutaneousemulsion.

Whitetoyellowishwhitefluidemulsion;odourcharacteristicofperfume.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanantipruriticandsarcopticideforuseinthemanagementofpruritusofanyaetiologyandinthetreatmentof

scabiesandpediculosis.

4.2Posologyandmethodofadministration

Pruritus

Applytotheaffectedarea2to3timesdaily.Euraxwillproviderelieffromirritationfor6-10hoursaftereach

application.Euraxcanbeusedinchildren.Therearenospecialdosagerecommendationsintheelderly.

Scabies

Afterathoroughbath,Euraxshouldbeappliedtoallareasbelowthechinwithparticularattentiontointerdigitalareas.

Itisadvisabletorepeatthetreatment24hourslater.Abathshouldbetakenadayafterwithachangeofclothesand

bedding.

Allcontactsshouldbetreatedsimultaneouslyinscabaticpatients.

Methodofadministration:Forcutaneoususe.

4.3Contraindications

Irish Medicines Board

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Date Printed 15/09/2011 CRN 2103335 page number: 1

4.4Specialwarningsandprecautionsforuse

Ifsymptomspersistconsultthedoctor.

Euraxcanbeusedforchildren,althoughitisadvisedthatyouconsultyourdoctorbeforeuseoninfants.

Forexternaluseonly.

Euraxshouldnotbeusedneartheeyesoronbrokenskin,orforweepingskinconditions.

ConsultyourdoctorbeforeusingEuraxifyouarepregnantorbreastfeeding.

Ifyousufferfromgenitalitching,consultyourdoctororpharmacistbeforeusingEurax.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Fertility,pregnancyandlactation

Thereisnoevidenceofriskduringpregnancy.Whenbreastfeeding,applicationshouldnotbemadetothenipples.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Useneartheeyesmayproduceinflammationofconjunctiva.Localirritationofskinmayoccur.

4.9Overdose

Symptomatictreatment.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Nonestated.

5.2Pharmacokineticproperties

Nonestated.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

GlycerolMonostearate40-55

Irish Medicines Board

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Date Printed 15/09/2011 CRN 2103335 page number: 2

2-Octyldodecanol

EmulsifyingCetostearylAlcohol(TypeA)

SorbicAcid

CitricAcidMonohydrate

Phenylethylalcohol

PropyleneGlycol

PerfumeGivaudanNo45(containingbenzylbenzoate)

PurifiedWater

6.2Incompatibilities

Notapplicable

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

100mlamberglassbottlewithatamperevidentcapmadeofpolypropyleneandpolyethylene.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLtd

WimblehurstRoad

Horsham

WestSussex

RH125AB

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA30/23/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1April1978

Irish Medicines Board

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Date Printed 15/09/2011 CRN 2103335 page number: 3

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 15/09/2011 CRN 2103335 page number: 4