CANESTEN

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0021/004/005
  • Authorization date:
  • 14-04-1978
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0021/004/005

CaseNo:2039996

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

BayerPLC

BayerHouse,StrawberryHill,Newbury,BerkshireRG141JA,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CanestenDermatologicalSpray

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom15/11/2007until13/04/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 16/11/2007 CRN 2039996 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CanestenDermatologicalSpray

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Clotrimazole1%w/v.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Cutaneousspray,solution

Colourlesstoslightlyyellowsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CanestenDermatologicalSprayisrecommendedinthetopicaltreatmentofinfectionsduetosuperficialdermatophytes,

candidaspeciesandotherfungisensitivetoclotrimazole.

4.2Posologyandmethodofadministration

Thesprayshouldbeappliedtopically2or3timesdaily.Topreventrelapse,treatmentshouldbecontinuedforatleast

twoweeksafterthedisappearanceofallsignsofinfection.

4.3Contraindications

Hypersensitivitytoclotrimazoleoranyoftheexcipientsinthisproduct.

4.4Specialwarningsandprecautionsforuse

CanestenDermatologicalSprayshouldnotbeusednearanakedflame,shouldnotbeallowedtocomeintocontact

withtheeyes,earsormucousmembranesandshouldnotbeinhaled.Allpossiblyinfectedareasshouldbetreatedatthe

sametime.

Thisproductcontainspropyleneglycol,whichmaycauseskinirritation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Well-conductedepidemiologicalstudiesindicatenoadverseeffectsofclotrimazoleonpregnancyoronhealthofthe

foetus/newbornchild.

Irish Medicines Board

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Date Printed 16/11/2007 CRN 2039996 page number: 2

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Rarelypatientsmayexperiencelocalmildburningorirritationafterapplyingthesolution.Veryrarelythepatientmay

findthisirritationintolerableandstoptreatment.

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,theminimalinhibitoryconcentration(MIC)valuesforthesetypesoffungiareinthe

regionsoflessthan0.062-4(-8)microg/mlsubstrate.Themodeofactionofclotrimazoleisfungistaticorfungicidal

dependingontheconcentrationofclotrimazoleatthesiteofinfection.In-vitroactivityislimitedtoproliferatingfungal

elements;fungalsporesareonlyslightlysensitive.

Inadditiontoitsantimycoticaction,clotrimazolealsoactsonTrichomonasVaginalis,gram-positivemicroorganisms

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

onLactobacilli.

Invitro,clotrimazoleinhibitsthemultiplicationsofCorynebacteriaandgram-positivecocci-withtheexceptionof

Enterococci-inconcentrationsof0.5-10microg/mlsubstrateandexertsatrichomonacidalactionat100microg/ml.

Primarilyresistancevariantsofsensitivefungalspeciesareveryrare;thedevelopmentofsecondaryresistanceby

Bodyasawhole: allergicreaction,pain.

Irish Medicines Board

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Date Printed 16/11/2007 CRN 2039996 page number: 3

5.2Pharmacokineticproperties

Pharmacokineticinvestigationsafterdermalapplicationhaveshownthatclotrimazoleispracticallynotabsorbedfrom

theintactorinflamedskinintothehumanbloodcirculation.Theresultingpeakserumconcentrationsofclotrimazole

werebelowthedetectionlimitof0.001microg/ml,reflectingthatclotrimazoleappliedtopicallydoesnotleadto

measurablesystemiceffectsorsideeffects.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltotheinformationincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Isopropylalcohol

Macrogol400

Propyleneglycol

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

Awhitepolyethylenebottlecontaining40mlofthesolution.Thebottleisfittedwithanatomiserforapplyingthe

solution.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Bayerplc

BayerHouse

StrawberryHill

Newbury

BerkshireRG141JA

England

Irish Medicines Board

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Date Printed 16/11/2007 CRN 2039996 page number: 4

8MARKETINGAUTHORISATIONNUMBER

PA21/4/5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14April1978

Dateoflastrenewal:14April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 16/11/2007 CRN 2039996 page number: 5