CANESTEN COMBI PESSARY & CREAM

Main information

  • Trade name:
  • CANESTEN COMBI PESSARY & CREAM
  • Dosage:
  • 500 mg/ 2%w
  • Pharmaceutical form:
  • Pessaries and Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CANESTEN COMBI PESSARY & CREAM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1447/082/001
  • Authorization date:
  • 01-10-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CanestenCombiPessary&Cream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Thepessarycontainsclotrimazole500mg.

Eachgramofcreamcontains20mgclotrimazole(equivalentto2%w/w).

Excipients:cetostearylalcohol.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Pessaryandvaginalcream.

ProductimportedfromtheUK:

White,convexpessarymarked‘BAYER’ononesideand‘MU’ontheotherside.

Awhiteoil-in-watercream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thepessaryisrecommendedforthetreatmentofcandidalvaginitis.

Thecreamisrecommendedforthetreatmentofcandidalvulvitis.Itshouldbeusedasanadjuncttotreatmentof

candidalvaginitis.

Thecreamcanalsobeusedfortreatmentofthesexualpartner’spenistopreventre-infection.

4.2Posologyandmethodofadministration

Thepessaryshouldbeinsertedintravaginally,ashighaspossible,usingtheapplicatorprovided.

Adults:

Insertonepessary,preferablyatnight.Asecondtreatmentmaybecarriedoutifnecessary.

Canestenpessariesneedmoistureinthevaginainordertodissolvecompletely,otherwiseundissolvedpiecesofthe

pessarymightcrumbleoutofthevagina.Piecesofundissolvedpessarymaybenoticedbywomenwhoexperience

vaginaldryness.Tohelppreventthisitisimportantthatthepessaryisinsertedashighaspossibleintothevaginaat

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/10/2011 CRN 2106337 page number: 1

Toinsertthepessary:

Generally:

Treatmentduringthemenstrualperiodshouldbeavoidedduetotheriskofthepessarybeingwashedoutbythe

mestrualflow.Thetreatmentshouldbefinishedbeforetheonsetofmenstruation.

Thecreamshouldbeappliedtwoorthreetimesdailytothevulvaandsurroundingareaandrubbedingently.

Ifthecreamisbeingusedfortreatmentofthesexualpartner’spenisitshouldbeappliedtwoorthreetimesdailyforup

totwoweeks.

Children

Asthisproductisadministeredwithanapplicator,paediatricuseinnotrecommended.

4.3Contraindications

Knownhypersensitivitytoclotrimazoleoranyoftheexcipientsinthisproduct.

4.4Specialwarningsandprecautionsforuse

Medicaladviceshouldbesoughtifthisisthefirsttimethepatienthasexperiencedsymptomsofcandidalvaginitis.

BeforeusingCanestenCombiPessary&Cream,medicaladvicemustbesoughtifanyofthefollowingareapplicable:

Morethantwoinfectionsofcandidalvaginitisinthelast6months.

Previoushistoryofasexuallytransmitteddiseaseorexposuretopartnerwithasexuallytransmitteddisease.

Pregnancyorsuspectedpregnancy.

Agedunder16orover60years.

1.PulloutplungerAuntilitstops.PlacethepessaryintotheapplicatorB.

2.Carefullyinsertapplicatorcontainingthepessaryasdeeplyasis

comfortableintothevagina.Thisisbestdonewiththepatient

lyingonherbackwiththekneesbentup.

3.PushplungerAuntilitstops,therebydepositingthepessaryinto

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/10/2011 CRN 2106337 page number: 2

CanestenCombiPessary&Creamshouldnotbeusedifthepatienthasanyofthefollowingsymptomswhereupon

medicaladviceshouldbesought:

Irregularvaginalbleeding

Abnormalvaginalbleedingorablood-staineddischarge.

Vulvalorvaginalulcers,blistersorsores.

Lowerabdominalpainordysuria.

Anyadverseeventssuchasredness,irritationorswellingassociatedwiththetreatment.

Feverorchills

Nauseaorvomiting.

Diarrhoea.

Foulsmellingvaginaldischarge.

Patientsshouldbeadvisedtoconsulttheirphysicianifthesymptomshavenotbeenrelievedwithinoneweekoftaking

CanestenCombiPessary&Cream.CanestenCombiPessary&Creamcanbeusedagainifthecandidalinfectionreturns

after7days.However,ifthecandidalinfectionrecursmorethantwicewithinsixmonths,patientsshouldbeadvisedto

consulttheirphysician.

Thisproductcontainscetostearylalcohol,whichmaycauselocalskinreactions(e.g.contactdermatitis).

Allpossiblyinfectedareasshouldbetreatedatthesametime.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Laboratorytestshavesuggestedthat,whenusedtogether,thisproductmaycausedamagetolatexcontraceptives.

Consequentlytheeffectivenessofsuchcontraceptivesmaybereduced.Patientsshouldbeadvisedtousealternative

precautionsforatleastfivedaysafterusingthisproduct.

4.6Fertility,pregnancyandlactation

Well-conductedepidemiologicalstudiesindicatenoadverseeventsofclotrimazoleonpregnancyoronhealthofthe

fetus/newbornchild.

Clotrimazolecanbeusedduringpregnancy,butonlyunderthesupervisionofaphysicianormidwife.

Duringpregnancyextracareshouldbetakenwhenusingtheapplicatortopreventthepossibilityofmechanicaltrauma.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

RarelypatientsmayexperiencelocalmildburningorirritationimmediatelyafterinsertingthePessary.Veryrarelythe

patientmayfindthisirritationintolerableandstoptreatment.

Otherundesirableeffects:

Bodyasawhole:allergicreaction(syncope,hypotension,dyspnea,gastrointestinaldisorders),pain

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/10/2011 CRN 2106337 page number: 3

4.9Overdose

Intheeventofaccidentaloralingestion,routinemeasuressuchasgastriclavageshouldbeperformedonlyifclinical

symptomsofoverdosebecomeapparent(e.g.dizziness,nauseaorvomiting).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:G01AF02

Clotrimazoleisanimidazolederivativewithabroadspectrumofantimycoticactivity.

MechanismofAction

Clotrimazoleactsagainstfungibyinhibitingergosterolsynthesis.Inhibitionofergosterolsynthesisleadstostructuraland

functionalimpairmentofthecytoplasmicmembrane.

Pharmacodynamiceffects

Clotrimazolehasabroadantimycoticspectrumofactioninvitroandinvivo,whichincludesdermatophytes,yeast,moulds,

Underappropriatetestconditions,theMICvaluesforthesetypesoffungiareintheregionsoflessthan0.062-4(-8)µg/ml

substrate.Themodeofactionofclotrimazoleisfungistaticorfungicidaldependingontheconcentrationofclotrimazoleat

thesiteofinfection.In-vitroactivityislimitedtoproliferatingfungalelements;fungalsporesareonlyslightlysensitive.

Inadditiontoitsantimycoticaction,clotrimazolealsoactsonTrichomonasvaginalis,gram-positivemicroorganisms

(Streptococci/Staphylococci)andgram-negativemicroorganisms(Bacteroides/Gardnerellavaginalis).Ithasnoeffecton

lactobacilli.

Invitro,clotrimazoleinhibitsthemultiplicationofCorynebacteriaandgram-positivecocci-withtheexceptionof

Enterococci-inconcentrationsof0.5-10µg/mlsubstrateandexertsatrichomonacidalactionat100µg/ml.

Primarilyresistantvariantsofsensitivefungalspeciesareveryrare;thedevelopmentofsecondaryresistanceby

sensitivefungihassofaronlybeenobservedinveryisolatedcasesundertherapeuticconditions.

5.2Pharmacokineticproperties

Pharmacokineticinvestigationsaftervaginalapplicationhaveshownthatonlyasmallamountofclotrimazole(3-10%

ofthedose)isabsorbed.Duetotherapidhepaticmetabolismofabsorbedclotrimazoleintopharmacologicallyinactive

metabolitestheresultingpeakplasmaconcentrationsofclotrimazoleaftervaginalapplicationofa500mgdosewere

lessthan10ng/ml,reflectingthatclotrimazoleappliedintravaginallydoesnotleadtomeasurablesystemiceffectsor

sideeffects.

Pharmacokineticinvestigationsafterdermalapplicationhaveshownthatclotrimazoleispracticallynotabsorbedfrom

theintactorinflamedskinintothehumanbloodcirculation.Theresultingpeakserumconcentrationsofclotrimazole

werebelowthedetectionlimitof0.001µg/ml,reflectingthatclotrimazoleappliedtopicallydoesnotleadtomeasurable

systemiceffectsorsideeffects.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltotheinformationincludedinother

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/10/2011 CRN 2106337 page number: 4

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Pessary:

Lactosemonohydrate

Microcrystallinecellulose

Lacticacid

Maizestarch

Crospovidone

Calciumlactatepentahydrate

Magnesiumstearate

Colloidalanhydroussilica

Hypromellose

Cream:

Sorbitanstearate

Polysorbate60

Cetylpalmitate

Cetostearylalcohol

Octyldodecanol

Benzylalcohol

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelf-lifeexpirydateofthisproductisthedateshownontheblisterstrips,tubelabelandoutercartonofthe

productasmarketedinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Thismedicinalproductshouldbestoredintheoriginalcarton.

6.5Natureandcontentsofcontainer

Blisterpackcontainingonepessary.

Aluminiumtubecontaining10gramsofcream.

Bothcomponentsareenclosedinanoverlabelledcardboardcartonwithadisposableapplicatorandapatient

informationleaflet.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/10/2011 CRN 2106337 page number: 5

7PARALLELPRODUCTAUTHORISATIONHOLDER

G&ALicensingLtd

Ballymurray

Co.Roscommon

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1447/82/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

October2010

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/10/2011 CRN 2106337 page number: 6