CIPRAMIL

Main information

  • Trade name:
  • CIPRAMIL Tablets 20 Milligram
  • Dosage:
  • 20 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CIPRAMIL Tablets 20 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/021/002
  • Authorization date:
  • 25-08-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cipramil20mgFilm-coatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains20mgcitalopram(ashydrobromide).

Excipients:Lactose

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet.

ProductimportedfromtheNetherlandsandtheUK:

White,ovaltabletsdeeplyscoredononeface,withtheletters‘C’and‘N’oneithersideofthescore.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofdepressiveillnessintheinitialphaseandasmaintenanceagainstpotentialrelapse/recurrence.

Cipramilisalsoindicatedinthetreatmentofpanicdisorderwithorwithoutagoraphobia.

4.2Posologyandmethodofadministration

Adults

TreatingDepression

Citalopramshouldbeadministeredasasingleoraldoseof20mgdaily.Dependentonindividualpatientresponsethis

maybeincreasedtoamaximumof60mgdaily.Thedosemaybegiveninthemorningorevening.

Atreatmentperiodofatleast6monthsisusuallynecessarytoprovideadequatemaintenanceagainstthepotentialfor

relapse.

TreatingPanicDisorder

Incommonwithotherpharmacotherapyusedinthispatientgroup,alowstartingdoseisadvisedtoreducethe

likelihoodofaparadoxicalinitialanxiogeniceffect.Asingledoseof10mgdailyisrecommendedforthefirstweek

beforeincreasingthedoseto20mgdaily.Thedosemaybefurtherincreased,uptoamaximumof60mgdaily

dependentonindividualpatientresponse;howeveranoptimumdoseof20-30mgdailywasindicatedinaclinical

study.

Maximumeffectivenessofcitalopramintreatingpanicdisorderisreachedafterabout3monthsandtheresponseis

maintainedduringcontinuedtreatment.Dependentonindividualpatientresponseitmaybenecessarytocontinue

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Elderlypatients

Therecommendeddailydoseis20mg.Dependentonindividualpatientresponsethismaybeincreasedtoamaximum

of40mgdaily.

Children&Adolescents(under18years)

Notrecommended,assafetyandefficacyhavenotbeenestablishedinthispopulation.

Reducedhepaticfunction

Dosageshouldberestrictedtothelowerendofthedoserange.

Reducedrenalfunction

Dosageadjustmentisnotnecessaryincasesofmildormoderaterenalimpairment.Noinformationisavailableincases

ofsevererenalimpairment(creatinineclearance<20ml/min).

MethodofAdministration

Citalopramtabletsareadministeredasasingledailydoseandcanbetakenatanytimeofthedaywithoutregardto

foodintake.

4.3Contraindications

Hypersensitivitytocitalopram.Sumatriptan'sserotonergiceffectsaresuspectedtobeenhancedbySSRIs.Untilfurther

evidenceisavailableitisadvisednottousecitalopramsimultaneouslywith5-HTagonistse.g.sumatriptan.

4.4Specialwarningsandprecautionsforuse

Useinchildrenandadolescentsunder18yearsofage

Cipramilshouldnotbeusedinthetreatmentofchildrenandadolescentsundertheageof18years.Suiciderelated

behaviours(suicideattemptandsuicidalthoughts),andhostility(predominatelyaggression,oppositionalbehaviourand

anger)weremorefrequentlyobservedinclinicaltrialsamongchildrenandadolescentstreatedwithantidepressants

comparedtothosetreatedwithplacebo.If,basedonclinicalneed,adecisiontotreatisneverthelesstaken,thepatient

shouldbecarefullymonitoredfortheappearanceofsuicidalsymptoms.Inaddition,long-termsafetydatainchildren

andadolescentsconcerninggrowth,maturationandcognitiveandbehaviouraldevelopmentarelacking.

Suicide/suicidalthoughts:

Depressionisassociatedwithanincreasedriskofsuicidalthoughts,selfharmandsuicide(suicide-relatedevents).This

riskpersistsuntilsignificantremissionoccurs.Asimprovementmaynotoccurduringthefirstfewweeksormoreof

treatment,patientsshouldbecloselymonitoreduntilsuchimprovementoccurs.Itisgeneralclinicalexperiencethatthe

riskofsuicidemayincreaseintheearlystagesofrecovery.

OtherpsychiatricconditionsforwhichProzacisprescribedcanalsobeassociatedwithanincreasedriskofsuicide-

relatedevents.Inaddition,theseconditionsmaybeco-morbidwithmajordepressivedisorder.Thesameprecautions

observedwhentreatingpatientswithmajordepressivedisordershouldthereforebeobservedwhentreatingpatients

withotherpsychiatricdisorders.

Patientswithahistoryofsuicide-relatedevents,thoseexhibitingasignificantdegreeofsuicidalideationpriorto

commencementoftreatmentareknowntobeatgreaterriskofsuicidalthoughtsorsuicideattempts,andshouldreceive

carefulmonitoringduringtreatment.Ameta-analysisofplacebo-controlledclinicaltrialsofantidepressantdrugsin

adultpatientswithpsychiatricdisordersshowedanincreasedriskofsuicidalbehaviourwithantidepressantscompared

toplaceboinpatient’slessthan25yearsold.

Closesupervisionofpatientsandinparticularthoseathighriskshouldaccompanydrugstherapyespeciallyinearly

treatmentandfollowingdosechanges.Patients(andcaregiversofpatientsshouldbealertedabouttheneedtomonitor

foranyclinicalworsening,suicidalbehaviourorthoughtandunusualchangesinbehaviourandtoseekmedicaladvice

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AswithotherSSRIs,citalopramshouldnotbegiventopatientsreceivingMonoamineOxidaseInhibitors(MAOIs),or

for14daysaftertheirdiscontinuation.MAOIsshouldnotbeintroducedforsevendaysafterdiscontinuationof

citalopram.Rarely,theoccurrenceof'serotoninsyndrome'hasbeenreportedinpatientsreceivingSSRIs.A

combinationofsymptoms,possiblyincludingagitation,tremor,myoclonusandhyperthermia,mayindicatethe

developmentofthiscondition.

SSRIsshouldbeadministeredwithcautioninpatientstreatedconcomitantlywithanticoagulants,drugswhichhavean

effectonplateletfunction(e.g.NSAIDsacetylsalicylicacid,aspirinandticlopidine)orotherdrugsthatmayincrease

theriskofbleeding.

Cautionshouldbeexercisedinpatientswithahistoryofbleedingabnormalities.

Experiencewithcitalopramhasnotrevealedanyclinicallyrelevantinteractionswithneuroleptics.However,aswith

otherSSRIs,thepossibilityofapharmacodynamicinteractioncannotbeexcluded.

Considerationshouldbegiventofactors,whichmayaffectthedispositionofaminormetaboliteofcitalopram

(didemethylcitalopram)sinceincreasedlevelsofthismetabolitecouldtheoreticallyprolongtheQT

intervalin

susceptibleindividuals.However,inECGmonitoringof2500patientsinclinicaltrials,including277patientswithpre-

existingcardiacconditions,noclinicallysignificantchangeswerenoted.

Undesirableeffectsmaybemorecommonduringconcomitantuseofserotoninre-uptakeinhibitorsandherbal

preparationscontainingStJohnsWort(Hypericumperforatum).

Aswithmostantidepressants,citalopramshouldbediscontinuedifthepatiententersamanicphase.Thereislittle

clinicalexperienceofconcurrentuseofcitalopramandECT.

Somepatientswithpanicdisorderexperienceaninitialanxiogeniceffectwhenstartingpharmacotherapy.Alow

startingdose(seePosology)reducesthelikelihoodofthiseffect.

Asimprovementofthedepressivestatemaynotoccurduringthefirstfewweeksormoreoftreatment,patientsshould

becloselymonitoredduringthisperiod.Itisgeneralclinicalexperiencewithallantidepressantsthattheriskofsuicide

mayincreaseintheearlystagesofrecovery.

Thepossibilityofsuicideattemptisinherentindepressionandmaypersistuntilsignificantremissionoccurs.

Potentiallysuicidalpatientsshouldnothaveaccesstolargequantitiesofdrugs.

Excipients:

Thetabletscontainlactosemonohydrate.Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapp

lactasedeficiencyorglucose-galactosemalabsorptionshouldnotreceivethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

MonoamineOxidaseInhibitors(MAOIs)shouldnotbeusedincombinationwithSSRIs(see4.4Specialwarningsand

precautionsforuse).

ThemetabolismofcitalopramisonlypartlydependentonthehepaticcytochromeP450isozymeCYP2D6and,unlike

someotherSSRIs,citalopramisonlyaweakinhibitorofthisimportantenzymesystemwhichisinvolvedinthe

metabolismofmanydrugs(includingantiarrhythmics,neuroleptics,beta-blockers,TCAsandsomeSSRIs).Protein

bindingisrelativelylow(<80%).Thesepropertiesgivecitalopramalowpotentialforclinicallysignificantdrug

interactions.

Thereisnopharmacokineticinteractionbetweenlithiumandcitalopram.However,therehavebeenreportsofenhanced

serotonergiceffectswhenSSRIshavebeengivenwithlithiumortryptophanandthereforetheconcomitantuseof

citalopramwiththesedrugsshouldbeundertakenwithcaution.Routinemonitoringoflithiumlevelsneednotbe

adjusted.

Inapharmacokineticstudynoeffectwasdemonstratedoneithercitalopramorimipraminelevels,althoughthelevelof

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influenceoncitalopramkinetics.

SSRIsmayincreasetheriskofbleedingiftheyareadministeredconcomitantlywithanticoagulantsordrugswhich

haveaneffectonplateletfunction(see4.4SpecialWarningsandPrecautionsforUse).

Nopharmacodynamicinteractionshavebeennotedinclinicalstudiesinwhichcitalopramhasbeengiven

concomitantlywithbenzodiazepines,neuroleptics,analgesics,lithium,alcohol,antihistamines,antihypertensivedrugs,

beta-blockersandothercardiovasculardrugs.

4.6Pregnancyandlactation

Clinicalexperienceofuseinpregnantwomenislimitedbutnoreports,whichmaycauseconcernhavebeenreceived.

Basedondatafromreproductiontoxicitystudies(segmentI,IIandIII)thereisnoreasontohavespecialconcernfor

theuseofcitalopraminwomenofchildbearingpotential.

NeonatesshouldbeobservedifmaternaluseofCipramilcontinuesintothelaterstagesofpregnancy,particularinthe

thirdtrimester.Abruptdiscontinuationshouldbeavoidedduringpregnancy.

ThefollowingsymptomsmayoccurintheneonatesaftermaternalSSRI/SNRIuseinlaterstagesofpregnancy:

respiratorydistress,cyanosis,apnoea,seizures,temperatureinstability,feedingdifficulty,vomiting,hypoglycaemia,

hypertonia,hypotonia,hyperreflexia,tremor,jitteriness,irritability,lethargy,constantcrying,somnolenceand

difficultysleeping.Thesesymptomscouldbeduetoeitherserotonergiceffectsordiscontinuationsymptoms.Ina

majorityofinstancesthecomplicationsbeginimmediatelyorsoon(<24hours)afterdelivery.

EpidemiologicaldatahavesuggestedthattheuseofSSRIsinpregnancy,particularinlatepregnancy,mayincreasethe

riskofpersistentpulmonaryhypertensioninthenewborn(PPHN).Theobservedriskwasapproximately5casesper

1000pregnancies.Inthegeneralpopulation1to2casesofPPHNper1000pregnanciesoccur.

Lactation

Citalopramisexcretedintobreastmilk.Itisestimatedthatthesucklinginfantwillreceiveabout5%oftheweight

relatedmaternaldailydose(inmg/kg).Nooronlyminoreventshavebeenobservedintheinfants.However,the

existinginformationisinsufficientforassessmentoftherisktothechild.

Cautionisrecommended.

4.7Effectsonabilitytodriveandusemachines

Citalopramdoesnotimpairintellectualfunctionandpsychomotorperformance.However,patientswhoareprescribed

psychotropicmedicationmaybeexpectedtohavesomeimpairmentofgeneralattentionandconcentrationeitherdueto

theillnessitself,themedicationorbothandshouldbecautionedabouttheirabilitytodriveacarandoperate

machinery.

4.8Undesirableeffects

Adverseeffectsobservedwithcitalopramareingeneralmildandtransient.Theyaremostprominentduringthefirst

oneortwoweeksoftreatmentandusuallyattenuateasthedepressivestateimproves.

Themostcommonlyobservedadverseeventsassociatedwiththeuseofcitalopramandnotseenatanequalincidence

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

eachinexcessoverplaceboislow(<10%).

Incomparativeclinicaltrialswithtricyclicantidepressantstheincidenceofadverseeventsoccurringwithcitalopram

wasfoundtobelowerinallcases.

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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,confusion,yawning.

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

Metabolicandnutritionaldisorders:Weightdecrease,weightincrease.

Cardiovasculardisorders,general:Hypotensionpostural.

Heartrateandrhythmdisorders:Tachycardia.

Respiratorysystemdisorders:Rhinitis.

Urinarysystemdisorders:Micturitiondisorder,polyuria.

Reproductivedisorders,male:Ejaculationfailure.

Reproductivedisorders,female:Anorgasmiafemale.

Bodyasawhole:Fatigue.

Rare(<1%)

Musculo-skeletalsystemdisorder:Myalgia.

CentralandPeripheralnervoussystemdisorders:Extrapyramidaldisorder,convulsions.

Hearingandvestibulardisorders:Tinnitus.

Psychiatricdisorders:Euphoria,libidoincreased,suicideattempt.

Respiratorysystemdisorders:Coughing.

Bodyasawhole:Malaise.

Hyponatraemia,sometimesassociatedwiththesyndromeofinappropriateantidiuretichormonesecretion(SIADH),has

beenreportedwiththeuseofSSRIsandotherantidepressants.

TreatmentwithSSRIshasoccasionallybeenassociatedwithsymptomssuggestiveofposturalhypotension,

hypotension,hypertensionandtachycardia.Therehavealsobeenrarereportsofsupraventricularandventricular

arrhythmias.Todatecausalityhasnotbeenestablished.

Rarelytherehavebeenreportsofbleedingabnormalitiessuchasecchymosis,purpura,gastrointestinal,gynaecological,

mucosalandcutaneousbleedingwithSSRIs(seeSection4.4SpecialWarningsandPrecautionsforUse).

SideeffectinDiscontinuation:Withdrawalreactionshavebeenreportedinassociationwithselectiveserotonin

reuptakeinhibitors(SSRIs),includingCipramil.Commonsymptomsincludedizziness,paraesthesia,headache,anxiety

andnausea.AbruptdiscontinuationoftreatmentwithCipramilshouldbeavoided.Themajorityofsymptoms

experiencedonwithdrawalofSSRIsarenon-seriousandself-limiting.

CasesofsuicidalideationandsuicidalbehaviourhavebeenreportedduringCitalopramtherapyorearlyaftertreatment

discontinuation(seesection4.4).

Classeffects

Epidemiologicalstudies,mainlyinpatients50yearsofageandolder,showanincreasedriskofbonefracturesin

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4.9Overdose

Citalopramisgiventopatientsatpotentialriskofsuicideandsomereportsofattemptedsuicidehavebeenreceived.

Detailisoftenlackingregardingprecisedoseorcombinationwithotherdrugsand/oralcohol.

Symptoms

Experiencefrom8casesconsideredduetocitalopramalonehasrecordedthefollowingsymptoms/signs:somnolence,

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

nausea,vomiting,cyanosis,hyperventilation.Nocasewasfatal.Theclinicalpicturewasinconsistent,noobservation

beingmadeinmorethantwoindividuals.

Sixfatalitieshavebeenreported.Inoneoverdosewassuspected;highpostmortemplasmalevelswereseenalthoughit

isnottechnicallypossibletointerpretthesewithconfidence.

Intheremainingfiveacombinationwithotherdrugshadbeentaken.Theclinicalsyndromeobservedpriortodeathin

threeofthesecaseswherecitalopramwastakenwithmoclobemidewasinterpretedasthatofserotoninsyndrome.No

clinicaldetailsareavailableontheothertwo.

Treatment

Thereisnospecificantidote.Treatmentissymptomaticandsupportive.Gastriclavageshouldbecarriedoutassoonas

possibleafteroralingestion.Medicalsurveillanceisadvisable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATC-code:N06AB04

Biochemicalandbehaviouralstudieshaveshownthatcitalopramisapotentinhibitorofserotonin(5-HT)-uptake.

Tolerancetotheinhibitionof5-HT-uptakeisnotinducedbylong-termtreatmentwithcitalopram.

CitalopramisthemostSelectiveSerotoninReuptakeInhibitor(SSRI)yetdescribed,withno,orminimal,effecton

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

IncontrasttomanytricyclicantidepressantsandsomeofthenewerSSRIs,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,otherSSRIsandMAOinhibitors,citalopramsuppressesREM-sleepandincreasesdeepslow-wave

sleep.

Althoughcitalopramdoesnotbindtoopioidreceptorsitpotentiatestheanti-nociceptiveeffectofcommonlyused

opioidanalgesics.Therewaspotentiationofd-amphetamine-inducedhyperactivityfollowingadministrationof

citalopram.

ThemainmetabolitesofcitalopramareallSSRIsalthoughtheirpotencyandselectivityratiosarelowerthanthoseof

citalopram.However,theselectivityratiosofthemetabolitesarehigherthanthoseofmanyofthenewerSSRIs.The

metabolitesdonotcontributetotheoverallantidepressanteffect.

Inhumanscitalopramdoesnotimpaircognitive(intellectualfunction)andpsychomotorperformanceandhasnoor

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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.

Elimination

Theeliminationhalf-life(T

)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.

Thereisnoclearrelationshipbetweencitalopramplasmalevelsandtherapeuticresponseorside-effects.

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

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Maizestarch

Lactosemonohydrate

Microcrystallinecellulose

Copovidone

Glycerol

Croscarmellosesodium

Magnesiumstearate

Hypromellose

Macrogol400

Titaniumdioxide(E171)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

PressthroughpacksconsistingofaluminiumfoilandUPVC/PVdCfoilincartonscontaining28tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

Middlesex

HA40NU

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1328/021/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

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10DATEOFREVISIONOFTHETEXT

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