FORTINOL LA

Main information

  • Trade name:
  • FORTINOL LA
  • Dosage:
  • 2 %w/ v
  • Pharmaceutical form:
  • Eye Drops Prolonged Rel.
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FORTINOL LA
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0118/048/002
  • Authorization date:
  • 03-12-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0118/048/002

CaseNo:2043927

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ChauvinPharmaceuticalsLimited

106LondonRoad,Kingston-upon-Thames,Surrey,KT26TN,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

FortinolLA2%w/vEyeDropsProlongedRel.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom28/11/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FortinolLA2%,Eyedrops,prolonged-release.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Carteololhydrochloride:2gper100ml(1mleyedrops,prolongedreleasecontainsCarteololhydrochloride20mg).

Excipient:benzalkoniumchloridesolution(10mg/100ml).

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,prolonged-release.

Clearandlightbrownyellowsolution .

ThepHisbetween6and7,compatiblewiththepHofthetears.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Intraocularhypertension.

Chronicopen-angleglaucoma.

4.2Posologyandmethodofadministration

Ocularuse

Twostrengthsofeyedropsareavailable:1%and2%.

InstillonedropofCarteolL.P.intotheaffectedeye,onceaday,inthemorning.

Toadministerthetreatment,gentlypulldownthelidoftheeyeandapplyonedropwhilelookingupwards,

closetheeyeafewseconds.

Eyeclosed,cleanproperlythesurplus.

Reclosethebottleaftereachuse.

ItisrecommendedthatthetreatmentbestartedbytheinstillationintotheaffectedeyeofonedropofCarteolL.P.

atthelowestdose.

However,thenormalizationofintraocularpressurebycarteololeyedropssometimestakesseveralweeks,and

consequentlytheevaluationofthetreatmentmustincludeameasurementoftheintraocularpressureandacorneal

examinationatthebeginningoftherapyandconsequentlyregularlyafteraperiodoftreatmentofapproximately4

weeks.

Theophthalmologistmay,ifdeemednecessary,co-administercarteololeyedropswithoneormoreother

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Theconcomitanteyedropsmustbeadministeredatleast15minutespriortoCarteolL.P.

Replacementofaformertreatment

WhencarteololeyedropsL.P.mustreplaceanothertypeofglaucomaeyedrops,thelattereyedropsmustbe

discontinuedattheendofacompletedayoftreatment,andcarteololeyedropsLAmustbeadministeredthe

followingdayatthedosageregimenofonedropintheaffectedeyeonceaday.

Ifcarteololeyedropsistobeusedasareplacementforseveralassociatedglaucomamedicinalproducts,onlyone

medicinalproductmaybediscontinuedatatime.

Intheeventofthereplacementofmioticeyedropsbycarteololeyedrops,anexaminationoftherefractionmay

provetobenecessarywhentheeffectsofthemioticshavedisappeared.

Themedicalprescriptionwillbeaccompaniedbyacheckoftheintraocularpressure,especiallyatthetimeofthe

initiationoftreatment.

Useinchildrenandadolescents(<18years)

Noclinicaltrialshavebeenconductedwiththeseeyedropsinchildrenandadolescents.Consequently,theuseof

theseeyedropsisnotrecommendedforthispatientgroup.

4.3Contraindications

Itisappropriatetokeepinmindthecontraindicationsofbeta-blockersadministeredbythegeneralroute,although

thesystemiceffectsofbeta-blockersareonlyobservedinexceptionalcasesafterocularinstillation.

Asthmaandchronicobstructivebronchopneumopathies.

Cardiacinsufficiency.

Cardiogenicshock.

Second-degreeandthird-degreeatrioventricularblocksnotcontrolledwithapacemaker.

Prinzmetal'sangina.

Sicksinussyndrome(includingsino-atrialblock).

Bradycardia(<45-50beatsperminute).

Raynaud’sdiseaseandperipheralcirculatorydisorders.

Untreatedpheochromocytoma.

Arterialhypotension.

Hypersensitivitytocarteolol,ortoanyoftheexcipients.

Combinationwithfloctafenine(seeSection4.5Interactionswithothermedicinalproductsandotherforms

ofinteractions).

Combinationwithsultopride(seeSection4.5Interactionswithothermedicinalproductsandotherformsof

interactions).

4.4Specialwarningsandprecautionsforuse

Ocular

Theco-administrationoftwobeta-blockereyedropsisnotrecommended(seeSection4.2Dosageregimenand

modeofadministration).

Intheeventthattheseeyedropsareadministeredtoreduceintraocularpressureinpatientssufferingfromacute

closed-angleglaucoma,amioticmustbeco-administered.Indeed,inthesepatients,theimmediateobjectiveofthe

treatmentisthereopeningoftheangle,whichrequirestheuseofamiotictocausepapillaryconstriction,since

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Choroidaldetachmentscontemporaneouswithocularhypotonyhavebeenreportedwithadministrationofaqueous

suppressanttherapy,aftersurgicaltreatmentofglaucoma(describedwithtimololandacetazolamide).

Contactlenswearers

Thereisariskofintolerancetocontactlensesbythereductionoflacrimalsecretions,generallyassociatedwith

beta-blockers.

Thepreservativeusedintheseeyedrops,benzalkoniumchloride,maycauseeyeirritation;itmaybedepositedon

anddiscoloursoftcontactlenses.

Consequently,theseeyedropsmustnotbeusedsimultaneouslywiththewearingofsoftcontactlenses.Lenses

mustberemovedbeforetheapplicationofthedropsandmaynotbereinserteduntilatleast15minutesafterthe

useoftheseeyedrops.

Reducedsensitivitytocarteololmayariseafterprolongedtreatment.Theabsenceoftachyphylaxisshould

thereforebecheckedannuallytoensurethatlong-termtherapyremainseffective.

General

Itisappropriatetokeepinmindthecontraindicationsofbeta-blockersadministeredbythegeneralroute,

althoughthesystemiceffectsofbeta-blockersareonlyobservedinexceptionalcasesafterocularinstillation.

Thismedicinalproductmustgenerallynotbecombinedwithamiodarone,certaincalciumantagonists(bepridil,

verapamil,diltiazem)andthebeta-blockersusedtotreatcardiacinsufficiency(seeSection4.5Interactionswith

othermedicinalproductsandotherformsofinteractions).

Sportsmen

Sportsmenshouldbewarnedthatthismedicinalproductcontainsanactivesubstancewhichmayinducepositive

analyticalresultsinanti-dopingcontrols.

Discontinuationoftreatment

Abeta-blockertreatmentadministeredbythegeneralroutemustneverbeinterruptedsuddenly,especiallyin

patientswithangina:suddendiscontinuationmayleadtoseriouscardiacrhythmdisorders,myocardialinfarction

orsuddendeath.

Thedosageregimenmustbereducedprogressively,i.e.overoneortwoweeks.

Bradycardia

Iftheheartratedropsbelow50-55beatsperminuteatrestandthepatientpresentssymptomsassociatedwith

bradycardia,thedosageregimenmustbereduced.

First-degreeatrioventricularblock

Inviewofthenegativedromotropiceffectofbeta-blockers,theymustbeadministeredwithcautiontopatients

presentingafirst-degreeatrioventricularblock.

Pheochromocytoma

Theuseofbeta-blockersinthetreatmentofhypertensionduetotreatedpheochromocytomarequiresstrict

monitoringofarterialpressure.

Elderlysubjects,subjectswithrenalinsufficiencyand/orhepaticinsufficiency

Intheseat-risksubjects,andwhenbeta-blockereyedropsareco-administeredwithasystemic

beta-blocker,anadjustmentofthedosageregimenisoftennecessary.

Diabeticsubjects

Pre-emptivelyscreenoutdiabetessufferersandstrengthenglycemicindexself-monitoringatthestartofthe

treatment.Theindicatorysignsofhypoglycemiamaybemasked,inparticulartachycardia,palpitationsand

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Psoriasis

Aggravationofthediseasehasbeenreportedunderadministrationofbeta-blockers,andtheindicationdeservesto

begivendueconsideration.

Allergicreactions

Inpatientssusceptibletosufferasevereanaphylacticreaction,whateveritsorigin,inparticulariodizedcontrast

mediumsorfloctafenine(seeSection4.5Interactionswithothermedicinalproductsandotherformsof

interactions)orduringdesensitizingtreatments,thebeta-blockertreatmentmayleadtoanaggravationofthe

reactionandresistancetoitstreatmentwithepinephrineatthenormaldoses.

GeneralAnaesthesia

Beta-blockersleadtoanattenuationofthesympatheticreflexphenomena.Theadministrationofabeta-blocker

treatmentreducestheriskofarrhythmia,myocardialischemiaandperioperativehypertensiveattacks.Itis

appropriatetoadvisetheanaesthesiologistthatthepatientisreceivingabeta-blockertreatment.

Ifthediscontinuationofthetreatmentisdeemednecessary,asuspensionof48hoursisconsideredtobesufficient

toallowthereappearanceofsensitivitytocatecholamines.

Incertaincases,thebeta-blockertreatmentmaynotbeinterrupted:

Inpatientsaffectedwithcoronaryinsufficiency,itisadvisabletocontinuethetreatmentuptothesurgical

procedure,inviewoftheriskassociatedwiththesuddendiscontinuationofbeta-blockers.

Intheeventofemergenciesortheimpossibilityofdiscontinuation,thepatientmustbeprotectedfrom

vagalpredominancebyadequatepremedicationofatropine,repeatedasnecessary.

Theanaesthesiamustmakeuseofproductswhichcauseaslittlemyocardialdepressionaspossible,and

bloodlossmustbecompensated.

Theincreaseintheanaphylacticriskassociatedwiththeintakeofbeta-blockersmustbetakenintoconsideration.

Thyrotoxicosis

Beta-blockersarecapableofmaskingcertainsignsofthyrotoxicosis,inparticularcardiovascularsigns.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

1) Eyedropssolution

Ophthalmologicmonitoringisnecessaryintheeventofconcomitanttreatmentwitheyedropssolutioncontaining

epinephrine(riskofmydriasis).

2) Othermedicinalproducts

Althoughthequantitiesofbeta-blockerspassingthroughthesystemiccirculationarelowafterocularinstillation,

theriskofdruginteractionsexists.Itisthereforeappropriatetotakeaccounttheinteractionsobservedwithbeta-

blockersadministeredbygeneralroute.

Contraindicatedco-administrations

Floctafenine

Intheeventofshockorhypotensionduetofloctafenine,reductionofcardiovascularcompensationreactionsby

beta-blockers.

Sultopride

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Co-administrationnotrecommended

Amiodarone

Contractility,automatismandconductiondisorders(suppressionofcompensatorysympatheticmechanisms).

Calciumantagonists(bepridil,diltiazemandverapamil)

Automatismdisorders(excessivebradycardia,sinusalarrest),sinoatrialandatrioventricularconductiondisorders,

andheartfailure(synergyofeffects).

SuchanassociationmustbemadeunderstrictclinicalandECGmonitoring,inparticularinelderlysubjectsorat

thestartoftreatment.

Beta-blockersusedincardiacinsufficiency

Riskofincreaseofundesirableeffectsofbeta-blockers,notablywithexcessiveriskofbradycardia.

Co-administrationsrequiringprecautionsforuse

Volatilehalogenatedanaesthetics

Reductionofcardiovascularcompensationreactionsbybeta-blockers(beta-adrenergicinhibitioncanbeprevented

duringthesurgicalprocedurebytheuseofbetastimulants).Asageneralrule,donotdiscontinuethebeta-blocker

treatmentand,inallevents,avoidsuddendiscontinuation.Theanesthetistshouldbeadvisedofthistreatment.

Anti-cholinesterases:

Donezepil,galantamine,rivastigmine,neostigmine,pyridostigmine,tacrine,ambenonium.Riskofexcessive

bradycardia(additionofbradycardiogeniceffects).Regularclinicalmonitoring.

Apotentiationofthesystemicbeta-blockereffectsoftheeyedropssolutionandanincreaseintheplasma

concentrationsofthebeta-blockerhavebeenreportedwiththeco-administrationofabeta-blockereyedrops

solutionandquinidine,probablyasaresultoftheinhibitionofthemetabolismofthebeta-blockerbyquinidine

(describedfortimolol).

Baclofen

Increaseintheanti-hypertensiveeffect.Monitoringofarterialpressureanddosageregimenadjustmentoftheanti-

hypertensiveifnecessary.

Clonidineandothercentralanti-hypertensives(alphamethyldopa,guanfacine,moxonidine,rilmenidine)

Significantincreaseinarterialpressureintheeventofsuddendiscontinuationofthetreatmentbythecentralanti-

hypertensive.Avoidthesuddendiscontinuationofthecentralanti-hypertensive.Clinicalmonitoring.

Insulin,hypoglycemicsulfamides

Allbeta-blockerscanmaskcertainsymptomsofhypoglycemia:palpitationsandtachycardia.Themajorityofnon-

cardioselectivebeta-blockersincreasetheincidenceandseverityofhypoglycemia.Warnthepatientand

strengthenbloodglucoseself-monitoring,especiallyatthestartofthetreatment.

Medicinalproductscausingtorsadedepointes

ClassIaanti-arrhythmics(quinidine,hydroquinidine,disopyramide)andclassIIIanti-arrhythmics(amiodarone,

dofetilide, ibutilide, sotalol), certain neuroleptics: Phenothiazines (chlorpromazine, cyamemazine,

levomepromazine,thioridazine,trifluoperazine),benzamides(amisulpride,sulpiride,tiapride),butyrophenones

(droperidol,haloperidol),otherneuroleptics(pimozide),andothermedicinalproductssuchas:bepridil,cisapride,

diphenamil,erythromycinIV,vincamineIV,mizolastrine,halofantrine,sparfloxacine,petamidine,moxifloxacine

etc.Increasedriskofventricularrhythmdisorders,notablytorsadedepointes.Clinicalandelectrocardiographic

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Propafenone

Contractility,automatismandconductiondisorders(suppressionofcompensatorysympatheticmechanisms).

ClinicalandECGmonitoring.

Co-administrationstobetakenintoconsideration

NSAIDs(generalroute)includingselectivecox-2inhibitors

Reductionoftheanti-hypertensiveeffect(inhibitionofvasodilatoryprostaglandinsbyNSAIDsandfluidandsalt

retentionwithpyrazoleNSAIDs).

Alphablockersforurologicalpurposes:Alfuzosine,doxazosine,prazosine,

tamsulosine,terazosine

Increaseinthehypotensiveeffect,riskofincreasedorthostatichypotension.

Amifostine

Increaseintheanti-hypertensiveeffect.

Calciumantagonists(dihydropyridines)

Hypotension,heartfailureinpatientssufferingfromlatentoruncontrolledcardiacinsufficiency(invitronegative

inotropiceffectofdihydropyridines,varyingindegreewiththeproducts,andlikelytobetoaddtothenegative

inotropiceffectsofbeta-blockers).Thepresenceofabeta-blockercanalsominimizethesympatheticreflex

reactionthatcomesintoplayintheeventofexcessivehemodynamicrepercussions.

Anti-depressantsoftheimipraminefamily(tricyclics),anti-psychotics

Anti-hypertensiveeffectandincreasedriskoforthostatichypotension(additiveeffect).

Mefloquine

Riskofexcessivebradycardia(additionofbradycardiogeniceffects).

4.6Pregnancyandlactation

Thesystemicpassageofbeta-blockersadministeredbytheocularrouteislowerthanbythegeneralroute,but

neverthelessitdoesoccur.

Pregnancy

TherearenoadequatedatafromtheuseofCarteolL.P.inpregnantwomen.Reproductivetoxicitystudiesin

animalsdonotindicateanyadverseeffectsrelevanttotheclinicaluseofCarteolL.P.(seesection5.3).

Aftersystemicuse,thebeta-blockingactionpersistsforseveraldaysafterbirthinthenewbornbabyofatreated

mother,andmaymanifestitselfintheformofabradycardia,respiratorydifficulty,orhypoglycemia.Butin

general,thisisofnoclinicalconsequence.

Nevertheless,duetothereductionofthecardiovascularcompensationreactions,heartfailuremayoccur,requiring

hospitalizationinintensivecare(see4.9Overdose),inwhichcasetheuseoffillersolutionsmustbeavoided(risk

ofacutepulmonaryoedema).

CarteolL.P.maybeprescribedduringpregnancyifnecessary.Intheeventoftreatmentuptodelivery,attentive

monitoringofthenewborn(heartrateandglycemicindexduringthefirst3to5daysoflife)isrecommended.

Lactation

Itisunknownwhethercarteololisexcretedinhumanbreastmilk.Animalstudieshaveshownexcretionof

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Adecisiononwhethertocontinue/discontinuetherapywithCarteolL.P.shouldbemadetakingintoaccountthe

benefitofbreast-feedingtothechildandthebenefitofCarteolL.P.therapytothemother.

Incaseoftreatmentduringlactation,takeintoaccountthepharmacologicalpropertiesofCarteolL.P.

(hypoglycaemia,bradycardia).

4.7Effectsonabilitytodriveandusemachines

Theseeyedropsareassociatedwithundesirableeffects(inparticular,visualdisturbances),whichmayimpairthe

abilitytodriveandusemachines.

4.8Undesirableeffects

Likeothertopicallyappliedophthalmicmedicinalproducts,carteololeyedropsmaybeabsorbedsystemicallyand

adversereactionsseenwithoralbeta-blockersmayoccur.

Benzalkoniumchloridemaycauseeyeandskinirritation(seeSection4.4.Specialwarningsandspecial

precautionsforuse).

Cardiacandvasculardisorders

Ocular:Syncope,palpitation,arrhythmia,heartblock.

Systemic:Bradycardia,hypotension,cardiacinsufficiency,slowinginatrioventricularconductionor

intensificationofanexistingatrioventricularblock,claudication,Raynaud’sphenomenon,coldhandsandfeet.

Eyedisorders

Ocular:Signsandsymptomsofocularirritation,includingmildburningorstingingsensationatthebeginningof

treatment,blurredvision,conjunctivalhyperaemia,conjunctivitis,blepharitis,keratitis,decreasedcorneal

sensitivity,anddryeyes.

Systemic:Visualdisturbancesincludingrefractivechanges(duetowithdrawalofmiotictherapyinsomecases),

ptosis,diplopia,choroidaldetachment(followingfiltrationsurgery).

Gastrointestinaldisorders

Ocular:Dyspepsia,drymouth.

Systemic:Nausea,vomiting,diarrhea,gastralgia.

Generaldisordersandadministrationsitedisorders

Ocular:Fatigue,chestpain.

Systemic:Asthenia.

Immunesystemdisorders

Ocular:Systemiclupuserythematosus.

Systemic:Signsandsymptomsofallergicreactionsincludinganaphylaxis,angioedema,urticaria,localizedand

generalizedrash.

Metabolismandnutritiondisorders

Systemic:Hypoglycaemia.

Nervoussystemandpsychiatricdisorders

Ocular:Headache,dizziness,increaseinsignsandsymptomsofmyastheniagravis.

Systemic:Depression,insomnia,nightmares,libidodecreased,impotence.

Respiratory,thoracic,andmediastinaldisorders

Ocular:Dyspnea,cough.

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Skinandsubcutaneoustissuedisorders

Ocular:Alopecia.

Systemic:Variousskinsymptoms,includingurticaria,anaphylaxis,angio-œdema(angioneuroticoedema),

cutaneousrash,psoriasiformrashorexacerbationofpsoriasis(seeSection4.4.Specialwarningsandspecial

precautionsforuse).

Biologically

Rarecasesofantinuclearantibodieshavebeenobserved,onlyexceptionallyaccompaniedbyclinicalsymptoms

suchaslupussyndrome,whichregressattreatmentdiscontinuation.

4.9Overdose

Althoughthequantitiesofbeta-blockerspassingintothesystemiccirculationarelowafterocularinstillation,the

riskofoverdosemustbekeptinmind.

Limitedexperiencefromocularoverdosing.

Intheeventofaccidentaloverdoseviatheocularroute,rinsetheeyeswithasterilesodiumchloride9mg/ml

(0.9%)solution.

Intheeventofaccidentaloralintakeormis-usage,thesymptomsandthestepstobetakenareidenticaltothose

foroverdoseonbeta-blockersviathegeneralroute.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticclass:Beta-blockingagent.

ATCcode:S01ED05

Atthegenerallevel

Carteolol is a non-cardioselective beta-blocker, with partial agonist potential [moderate intrinsic

sympathomimeticactivity(ISA)],andanon-significantmembrane-stabilizingeffect(localorquinidine-like

anaesthetic).

Attheocularlevel

Carteololhydrochlorideeyedropsreduceintraocularpressure,whetherassociatedwithglaucomaornot,by

reducingthesecretionofaqueoushumour.

Itsactivitybecomesapparentusuallyapproximately30minutesafterinstillation,peaksbetween2and4

hoursandisstillpresentafter24hours.

Stabilityofthehypotensiveeffectovertime:theeffectcanremainconstantforoneyear.

However,areductioninsensitivitytocarteololhydrochlorideremainspossible,especiallyafteramore

prolongedtreatment.

Thereispracticallynochangeinthepupillarydiameteroraccommodation.

TheexcipientofCarteolL.P.1%containsahydrosolublepolymer(alginicacid)whichpossessesphysical

properties(suchasbioadhesivity,ionicinteractionsetc.)whichpermitthefrequencyofdailyinstillationsto

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5.2Pharmacokineticproperties

Meanplasmaticconcentrationsobservedafter2monthsofrepeatedinstillationsofCarteol2%inglaucomatous

patientsarelowerwiththeprolonged-releaseformulationgivenonceaday(Cmax=1.72ng/ml)thanwiththe

regularformulationgiventwiceaday(Cmax=3.64ng/ml).

Althoughtherenalfunctionisimportantforelimination,nostudyhasbeenconductedonpatientssufferingfrom

renalinsufficiency.

5.3Preclinicalsafetydata

Preclinicaldatarevealnospecialhazardforhumansbasedonconventionalstudiesofsafetypharmacology,

repeateddosetoxicity,genotoxicityorcarcinogenicity.

Inreproductivetoxicitystudies,embryotoxicitywasseenathighoraldosesresultinginsystemicexposurelevels

consideredsufficientlyinexcessofsystemicexposureatclinicaluseofCarteoleye-drops.Carteololwasnot

teratogenicinreproductivetoxicitystudies.

Inrats,ithasbeenreportedthatcarteololhydrochlorideiscapableofpassingthroughtheplacentalbarrierandwas

excretedinsmallquantitiesinbreastmilk.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzalkoniumchloridesolution

Alginicacid(E400)

Sodiumdihydrogenphosphatedihydrate(E339)

Disodiumphosphatedodecahydrate(E339)

Sodiumchloride

Sodiumhydroxide(forpHadjustment)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

Shelf-lifeafterfirstopeningofthecontainer:28days.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

3mlindropper-container(PE)withscrewcap(polypropylene).

3x3mlindropper-container(PE)withscrewcap(polypropylene).

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ChauvinPharmaceuticalsLimited.

106LondonRoad

Kingston-Upon-Thames

KT26TN

England

8MARKETINGAUTHORISATIONNUMBER

PA0118/048/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:3 rd

December2004

Dateoflastrenewal:9 th

November2006

10DATEOFREVISIONOFTHETEXT

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