CANESTEN

Main information

  • Trade name:
  • CANESTEN Cutaneous Solution 1 %w/ v
  • Dosage:
  • 1 %w/ v
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CANESTEN Cutaneous Solution 1 %w/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0021/004/003
  • Authorization date:
  • 01-04-1977
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0021/004/003

CaseNo:2038189

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BayerPLC

BayerHouse,StrawberryHill,Newbury,BerkshireRG141JA,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CanestenSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom26/07/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2038189 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CanestenSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Containsclotrimazole1.0%w/v(equivalentto10mg/ml).

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneoussolution

Aclear,colourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Abroadspectrumantifungalforuseinthetopicaltreatmentofinfectionsduetosuperficialdermatophytes,Candida

speciesandotherfungisensitivetotheanti-infective:Trichomonas,StaphylococciandBacteroides.Thedrughasno

effectonLactobacilli.

4.2Posologyandmethodofadministration

Canestensolutionshouldbethinlyandevenlyappliedtotheaffectedarea2or3timesdaily.Topreventrelapse,

treatmentshouldbecontinuedforatleasttwoweeksafterthedisappearanceofallsignsofinfection.

4.3Contraindications

HypersensitivitytoclotrimazoleorMacrogol400.

4.4Specialwarningsandprecautionsforuse

Allpossibleinfectedareasshouldbetreatedatthesametime.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

TherehavebeenreportsofaheatreactionwhenCanestenSolutionisusedconcomitantlywithSofradexdropsinthe

ear.

4.6Pregnancyandlactation

Well-conductedepidemiologicalstudiesindicatenoadverseeffectsofclotrimazoleonpregnancyoronthehealth

ofthefoetus/newbornchild.

Irish Medicines Board

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Date Printed 22/09/2007 CRN 2038189 page number: 2

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Rarelypatientsmayexperiencelocalmildburningorirritationimmediatelyafterapplyingthesolution.Veryrarelythe

patientmayfindthisirritationintolerableandstoptreatment.

Otherundesirableeffects:

4.9Overdose

Intheeventofaccidentaloralingestion,routinemeasuressuchasgastriclavageshouldbeperformedonlyifclinical

symptomsofoverdosebecomeapparent(e.g.dizziness,nauseaorvomiting).

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:D01AC01.

Clotrimazoleisanimidazolederivativewithabroadspectrumofantimycoticactivity.

MechanismofAction

Clotrimazoleactsagainstfungibyinhibitingergosterolsynthesis.Inhibitionofergosterolsynthesisleadstostructural

andfunctionalimpairmentofthecytoplasmicmembrane.

Pharmacodynamiceffects

Clotrimazolehasabroadantimycoticspectrumofactioninvitroandinvivo,whichincludesdermatophytes,yeast,

moulds,etc.

Underappropriatetestconditions,theMICvaluesforthesetypesoffungiareintheregionsoflessthan0.062-4(-8)

µg/mlsubstrate.Themodeofactionofclotrimazoleisfungistaticorfungicidaldependingontheconcentrationof

clotrimazoleatthesiteofinfection.In-vitroactivityislimitedtoproliferatingfungalelements;fungalsporesareonly

slightlysensitive.

Inadditiontoitsantimycoticaction,clotrimazolealsoactsonTrichomonasVaginalis,gram-positivemicroorganisms

(Streptococci/Staphylococci)andgram-negativemicroorganisms(Bacteroides/GardnerellaVaginalis).Ithasnoeffect

onLactobacilli.

Invitro,clotrimazoleinhibitsthemultiplicationofCorynebacteriaandgram-positivecocci-withtheexceptionof

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

Primarilyresistantvariantsofsensitivefungalspeciesareveryrare;thedevelopmentofsecondaryresistanceby

sensitivefungihassofaronlybeenobservedinveryisolatedcasesundertherapeuticconditions.

5.2Pharmacokineticproperties

Pharmacokineticinvestigationsafterdermalapplicationhaveshownthatclotrimazoleispracticallynotabsorbedfrom

theintactorinflamedskinintothehumanbloodcirculation.Theresultingpeakserumconcentrationsofclotrimazole

werebelowthedetectionlimitof0.001microg/ml,reflectingthatclotrimazoleappliedtopicallydoesnotleadto

Bodyasawhole: allergicreaction,pain.

Irish Medicines Board

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Date Printed 22/09/2007 CRN 2038189 page number: 3

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltotheinformationinothersectionsof

theSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol400

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Whiteopaque20mlHDPEbottlewithPEdropperinsertandPEscrew-oncap.

Packsize:20ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Bayerplc

BayerHouse

StrawberryHill

Newbury

BerkshireRG141JA

England

Tradingas:Bayerplc,ConsumerCareDivision

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 22/09/2007 CRN 2038189 page number: 4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1977

Dateoflastrenewal:01April2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 22/09/2007 CRN 2038189 page number: 5