ECOSTATIN

Main information

  • Trade name:
  • ECOSTATIN Cream 1 %w/ w
  • Dosage:
  • 1 %w/ w
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ECOSTATIN Cream 1 %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0002/024/001
  • Authorization date:
  • 30-01-1978
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EcostatinCream1%w/w

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Econazolenitrate1.0%w/w.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Cream.

Asmoothwhitetooff-whiteaqueouscream,withadistinctlyperfumedodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetopicaltreatmentoffungaloryeastinfectionsandcertainskininfectionscausedbystreptococcior

staphylococci.Theseincluderingworm(Tinea)infections,athlete’sfoot,paronychia,pityriasisversicolor,erythrasma,

intertrigo,fungalnappyrash,candidalvulvitisandcandidalbalanitis.

4.2Posologyandmethodofadminstration

AdultsandChildren:

Tobemassagedgentlyintotheaffectedandsurroundingskinareamorningandevening.Itisparticularlysuitablefor

moistorweepinglesions.

Infantsandneonates:

Nospecialdosagerecommendations.

Elderly:

Nospecificdosagerecommendationsorprecautionsapply.

4.3Contraindications

Patientswithahistoryofsensitivitytoanyofthecomponentsofthepreparation.

4.4Specialwarningsandprecautionsforuse

Thispreparationisnotfororaluse.Itshouldnotbeusedinorneartheeyes.WhenEcostatinCreamisbeingusedon

Irish Medicines Board

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Date Printed 16/06/2006 CRN 2024312 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Pregnancyandlactation

Thereisnoevidenceofateratogeniceffectinanimals.Systemicabsorptionislikelytobenegligible.However,as

withotheragents,useshouldbeavoidedduringthefirsttrimesterofpregnancy.Thereisnoevidenceofadverse

effectofuseduringlaterstages.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Sideeffectsarelimitedtolocaldiscomfortandirritation,manifestedbyerythema,burningorstingingsensationsor

pruritis.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Econazolenitrateisabroadspectrumantifungalagent,activeagainstdermatophytes(Trichophytonrubrum,

Trichophytonmentagrophytes;EpidermophytonfloccosumandMalasseziafurfur);pathogenicyeasts;Candida

albicansandotherCandidaspecies.Alsoactiveagainstsomegram-positivebacteria,e.g.Staphylococciand

Streptococci.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

See4.6,Pregnancyandlactation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzoicacid

Butylatedhydroxyanisole

Liquidparaffin

Ethoxylatedoleicacidglycerides

Stearateestersofethyleneglycolandpolyoxyethyleneglycol

Perfume

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25 0

C.Donotfreeze.

6.5Natureandcontentsofcontainer

Blindendepoxyresinlinedaluminiumtubespackedinacarton.Tubesizes:15gand30g.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Bristol-MyersSquibbPharmaceuticalsLimited

Swords

Co.Dublin

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA2/24/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:30January1978

Dateoflastrenewal:30January2003

10DATEOFREVISIONOFTHETEXT

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Date Printed 16/06/2006 CRN 2024312 page number: 3