BENTIFEN SINGLE DOSE UNIT

Main information

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

Documents

Localization

  • Available in:
  • BENTIFEN SINGLE DOSE UNIT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0013/113/002
  • 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)

PA0013/113/002

CaseNo:2037810

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NovartisPharmaceuticalsUKLtd

FrimleyBusinessPark,Frimley,Camberley,Surrey,GU167SR,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BENTIFEN0.25mg/mleyedropssolutioninsingle-dosecontainers

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,solutioninsingle-dosecontainers

2QUALITATIVEANDQUANTITATIVECOMPOSITION

0.4mlcontains0.138mgketotifenfumaratecorrespondingto0.1mgketotifen.

Eachdropcontains9.5microgramketotifenfumarate.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Eyedrops,solutioninsingle-dosecontainers

Clear,colourlesstofaintlyyellowsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Symptomatictreatmentofseasonalallergicconjunctivitis.

4.2Posologyandmethodofadministration

Adults,elderlyandchildren(age3andolder):onedropofBENTIFENintotheconjunctivalsactwiceaday.The

contentsofasingle-dosecontaineraresufficientforoneadministrationintobotheyes.

Thecontentsremainsterileuntiltheoriginalclosureisbroken.Toavoidcontaminationdonottouchanysurfacewith

thetipofthecontainer.

4.3Contraindications

Hypersensitivitytoketotifenortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Nospecialwarning.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

IfBENTIFENisusedconcomitantlywithothereyemedicationstheremustbeanintervalofatleast5minutesbetween

themedications.

TheuseoforaldosageformsofketotifenmaypotentiatetheeffectsofCNSdepressants,antihistaminesandalcohol.

AlthoughthishasnotbeenobservedwithBENTIFENeyedrops,thepossibilityofsucheffectscannotbeexcluded.

4.6Pregnancyandlactation

Irish Medicines Board

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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.

Oralingestionofthecontentsofasingle-dosecontainerwouldbeequivalentto0.1mgofketotifenwhichis5%ofa

recommendedoraldailydosefora3yearoldchild.Clinicalresultshaveshownnoserioussignsorsymptomsafteroral

ingestionofupto20mgofketotifen.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Ophthalmologicals,otherantiallergics.

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KetotifenisahistamineH-receptorantagonist.Invivoanimalstudiesandinvitrostudiessuggesttheadditional

activitiesofmastcellstabilisationandinhibitionofinfiltration,activationanddegranulationofeosinophils.

5.2Pharmacokineticproperties

Inapharmacokineticstudyconductedin18healthyvolunteerswithBENTIFENeyedrops,plasmalevelsofketotifen

afterrepeatedocularadministrationfor14dayswereinmostcasesbelowthelimitofquantitation(20pg/ml).

Afteroraladministration,ketotifeniseliminatedbiphasically,withaninitialhalflifeof3to5hoursandaterminalhalf

lifeof21hours.About1%ofthesubstanceisexcretedunchangedintheurinewithin48hoursand60to70%as

metabolites.Themainmetaboliteisapracticallyinactiveketotifen-N-glucuronide.

5.3Preclinicalsafetydata

PreclinicaldatarevealnospecialhazardwhichisconsideredrelevantinconnectionwithuseofBENTIFENeyedrops

inhumansbasedonconventionalstudiesofsafetypharmacology,repeateddosetoxicity,genotoxicity,carcinogenic

potentialandtoxicitytoreproduction.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol(E422)

Sodiumhydroxide(E524)

Waterforinjections

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Inunopenedblister:2years.

Openedblister:28days.

Single-dosecontainersstoredwithoutblisterintheoutercarton:3months.

Afteropening,thecontentsofasingle-dosecontainershouldbeusedimmediately.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Thecontainerisatransparent0.4mlLDPEsingle-dosecontainer.Blocksof5single-dosecontainersareeachpacked

inablistermadeofPVC,aluminium,polyamidetraysealedwithanaluminiumfoilcoverandpaperlayer.Carton

boxesof5,20,30,50and60single-dosecontainers.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

NovartisPharmaceuticalsUKLimited

FrimleyBusinessPark

Frimley

Camberley

SurreyGU167SR

England

8MARKETINGAUTHORISATIONNUMBER

PA13/113/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24March2005

Dateoflastrenewal:30June2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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