ALOMIDE ALLERGY 0.1% W/ V EYE DROPS, SOLUTION

Main information

  • Trade name:
  • ALOMIDE ALLERGY 0.1% W/ V EYE DROPS, SOLUTION
  • Dosage:
  • 0.1 %w/ v
  • Pharmaceutical form:
  • Eye Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALOMIDE ALLERGY 0.1% W/V EYE DROPS, SOLUTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0290/063/002
  • Authorization date:
  • 03-06-2003
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0290/063/002

CaseNo:2080568

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

AlconLaboratories(UK)Ltd

PentagonPark,BoundaryWay,HemelHempstead,HertfordshireHP27UD,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AlomideAllergy0.1%w/vEyedrops,solution

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom06/07/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 06/07/2010 CRN 2080568 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AlomideAllergy0.1%w/vEyedrops,solution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Contains0.1%w/vlodoxamideaslodoxamidetrometamol.

Excipient:contains0.007%w/vbenzalkoniumchlorideasbenzalkoniumchloridesolution.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,solution(eyedrops).

Aclearcolourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Alomideisindicatedinthetreatmentoftheocularsignsandsymptomsofallergicconjunctivitis.

4.2Posologyandmethodofadministration

Adultsandchildren(4yearsandabove):Oneortwodropsineacheyefourtimesadayatregularintervals.

Alomidetherapyisdependentuponitsadministrationatregularintervals,asdirected.

Alomidetherapyshouldnotbeusedformorethan4weekswithoutseekingmedicaladvice.

ImprovementsinsignsandsymptomsinresponsetoAlomidetherapy(decreaseddiscomfort,itching,foreignbody

sensation,photophobia,acuteocularpain,tearing,discharge,erythema/swelling,conjunctivalredness,limbalreaction,

epithelialdisease,ptosis)areusuallyevidentwithinafewdays,butlongertreatmentforuptofourweeksissometimes

required.Oncesymptomaticimprovementhasbeenestablished,therapyshouldbecontinuedforaslongasneededto

sustainimprovement.

Instillationofeyedropsinallergicconjunctivitismaycausediscomfortinitially;thiswilldeclinewithimprovementof

thedisease(see4.8UndesirableEffects).

Childrenlessthan4years:ThesafetyandeffectivenessofAlomideinchildrenbelowtheageoffouryearshavenot

beenestablished.

Elderly:TherearenospecialprecautionstobefollowedinprescribingAlomidefortheelderly.

Ifrequired,corticosteroidsmaybeusedconcomitantlywithAlomide.

4.3Contraindications

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medicament.

4.4Specialwarningsandprecautionsforuse

Alomideisnotforinjection.Therecommendedfrequencyofadministrationshouldnotbeexceeded.Aswithall

preparationscontainingbenzalkoniumchloride,usersofsoft(hydrophilic)contactlensesshouldrefrainfromwearing

lenseswhileundertreatmentwithAlomide.Lensesmaybewornwithinafewhoursofdiscontinuationoftreatment.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Reproductionstudieswithlodoxamidetrometamoladministeredorallytoratsandrabbitsindosesof100mg/kg/day

(morethan5000timestheproposedhumandose)producednoevidenceofdevelopmentaltoxicity.However,thereare

noadequateandwell-controlledstudiesinpregnantwomen.Sinceanimalreproductionstudiesarenotalwayspredictive

ofhumanresponse,Alomideshouldbeusedduringpregnancyonlyifclearlyneeded.

Itisnotknownwhetherlodoxamideissecretedinhumanmilk.Becausemanydrugsareexcretedinhumanmilk,

cautionshouldbeexercisedwhenAlomideisadministeredtonursingmothers.

4.7Effectsonabilitytodriveandusemachines

Alomideisunlikelytoaffectauser’sabilitytodriveortousemachinery.

4.8Undesirableeffects

DuringclinicalstudiesofAlomide,themostfrequentlyreportedocularadverseexperiencesweretransientburning,

stinging,ordiscomfortuponinstillation,whichoccurredin13%ofpatients.Otheroculareventsoccurringin1to5%of

thepatientsincludedocularpruritus,blurredvision,lidmargincrusting,dryeye,tearingandhyperaemia.Eventsthat

occurredinlessthan1%ofthepatientsincludedforeignbodysensation,ocularpain,discharge,ocularoedema,ocular

fatigue,ocularwarmingsensation,lidoedema,chemosis,anteriorchambercells,epitheliopathy,keratopathy/keratitis,

blepharitis,stickysensation,cornealerosion,dimvision,cornealabrasionandallergy.Non-oculareventsarerareand

reportedatincidencesbelow1%;theseincludedwarmsensation,headache,nausea,stomachdiscomfort,dizziness,

somnolence,drynose,sneezingandrash.

4.9Overdose

Intheeventofatopicaloverdose,flushfromtheeyewithrunningwater.Accidentaloverdoseofanoralpreparationof

120to180mgoflodoxamideresultedintemporarysensationofwarmth,profusesweating,diarrhoea,light-headedness

andafeelingofstomachdistension;nopermanentadverseeffectswereobserved.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Lodoxamide,amastcellstabiliserinhibitstheinvivoTypeIimmediatehypersensitivityreactioninanimalsandman.

Invitrostudieshavedemonstratedtheabilityoflodoxamidetostabilisemastcellsandpreventtheantigenspecific

inducedreleaseofhistamine.Inaddition,lodoxamidepreventsthereleaseofothermastcellinflammatorymediators

(i.e.SRS-A,slowreactingsubstancesofanaphylaxisalsoknownasthepeptido-leukotrienes).Lodoxamideinhibits

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5.2Pharmacokineticproperties

Theoralbioavailabilityof 14

C-lodoxamideinmanis71%,approximately87%oftheabsorbeddrugundergoesbio

transformation.Themetabolictransformationoflodoxamideresultsfromstepwisehydrolysisoftheoxylamidegroups

toformthemonoxamateandthediamine.Thediamineundergoesfurtherhydroxylationfollowedbyconjugationto

eithertheO-glucuronideorO-sulphate.TheO-glucuronideandO-sulphatemetabolitesaccountfor79%ofthe

biotransformedlodoxamide,withthemonoxamateanddiamineaccountingfor5%and3%oftheexcretedmetabolites.

Only2.7%oftheabsorbeddoseisrecoveredasunchangeddrugintheurine.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichwereadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzalkoniumchloride

Mannitol(E421)

Hypromellose

Sodiumcitratedihydrate

Citricacidmonohydrate

Disodiumedetate

Tyloxapol

Sodiumhydroxide(forpHadjustment)

Hydrochloricacidconcentrated(forpHadjustment)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened:2years.

Onceopened:Discardfourweeksafterfirstopening.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Low-densitypolyethyleneDROP-TAINER®bottlecontaining5mlofsolutionwithlowdensitypolyethylene

dispensingplugandtamperevidentpolypropylenescrewcap.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

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Date Printed 06/07/2010 CRN 2080568 page number: 4

AlconLaboratories(UK)Ltd

PentagonPark

BoundaryWay

HemelHempstead

Hertfordshire

HP27UD

England

8MARKETINGAUTHORISATIONNUMBER

PA290/63/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:03June2003

Dateoflastrenewal:03june2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 06/07/2010 CRN 2080568 page number: 5