AZELASTINE 0.5 Mg/Ml Eye Drops Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
AZELASTINE HYDROCHLORIDE
Available from:
Meda Health Sales Ireland Limited
ATC code:
S01GX07
INN (International Name):
AZELASTINE HYDROCHLORIDE
Dosage:
0.5 Mg/Ml
Pharmaceutical form:
Eye Drops Solution
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Other antiallergics
Authorization status:
Authorised
Authorization number:
PA1332/010/001
Authorization date:
2006-06-13

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PackageLeaflet:Informationforthepatient

Azelastine 0.5mg/mlEye Drops,Solution

Azelastine hydrochloride

Read allofthisleafletcarefullybefore youstartusingthismedicinebecauseitcontains

importantinformationforyou. *)

Keep thisleaflet.Youmayneedtoread itagain.

Ifyouhave anyfurtherquestions,askyourdoctororpharmacist.

Thismedicinehasbeenprescribedforyouonly.Do notpassitontoothers.Itmayharmthem,

eveniftheirsignsofillnessarethesame asyours.

Ifyou getanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossible side

effectsnotlistedinthisleaflet.Seesection4.

InthisleafletAzelastine0.5mg/mlEye Drops,Solution is calledAzelastine.

Whatisinthisleaflet

1.WhatAzelastineisandwhatitisusedfor

2.WhatyouneedtoknowbeforeyouuseAzelastine

3.HowtouseAzelastine

4.Possible side effects

5.Howto storeAzelastine

6.Contentsofthepackandotherinformation.

Azelastinecontainstheactive substanceazelastinehydrochloride,whichbelongsto agroup of

medicinescalledantiallergics(antihistamines).Antihistaminesworkbypreventingtheeffectsof

substancessuchashistamine thatthebodyproducesaspartofanallergicreaction.Azelastine

hasbeenshown to reduce inflammationoftheeye.

Azelastinecanbeusedto treatand preventeyedisorderswhich yougetwith hayfever(seasonal

allergicconjunctivitis)inadultsandchildrenaged4 yearsandabove.

Azelastinecanbeusedforeyedisorderscausedbyanallergytosubstances suchas house dust

mitesoranimalhair(perennialallergicconjunctivitis)inadultsandchildrenaged12yearsand

above.

Youmusttalkto adoctorifyoudonotfeelbetterorifyoufeelworseafter2 days.

Azelastineis notsuitablefortreatingeye infections.

Do notuseAzelastine:

if youareallergictoazelastine hydrochlorideoranyoftheotheringredientsofthismedicine

(listedinsection6).

1.WhatAzelastineisandwhatitisusedfor

2.Whatyouneedto knowbeforeyouuseAzelastine

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Talkto yourdoctororpharmacistbeforeusingAzelastine:

- ifyouarenotsurewhetheryoureye disordersarecausedbyanallergy.Inparticularif

onlyone eye is affected;ifyourvisionisimpaired;ortheeye hurtsandyoudonothave

anysymptomsin yournose,youmayhave aninfectionratherthan anallergy

- ifthecomplaintsworsenorlastlongerthan48hourswithoutremarkable improvement

despite theuseofAzelastine

- ifyouwearcontactlenses.

Childrenand adolescents

Forthetreatmentofeyedisorderscausedbyhayfever(seasonalallergicconjunctivitis):

Do notgive thismedicine tochildrenbelow4yearsofage,because safetyand efficacyhave not

beenestablished.

Forthetreatmentofeyedisorderscausedbyanallergy(non-seasonal(perennial)allergic

conjunctivitis):

Do notgive thismedicine tochildrenbelow12yearsofage,because safetyand efficacyhave not

beenestablished.

OthermedicinesandAzelastine

EvenifAzelastineisnotknown tobeaffectedbyothermedicines,tellyourdoctororpharmacistif

youaretaking,have recentlytakenormighttakeanyothermedicines.

Pregnancyand breast-feeding

Ifyouarepregnantorbreast-feeding,thinkyoumaybepregnantorareplanningtohave ababy,

ask yourdoctororpharmacistforadvice beforetakingthismedicine.

Drivingand usingmachines

Yoursightmaybecomeblurredfora shorttime afteryouuseAzelastine.Ifthishappens,waituntil

yoursightclearsbeforeyoudrive orusemachinery.

Azelastinecontainsbenzalkoniumchloride

Azelastine contains thepreservative benzalkoniumchloride,which isknown to discoloursoft

contactlenses . Avoid contactwith softcontactlenses.

Remove contactlensespriorto application andwaitatleast15minutesbeforereinsertion. .

Benzalkoniumchloridemaycauseanallergicreaction (eye irritation).

Alwaysusethismedicineexactlyas yourdoctororpharmacisthastoldyou.Checkwith your

doctororpharmacistifyouarenotsure.

Remember:

Azelastineshould onlybe appliedtotheeyes.

Therecommended doseis:

Eyedisorderscausedbyhayfever(seasonalallergicconjunctivitis)

Use inadultsand children aged4yearsandabove

3.HowtouseAzelastine

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Ifyouanticipatecontactwithpollen,theusualdoseofAzelastinemaybetakenasapreventive

measurebeforegoing outside.

Eyedisorderscausedbyanallergy(non-seasonal(perennial)allergicconjunctivitis)

Use inadultsand children aged12yearsandabove

Theusualdoseisonedropin each eye inthemorningand evening.

Ifyoursymptomsaresevere,yourdoctormayincrease yourdoseto onedropin eacheye,upto

fourtimesaday.

Reliefofsymptomsofallergicconjunctivitisshould benoticedafter15-30minutes.

PuttinginyourAzelastineeye drops

Tohelp youputin youreyedropscorrectly,youmayfinditusefultositinfrontofamirrorso you

canseewhatyouare doingforthefirstfewtimes.

1. Wash yourhands.

2. Gentlywipearoundyoureyes with atissuestoremove anymoisture(Diagram1).

3. Unscrewthetopofthebottleandcheckthatthedropperisclean.

4. Gentlypullyourlowereyelid down (Diagram2).

5. Carefullyplacethedropinsidethemiddle ofyourlowereyelid(Diagram3).Takecarenotto

letthedroppertouchyoureye.

6. Release yourlowereye lid andgentlypressonthe innercornerofyoureye againstthe

bridgeofyournose(Diagram4).Keepingyourfingerpressed againstyournose,slowlyblink

youreyes afewtimestospreadthedropacrossthesurfaceofyoureye.

7. Blotawayanyexcess medicinewith atissue.

8. Repeatthisforyourothereye.

Diagram1 Diagram2 Diagram3 Diagram4

Durationoftreatment

Ifpossible,youshould useAzelastineregularlyuntilyoursymptomshavedisappeared.

Do nottakeAzelastineformorethan6 weeks.

IfyouusemoreAzelastinethanyoushould

IfyouputtoomuchAzelastineintoyoureyes youareunlikelyto have anyproblems.Ifyouare

worried,contactyourdoctor.Ifyouaccidentally swallow Azelastine, contactyourdoctorornearest

hospitalcasualtydepartmentassoon aspossible.

IfyouforgettouseAzelastine

Useyoureye dropsassoon asyouremember,thentakethenextdoseattheusualtime.Do not

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take adouble dosetomakeupforamisseddose.

Ifyoustop usingAzelastine

Ifyouinterrupttheuse ofAzelastineyoursymptomsare likelytoreturn.

Ifyouhave anyfurtherquestionsontheuseofthismedicine,askyourdoctororpharmacist.

Like allmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.

Theseeffectsinclude:

Common(mayaffectupto1in10people): Slightirritation(burning,itching,watering)in the

eyes afterputtinginAzelastine.Thisshouldnotlastlong.

Uncommon(mayaffectupto1in100people): Abittertaste inyourmouth.Thisshouldquickly

disappearespeciallyifyouhave asoftdrink.

Veryrare(mayaffectupto 1in 10,000people): An allergicreaction(suchas rashand itching).

Reportingofsideeffects

Ifyougetanysideeffects,talkto yourdoctor,pharmacistornurse.Thisincludes anypossible side

effectsnotlistedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviaHPRA

Pharmacovigilance,EarlsfortTerrace,IRL-Dublin 2;Tel:+353 16764971;Fax:+353 16762517.

Website:www.hpra.ie;E-mail:medsafety@hpra.ie.Byreportingsideeffectsyoucanhelp provide

moreinformationonthesafetyofthismedicine.

Keepthismedicineoutofthesightandreachofchildren.

Do notusethismedicineaftertheexpirydatewhich is statedonthebottlelabeland theouter

carton.Theexpirydate referstothelastdayofthatmonth.

Once opened:Donotusethismedicineifthebottle hasbeenopenforlongerthan 4weeks.

Thismedicinedoesnotrequireanyspecialstorageconditions.

Do notthrowawayanymedicinesvia wastewaterorhousehold waste.Askyourpharmacisthowto

throwawaymedicinesyounolongeruse.Thesemeasureswillhelp protecttheenvironment.

WhatAzelastinecontains

Theactive substance isazelastine hydrochloride 0.05%(0.5mg/ml).Eachdropcontains0.015mg

azelastine hydrochloride.

Theotheringredientsarebenzalkonium chloride, disodiumedetate,hypromellose,liquidsorbitol

(crystallising)(E420i),sodiumhydroxide(E524)andwaterforinjections.

WhatAzelastinelookslikeandcontents ofthepack

4.Possiblesideeffects

5.Howto storeAzelastine

6.Contents ofthepackandotherinformation

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Azelastinecomesin aplastic bottle with adropperattachment.Onebottlecontains either6,8or

10mleye drops,solution.Notallpacksizes maybemarketed.

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MarketingAuthorisation Holder

Meda Health Sales IrelandLimited

Unit34/35,BlockA

DunboyneBusinessPark

Dunboyne

Co.Meath

Ireland

Manufacturer

MEDAPharmaGmbH&Co.KG

Benzstrasse1

61352 BadHomburg

Germany

Tel:+49(0)6172888-01

fax:+49(0)6172888-2740

e-mail:medinfo@medapharma.de

ThismedicinalproductisauthorisedintheMemberStatesoftheEEAunderthefollowing

names: **)

UnitedKingdom: Azelastine

Ireland: Azelastine Eye Drops

Italy Lasticom

Austria,Denmark,Finland,Portugal,Sweden,The Netherlands: Oculastin

Spain: Corifina

Germany AllergodilakutAugentropfen

AllergodilAugentropfen

Thisleafletwaslastrevised inApril2015.

*) Incasethenationallicenseconcernedisa

[Medicinalproductnotsubjecttomedicalprescription], thefollowingtextaccordingtoqrdwillbeinserted,

althoughithasnotbeenuser tested.

Read allofthisleafletcarefullybefore youstartusingthismedicinebecauseitcontains

importantinformationforyou.

Alwaysusethismedicine exactlyas describedin thisleafletorasyourdoctororpharmacisthas

told you. *)

Keep thisleaflet.Youmayneedtoread itagain.

Askyourpharmacistifyouneedmoreinformationoradvice.

Ifyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossible side

effectsnotlistedinthisleaflet.Seesection4.

Youmusttalkto adoctorifyoudonotfeelbetterorifyoufeelworseafter2 days.Reliefof

symptomsofallergicconjunctivitisshould benoticedafter15-30minutes.

**)Thislisthasnotbeenincludedin theusertested version

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***) Incasethenationallicenseconcernedisa

[Medicinalproductnotsubjecttomedicalprescription], thefollowingtextaccordingtoqrdwillbeinserted,

althoughithasnotbeenuser tested.

Alwaysusethismedicineexactlyasdescribedin thisleafletorasyourdoctororpharmacisthas

told you.Checkwith yourdoctororpharmacistifyouarenotsure.

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AzelastineEyeDrops.

0.5mg/ml,EyeDrops,solution.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Azelastinehydrochloride0.05%(0.5mg/ml).Eachdropcontains0.015mgazelastinehydrochloride.

Excipientwithknowneffect:1mlcontains0.125mgbenzalkoniumchloride.

Forthefulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,solution.

Clear,colourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentandpreventionofthesymptomsofseasonalallergicconjunctivitisinadultsandchildren4yearsandolder.

Treatmentofthesymptomsofnon-seasonal(perennial)allergicconjunctivitisinadultsandchildren12yearsandolder.

4.2Posologyandmethodofadministration

Seasonalallergicconjunctivitis:Theusualdosageinadultsandchildren4yearsandolderisonedropineacheyetwice

dailythatcanbeincreased,ifnecessary,tofourtimesdaily.IfallergenexposureisanticipatedAzelastineeyedrops

shouldbeadministeredprophylactically,priortotheexposure.

Non-seasonal(perennial)allergicconjunctivitis:Theusualdosageinadultsandchildren12yearsandolderisonedrop

ineacheyetwicedailythatcanbeincreased,ifnecessary,tofourtimesdaily.

Assafetyandefficacyhavebeendemonstratedinclinicaltrialsforaperiodofupto6weeks,thedurationofany

courseshouldbelimitedtoamaximumof6weeks.

Patientsshouldbeadvisedtocontacttheirdoctorifsymptomsworsenordonotapproveafter48hours.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipientslistedinsection6.1.

4.4Specialwarningsandprecautionsforuse

Azelastineeyedropsisnotintendedfortreatmentofeyeinfections.

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contactlensesshouldbeavoided.Contactlensesshouldberemovedpriortoapplicationandthepatientshouldwaitat

least15minutesbeforereinsertion.Knowntodiscoloursoftcontactlenses.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

NospecificinteractionstudieswithAzelastineeyedropshavebeenperformed.Interactionstudiesathighoraldoses

azelastinehavebeenperformedhowevertheybearnorelevancetoAzelastineeyedrops,assystemiclevels,after

administrationoftheeyedrops,areinthepicogramrange.

4.6Fertility,pregnancyandlactation

Fertility

Effectsonhumanfertilityhavenotbeeninvestigated.

Pregnancy

Thereisinsufficientinformationavailabletoestablishthesafetyofazelastineinhumanpregnancy.Athighoraldoses

azelastinehasshowntoinduceadverseeffects(foetaldeath,growthretardationandskeletalmalformation)in

experimentalanimals.Localocularapplicationwillresultinminimalsystemicexposure(picogramrange).However,

cautionshouldbeexercisedwhenusingAzelastineeyedropsduringpregnancy.

Breast-feeding

Azelastineisexcretedintothemilkinlowquantities.Forthatreason,Azelastineeyedropsisnotrecommendedduring

lactation.

4.7Effectsonabilitytodriveandusemachines

Themild,transientirritationwhichcanbeexperiencedafterapplicationofAzelastineeyedropsisunlikelytoaffect

visiontoanygreaterextent.However,ifthereareanytransienteffectsonvision,thepatientshouldbeadvisedtowait

untilthisclearsbeforedrivingoroperatingmachinery.

4.8Undesirableeffects

Theassessmentofundesirableeffectsisbasedonthefollowingfrequencies:

Verycommon(1/10)

Common(1/100to<1/10)

Uncommon(1/1,000to<1/100)

Rare(1/10,000to<1/1,000)

Veryrare(<1/10,000)

Notknown(cannotbeestimatedfromtheavailabledata)

Immunesystemdisorders

Veryrare:Allergicreactions(suchasrashandpruritus).

Nervoussystemdisorders

Uncommon:Bittertaste

Eyedisorders

Common:Mild,transientirritationintheeye

Reportingofsuspectedadversereactions

ReportingofsuspectedadversereactionsReportingsuspectedadversereactionsafterauthorisationofthemedicinal

productisimportant.Itallowscontinuedmonitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcare

professionalsareaskedtoreportanysuspectedadversereactionsviaHPRAPharmacovigilance,EarlsfortTerrace,IRL

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4.9Overdose

Nospecificreactionsafterocularoverdosageareknown,andwiththeocularrouteofadministration,overdosage

reactionsarenotanticipated.

Thereisnoexperiencewiththeadministrationoftoxicdosesofazelastinehydrochlorideinhumans.Inthecaseof

overdoseorintoxication,disturbancesofthecentralnervoussystemaretobeexpectedbasedontheresultsofanimal

experiments.Treatmentofthesedisordersmustbesymptomatic.Thereisnoknownantidote.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Antiallergics

ATCcode:S01GX07

Azelastine,aphthalazinonederivativeisclassifiedasapotentlong-actinganti-allergiccompoundwithselectiveH1

antagonistproperties.Anadditionalanti-inflammatoryeffectcouldbedetectedaftertopicalocularadministration.

Datafrominvivo(pre-clinical)andinvitrostudiesshowthatazelastineinhibitsthesynthesisorreleaseofthechemical

mediatorsknowntobeinvolvedinearlyandlatestageallergicreactionse.g.leukotriene,histamine,PAFand

serotonin.

Todate,longtermtherapyECGevaluationsofpatientstreatedwithhighoraldosesofazelastine,haveshownthatin

multipledosestudies,thereisnoclinicallysignificanteffectofazelastineonthecorrectedQT(QTc)interval.

Noassociationofazelastinewithventriculararrhythmiaortorsadedepointeswasobservedinover3700patients

treatedwithoralazelastine.

Reliefofsymptomsofallergicconjunctivitisshouldbenoticedafter15-30minutes.

5.2Pharmacokineticproperties

Generalcharacteristics(systemicpharmacokinetics)

Followingoraladministrationazelastineisrapidlyabsorbedshowinganabsolutebioavailabilityof81%.Foodhasno

influenceonabsorption.Thevolumeofdistributionishighindicatingdistributionpredominantlyintotheperiphery.

Thelevelofproteinbindingisrelativelylow(80-90%,aleveltoolowtogiveconcernoverdrugdisplacement

reactions).

Plasmaeliminationhalf-livesafterasingledoseofazelastineareapproximately20hoursforazelastineandabout45

hoursforthetherapeuticallyactivemetaboliteN-Desmethylazelastine.Excretionoccursmainlyviathefaeces.The

sustainedexcretionofsmallamountsofthedoseinthefaecessuggeststhatsomeentero-hepaticcirculationmaytake

place.

Characteristicsinpatients(ocularpharmacokinetics)

AfterrepeatedocularapplicationofAllergodileyedrops(uptoonedropineacheye,fourtimesdaily),Cmaxsteady

stateplasmalevelsofazelastinehydrochloridewereverylowandweredetectedatorbelowthelimitofquantification.

5.3Preclinicalsafetydata

Azelastinehydrochloridedisplayednosensitisingpotentialintheguineapig.Azelastinedemonstratednogenotoxic

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Inmaleandfemalerats,azelastineatoraldosesgreaterthan3.0mg/kg/daycausedadose-relateddecreaseinthe

fertilityindex;nosubstance-relatedalterationswerefoundinthereproductiveorgansofmalesorfemalesduring

chronictoxicitystudies,however.

Embryotoxicandteratogeniceffectsinrats,miceandrabbitsoccurredonlyatmaternaltoxicdoses(forexample,

skeletalmalformationswereobservedinratsandrabbitsatdosesof68.6mg/kg/day).

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzalkoniumchloride,disodiumedetate,hypromellose,liquidsorbitol(crystallising),sodiumhydroxide,waterfor

injections.

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

Onceopened:donotuseforlongerthan4weeks.

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

10mlopaqueHDPEbottleandLDPEdropperwithwhiteHDPEscrewcap.Onebottlecontainseither6ml,8mlor10

mlsolution.Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

MedaHealthSalesIrelandLimited

Unit34/35,BlockA

DunboyneBusinessPark

Dunboyne

CoMeath

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1332/010/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

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Date Printed 12/09/2016 CRN 2179128 page number: 4

Dateoflastrenewal: 17February2008

10DATEOFREVISIONOFTHETEXT

Health Products Regulatory Authority

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Date Printed 12/09/2016 CRN 2179128 page number: 5

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