ALBALON LIQUIFILM EYE DROPS SOLUTION

Main information

  • Trade name:
  • ALBALON LIQUIFILM EYE DROPS SOLUTION
  • Dosage:
  • 1mg/ml Mg/Ml
  • Pharmaceutical form:
  • Eye Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALBALON LIQUIFILM EYE DROPS SOLUTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0148/016/001
  • Authorization date:
  • 01-11-1982
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0148/016/001

CaseNo:2077287

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

AllerganPharmaceuticalsIreland

CastlebarRoad,Westport,Co.Mayo,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ALBALON1mg/mlLiquifilmEyeDropsSolution

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom25/08/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 25/08/2010 CRN 2077287 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ALBALON1mg/mlLiquifilmEyeDropsSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Naphazolinehydrochloride1mg/ml(0.1%w/v)

Excipients:containsBenzalkoniumchloride0.04mg/ml(0.004%w/v)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,solution.

Clear,colourlesstostraw-colouredsterilesolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ALBALONisindicatedforuseasatopicalocularvasoconstrictor.

4.2Posologyandmethodofadministration

Adultsonly:theusualdoseisoneortwodrops3to4hoursorasinstructedbythephysician.

MethodofAdministration:topicalintotheconjunctivalsac(theheadshouldbetiltedbackandthelowereyelid

depressedtoformapocket,forinstillation).Aswithanyeyedrops,toreducepossiblesystemicabsorption,itis

recommendedthatthelachrymalsacbecompressedatthemedialcanthus(punctualocclusion)foroneminute.This

shouldbeperformedimmediatelyfollowingtheinstillationofeachdrop.

4.3Contraindications

Useinpatientswithaknownhypersensitivetonaphazolinehydrochlorideoranyingredientintheproduct.

Thisproductshouldnotbeusedinpatientswithnarrowangleglaucomaorinthepresenceofananatomicallynarrow

angle.

Useinpatientstakingmonoamineoxidaseinhibitorsorwithin14daysofstoppingsuchmedication.

Naphazolinehydrochlorideshouldnotbeusedininfantsundertwoyearsold.

4.4Specialwarningsandprecautionsforuse

Usewithcautiononaninflamedeye,ashyperaemiagreatlyincreasestherateofsystemicabsorptionthroughthe

conjunctivaandprolongedorfrequentuse,especiallyinaninflamedeye,mayresultinincreasedabsorptionand

possiblesystemiceffects.

Thepunctashouldbedepressedafterinstillationofdropstoreducedrainagethroughthenasolacrimalducttotheoral

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CNSdepressionleadingtocomaandmarkedreductioninbodytemperaturemayoccurinchildrenespeciallyinfants.

Usewithcareinpatientssufferingfromcardiovasculardisease,hypertension,diabetesorhyperthyroidism.

Ifredeyepersists,furtherconsultationshouldbeundertaken.

ThepreservativeinALBALON,benzalkoniumchloride,maycauseeyeirritation.Avoidcontactwithsoftcontact

lenses.Thecontactlensesshouldberemovedpriortoapplicationandreinsertedafteratleast15minutes.Benzalkonium

chlorideisknowntodiscoloursoftcontactlenses.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Decongestantsmayincreasetheactivityof:

Tricyclicantidepressants.

Concurrentuseofmaprotilineortricyclicantidepressantsandnaphazolinemaypotentiatethepressoreffectof

naphazoline.

AseverehypertensivecrisismayensueinpatientsunderMAOinhibitormedicationfromuseofasympathomimetic

drug(seesection4.3).

Decongestantsmaydecreasetheactivityof:

Analgesics

Anticholinesterases

4.6Pregnancyandlactation

Pregnancy:

Therearenoadequateexperimentalstudiesinanimalsforidentifyingapotentialimpactonpregnancy,embryonic

development,foetaldevelopmentorpostnataldevelopment.Thepotentialriskforhumansis(therefore)notknown.

ALBALONshouldnotbeusedduringPregnancy,unlessitisclearlynecessary.

Lactation:

Itisunknownwhethernaphazolineissecretedinbreastmilk.ThereforeALBALONshouldnotbeusedduring

lactation.

4.7Effectsonabilitytodriveandusemachines

ALBALONmaycausedizziness,fatigueand/ordrowsinesswhichmayimpairtheabilitytodriveoroperatemachinery.

ALBALONmaycauseblurredand/orabnormalvisionwhichmayalsoimpairtheabilitytodriveortousemachinery,

especiallyatnightorinreducedlighting.Thepatientshouldwaituntilthesesymptomshaveclearedbeforedrivingor

usingmachinery.

4.8Undesirableeffects

MetabolismandNutritionDisorders:

Notknown:Hyperglycaemia

NervousSystemDisorders:

Notknown:Somnolence,Dizziness,Weakness,Headache,Nervousness

EyeDisorders:

Notknown:Intraocularpressureincreased,Punctatekeratitis,Blurring,Mydriasis,Allergy,Lacrimationincreased,Eye

pain,Eyeirritation,Ocularhyperaemia

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Notknown:Arrhythmia

VascularDisorders:

Notknown:Hypertension

GastrointestinalDisorders:

Notknown:Nausea

GeneralDisordersandAdministrationSiteConditions:

Notknown:Hyperhidrosis

4.9Overdose

Accidentalingestion(especiallyinchildren)maycausemarkedsedationrequiringemergencytreatment.

5PHARMACOLOGICALPROPERTIES

PharmacotherapeuticGroup:Sympathomimeticsusedasdecongestants.

ATCcode:SOIGA01

5.1Pharmacodynamicproperties

ALBALONisindicatedforuseasatopicalocularvasoconstrictor.ThepotentvasoconstrictiveactionofALBALONis

providedbynaphazolinehydrochloride,adrugbelongingtotheimidazolineclassofsympathomimetics.Thisactive

ingredientisawell-knownandestablishedcompound,havingbeensynthesizedin1940.Itiscurrentlyusedasa

vasoconstrictorinseveralmedicaments.Naphazolinehydrochlorideconstrictsthevascularsystemoftheconjunctiva.

Itispresumedthiseffectisduetodirectactionofthedruguponthealpha(excitatory)receptorsofthevascularsmooth

muscle.Naphazolineischaracterizedbyarelativelylongdurationofaction;onedropofALBALONbringsmorethan

threehoursofeffectivedecongestantactivity,eventoeyeswithrepeatedinsult.ThischaracteristicofALBALONis

especiallyhelpfulforthoselivinginanareawithconstantirritantssuchaspollutionanddust.

5.2Pharmacokineticproperties

Referto5.1.

5.3Preclinicalsafetydata

NorelevantpreclinicaldataareknownfortheapplicationofALBALON.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Poly(vinylalcohol)

Disodiumedetate

Sodiumchloride

Sodiumcitratedihydrate

Citricacidmonohydrate

Benzalkoniumchloride

Sodiumhydroxide(forpHadjustment)

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6.2Incompatibilities

Refertosection4.4

6.3ShelfLife

Shelflife:3years

In-useshelflife:Unusedcontentsshouldbediscardedwithin28daysoffirstopening.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Keepthebottleintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Theproductwillbemarketedasasterilesolutionina15mlsizebottlewithdropperapplicator.Allbottlesandtipsare

madefromlowdensitypolyethylene.Thecapsaremadeofpolystyrene.Asafetysealisplacedaroundthebottlecap

toensureintegrityoftheproduct.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AllerganPharmaceuticalsIreland

CastlebarRoad

Westport

CountyMayo

8MARKETINGAUTHORISATIONNUMBER

PA148/16/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

November1982

Dateoflastrenewal:1 st

November2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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