BETAGAN 0.5 %w/v Eye Drops Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
LEVOBUNOLOL HYDROCHLORIDE
Available from:
LTT Pharma Limited
INN (International Name):
LEVOBUNOLOL HYDROCHLORIDE
Dosage:
0.5 %w/v
Pharmaceutical form:
Eye Drops Solution
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization number:
PPA1562/056/001
Authorization date:
0000-00-00

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Betagan0.5%w/vEyeDrops,Solution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onemlsolutioncontains5.0mglevobunololhydrochloride,equivalentto4.4mglevobunolol.

Excipient(s):Containsbenzalkoniumchloride0.04mg/ml.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

EyeDrops,Solution

ProductimportedfromtheUK:

Aclear,colourlesstolightyellowsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthecontrolofintraocularpressureinchronicopenangleglaucomaandocularhypertension.

4.2Posologyandmethodofadministration

Posology

Adults(includingtheelderly):

TherecommendeddosageisonedropofBetaganintheaffectedeye(s)onceortwicedaily.

PaediatricPopulation

Betaganisnotrecommendedforuseinchildrenduetolackofsafetyandefficacydata(seeSection5.1).

IntraocularpressureshouldbemeasuredapproximatelyfourweeksafterstartingtreatmentwithBetaganasareturnto

normalocularpressurecantakeafewweeks.

Methodofadministration:topicalintotheconjunctivalsac.

Whenusingnasolacrimalocclusionorclosingtheeyelidsfor2minutes,thesystemicabsorptionisreduced.Thismay

resultinadecreaseinsystemicsideeffectsandanincreaseinlocalactivity.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipientslistedinsection6.1.

Reactiveairwaydiseaseincludingbronchialasthmaorahistoryofbronchialasthma,severechronicobstructive

pulmonarydisease.

Sinusbradycardia,sicksinussyndrome,sino-atrialblock,secondandthird-degreeatrioventricularblocknotcontrolled

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4.4Specialwarningsandprecautionsforuse

Likeothertopicallyappliedophthalmicagents,Betaganisabsorbedsystemically.Duetothebeta-adrenergic

componentofBetagan(levobunolol),thesametypesofcardiovascular,pulmonaryandotheradversereactionsasseen

withsystemicbeta-blockersmayoccur.IncidenceofsystemicADRsaftertopicalophthalmicadministrationarelower

thanforsystemicadministration.Toreducethesystemicabsorption,see4.2.

Cardiacdisorders:Inpatientswithcardiovasculardiseases(e.g.coronaryheartdisease,Prinzmetal'sanginaand

cardiacfailure)andhypotension,therapywithbeta-blockersshouldbecriticallyassessedandtherapywithotheractive

substancesshouldbeconsidered.Patientswithcardiovasculardiseasesshouldbewatchedforsignsofdeteriorationof

thesediseasesandofadversereactions.

Duetotheirnegativeeffectonconductiontime,beta-blockersshouldonlybegivenwithcautiontopatientswithfirst

degreeatrioventricularblock.

Vasculardisorders:Patientswithsevereperipheralcirculatorydisturbancedisorders(i.e.severeformsofRaynaud’s

diseaseorRaynaud’ssyndrome)shouldbetreatedwithcaution.

Respiratorydisorders:Respiratoryreactions,includingdeathduetobronchospasminpatientswithasthmahavebeen

reportedfollowingadministrationoflevobunolol.

Betaganshouldbeusedwithcautioninpatientswithmild/moderatechronicobstructivepulmonarydisease(COPD)

andonlyifthepotentialbenefitoutweighsthepotentialrisk.

Hypoglycaemia/diabetes:Beta-blockersshouldbeadministeredwithcautioninpatientssubjecttospontaneous

hypoglycaemiaortopatientswithlabilediabetesasbeta-blockersmaymaskthesignsandsymptomsofacute

hypoglycaemia.

Beta-blockersmayalsomaskthesignsofhyperthyroidism

Cornealdiseases:Ophthalmicbeta-blockersmayinducedrynessofeyes.Patientswithcornealdiseasesshouldbe

treatedwithcaution.

Otherbeta-blockingagents:Theeffectonintra-ocularpressureortheknowneffectsofsystemicbeta-blockademaybe

exaggeratedwhenlevobunololisgiventopatientsalreadyreceivingasystemicbetablockingagent.Theresponseof

thesepatientsshouldbecloselyobserved.Theuseoftwotopicalbeta-adrenergicblockingagentsisnotrecommended

(seesection4.5).

AnaphylacticReactions:Whiletakingbeta-blockers,patientswithahistoryofatopyorahistoryofsevere

anaphylacticreactiontoavarietyofallergensmaybemorereactivetorepeatedchallengewithsuchallergensand

unresponsivetotheusualdoseofadrenalineusedtotreatanaphylacticreactions.

Choroidaldetachment:Choroidaldetachmenthasbeenreportedwithadministrationofaqueoussuppressanttherapy

(e.g.timolol,acetazolamide)afterfiltrationprocedures.

Surgicalanaesthesia:beta-blockingophthalmologicalpreparationsmayblocksystemicbeta-agonisteffectse.g.of

adrenaline.TheanaesthetistmustbeinformedwhenthepatientisreceivingBetagan.

ThepreservativeinBetagan,benzalkoniumchloride,maycauseeyeirritation.Removecontactlensespriorto

applicationandwaitatleast15minutesbeforereinsertion.Benzalkoniumchlorideisknowntodiscoloursoftcontact

lenses.Avoidcontactwithsoftcontactlenses.

Betagancontainssodiummetabisulphitewhichmayrarelycauseseverehypersensitivityreactionsandbronchospasm.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nospecificdruginteractionstudieshavebeenperformedwithlevobunolol.

Thereisapotentialforadditiveeffectsresultinginhypotension,and/ormarkedbradycardiawhenophthalmicbeta-

blockersolutionsareadministeredconcomitantlywithoralcalciumchannelblockers,beta-adrenergicblockingagents,

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Mydriasisresultingfromconcomitantuseofophthalmicbeta-blockersandadrenaline(epinephrine)hasbeenreported

occasionally.

4.6Fertility,pregnancyandlactation

Pregnancy

Therearenoadequatedatafortheuseoflevobunololinpregnantwomen.Levobunololshouldnotbeusedduring

pregnancyunlessclearlynecessary.Toreducethesystemicabsorption,see4.2.

Epidemiologicalstudieshavenotrevealedmalformativeeffectsbutshowariskforintrauterinegrowthretardation

whenbeta-blockersareadministeredbytheoralroute.Inaddition,signsandsymptomsofbeta-blockade(e.g.

bradycardia,hypotension,respiratorydistressandhypoglycaemia)havebeenobservedintheneonatewhenbeta-

blockershavebeenadministereduntildelivery.IfBetaganisadministereduntildelivery,theneonateshouldbe

carefullymonitoredduringthefirstdaysoflife.Animalstudieswithlevobunololhaveshownreproductivetoxicityat

dosessignificantlyhigherthanwouldbeusedinclinicalpractice.

Breast-Feeding

Beta-blockersareexcretedinbreastmilk.However,attherapeuticdosesoflevobunololineyedrops,itisnotlikelythat

sufficientamountswouldbepresentinbreastmilktoproduceclinicalsymptomsofbeta-blockadeintheinfant.

Toreducethesystemicabsorption,see4.2.

Iftreatmentwithlevobunololduringlactationisconsiderednecessaryforthebenefitofthemother,consideration

shouldbegiventothecessationofbreastfeeding.

4.7Effectsonabilitytodriveandusemachines

Betaganhasminorinfluenceontheabilitytodriveandusemachines.Betaganmaycausetransientblurringofvision,

fatigueand/ordrowsinesswhichmayimpairtheabilitytodriveoroperatemachines.Thepatientshouldwaituntil

thesesymptomshaveclearedbeforedrivingorusingmachinery.

4.8Undesirableeffects

Likeothertopicallyappliedophthalmicdrugs,levobunololisabsorbedintothesystemiccirculation.Thismaycause

similarundesirableeffectsasseenwithsystemicbeta-blockingagents.IncidenceofsystemicADRsaftertopical

ophthalmicadministrationofbeta-blockingagentsislowerthanforsystemicadministration.

Withineachfrequencygrouping,undesirableeffectsarepresentedinorderofdecreasingseriousness.Thefollowing

terminologieshavebeenusedinordertoclassifytheoccurrenceofundesirableeffects: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).

Thefollowingadversereactionshavebeenreportedwithlevobunolol:

PsychiatricDisorders

Notknown:Depression

NervousSystemDisorders

Notknown:Confusion,Dizziness,Somnolence,Lethargy,Headache,Insomnia

EyeDisorders

VeryCommon:Eyeirritation,Eyepain

Common:Blepharitis,Conjunctivitis

Notknown:Conjunctival/Ocularhyperaemia,Conjuctivitisallergic,Cornealreflexdecreased,Iridocyclitis,Keratitis,

Visionblurred,Punctatekeratitis,Eye/Eyelidspruritus,Eye/Eyelidoedema,Eyedischarge,Lacrimationincreased,Dry

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CardiacDisorders

Notknown:Syncope,Bradycardia,Atrioventricularblock,Palpitations

VascularDisorders

Notknown:Hypotension,Raynaud’sphenomenon

Respiratory,Thoracic,andMediastinalDisorders

Notknown:Asthma,Dyspnoea,Throatirritation,Nasaldiscomfort

GastrointestinalDisorders

Notknown:Nausea

SkinandSubcutaneousTissueDisorders

Notknown:Urticaria,Dermatitiscontact(includingallergiccontactdermatitis),Rash,Erythemaofeyelid,Eyelid

eczema,Skinexfoliation,Lichenoidkeratosis,Pruritus

GeneralDisordersandAdministrationSiteConditions

Notknown:Faceoedema,Fatigue/asthenia

Additionaladversereactionshavebeenseenwithotherophthalmicbeta-blockersandmaypotentiallyoccurwith

Betagan:

EyeDisorders:Choroidaldetachmentfollowingfiltrationsurgery,Cornealerosion,Diplopia,Ptosis

ImmuneSystemDisorders:Anaphylacticreaction,Systemicallergicreactionsincludingangioedema

MetabolismandNutritionDisorders:Hypoglycaemia

Psychiatricdisorders:Memoryloss,Nightmares

NervousSystemDisorders:Cerebralischemia,Cerebrovascularaccident,Increasesinsignsandsymptomsof

myastheniagravis,Paraesthesia

CardiacDisorders:Arrhythmia,Cardiacarrest,Cardiacfailure,Chestpain,Congestiveheartfailure,Oedema

Vasculardisorders:Coldhandsandfeet

Respiratory,Thoracic,andMediastinalDisorders:Bronchospasm(predominantlyinpatientswithpre-existing

bronchospasticdisease),Cough

GastrointestinalDisorders:Abdominalpain,Diarrhoea,Dysgeusia,Drymouth,Dyspepsia,vomiting

SkinandSubcutaneousTissueDisorders:Alopecia,Psoriasiformrashorexacerbationofpsoriasis

MusculoskeletalandConnectiveTissueDisorders:Myalgia

ReproductiveSystemandBreastDisorders:Decreasedlibido,Sexualdysfunction

4.9Overdose

TherearenodataavailableonhumanoverdosagewithBetagan,whichisunlikelytooccurviatheocularroute.Should

accidentalocularoverdosageoccur,flushtheeye(s)withwaterornormalsaline.Ifaccidentallyingested,systemic

symptomsmayresultandeffortstodecreasefurtherabsorptionmaybeappropriate.Thesymptomsassociatedwith

systemicoverdosagearemostlikelytobebradycardia,hypotension,bronchospasmandcardiacfailure.Therapyfor

overdosageofabeta-adrenergicagentshouldbeinstituted,suchasintravenousadministrationofatropinesulphate0.25

to2mgtoinducevagalblockade.Conventionaltherapyforhypotension,bronchospasm,heartblockandcardiacfailure

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

SafetyandeffectivenessofBetaganinpaediatricpatientshavenotbeenestablished.

Levobunololisanon-cardioselectivebeta-adrenoceptorblockingagent,equipotentatbothbetaandbetareceptors.

Levobunololisgreaterthan60timesmorepotentthanitsdextroisomerinitsbeta-blockingactivity.

Inordertoobtainthehighestdegreeofbeta-blockingpotentialwithoutincreasingthepotentialfordirectmyocardial

depression,thelevoisomer,levobunolol,isused.Levobunololdoesnothavesignificantlocalanaesthetic(membrane-

stabilising)orintrinsicsympathomimeticactivity.BetaganhasshowntobeaseffectiveasTimololinlowering

intraocularpressure.

Betaganwheninstilledintheeyewilllowerelevatedintraocularpressureaswellasnormalintraocularpressure,

whetherornotaccompaniedbyglaucoma.Elevatedintraocularpressurepresentsamajorriskfactorinthepathogenesis

ofglaucomatousfieldloss.Thehigherthelevelofintraocularpressure,thelikelihoodofopticnervedamageandvisual

fieldloss.

Theprimarymechanismofactionoflevobunololinreducingintraocularpressureismostlikelyadecreaseinaqueous

humourproduction.Betaganreducesintraocularpressurewithlittleornoeffectonpupilsizeincontrasttothemiosis

whichcholinergicagentsareknowntoproduce.

Theblurredvisionandnightblindnessoftenassociatedwithmioticswouldnotbeexpectedwiththeuseof

Betagan.Patientswithcataractsavoidtheinabilitytoseearoundlenticularopacitiescausedbypupilconstriction.

5.2Pharmacokineticproperties

TheonsetofactionwithonedropofBetagancanbedetectedwithinonehourafterinstillation,withmaximumeffect

seenbetweentwoandsixhours.Asignificantdecreasecanbemaintainedforupto24hoursfollowingasingledose.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Poly(vinylalcohol)

Benzalkoniumchloride

Sodiummetabisulphite(E223)

Sodiumchloride

Disodiumedetate

Sodiumphosphatedibasicheptahydrate

Potassiumdihydrogenphosphate

Sodiumhydroxide(toadjustph)or

Hydrochloricacid(toadjustph)

Purifiedwater

6.2Incompatibilities

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6.3Shelflife

TheshelflifeexpirydateforthisproductshallbethedateshownontheBottleandouterpackageoftheproductonthe

marketinthecountryoforigin.

Afteropening:1month

6.4Specialprecautionsforstorage

Donotstoreabove25 o

C.Keepthebottleintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Bottleanddroppertipmadeoflowdensitypolyethylene.Thecapiseithera''traditional'',highimpact,polystyrenecap

orahighimpact,polystyrenecompliancecap(C-Cap)withanexternalrotatingsleeveindicatingdailydosagestatus.

Bothhaveasafetysealtoensureintegrity.

5mlBottles.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

LTTPharmaLimited

Unit18,OxleasowRoad

EastMoonsMoat

Redditch

WorcestershireB980RE

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1562/056/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Thedateoffirstauthorisation:26 th

August2011

10DATEOFREVISIONOFTHETEXT

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Date Printed 24/02/2014 CRN 2136605 page number: 6

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