CIPRAPINE

Main information

  • Trade name:
  • CIPRAPINE Film Coated Tablet 10 Milligram
  • Dosage:
  • 10 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CIPRAPINE Film Coated Tablet 10 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0281/117/001
  • Authorization date:
  • 18-06-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Ciprapine10mgfilm-coatedtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontains10mgcitalopramascitalopramhydrobromide.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet

Round,white,biconvextabletswithadiameterof6mm.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofmajordepressiveepisodes.

4.2Posologyandmethodofadministration

Citalopramshouldbeadministeredasasingleoraldose,eitherinthemorningorintheevening.Thetabletscanbe

takenwithorwithoutfood,butwithfluid.

Followingtreatmentinitiation,anantidepressanteffectshouldnotbeexpectedforatleasttwoweeks.Treatmentshould

continueuntilthepatienthasbeenfreeofsymptomsfor4-6months.Citalopramshouldbewithdrawnslowly,itis

advisedthatthedoseisgraduallyreducedover1-2weekperiods.

Adults:

Therecommendedstartingdoseis20mgperday.Ifnecessary,thedosecanbeincreasedupto40mgperday,

dependingontheindividualresponseofthepatient.Themaximumdoseis60mgperday.

Elderlypatients(>65yearsofage):

Forelderlypatientsthedoseshouldbedecreasedtohalfoftherecommendeddose,e.g.10-20mgperday.Depending

ontheindividualresponseofthepatient,thedosecanbeincreased.

Childrenandadolescentsundertheageof18:

Notrecommended,assafetyandefficacyhavenotbeenestablishedinthispopulation.

Reducedrenalfunction:

Dosageadjustmentisnotrequiredifthepatienthasmildtomoderaterenalimpairment.Noinformationisavailableon

treatmentofpatientswithsevererenalimpairment(creatinineclearancelessthan20ml/min)(seeSection4.4Special

warningsandspecialprecautionsforuse).

Reducedhepaticfunction:

Patientswithhepaticimpairmentshouldreceiveastartingdoseof10mgperday.Thedoseshouldnotexceed30mg

perday.Thesepatientsshouldbeclinicallymonitored(seeSection4.4Specialwarningsandspecialprecautionsfor

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4.3Contraindications

Hypersensitivitytocitalopramortoanyoftheexcipients.

CitalopramshouldnotbegiventopatientsreceivingMonoamineOxidaseInhibitors(MAOIs)including

selegilineindailydosesexceeding10mg/day.Citalopramshouldnotbegivenforfourteendaysafter

discontinuationofanirreversibleMAOIorforthetimespecifiedafterdiscontinuationofareversibleMAOI

(RIMA)asstatedintheprescribingtextoftheRIMA.MAOIsshouldnotbeintroducedforsevendaysafter

discontinuationofcitalopram.

CasesofseriousandsometimesfatalreactionshavebeenreportedinpatientsreceivinganSSRIincombinationwitha

monoamineoxidaseinhibitor(MAOI),includingtheselectiveMAOIselegilineandthereversibleMAOI(RIMA),

moclobemideandinpatientswhohaverecentlydiscontinuedanSSRIandhavebeenstartedonaMAOI.

Somecasespresentedwithfeaturesresemblingserotoninsyndrome.Symptomsofanactivesubstanceinteractionwith

aMAOIinclude:hyperthermia,rigidity,myoclonus,autonomicinstabilitywithpossiblerapidfluctuationsofvital

signs,mentalstatuschangesthatincludeconfusion,irritabilityandextremeagitationprogressingtodeliriumandcoma.

4.4Specialwarningsandprecautionsforuse

Citalopramshouldbeprescribedinthesmallestquantityoftabletsinordertoreducetheriskofoverdose.

Citalopramshouldnotbeusedconcomitantlywithmedicinalproductswithserotonergiceffectssuchassumatriptanor

othertriptans,tramadol,oxitriptanandtryptophan.

Inpatientswithdiabetes,treatmentwithanSSRImayalterglycaemiccontrol.Insulinand/ororalhypoglycaemic

dosagemayneedtobeadjusted.

Citalopramshouldbediscontinuedinanypatientwhodevelopsseizures.Citalopramshouldbeavoidedinpatientswith

unstableepilepsyandpatientswithcontrolledepilepsyshouldbecarefullymonitored.Citalopramshouldbe

discontinuedifthereisanincreaseinseizurefrequency.

Thereislittleclinicalexperienceofconcurrentadministrationofcitalopramandelectro-convulsivetherapy,therefore

cautionisadvisable.

Citalopramshouldbeusedwithcautioninpatientswithahistoryofmania/hypomania.Citalopramshouldbe

discontinuedinanypatiententeringamanicphase.Therehavebeenreportsofprolongedbleedingtimeand/orbleeding

abnormalitiessuchasecchymosis,gynaecologicalhaemorrhages,gastrointestinalbleedingsandothercutaneousor

mucousbleedingswithSSRIs(seeSection4.8Undesirableeffects).CautionisadvisedinpatientstakingSSRIs,

particularlyinconcomitantusewithactivesubstancesknowntoaffectplateletfunctionorotheractivesubstancesthat

canincreasetheriskofhaemorrhageaswellasinpatientswithahistoryofbleedingdisorders(seeSection4.5

Interactions).

InrarecasesaserotoninsyndromehasbeenreportedinpatientsusingSSRIs.Acombinationofsymptoms,suchas

agitation,tremor,myoclonusandhyperthermiamayindicatethedevelopmentofthiscondition.Treatmentwith

citalopramshouldbediscontinuedimmediatelyandsymptomatictreatmentinitiated.

Treatmentofpsychoticpatientswithdepressiveepisodesmayincreasepsychoticsymptoms.

Suicide/suicidalthoughtsorclinicalworsening:

Depressionisassociatedwithanincreasedriskofsuicidalthoughts,selfharmandsuicide(suicide-relatedevents).This

riskpersistsuntilsignificantremissionoccurs.Asimprovementmaynotoccurduringthefirstfewweeksormoreof

treatment,patientsshouldbecloselymonitoreduntilsuchimprovementoccurs.Itisgeneralclinicalexperiencethatthe

riskofsuicidemayincreaseintheearlystagesofrecovery.

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commencementoftreatmentareknowntobeatgreaterriskofsuicidalthoughtsorsuicideattempts,andshouldreceive

carefulmonitoringduringtreatment.

Ameta -analysisofplacebo-controlledclinicaltrialsofantidepressantdrugsinadultpatientswithpsychiatricdisorders

showedanincreasedriskofsuicidalbehaviourwithantidepressantscomparedtoplaceboinpatientslessthan25years

old.

Closesupervisionofpatientsandinparticularthoseathighriskshouldaccompanydrugtherapyespeciallyinearly

treatmentandfollowingdosechanges.Patients(andcaregiversofpatients)shouldbealertedabouttheneedtomonitor

foranyclinicalworsening,suicidalbehaviourorthoughtsandunusualchangesinbehaviourandtoseekmedicaladvice

immediatelyifthesesymptomspresent.

Useinchildrenandadolescentsunder18yearsofage

Ciprapine10mgfilm-coatedtabletsshouldnotbeusedinthetreatmentofchildrenandadolescentsundertheageof18

years.Suicide-relatedbehaviours(suicideattemptandsuicidalthoughts),andhostility(predominantlyaggression,

oppositionalbehaviourandanger)weremorefrequentlyobservedinclinicaltrialsamongchildrenandadolescents

treatedwithantidepressantscomparedtothosetreatedwithplacebo.If,basedonclinicalneed,adecisiontotreatis

neverthelesstaken,thepatientshouldbecarefullymonitoredfortheappearanceofsuicidalsymptoms.Inaddition,

long-termsafetydatainchildrenandadolescentsconcerninggrowth,maturationandcognitiveandbehavioural

developmentarelacking.

Theuseofcitalopraminpatientswithsevererenalimpairment(creatinineclearancelessthan20ml/min.)isnot

recommendedasnoinformationisavailableonuseinthesepatients.(seeSection4.2Posologyandmethodof

administration).

Incasesofimpairedhepaticfunctiondosereductionisrecommended(seeSection4.2Posologyandmethodof

administration)andliverfunctionhastobecloselymonitored.

Hyponatraemiaandthesyndromeofinappropriateanti-diuretichormonesecretion(SIADH)hasbeenreportedrarely,

predominantlyintheelderly,andgenerallyreversesondiscontinuationoftherapy.

UndesirableeffectsmaybemorecommonduringconcomitantuseofcitalopramandherbalpreparationscontainingSt

John'swort(Hypericumperforatum).ThereforecitalopramandStJohn'swortpreparationsshouldnotbetaken

concomitantly(seeSection4.5Interactions).

Atthebeginningofthetreatment,insomniaandagitationcanoccur.Adosetitrationmaybehelpful.

Increasedlevelsofaminormetaboliteofcitalopram(didemethylcitalopram)couldtheoreticallyprolongtheQTc

intervalinsusceptibleindividuals.ECGmonitoringof2500patientsinclinicaltrials,including277patientwithpre-

existingcardiacconditionsdidnotrevealclinicallysignificantchanges.However,ECGmonitoringmaybeadvisablein

caseofoverdoseorconditionsofalteredmetabolismwithincreasedpeaklevels,e.g.liverimpairment.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Pharmacodynamicinteractions

ThesimultaneoususeofcitalopramandMAO-inhibitorscanresultinseveresideeffects,includingtheserotonin

syndrome(seeSection4.3Contraindications).

Theserotonergiceffectofsumatriptanmaybepotentiatedbyselectiveserotoninre-uptakeinhibitors(SSRIs).Until

furtherinformationisavailable,thesimultaneoususeofcitalopramand5-HTagonists,suchassumatriptanandother

triptans,isnotrecommended(seeSection4.4Specialwarningsandspecialprecautionsforuse).

Cautioniswarrantedforpatientswhoarebeingtreatedsimultaneouslywithanticoagulants,medicinalproductsthat

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medicines(e.g.atypicalantipsychotics,phenothiazines,tricyclicdepressants)thatcanincreasetheriskofhaemorrhage

(seeSection4.4Specialwarningsandspecialprecautionsforuse).

Experiencewithcitalopramhasnotrevealedanyclinicallyrelevantinteractionswithneuroleptics.However,aswith

otherSSRIs,thepossibilityofapharmacodynamicinteractioncannotbeexcluded.

UndesirableeffectsmaybemorecommonduringconcomitantuseofcitalopramandherbalpreparationscontainingSt

John'swort(Hypericumperforatum)(seeSection4.4Specialwarningsandspecialprecautionsforuse).

Nopharmacodynamicorpharmacokineticinteractionshavebeendemonstratedbetweencitalopramandalcohol.

However,thecombinationofcitalopramandalcoholisnotadvisable.

Pharmacokineticinteractions

Pharmacokineticinteractionsbasedonplasma-proteinbindingshouldnotbeexpected.Citalopramisaweakinhibitor

ofCYP2D6.Althoughclinicallyrelevantmedicinalinteractionswithcitalopramareunusual,aninteractioncannotbe

excludedifcitalopramisadministeredsimultaneouslywithanothermedicinalproductthatismetabolisedbyCYP2D6.

Co-administrationofcitalopramandmetoprolol(CYP2D6substrate)resultedinatwo-foldincreaseintheplasma

levelsofmetoprolol.Noclinicallysignificanteffectsonbloodpressureorheartratewereobserved.

Cimetidine,aknownenzyme-inhibitor,causedaslightriseintheaveragesteady-statecitalopramlevels.Cautionis

thereforerecommendedwhenadministeringhighdosesofcitalopramincombinationwithhighdosesofcimetidine.

Thereisnopharmacokineticinteractionbetweenlithiumandcitalopram.However,therehavebeenreportsofenhanced

serotonergiceffectswhenSSRIswereadministeredincombinationwithlithiumortryptophan.Cautionisadvised

duringsimultaneoususeofcitalopramwiththeseactivesubstances.Routinemonitoringoflithiumlevelsshouldbe

continuedasusual.

Inapharmacokineticstudynoeffectwasdemonstratedoneithercitalopramorimipraminelevels,althoughthelevelof

desipramine,theprimarymetaboliteofimipraminewasincreased.Whendesipramineiscombinedwithcitalopram,an

increaseofthedesipramineplasmaconcentrationhasbeenobserved.Areductionofthedesipraminedosemaybe

needed.

Nopharmacokineticinteractionwasobservedbetweencitalopramandlevomepromazine,digoxinorcarbamazepine

anditsmetabolitecarbamazepine-epoxide.

Theabsorptionandotherpharmacokineticpropertiesofcitalopramhavenotbeenreportedtobeaffectedbyfood.

4.6Fertility,pregnancyandlactation

Pregnancy:

TherearelimiteddatafromtheuseofCitalopraminpregnantwomen.Epidemiologicaldatahavesuggestedthatthe

useofSSRIsinpregnancy,particularlyinlatepregnancy,mayincreasetheriskofpersistentpulmonaryhypertension

inthenewborn(PPHN).Theobservedriskwasapproximately5casesper1000pregnancies.Inthegeneralpopulation

1to2casesofPPHNper1000pregnanciesoccur.

Studiesinratshaveshownteratogeniceffectsathighdoseswhichcausedmaternaltoxicity(seeSection5.3Preclinical

safetydata).Thepotentialriskforhumansisunknown.Citalopramshouldonlybeusedinpregnancyifconsidered

clearlynecessary.

Withdrawalsymptomsmayoccurintheneonateaftermaternalcitalopramusenearterm.Casesofwithdrawal

symptomsinthenewbornchildhavebeendescribedaftertheuseofSSRIattheendofpregnancy.

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Citalopramisexcretedinmilkinsmallquantities.Theadvantagesofbreastfeedingshouldout-weighthepotential

adverseeffectsforthechild .

4.7Effectsonabilitytodriveandusemachines

Citalopramhasminorormoderateinfluenceontheabilitytodriveandusemachines.

Psychoactivemedicinalproductscanreducetheabilitytomakejudgementsandtoreacttoemergencies.Patients

shouldbeinformedoftheseeffectsandbewarnedthattheirabilitytodriveacaroroperatemachinerycouldbe

affected.

4.8Undesirableeffects

Adversereactionsobservedwithcitalopramareingeneralmildandtransient.Theyaremostprominentduring

thefirstweeksoftreatmentandusuallyattenuateasthedepressivestateimproves.

Treatmentemergentadverseeventsreportedinclinicaltrials:

verycommon

(>10%) common

(>1%,<10%) uncommon

(>0,1%,<1%) veryrare

(<0,01%,

includingisolated

reports)

Psychiatric

disorders somnolence,

insomnia,

agitation,

nervousness sleepdisorders,

impaired

concentration,

abnormal

dreaming,

amnesia,anxiety,

decreasedlibido,

increasedappetite,

anorexia,apathy,

suicideattempt,

euphoria,

increasedlibido hallucinations,

mania,

depersonalisation,

panicattack(these

symptomsmaybe

duetothe

underlying

disease)

Nervous

system

disorders headache,tremor,

dizziness migraine,

paraesthesia extrapyramidal

disorder,

convulsions

Cardiac

disorders palpitations tachycardia bradycardia supraventricular

andventricular

arrhythmia

Vascular

Disorders postural

hypotension,

hypotension,

hypertension

Gastrointestinal

disorders nausea,dry

mouth,

constipation,

diarrhoea dyspepsia,

vomiting,

abdominalpain,

flatulence,

increased

salivation

Renalandurinary

disorders micturition

disorder,polyuria

Metabolismand

nutrition weightdecrease,

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Rare(>0,01%,<0.1%)

Haemorrhage(forexample,gynaecologicalhaemorrhage,gastrointestinalhaemorrhage,ecchymosisandother

formsofskinhaemorrhageorbleedinginthemucousmembranes)canoccuronrareoccasions.

InrarecasesaserotoninsyndromehasbeenreportedinpatientsusingSSRIs.Hyponatriaemiaandthesyndrome

ofinappropriateanti-diuretichormonesecretion(SIADH)hasbeenreportedrarely,predominantlyintheelderly

(seeSection4.4“Specialwarningsandspecialprecautionsforuse”).

FrequencyNotKnown:

Casesofsuicidalideationandsuicidalbehaviourshavebeenreportedduringcitalopramtherapyorearlyaftertreatment

discontinuation(seesection4.4).

Withdrawalreactions

Withdrawalreactionsmayoccurwhentreatmentisstopped,althoughthepreclinicalandclinicaldatadonot

suggestthatcitalopramcausesdependency.Withdrawalreactionsinclude:dizziness,paraesthesia,headache,

nauseaandanxiety.Mostofthewithdrawalreactionsaremildandself-limitinginnature.Iftreatmentisbeing

stopped,itisadvisedthatthedoseisgraduallyreducedover1-2weekperiods.

Classeffects

Epidemiologicalstudies,mainlyinpatients50yearsofageandolder,showanincreasedriskofbonefracturesin

Disorders

Hepato-biliary

disorders increasedliver

enzymevalues

Respiratory

disorders rhinitis,sinusitis coughing

Reproductive

system

disorders ejaculationfailure,

female

anorgasmia,

dysmenorrhoea,

impotence galactorrhoea

Skindisorders increased

sweating rash,pruritus photosensitivity angiodema

Eyedisorders abnormal

accommodation abnormalities

ofvision

Specialsenses

disorders tasteabnormalities

Earand

labyrinth

disorders tinnitus

Musculoskeletal

disorders myalgia arthralgia

General

disorders asthenia fatigue,yawning allergicreactions,

syncope,malaise anaphylactoid

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4.9Overdose

Symptomsofoverdose

Eightcasesareknownofacutecitalopramoverdose,atdosesofupto2000mg.Thefollowingsymptomswere

observed:somnolence,coma,stupor,seizure,sinustachycardia,transpiration,nausea,retching,cyanosis,

hyperventilationandrarelyECGchanges.Allpatientsrecovered.

Sixfatalcasesareknown,mainlyaftercombinationwithothermedicinalproducts.

Treatmentofanoverdose

Thereisnoknownspecificantidotetocitalopram.Treatmentshouldbesymptomaticandsup-portive.

Ifpossible,thepatientshouldbemadetovomit,afterwhichactivatedcarbonandanosmoticallyworkinglaxative

(suchassodiumsulfate)shouldbegiven.Stomachevacuationshouldbecon-sidered.Ifconsciousnessisimpairedthe

patientshouldbeintubated.Monitoringofcardiacandvitalsignsisrecommendedtogetherwithgeneralsymptomatic

supportivemeasures.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:

Antidepressant,Selectiveserotoninreuptakeinhibitors

ATCcode:N06AB04

Mechanismofactionandpharmacodynamiceffects

Tolerancetotheinhibitoryeffectofcitalopramon5-HTuptakedoesnotoccurduringlong-termtreatment.The

antidepressanteffectisprobablyconnectedwiththespecificinhibitionofserotoninuptakeinthebrainneurons.

Citalopramhasalmostnoeffectontheneuronaluptakeofnoradrenaline,dopamineandgamma-aminobutyricacid.

Citalopramshowsnoaffinity,oronlyverylittle,forcholinergic,histaminergicandavarietyofadrenergic,serotonergic

anddopaminergicreceptors.

Citalopramisabi-cyclicisobenzophurane-derivativethatischemicallynotrelatedtotricyclicandtetracyclic

antidepressantsorotheravailableantidepressants.Themainmetabolitesofcitalopramarealsoselectiveserotonin

uptakeinhibitors,thoughtoalesserdegree.Themetabolitesarenotreportedtocontributetotheoverallantidepressant

effect.

5.2Pharmacokineticproperties

Generalcharacteristicsoftheactivesubstance

Absorption

Citalopramisrapidlyabsorbedfollowingoraladministration:themaximumplasmaconcentra-tionisreachedon

averageafter4(1-7)hours.Absorptionisindependentoffoodintake.Oralbioavailabilityisapproximately80%.

Distribution:

Theapparentdistributionvolumeis12-17l/kg.Theplasma-proteinbindingofcitalopramanditsmetabolitesisbelow

80%.

Bio-transformation:

Citalopramismetabolisedintodemethylcitalopram,didemethylcitalopram,citalopram-N-oxideandthedeaminated

propionicacid-derivative.Thepropionicacid-derivativeispharmacologi-callyinactive.Demethylcitalopram,

didemethylcitalopramandcitalopram-N-oxideareselectiveserotoninuptakeinhibitors,althoughweakerthanthe

parentcompound.

Invivoresearchhasdemonstratedthattheplasmalevelsofcitalopramanditsmetabolitesde-pendonthe

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accordingtothesephenotypes.

Elimination:

Theplasmahalf-lifeisapproximately1½days.Aftersystemicadministration,theplasmaclear-anceisapproximately

0.3-0.4l/minandafteroraladministrationtheplasmaclearanceisap-proximately0.4l/min.

Citalopramismainlyeliminatedviatheliver(85%),butalsopartly(15%)viathekidneys.Ofthequantityof

citalopramadministered,12-23%iseliminatedunalteredviatheurine.Hepaticclearanceisapproximately0.3l/min

andrenalclearanceis0.05-0.08l/min.Steady-stateconcentrationsarereachedafter1-2weeks.Alinearrelationship

hasbeendem-onstratedbetweenthesteady-stateplasmalevelandthedoseadministered.Atadoseof40mgperday,

anaverageplasmaconcentrationofapproximately300nmol/lisreached.Thereisnoclearrelationshipbetween

citalopramplasmalevelsandtherapeuticresponseorsideeffects.

Characteristicsrelatingtopatients

Longerplasmahalf-lifevaluesandasmallerclearancehavebeenfoundinolderpatientsduetoareducedmetabolism.

Theeliminationofcitalopramprogressesmoreslowlyinpatientswithreducedliverfunction.Theplasmahalf-lifeof

citalopramisapproximatelytwiceaslongandthesteady-stateplasmaconcentrationapproximatelytwiceashighin

comparisonwithpatientswithanormalliverfunc-tion.Theeliminationofcitalopramprogressesmoreslowlyin

patientswithamildtomoderaterenalfunctiondisorder,withoutanymajorimpactonthepharmacokineticsof

citalopram.Noinforma-tionisavailableontreatmentofpatientswithsevererenalimpairment(creatinineclearance

lessthan20ml/min)(seeSection4.4Specialwarningsandspecialprecautionsforuse).

5.3Preclinicalsafetydata

Inlaboratoryanimalsnoevidenceforaspecialhazardforhumanswasfound.Thisisbasedonconventionalstudiesof

safetypharmacology,repeateddosetoxicity,genotoxicityandcarcinogenicpotential.Phospholipidosisinseveralorgans

wasobservedinrepeateddosetoxicitystudiesinrats.Thisreversibleeffectisknownforseverallipophilicaminesandw

notconnectedwithmorphologicalandfunctionaleffects.Theclinicalrelevanceisnotclear.Embryotoxicitystudiesinr

haveshownskeletalanomaliesathighmaternaltoxicdoses.Theeffectscouldpossiblyberelatedtothepharmacologica

activityorcouldbeanindirecteffectrelatedtomaternaltoxicity.Thepotentialriskforhumansisunknown.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Core:

Mannitol

Microcrystallinecellulose

Colloidalsilica,anhydrous

Magnesiumstearate

Coating:

Hypromellose

Macrogol6000

Titaniumdioxide(E171)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

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Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

Ciprapine10mgfilm-coatedtablets;packedinPVC/PVDC/Alblistersareavailableinpacksizesof10,14,20,28,30,

50,56,98and100tabletsperbox,100x1unitdoseblister.

HDPEtabletcontainerwithaLDPEtamperevidentcapcontaining250,500tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PinewoodLaboratoriesLimited

Ballymacarbry

Clonmel

Co.Tipperary

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA281/117/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18June2004

Dateoflastrenewal:18February2009

10DATEOFREVISIONOFTHETEXT

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