BETAGAN

Main information

  • Trade name:
  • BETAGAN Ear Drops Solution 0.5 %w/ v
  • Dosage:
  • 0.5 %w/ v
  • Pharmaceutical form:
  • Ear Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETAGAN Ear Drops Solution 0.5 %w/v
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/210/001
  • Authorization date:
  • 18-01-2008
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Betagan0.5%w/vEyeDrops,Solution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Levobunololhydrochloride0.5%w/v

ProductimportedfromSpain:

Clear,viscous,sterile,colourlesstolightyelloweyedropssolution

Excipients:Benzalkoniumchloride.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,solution.

Clear,viscous,sterile,colourlesstolightyelloweyedropssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthecontrolofintraocularpressureinchronicopenangleglaucomaandocularhypertension.

4.2Posologyandmethodofadministration

Adults(includingtheelderly):therecommendeddosageofBetaganisonedropintheaffectedeye(s)onceortwice

daily.

Betaganisnotrecommendedforuseinchildrenduetolackofsafetyandefficacydata(seesection5.1.).

Methodofadministration:topicalintotheconjunctivalsac.

Concurranttherapymaybeusedwherenecessary.

Aswithanyeyedrops,toreducepossiblesystemicabsorption,itisrecommendedthatthelachrymalsacbecompressed

atthemedialcanthus(punctualocclusion)foroneminute.Thisshouldbeperformedimmediatelyfollowingthe

instillationofeachdrop.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Bronchialasthma(orahistoryofbronchialasthma)orchronicobstructivepulmonarydisease.

Uncontrolledcardiacfailure.

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4.4Specialwarningsandprecautionsforuse

Aswithothertopicallyappliedophthalmicdrugs,Betaganmaybeabsorbedsystemicallyandadversereactionstypical

oforalbeta-adrenoceptoragentsmayoccur.

Respiratoryandcardiacreactionshavebeenreportedincluding,rarely,deathduetobronchospasmorassociatedwith

cardiacfailure.

CongestiveheartfailureshouldbeadequatelycontrolledbeforebeginningtherapywithBetagan.Inpatientswitha

historyofsignificantcardiacdisease,pulseratesshouldbemonitored.

Becausetheseagentsmayblockthesystemiceffectsofhypoglycaemiatheyshouldbeusedwithcautionindiabetic

patientswhouseinsulinororalhypoglycaemicdrugs.

Stevens-Johnsonsyndromehasbeenreportedfollowingtheuseoflevobunolol;howeveracausalrelationshiphasnot

beenestablished.

Beta-blockershavebeenassociatedwithalopecia;however,acausalrelationshipbetweenlevobunololandalopeciahas

notbeenestablished.

ThepreservativeinBetagan,bensalkoniumchloride,maycauseeyeirritation.Avoidcontactwithsoftcontactlenses.

Removecontactlensespriortoapplicationandwaitatleast15minutesbeforereinsertion.Benzalkoniumchlorideis

knowntodiscoloursoftcontactlenses.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Additiveeffectsmaybenotediftheproductisusedinpatientstakingsystemicantihypertensivedrugs.Thesepossible

additiveeffectsmayincludehypotension,includingorthostatichypotension,bradycardia,dizziness,and/orsyncope.

Conversely,systemicbeta-adrenoceptorblockingagentsmaypotentiatetheocularhypotensiveeffectofBetagan.

4.6Fertility,pregnancyandlactation

Forlevobunololhydrochloridenoclinicaldataonexposedpregnanciesareavailable.

Betaganshouldnotbeusedduringpregnancyunlessclearlynecessary.

Iftreatmentwithlevobunololhydrochlorideduringlactationisconsiderednecessaryforthebenefitofthemother,

considerationshouldbegiventothecessationofbreastfeeding.

4.7Effectsonabilitytodriveandusemachines

Betaganmaycausefatigueand/ordrowsiness,whichmayimpairtheabilitytodriveoroperatemachinery.

Betaganmaycauseblurredand/orabnormalvision,whichmayalsoimpairtheabilitytodriveortousemachinery,

especiallyatnightorinreducedlighting.Thepatientshouldwaituntilthesesymptomshaveclearedbeforedrivingor

usingmachinery.

4.8Undesirableeffects

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).

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NotKnown:Hypersensitivity

PsychiatricDisorders

Notknown:Depression

NervousSystemDisorders

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

EyeDisorders

VeryCommon:Eyeirriataion,Conjunctivalirritation

Common:Blepharitis,Conjunctivitis

Notknown:Cornealreflexdecreased,Iridocyclitis,Keratitis,Visualdisturbance,Eye/Eyelidspruritus,Eye/Eyelid

oedema,Eyedischarge,Lacrimationincreased,Ocularhyperaemia.

CardiacDisorders

Notknown:Syncope,Bradycardia,Atrioventricularblock,Palpitations

VascularDisorders

Notknown:Hypotension

Respiratory,Thoracic,andMediastinalDisorders

Notknown:Asthma,Dyspnoea,Throatirritation,Nasaldiscomfort

GastrointestinalDisorders

Notknown:Nausea

SkinandSubcutaneousTissueDisorders

Notknown:Urticaria,Dermatitis,Rash,Erythema,Skinexfoliation,Lichenoidkeratosis,Pruritus

GeneralDisordersandAdministrationSiteConditions

Notknown:Faceoedema,Asthenia

Thefollowingadditionaladversereactionshavebeenreportedwithophthalmicuseofbeta

andbeta

(non-selective)

blockingagents.

Cardiovascular:cerebrovascularaccident,cerebralischaemia,congestiveheartfailure,cardiacarrest.

Respiratory:respiratoryfailure.

4.9Overdose

TherearenodataavailableonhumanoverdosagewithBetagan,whichisunlikelytooccurviatheocularroute.Should

accidentalocularoverdosageoccur,flushtheeye(s)withwaterornormalsaline.Ifaccidentallyingestedsystemic

symptomsmayresult.Thesymptomsassociatedwithsystemicoverdosagearemostlikelytobebradycardia,

hypotension,bronchospasmandcardiacfailure.Therapyforoverdosageofabeta-adrenergicagentshouldbeinstituted,

suchasintravenousadministrationofatropinesulphate0.25to2mgtoinducevagalblockade.Conventionaltherapy

forhypotension,bronchospasm,heartblockandcardiacfailuremaybenecessary.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

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Levobunololisanon-cardioselectivebeta-adrenoceptorblockingagent,equipotentatbothbeta1andbeta2receptors.

Levobunololisgreaterthan60timesmorepotentthanitsdextroisomerinitsbeta-blockingactivity.Inordertoobtain

thehighestdegreeofbeta-blockingpotentialwithoutincreasingthepotentialfordirectmyocardialdepression,thelevo

isomer,levobunolol,isused.Levobunololdoesnothavesignificantlocalanaesthetic(membrane-stabilising)or

intrinsicsympathomimeticactivity.BetaganhasshowntobeaseffectiveasTimololinloweringintraocularpressure.

Betaganwheninstilledintheeyewilllowerelevatedintraocularpressureaswellasnormalintraocularpressure,

whetherornotaccompaniedbyglaucoma.Elevatedintraocularpressurepresentsamajorriskfactorinthepathogenesis

ofglaucomatousfieldloss.Thehigherthelevelofintraocularpressure,thelikelihoodofopticnervedamageand

visualfieldloss.

Theprimarymechanismofactionoflevobunololinreducingintraocularpressureismostlikelyadecreaseinaqueous

humourproduction.Betaganreducesintraocularpressurewithlittleornoeffectonpupilsizeincontrasttothemiosis

whichcholinergicagentsareknowntoproduce.Theblurredvisionandnightblindnessoftenassociatedwithmiotics

wouldnotbeexpectedwiththeuseofBetagan.Patientswithcataractsavoidtheinabilitytoseearoundlenticular

opacitiescausedbypupilconstriction.

5.2Pharmacokineticproperties

TheonsetofactionwithonedropofBetagancanbedetectedwithinonehourafterinstillation,withmaximumeffect

seenbetweentwoandsixhours.Asignificantdecreasecanbemaintainedforupto24hoursfollowingasingledose.

5.3Preclinicalsafetydata

Notapplicable

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polyvinylalcohol

Benzalkoniumchloride

Sodiummetabisulphite(E223)

Sodiumchloride

Disodiumedetate

Sodiumphosphate,dibasic,heptahydrate

Potassiumdihydrogenphosphate

Sodiumhydroxide

Hydrochloricacid

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

Afterfirstopening:discardafter1month.

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Donotstoreabove25°C.Storethebottleintheoriginalpackageinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

10mlwhiteplasticbottlewithdroppertipandsafetyseal.Thebottleisfilledwith5mlofBetagan.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA465/210/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisastion:18thJanuary2008

10DATEOFREVISIONOFTHETEXT

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