CANESTEN 10 MG/ G CREAM.

Main information

  • Trade name:
  • CANESTEN 10 MG/ G CREAM.
  • Dosage:
  • 10 mg/ g
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CANESTEN 10 MG/G CREAM.
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/048/001A
  • Authorization date:
  • 14-04-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA0465/048/001A

CaseNo:2066430

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

PCOManufacturingLimited

Unit10,AshbourneBusinessPark,Rath,Ashbourne,Co.Meath,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Canesten10mg/gcream.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom24/08/2009until13/04/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/08/2009 CRN 2066430 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Canesten10mg/gCream.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramofcreamcontains10mgclotrimazole.

Forexcipients,see6.1

3PHARMACEUTICALFORM

Cream.

Awhiteoil-inwatertypecream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Abroadspectrumantifungalforuseinthetopicaltreatmentofinfectionsduetosuperficialdermatophytes,Candida

speciesandotherfungisensitivetotheanti-infective:Trichomonas,staphylococcusandBacteroides.Thedrughasno

effectonlactobacilli.

4.2Posologyandmethodofadministration

CanestenCreamshouldbeappliedtotheaffectedarea2or3timesdaily.Topreventrelapse,treatmentshouldbe

continuedforatleasttwoweeksafterthedisappearanceofallsignsofinfection.

4.3Contraindications

Canestencreamiscontra-indicatedinpatientswithaknownhypersensitivitytoClotrimazole.

4.4Specialwarningsandprecautionsforuse

NoneotherthanthepossibilityofhypersensitivitytoClotrimazole.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Laboratorytestshavesuggestedthat,whenusedtogether,thisproductmaycausedamagetolatexcontraceptives.

Consequentlytheeffectivenessofsuchcontraceptivesmaybereduced.Patientsshouldbeadvisedtousealternative

precautionsforatleastfivedaysafterusingthisproduct.

4.6Pregnancyandlactation

Studiesinanimalshaveonlyshownfoetotoxicityafterhighdosageorally.Noteratogeniceffecthasbeenseenin

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/08/2009 CRN 2066430 page number: 2

4.7Effectsonabilitytodriveandusemachines

Canestenispresumedtobesafeorunlikelytoproduceaneffect.

4.8Undesirableeffects

Thefollowingadversereactionshavebeenreportedinconnectionwiththetopicaluseofclotrimazole:erythema,

stinging,blistering,peeling,oedema,pruritus,urticaria,burningandgeneralirritationoftheskin.

4.9Overdose

Acuteoverdosewithtopicalapplicationofclotrimazoleisunlikelyandwouldnotbeexpectedtoleadtoahealth-

threateningsituation.

Accidentaloralingestion:

Intheevent,routinemeasuressuchasgastriclavageshouldbeperformedassoonaspossibleafteringestion.All

possiblyinfectedareasshouldbetreatedatthesametime.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theimidazoles,ofwhichclotrimazoleisone,arebroadspectrumantifungalagents.Theyactbyinterferingwiththe

integrityandfunctionofthefungalcellmembrane.Themechanismbywhichtheydothisexplainstheirselectivityfor

fungibutdoesnotexplaintheiractionsongram-positivebacteria,anaerobes,andtrichomonads.

5.2Pharmacokineticproperties

Followingtopicaladministrationclotrimazoleappearstobeminimallyabsorbed.

5.3Preclinicalsafetydata

None.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

SorbitanStearate

Polysorbate60

CetylPalmitate

Cetostearylalcohol

2-Octyldodecanol

Benzylalcohol

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelflifeexpirydateofthisproductshallbethedateonthecontainerandouterpackageoftheproductinthe

Irish Medicines Board

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Date Printed 24/08/2009 CRN 2066430 page number: 3

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Aluminiumtubeswithscrewoncapscontaining20gcream.Eachtubeiscontainedwithinacardboardcarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

PCOManufacturingLimited

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8ParallelProductAuthorisationNumber

PPA0465/048/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01/01/1977

Dateoflastrenewal:14/01/2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 24/08/2009 CRN 2066430 page number: 4