BENTIFEN

Main information

  • Trade name:
  • BENTIFEN Eye Drops Solution 0.25 Mg/Ml
  • Dosage:
  • 0.25 Mg/Ml
  • Pharmaceutical form:
  • Eye Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BENTIFEN Eye Drops Solution 0.25 Mg/Ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0013/113/001
  • Authorization date:
  • 24-03-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0013/113/001

CaseNo:2037810

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NovartisPharmaceuticalsUKLtd

FrimleyBusinessPark,Frimley,Camberley,Surrey,GU167SR,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BENTIFEN0.25mg/mleyedropssolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom11/12/2007until29/06/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/01/2008 CRN 2037810 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BENTIFEN0.25mg/ml,eyedrops,solution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onemlcontains0.345mgketotifenfumaratecorrespondingto0.25mgketotifen.

Eachdropcontains8.5microgramketotifenfumarate.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Eyedrops,solution

Clear,colourlesstofaintlyyellowsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Symptomatictreatmentofseasonalallergicconjunctivitis.

4.2Posologyandmethodofadministration

Adults,elderlyandchildren(age3andolder):onedropofBENTIFENintotheconjunctivalsactwiceaday.

Thecontentsanddispenserremainsterileuntiltheoriginalclosureisbroken.Toavoidcontaminationdonottouchany

surfacewiththedroppertip.

4.3Contraindications

Hypersensitivitytoketotifenortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

TheformulationofBENTIFENeyedropscontainsbenzalkoniumchlorideasapreservative,whichmaybedepositedin

softcontactlenses;thereforeBENTIFENeyedropsshouldnotbeinstilledwhilethepatientiswearingtheselenses.

Thelensesshouldberemovedbeforeapplicationofthedropsandnotreinsertedearlierthan15minutesafteruse.

Alleyedropspreservedwithbenzalkoniumchloridemaypossiblydiscoloursoftcontactlenses.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

IfBENTIFENisusedconcomitantlywithothereyemedicationstheremustbeanintervalofatleast5minutesbetween

thetwomedications.

TheuseoforaldosageformsofketotifenmaypotentiatetheeffectofCNSdepressants,antihistaminesandalcohol.

Irish Medicines Board

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4.6Pregnancyandlactation

Therearenoadequatedatafromtheuseofketotifeneyedropsinpregnantwomen.Animalstudiesusingmaternally

toxicoraldosesshowedincreasedpre-andpostnatalmortality,butnoteratogenicity.Systemiclevelsafterocular

administrationaremuchlowerthanafteroraluse.Cautionshouldbeexercisedwhenprescribingtopregnantwomen.

Althoughanimaldatafollowingoraladministrationshowexcretionintobreastmilk,topicaladministrationtohumanis

unlikelytoproducedetectablequantitiesinbreastmilk.BENTIFENeyedropscanbeusedduringlactation.

4.7Effectsonabilitytodriveandusemachines

Anypatientwhoexperiencesblurredvisionorsomnolenceshouldnotdriveoroperatemachines.

4.8Undesirableeffects

Attherecommendeddose,thefollowingundesirableeffectshavebeenreported:

Eyedisorders:

Commoneffects:Eyeirritation,eyepain,punctatekeratitis.

Uncommoneffects:Visionblurred(duringinstillation),dryeye,eyeliddisorder,conjunctivitis,photophobia,

conjunctivalhaemorrhage.

Nervoussystemdisorders:

Uncommoneffects:Headache.

Generaldisordersandadministrationsiteconditions:

Uncommoneffects:Somnolence.

Skinandsubcutaneoustissuedisorders:

Uncommoneffects:Rash,eczema,urticaria.

Gastrointestinaldisorders:

Uncommoneffects:Drymouth.

Immunesystemdisorders:

Uncommoneffects:Hypersensitivity.

4.9Overdose

Nocaseofoverdosehasbeenreported.

Oralingestionofthecontentsofa5mlbottlewouldbeequivalentto1.25mgofketotifenwhichis60%ofa

recommendedoraldailydosefora3yearoldchild.Clinicalresultshaveshownnoserioussignsorsymptomsafteroral

ingestionofupto20mgofketotifen.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Ophthalmologicals,otheranti-allergics.

ATCcode:S01GX08.

KetotifenisahistamineH-receptorantagonist.Invivoanimalstudiesandinvitrostudiessuggesttheadditional

Irish Medicines Board

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5.2Pharmacokineticproperties

Inapharmacokineticstudyconductedin18healthyvolunteerswithBENTIFENeyedrops,plasmalevelsofketotifen

afterrepeatedocularadministrationfor14dayswereinmostcasesbelowthelimitofquantitation(20pg/ml).

Afteroraladministration,ketotifeniseliminatedbiphasicallywithaninitialhalf-lifeof3to5hoursandaterminalhalf-

lifeof21hours.About1%ofthesubstanceisexcretedunchangedintheurinewithin48hoursand60to70%as

metabolites.Themainmetaboliteisthepracticallyinactiveketotifen-N-glucuronide.

5.3Preclinicalsafetydata

PreclinicaldatarevealnospecialhazardwhichisconsideredrelevantinconnectionwithuseofBENTIFENeyedrops

inhumansbasedonconventionalstudiesofsafetypharmacology,repeateddosetoxicity,genotoxicity,carcinogenic

potentialandtoxicitytoreproduction.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzalkoniumchloride

Glycerol(E422)

Sodiumhydroxide(E524)

Waterforinjections

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Inunopenedbottle:2years.

Afteropening:4weeks.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Thecontainerisawhite-colouredLDPEbottlewithatransparentLDPEdropperandawhiteHDPEscrewcapwithan

integratedsafetyring.Onebottlecontains5mlofthesolution.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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Date Printed 04/01/2008 CRN 2037810 page number: 4

7MARKETINGAUTHORISATIONHOLDER

NovartisPharmaceuticalsUKLimited

FrimleyBusinessPark

Frimley

Camberley

Surrey

GU167SR

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA13/113/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24March2005

Dateoflastrenewal:30June2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 04/01/2008 CRN 2037810 page number: 5