CIPRALAM 40 MG FILM-COATED TABLETS

Main information

  • Trade name:
  • CIPRALAM 40 MG FILM-COATED TABLETS
  • Dosage:
  • 40 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CIPRALAM 40 MG FILM-COATED TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1380/027/003
  • Authorization date:
  • 14-12-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1380/027/003

CaseNo:2065994

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ActavisGroupPTCehf

Reykjavikurvegi76-78,220Hafnarfjordur,Iceland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Cipralam40mgFilm-coatedtablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom08/06/2009until09/03/2011.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 08/06/2009 CRN 2065994 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cipralam40mgFilm-coatedtablet

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains40mgCitalopramasCitalopramhydrobromide

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet

White,circular,coated,biconvex,scoredonbothsideswithsidescores.

Thetabletcanbedividedintoequalhalves.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofdepressiveillnessintheinitialphaseandasmaintenanceagainstpotentialrelapse/recurrence.

Cipralamisalsoindicatedinthetreatmentofpanicdisorderwithorwithoutagoraphobia.

4.2Posologyandmethodofadministration

Posology:

TreatingDepression:Cipralamshouldbeadministeredasasingleoraldoseof20mgdaily.Dependentonindividual

patientresponsethismaybeincreasedtoamaximumof60mgdaily.Thedosemaybegiveninthemorningor

evening.

Atreatmentperiodofatleast6monthsisusuallynecessarytoprovideadequatemaintenanceagainstthepotentialfor

relapse.

TreatingPanicDisorder:Incommonwithotherpharmacotherapyusedinthispatientgroup,alowstartingdoseis

advisedtoreducethelikelihoodofaparadoxicalinitialanxiogeniceffect.Asingleoraldoseof10mgdailyis

recommendedforthefirstweekbeforeincreasingthedoseto20mgdaily.Thedosemaybefurtherincreased,uptoa

maximumof60mgdailydependentonindividualpatientresponse;howeveranoptimumdoseof20-30mgdailywas

indicatedinaclinicalstudy.

Maximumeffectivenessofcipralamintreatingpanicdisorderisreachedafterabout3monthsandtheresponseis

maintainedduringcontinuedtreatment.Dependentonindividualpatientresponseitmaybenecessarytocontinue

treatmentforseveralmonths.

Elderlypatients:Therecommendeddailydoseis20mg.Dependentonindividualpatientresponsethismaybe

increasedtoamaximumof40mgdaily.

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Reducedhepaticfunction:Dosageshouldberestrictedtothelowerendofthedoserange.

Reducedrenalfunction:Dosageadjustmentisnotnecessaryincasesofmildormoderaterenalimpairment.No

informationisavailableincasesofsevererenalimpairment(creatinineclearance<20mL/min).

Methodofadministration:

Cipralamtabletsareadministeredasasingledailydoseandcanbetakenanytimeofthedaywithoutregardtofood

intake.

4.3Contraindications

Hypersensitivitytocitalopram.

Sumatriptan’sserotonergiceffectsaresuspectedtobeenhancedbySSRIs.Untilfurtherevidenceisavailableitis

advisednottousecitalopramsimultaneouslywith5-HTagonistse.g.sumatriptan.

4.4Specialwarningsandprecautionsforuse

AswithotherSSRIs,citalopramshouldnotbegiventopatientsreceivingMonoamineOxidaseInhibitors(MAOIs)or

for14daysaftertheirdiscontinuation.MAOIsshouldnotbeintroducedforsevendaysafterdiscontinuationof

citalopram.Rarely,theoccurrenceof‘serotoninsyndrome’hasbeenreportedinpatientsreceivingSSRIs.A

combinationofsymptoms,possiblyincludingagitation,tremor,myoclonusandhyperthermia,mayindicatethe

developmentofthiscondition.

Experiencewithcitalopramhasnotrevealedanyclinicallyrelevantinteractionswithneuroleptics.However,aswith

otherSSRIs,thepossibilityofapharmacodynamicinteractioncannotbeexcluded.

Considerationshouldbegiventofactorswhichmayaffectthedispositionofaminormetaboliteofcitalopram

(didemethylcitalopram)sinceincreasedlevelsofthismetabolitecouldtheoreticallyprolongtheQTcintervalin

susceptibleindividuals.However,inECGmonitoringof2500patientsinclinicaltrials,including277patientswithpre-

existingcardiacconditions,noclinicallysignificantchangeswerenoted.

Aswithmostantidepressants,citalopramshouldbediscontinuedifthepatiententersamanicphase.Thereislittle

clinicalexperienceofconcurrentuseofcitalopramandECT.

Inpatientswithdiabetes,treatmentwithanSSRImayalterglycaemiccontrol.Insulinand/ororalhypoglycaemic

dosagemayneedtobeadjusted.

Therehavebeenreportsofprolongedbleedingtimeand/orbleedingabnormalitiessuchasecchymosis,gynaecological

haemorrhages,gastrointestinalbleedingandothercutaneousormucusbleedingwithSSRIs(seeSection4.8

UndesirableEffects).CautionisadvisedinpatientstakingSSRIs,particularlyinconcomitantusewithactive

substancesknowntoaffectplateletfunctionorotheractivesubstancesthatcanincreasetheriskofhaemorrhageaswell

asinpatientswithahistoryofbleedingdisorders(seeSection4.5Interactions).

Citalopramshouldbediscontinuedinanypatientwhodevelopsseizures.Citalopramshouldbeavoidedinpatientswith

unstableepilepsyandpatientswithcontrolledepilepsyshouldbecarefullymonitored.Citalopramshouldbe

discontinuedifthereisanincreaseinseizurefrequency.

Suicide/suicidalthoughtsorclinicalworsening

Depressionisassociatedwithanincreasedriskofsuicidalthoughts,selfharmandsuicide(suicide-relatedevents).This

riskpersistsuntilsignificantremissionoccurs.Asimprovementmaynotoccurduringthefirstfewweeksormoreof

treatment,patientsshouldbecloselymonitoreduntilsuchimprovementoccurs.Itisgeneralclinicalexperiencethatthe

riskofsuicidemayincreaseintheearlystagesofrecovery.

Otherpsychiatricconditionsforwhichcitalopramisprescribedcanalsobeassociatedwithanincreasedriskofsuicide-

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observedwhentreatingpatientswithmajordepressivedisordershouldthereforebeobservedwhentreatingpatients

withotherpsychiatricdisorders.

Patientswithahistoryofsuicide-relatedevents,orthoseexhibitingasignificantdegreeofsuicidalideationpriorto

commencementoftreatmentareknowntobeatgreaterriskofsuicidalthoughtsorsuicideattempts,andshouldreceive

carefulmonitoringduringtreatment.

Ameta-analysisofplacebo-controlledclinicaltrialsofantidepressantdrugsinadultpatientswithpsychiatricdisorders

showedanincreasedriskofsuicidalbehaviourwithantidepressantscomparedtoplaceboinpatientslessthan25years

old.Closesupervisionofpatientsandinparticularthoseathighriskshouldaccompanydrugtherapyespeciallyinearly

treatmentandfollowingdosechanges.Patients(andcaregiversofpatients)shouldbealertedabouttheneedtomonitor

foranyclinicalworsening,suicidalbehaviourorthoughtsandunusualchangesinbehaviourandtoseekmedicaladvice

immediatelyifthesesymptomspresent.

Useinchildrenandadolescentsunder18yearsofage:

Citalopramtabletsshouldnotbeusedinthetreatmentofchildrenandadolescentsundertheageof18years,exceptfor

patientswithOCD.Suicide-relatedbehaviours(suicideattemptandsuicidalthoughts)andhostility(predominantly

aggression,oppositionalbehaviourandanger)weremorefrequentlyobservedinclinicaltrialsamongchildrenand

adolescentstreatedwithantidepressantscomparedwiththosetreatedwithplacebo.If,basedonclinicalneed,adecision

totreatisneverthelesstaken;thepatientshouldbecarefullymonitoredfortheappearanceofsuicidalsymptoms.In

addition,long-termsafetydatainchildrenandadolescentsconcerninggrowth,maturationandcognitiveand

behaviouraldevelopmentarelacking.

Somepatientswithpanicdisorderexperienceaninitialanxiogeniceffectwhenstartingpharmacotherapy.Alow

startingdose(seesection4.2,Posologyandmethodofadministration)reducesthelikelihoodofthiseffect.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

MonoamineOxidaseInhibitors(MAOIs)shouldnotbeusedincombinationwithSSRIs(seesection4.4,Special

warningsandprecautionsforuse).

ThemetabolismofcitalopramisonlypartlydependentonthehepaticcytochromeP450isozymeCYP2D6and,unlike

someotherSSRIs;citalopramisonlyaweakinhibitorofthisimportantenzymesystemwhichisinvolvedinthe

metabolismofmanydrugs(includingantiarrhythmics,neuroleptics,beta-blockers,TCAs(Tricyclic

Antidepressants)andsomeSSRIs).Proteinbindingisrelativelylow(<80%).Thesepropertiesgivecitalopramalow

potentialforclinicallysignificantdruginteractions.

Thereisnopharmacokineticinteractionbetweenlithiumandcitalopram.Howevertherearehavebeenreportsof

enhancedeffectswhenSSRIshavebeengivenwithlithiumortryptophanandthereforetheconcomitantuseof

citalopramwiththesedrugsshouldnotbeundertakenwithcaution.Routinemonitoringoflithiumlevelsneednotbe

adjusted.

Inapharmacokineticstudynoaffectwasdemonstratedoneithercitalopramorimipraminelevels,althoughthelevelof

desipramine,theprimarymetaboliteofimipramine,wasincreased.Inanimalstudiescimetidinehadlittleorno

influenceoncitalopramkinetics.

Nopharmacodynamicinteractionshavebeennotedinclinicalstudiesinwhichcitalopramhasbeengiven

concomitantlywithbenzodiazepines,neuroleptics,analgesics,lithium,antihistamines,antihypertensivedrugs,beta-

blockersandothercardiovasculardrugs.

NopharmacodynamicorpharmacokineticinteractionshavebeendemonstratedbetweenCitalopramandalcohol.

However,thecombinationofCitalopramandalcoholisnotadvisable.

Cautionisessentialforpatientswhoarebeingtreatedsimultaneouslywithanticoagulants,medicinesthataffectthe

functionofthrombocytes,suchasNSAIDs,acetylsalicylicacid,dipyridamol,andticlopidineorothermedicines(e.g.

atypicalantipsychotics,Phenothiazines,tricylicantidepressants)thatcanincreaseriskofhaemorrhage(seeSection4.4

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4.6Pregnancyandlactation

CategoryB1.

Animalstudiesdidnotprovideanyevidenceofteratogenicpotentialandcitalopramdoesnotaffectreproductionor

perinatalconditions.Citalopramappearsinmilkinverylowconcentrations.

Duetolimitedhumandatacitalopramshouldonlybeusedinpregnancyifconsiderednecessaryandundertheclose

supervisionofaphysician.Innursingmothers,cautionisrecommendedasitisnotknownwhethercitalopramexcreted

inmilkmayaffecttheinfant.

4.7Effectsonabilitytodriveandusemachines

Citalopramdoesnotimpairintellectualfunctionandpsychomotorperformance.However,patientswhoareprescribed

psychotropicmedicationmaybeexpectedtohavesomeimpairmentofgeneralattentionandconcentrationeitherdueto

theillnessitself,themedicationorbothandshouldbecautionedabouttheirabilitytodriveacarandoperate

machinery.

4.8Undesirableeffects

Adverseeffectsobservedwithcitalopramareingeneralmildandtransient.Theyaremostprominentduringthefirst

oneortwoweeksoftreatmentandusuallyattenuateasthedepressivestateimproves.

Themostcommonlyobservedadverseeventsassociatedwiththeuseofcitalopramandnotseenatanequalincidence

amongplacebo-treatedpatientswere:nausea,somnolence,drymouth,increasedsweatingandtremor.Theincidenceof

eachinexcessoverplaceboislow(<10%).

Incomparativeclinicaltrialswithtricyclicantidepressantstheincidenceofadverseeventsoccurringwithcitalopram

wasfoundtobelowerinallcases.

Treatmentemergentadverseeventsreportedinclinicaltrials(N=2985):

Frequent(>5-20%)

Skinandappendagesdisorders:SweatingIncreased(13%).

CentralandPeripheralnervoussystemdisorders:Headache(19%),tremor(12%),dizziness(8%).

Visiondisorders:AccommodationAbnormal(5%).

Psychiatricdisorders:Somnolence(17%),insomnia(12%),agitation(6%),nervousness(6%).

Gastro-intestinalsystemdisorders:Nausea(20%),mouthdry(18%),constipation(10%),diarrhoea(7%).

Heartrateandrhythmdisorders:Palpitation(6%).

Bodyasawhole:Asthenia(11%).

Lessfrequent(1-<5%)

Skinandappendagesdisorders:Rash,pruritus.

CentralandPeripheralnervoussystemdisorders:Paraesthesia,migraine.

Visiondisorders:visionabnormal.

Specialsensesother,disorder:Tasteperversion.

Psychiatricdisorders:sleepdisorder,libidodecreased,concentrationimpaired,dreamingabnormal,amnesia,anxiety,

appetiteincreased,anorexia,apathy,impotence,suicideattempt,confusion,yawning.

Gastro-Intestinalsystemdisorders:Dyspepsia,vomiting,abdominalpain,flatulence,salivaincreased.

Metabolicandnutritionaldisorders:Weightdecrease,weightincrease.

Cardiovasculardisorders,general:Hypotensionpostural.

Heartrateandrhythmdisorders:Tachycardia

Respiratorysystemdisorders:Rhinitis.

Urinarysystemdisorders:Micturitiondisorder,polyuria.

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Reproductivedisorders,female:Anorgasmiafemale.

Bodyasawhole:Fatigue

Rare(<1%)

Musclo-skeletalsystemdisorder:Myalgia.

CentralandPeripheralnervoussystemdisorders:Extrapyramidaldisorder,convulsions.

Hearingandvestibulardisorders:Tinnitus.

Psychiatricdisorders:Euphoria,libidoincreased,Hallucinations.

Respiratorysystemdisorders:Coughing.

Bodyasawhole:Malaise.

SkinDisorders:Angioedema

Hyponatraemia,sometimesassociatedwiththesyndromeofinappropriateantidiuretichormonesecretion(SIADH),has

beenreportedwiththeuseofSSRIsandotherantidepressants.

TreatmentwithSSRIshasoccasionallybeenassociatedwithsymptomssuggestiveofposturalhypotension,

hypotension,hypertensionandtachycardia.Therehavealsobeenrarereportsofsupraventricularandventricular

arrhythmias.Todatecausalityhasnotbeenestablished.

SideeffectinDiscontinuation:Withdrawalreactionshavebeenreportedinassociationwithselectiveserotonin

reuptakeinhibitors(SSRIs),includingcitalopram.Commonsymptomsincludedizziness,paraesthesia,headache,

anxietyandnausea.Abruptdiscontinuationoftreatmentwithcitalopramshouldbeavoided.Themajorityof

symptomsexperiencedonwithdrawalofSSRIsarenon-seriousandself-limiting.

Casesofsuicidalideationandsuicidalbehaviourshavebeenreportedduringcitalopramtherapyorearlyaftertreatment

discontinuation(seesection4.4).

Haemorrhage(forexample,gynaecologicalhaemorrhage,gastrointestinalhaemorrhage,ecchymosisandotherformsof

skinhaemorrhageorbleedinginthemucusmembranes)canoccuronrareoccasions.

4.9Overdose

Citalopramisgiventopatientsatpotentialriskofsuicideandsomereportsofattemptedsuicidehavebeenreceived.

Detailisoftenlackingregardingprecisedoseorcombinationwithotherdrugsand/oralcohol.

Symptoms

Experiencefrom8casesconsideredduetocitalopramalonehasrecordedthefollowingsymptoms/signs:somnolence,

coma,stiffenedexpression,episodeofgrandmalconvulsion,sinustachycardia,occasionalnodalrhythm,sweating,

nausea,vomiting,cyanosis,andhyperventilation.Nocasewasfatal.Theclinicalpicturewasinconsistent,no

observationbeingmadeinmorethantwoindividuals.

Sixfatalitieshavebeenreported.Inoneoverdosewassuspected;highpostmortemplasmalevelswereseenalthoughit

isnottechnicallypossibletointerpretthesewithconfidence.

Intheremainingfiveacombinationwithotherdrugshadbeentaken.Theclinicalsyndromeobservedpriortodeathin

threeofthesecaseswherecitalopramwastakenwithmoclobemidewasinterpretedasthatofserotoninsyndrome.No

clinicaldetailsareavailableontheothertwo.

Treatment

Thereisnospecificantidote.Treatmentissymptomaticandsupportive.Gastriclavageshouldbecarriedoutassoonas

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATC-code:N06AB04

Biochemicalandbehaviouralstudieshaveshownthatcitalopramisapotentinhibitoroftheserotonin(5-HT)-uptake.

Tolerancetotheinhibitionof5-HT-uptakeisnotinducedbylong-termtreatmentwithcitalopram.

CitalopramisthemostSelectiveSerotoninReuptakeInhibitor(SSRI)yetdescribed,withno,orminimal,effecton

noradrenaline(NA),dopamine(DA)andgammaaminobutyricacid(GABA)uptake.

IncontrasttomanytricyclicantidepressantsandsomeofthenewerSSRI's,citalopramhasnoorverylowaffinityfora

seriesofreceptorsincluding5-HT

,5-HT

,DAD

andD

receptors,

-adrenoceptors,histamineH

muscarinecholinergic,benzodiazepine,andopioidreceptors.Aseriesoffunctionalinvitrotestsinisolatedorgansas

wellasfunctionalinvivotestshaveconfirmedthelackofreceptoraffinity.Thisabsenceofeffectsonreceptorscould

explainwhycitalopramproducesfewerofthetraditionalside-effectssuchasdrymouth,bladderandgutdisturbance,

blurredvision,sedation,cardiotoxicityandorthostatichypotension.

Suppressionofrapideyemovement(REM)sleepisconsideredapredictorofantidepressantactivity.Liketricyclic

antidepressants,otherSSRI'sandMAOinhibitors,citalopramsuppressesREM-sleepandincreasesdeepslow-wave

sleep.

Althoughcitalopramdoesnotbindtoopioidreceptorsitpotentiatestheanti-nociceptiveeffectofcommonlyused

opioidanalgesics.Therewaspotentiationofd-amphetamine-inducedhyperactivityfollowingadministrationof

citalopram.

ThemainmetabolitesofcitalopramareallSSRIsalthoughtheirpotencyandselectivityratiosarelowerthanthoseof

citalopram.However,theselectivityratiosofthemetabolitesarehigherthanthoseofmanyofthenewerSSRIs.The

metabolitesdonotcontributetotheoverallantidepressanteffect.

Inhumanscitalopramdoesnotimpaircognitive(intellectualfunction)andpsychomotorperformanceandhasnoor

minimalsedativeproperties,eitheraloneorincombinationwithalcohol.

Citalopramdidnotreducesalivaflowinasingledosestudyinhumanvolunteersandinnoneofthestudiesinhealthy

volunteersdidcitalopramhavesignificantinfluenceoncardiovascularparameters.Citalopramhasnoeffectonthe

serumlevelsofprolactinandgrowthhormone.

5.2Pharmacokineticproperties

Absorption

Absorptionisalmostcompleteandindependentoffoodintake(T

average/mean3.8hours).Oralbioavailabilityis

about80%.

Distribution

Theapparentvolumeofdistribution(V

isabout12.3L/kg.Theplasmaproteinbindingisbelow80%forcitalopram

anditsmainmetabolites.

Biotransformation

Citalopramismetabolisedtotheactivedemethylcitalopram,didemethylcitalopram,citalopram-N-oxideandaninactive

deaminatedpropionicacidderivative.AlltheactivemetabolitesarealsoSSRIs,althoughweakerthantheparent

compound.Unchangedcitalopramisthepredominantcompoundinplasma.

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Theeliminationhalf-life(T

½ß )isabout1.5daysandthesystemiccitalopramplasmaclearance(Cl

)isabout0.33

L/min,andoralplasmaclearance(Cl

oral )isabout0.41L/min.

Citalopramisexcretedmainlyviatheliver(85%)andtheremainder(15%)viathekidneys.About12%ofthedaily

doseisexcretedinurineasunchangedcitalopram.Hepatic(residual)clearanceisabout0.35L/minandrenalclearance

about0.068L/min.

Thekineticsarelinear.Steadystateplasmalevelsareachievedin1-2weeks.Averageconcentrationsof250nmol/L

(100-500nmol/L)areachievedatadailydoseof40mg.Thereisnoclearrelationshipbetweencitalopramplasma

levelsandtherapeuticresponseorsideeffects.

Elderlypatients(>65years)

Longerhalf-livesanddecreasedclearancevaluesduetoareducedrateofmetabolismhavebeendemonstratedin

elderlypatients.

Reducedhepaticfunction

Citalopramiseliminatedmoreslowlyinpatientswithreducedhepaticfunction.Thehalf-lifeofcitalopramisabout

twiceaslongandsteadystatecitalopramconcentrationsatagivendosewillbeabouttwiceashighasinpatientswith

normalliverfunction.

Reducedrenalfunction

Citalopramiseliminatedmoreslowlyinpatientswithmildtomoderatereductionofrenalfunction,withoutanymajor

impactonthepharmacokineticsofcitalopram.Atpresentnoinformationisavailablefortreatmentofpatientswith

severelyreducedrenalfunction(creatinineclearance<20mL/min).

5.3Preclinicalsafetydata

Citalopramhaslowacutetoxicity.Inchronictoxicitystudiestherewerenofindingsofconcernforthetherapeuticuse

ofcitalopram.Basedondatafromreproductiontoxicitystudies(segmentI,IIandIII)thereisnoreasontohavespecial

concernfortheuseofcitalopraminwomenofchild-bearingpotential.Citalopramhasnomutagenicorcarcinogenic

potential.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Mannitol

Cellulose,microcrystalline

Silica,colloidalanhydrous

Magnesiumstearate

FilmCoat

Hypromellose

Titaniumdioxide(E171)

Macrogol6000

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

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6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

6.5Natureandcontentsofcontainer

PVC/PVDC/AlStriporHDPETabletContainerwithLDPECap

Packsizes:7,14,21,28,30,50,56,60,84,98,100or500tablets

Notallpacksizemaybemarketed

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ActavisGroupPTCehf

Reykjavikurvegi76-78

220Hafnarfjordur

Iceland

8MARKETINGAUTHORISATIONNUMBER

PA1380/27/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:10March2006

10DATEOFREVISIONOFTHETEXT

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