ECOSTATIN

Main information

  • Trade name:
  • ECOSTATIN Pessary 150 Milligram
  • Dosage:
  • 150 Milligram
  • Pharmaceutical form:
  • Pessary
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ECOSTATIN Pessary 150 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0002/024/002
  • Authorization date:
  • 30-01-1978
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EcostatinPessaries150mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachpessarycontainsEconazolenitrate150mg.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Pessary

Cream-whitetoyellowishopaque,ovalpessarywithafat-likeodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Vulvovaginalcandidosis.

4.2Posologyandmethodofadminstration

Adults:

Onepessarytobeinsertedatbedtimeforthreeconsecutivenights.Administrationshouldbecontinuedevenif

menstruationoccurs,anddespitethedisappearanceofsignsandsymptomsoftheinfection.

Thepessaryshouldbeinsertedhighintothevaginawhilethepatientissupine.

Althoughathree-daycourseoftherapyusuallysuffices,itmaybenecessarytoinstituteasecondcourseoftherapy.

Childrenandinfants:

Vulvo-vaginalcandidosisisnotnormallyaprobleminchildren,thereforetherearenospecificdosage

recommendation.

Elderly:

Nospecificdosagerecommendationsorprecautionsapply.

4.3Contraindications

Patientswithahistoryofsensitivitytoanyofthecomponentsofthepreparation.

4.4Specialwarningsandprecautionsforuse

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 16/06/2006 CRN 2024319 page number: 1

Itisimportanttoensuretheconcurrenttreatmentofpartners.

Avoidcontactbetweenthepessaryandcontraceptivediaphragmsandcondomssincetherubbermaybedamagedby

thepreparation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None,exceptsee4.4above.

4.6Pregnancyandlactation

Thereisnoevidenceofateratogeniceffectinanimals.Systemicabsorptionislikelytobenegligible.However,as

withotheragents,useshouldbeavoidedduringthefirsttrimesterofpregnancy.Thereisnoevidenceofadverse

effectofuseduringlaterstages.

Inpregnancy,extracareshouldbetakeninusingtheapplicatortopreventthepossibilityofmechanicaltrauma.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Sideeffectsarelimitedtooccasionallocaldiscomfortandirritation,manifestedbyerythema,burningorstinging

sensationsorpruritis.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Econazolenitratehasabroadspectrumofantifungalactivity.ItishighlyactiveagainstCandidaalbicansandother

Candidaspeciesandiseffectiveincontrollinginfectionsofthevaginaandvulvacausedbysuchorganisms(thrush).

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

See4.6,Pregnancyandlactation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 16/06/2006 CRN 2024319 page number: 2

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

3pessariesinplasticfoillinedpolyvinylchloridecontainers,packedincardboardcartons,withapplicatorand

directionsforuse.

Thetwinpackincludesa15gtubeofcream.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

ThePILwillcontaindiagrammaticalinstructionsforinsertingthepessary.

7MARKETINGAUTHORISATIONHOLDER

Bristol-MyersSquibbPharmaceuticalsLimited

Swords

CountyDublin

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA2/24/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:30January1978

Dateoflastrenewal:30January2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 16/06/2006 CRN 2024319 page number: 3