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:
  • PPA1447/068/001
  • Authorization date:
  • 12-11-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Eurax10%w/wCream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Crotamiton10%w/w

Excipients:Methylparahydroxybenzoate(E218)andstearylalcohol

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream

ProductimportedfromtheUK:

Awhitetocreamcolouredcream,givingahomogenoussmear,apartfromtrappedairbubbles;odourcharacteristicof

perfume

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 26/10/2011 CRN 2107054 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

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2011 CRN 2107054 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Methylparahydroxybenzoate(E218)

Sodiumlaurilsulfate

Ethyleneglycolmonopalmitostearate

Concentratedammoniasolution

Phenylethylalcohol

Glycerol

Triethanolamine

Stearylalcohol

Stearicacid

Hardparaffin

Whitebeeswax

Perfume

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelf-lifeexpirydateofthisproductisthedateshownonthetubeandouterpackageoftheproductonthemarket

inthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Overlabelledtubeinanoverlabelledcarton.

Packsize:30g

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

G&ALicensingLtd

Ballymurray

Co.Roscommon

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2011 CRN 2107054 page number: 3

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1447/68/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12thNovember2010

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/10/2011 CRN 2107054 page number: 4