CLARITYN

Main information

  • Trade name:
  • CLARITYN Syrup 5 MG/5ml
  • Dosage:
  • 5 MG/5ml
  • Pharmaceutical form:
  • Syrup
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLARITYN Syrup 5 MG/5ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1286/032/002
  • Authorization date:
  • 26-11-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Clarityn1mg/1mlSyrup

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1mlofsyrupcontains1mgofloratadine

Thequantityofsucroseintheloratadinesyrupcompositionis600mg/ml.Theamountofsucroseper5ml(5mg)

doseis3grams.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Syrup

Aclear,colourlesstolightyellowsyrup.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ClaritynSyrupisindicatedforthesymptomatictreatmentofallergicrhinitisandchronicidiopathicurticaria.

4.2Posologyandmethodofadministration

Adultsandchildrenover12yearsofage:10ml(10mg)ofthesyruponcedaily.

Thesyrupmaybetakenwithoutregardtomealtime.

Children2to12yearsofagearedosedbyweight:

Bodyweightmorethan30kg:10ml(10mg)ofthesyruponcedaily.

Bodyweight30kgorless:5ml(5mg)ofthesyruponcedaily.

EfficacyandsafetyofClaritynSyrupinchildrenunder2yearsofagehasnotbeenestablished.

Patientswithsevereliverimpairmentshouldbeadministeredalowerinitialdosebecausetheymayhavereduced

clearanceofloratadine.Aninitialdoseof10mgeveryotherdayisrecommendedforadultsandchildrenweighing

morethan30kg,andforchildrenweighing30kgorless,5ml(5mg)everyotherdayisrecommended.

Nodosageadjustmentsarerequiredintheelderlyorinpatientswithrenalinsufficiency.

4.3Contraindications

ClaritynSyrupiscontraindicatedinpatientswhoarehypersensitivetotheactivesubstanceortoanyofthe

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4.4Specialwarningsandprecautionsforuse

ClaritynSyrupshouldbeadministeredwithcautioninpatientswithsevereliverimpairment(see4.2).

Thismedicinalproductcontainssucrose;thuspatientswithrarehereditaryproblemsoffructoseintolerance,

glucose-galactosemalabsorptionorsucrase-isomaltaseinsufficiencyshouldnottakethismedicine.

TheadministrationofClaritynSyrupshouldbediscontinuedatleast48hoursbeforeskintestssinceantihistamines

maypreventorreduceotherwisepositivereactionstodermalreactivityindex.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Whenadministeredconcomitantlywithalcohol,ClaritynSyruphasnopotentiatingeffectsasmeasuredby

psychomotorperformancestudies.

PotentialinteractionmayoccurwithallknowninhibitorsofCYP3A4orCYP2D6resultinginelevatedlevelsof

loratadine(seeSection5.2),whichmaycauseanincreaseinadverseevents.

4.6Fertility,pregnancyandlactation

Loratadinewasnotteratogenicinanimalstudies.Thesafeuseofloratadineduringpregnancyhasnotbeen

established.TheuseofClaritynSyrupduringpregnancyisthereforenotrecommended.

Loratadineisexcretedinbreastmilk,thereforetheuseofloratadineisnotrecommendedinbreast-feedingwomen.

4.7Effectsonabilitytodriveandusemachines

Inclinicaltrialsthatassesseddrivingability,noimpairmentoccurredinpatientsreceivingloratadine.However,

patientsshouldbeinformedthatveryrarelysomepeopleexperiencedrowsiness,whichmayaffecttheirabilityto

driveorusemachines.

4.8Undesirableeffects

Inclinicaltrialsinapaediatricpopulationchildrenaged2through12years,commonadversereactionsreportedin

excessofplacebowereheadache(2.7%),nervousness(2.3%)andfatigue(1%).

InclinicaltrialsinvolvingadultsandadolescentsinarangeofindicationsincludingARandCIU,atthe

recommendeddoseof10mgdaily,adversereactionswithloratadinewerereportedin2%ofpatientsinexcessof

thosetreatedwithplacebo.Themostfrequentadversereactionsreportedinexcessplaceboweresomnolence

(1.2%),headache(0.6%),increasedappetite(0.5%)andinsomnia(0.1%).Otheradversereactionsreportedvery

rarelyduringthepost-marketingperiodarelistedinthefollowingtable.

4.9Overdose

Overdosagewithloratadineincreasedtheoccurrenceofanticholinergicsymptoms.Somnolence,tachycardiaand

Immunedisorders Anaphylaxis

Nervoussystemdisorders Dizziness

Cardiacdisorders Tachycardia,palpitation

Gastrointestinaldisorders Nausea,drymouth,gastritis

Hepato-biliarydisorders Abnormalhepaticfunction

Skinandsubcutaneoustissuedisorders Rash,alopecia

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Intheeventofoverdosage,generalsymptomaticandsupportivemeasuresaretobeinstitutedandmaintainedforas

longasnecessary.Administrationofactivatedcharcoalasaslurrywithwatermaybeattempted.Gastriclavage

maybeconsidered.Loratadineisnotremovedbyhaemodialysisanditisnotknownifloratadineisremovedby

peritonealdialysis.Medicalmonitoringofthepatientistobecontinuedafteremergencytreatment.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:antihistamines–H

antagonist,ATCcode:R06AX13.

Loratadine,theactiveingredientinClaritynSyrup,isatricyclicantihistaminewithselective,peripheralH

receptoractivity.

Loratadinehasnoclinicallysignificantsedativeoranticholinergicpropertiesinthemajorityofthepopulationand

whenusedattherecommendeddosage.

Duringlong-termtreatmenttherewerenoclinicallysignificantchangesinvitalsigns,laboratorytestvalues,

physicalexaminationsorelectrocardiograms.

LoratadinehasnosignificantH

-receptoractivity,doesnotinhibitnorepinephrineuptakeandhaspracticallyno

influenceoncardiovascularfunctionoronintrinsiccardiacpacemakeractivity.

5.2Pharmacokineticproperties

Afteroraladministration,loratadineisrapidlyandwellabsorbedandundergoesextensivefirstpassmetabolism,

mainlybyCYP3A4andCYP2D6.Themajormetabolite-desloratadine(DL)-ispharmacologicallyactiveand

responsibleforalargepartoftheclinicaleffect.LoratadineandDLachievemaximumplasmaconcentrations

)between1-1.5hoursand1.5-3.7hoursafteradministration,respectively.

Increaseinplasmaconcentrationsofloratadinehasbeenreportedafterconcomitantusewithketoconazole,

erythromycinandcimetideincontrolledtrials,butwithoutclinicallysignificantchanges(including

electrodiographic).

Loratadineishighlybound(97%to99%)anditsactivemetabolitemoderatelybound(73%to76%)toplasma

proteins.

Inhealthysubjects,plasmadistributionhalf-livesofloratadineanditsactivemetaboliteareapproximately1and2

hours,respectively.Themeaneliminationhalf-livesinhealthyadultssubjectswere8.4hours(range=3to20

hours)forloratadineand28hours(range=8.8to92hours)forthemajoractivemetabolite.

Approximately40%ofthedoseisexcretedinurineand42%inthefaecesovera10dayperiodandmainlyinthe

formofconjugatedmetabolites.Approximately27%ofthedoseiseliminatedintheurineduringthefirst24hours.

Lessthan1%oftheactivesubstanceisexcretedunchangedinactiveform,asloratadineorDL.

Thebioavailabilityparametersofloratadineandoftheactivemetabolitearedoseproportional.

Thepharmacokineticprofileofloratadineanditsmetabolitesiscomparableinhealthyadultvolunteersandin

healthygeriatricvolunteers.

Concomitantingestionoffoodcandelayslightlytheabsorptionofloratadinebutwithoutinfluencingtheclinical

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Inpatientswithchronicrenalimpairment,boththeAUCandpeakplasmalevels(C

)increasedforloratadine

anditsmetaboliteascomparedtotheAUCsandpeakplasmalevels(C

)ofpatientswithnormalrenalfunction.

Themeaneliminationhalf-livesofloratadineanditsmetabolitewerenotsignificantlydifferentfromthatobserved

innormalsubjects.Haemodialysisdoesnothaveaneffectonthepharmacokineticsofloratadineoritsactive

metaboliteinsubjectswithchronicrenalimpairment.

Inpatientswithchronicalcoholicliverdisease,theAUCandpeakplasmalevels(C

)ofloratadineweredouble

whilethepharmacokineticprofileoftheactivemetabolitewasnotsignificantlychangedfromthatinpatientswith

normalliverfunction.Theeliminationhalf-livesforloratadineanditsmetabolitewere24hoursand37hours,

respectively,andincreasedwithincreasingseverityofliverdisease.

Loratadineanditsactivemetaboliteareexcretedinthebreastmilkoflactatingwomen.

5.3Preclinicalsafetydata

Preclinicaldatarevealnospecialhazardbasedonconventionalstudiesofsafety,pharmacology,repeateddose

toxicity,genotoxicityandcarcinogenicpotential.

Inreproductivetoxicitystudies,noteratogeniceffectswereobserved.However,prolongedparturitionandreduced

viabilityofoffspringwereobservedinratsatplasmalevels(AUC)10timeshigherthanthoseachievedwith

clinicaldoses.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

PropyleneGlycol(E1520)

Glycerol(E422)

CitricAcidanhydrous

SodiumBenzoate(E211)

Sucrose

ArtificialPeachFlavour

PurifiedWater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

24months;afterfirstopening,thesyrupisstablefor1month.

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.Donotfreeze.Keepthebottleintheouter

cartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Amberglassbottlesof60,70,100or120mlwithatamper-evident,child-proofpolypropylenecap.A5mlplastic

spoonisincluded.

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6.6Specialprecautionsfordisposal

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

MerckSharp&DohmeIreland(HumanHealth)Limited

PelhamHouse

SouthCountyBusinessPark

Leopardstown

Dublin18

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1286/32/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18 th

January1994

Dateoflastrenewal:8 th

November2007

10DATEOFREVISIONOFTHETEXT

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