CLARITYN

Main information

  • Trade name:
  • CLARITYN Tablets 10 Milligram
  • Dosage:
  • 10 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLARITYN Tablets 10 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1286/032/001
  • Authorization date:
  • 26-11-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Clarityn10mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains10mgloratadine.

Thequantityoflactosemonohydrateintheloratadine10mgtabletcompositionis71.3mg.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet:Thescorelineofthetabletisonlytofacilitatebreakingforeaseofswallowingandnottodivideinto

equaldoses.

Tablet:Whitetooff-white,ovaltabletwithflaskandbowl,scoreand‘10’ononesideandplainontheotherside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ClaritynTabletsareindicatedforthesymptomatictreatmentofallergicrhinitisandchronicidiopathicurticaria.

4.2Posologyandmethodofadministration

Adultsandchildrenover12yearsofage:10mgoncedaily(onetabletoncedaily).Thetabletmaybetakenwithout

regardtomealtime.

Children2to12yearsofagearedosedbyweight:

Bodyweightmorethan30Kg:10mgoncedaily(onetabletoncedaily).

The10mgtabletisnotappropriateinchildrenwithabodyweightlessthan30kg.

EfficacyandsafetyofClaritynTabletsinchildrenunder2yearsofagehasnotbeenestablished.

Patientswithsevereliverimpairmentshouldbeadministeredalowerinitialdosebecausetheymayhavereduced

clearanceofloratadine.Aninitialdoseof10mgeveryotherdayisrecommendedforadultsandchildrenweighingmore

than30Kg.

Nodosageadjustmentsarerequiredintheelderlyorinpatientswithrenalinsufficiency.

4.3Contraindications

ClaritynTabletsarecontraindicatedinpatientswhoarehypersensitivetotheactivesubstanceortoanyofthe

excipientsintheseformulations.

4.4Specialwarningsandprecautionsforuse

ClaritynTabletsshouldbeadministeredwithcautioninpatientswithsevereliverimpairment(see4.2).

Thismedicinalproductcontainslactose:thuspatientswithrarehereditaryproblemsofgalactoseintolerance,theLapp

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TheadministrationofClaritynTabletsshouldbediscontinuedatleast48hoursbeforeskintestssinceantihistamines

maypreventorreduceotherwisepositivereactionstodermalreactivityindex.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Whenadministeredconcomitantlywithalcohol,ClaritynTabletshavenopotentiatingeffectsasmeasuredby

psychomotorperformancestudies.

PotentialinteractionmayoccurwithallknowninhibitorsofCYP3A4orCYP2D6resultinginelevatedlevelsof

loratadine(seeSection5.2),whichmaycauseanincreaseinadverseevents.

4.6Fertility,pregnancyandlactation

Loratadinewasnotteratogenicinanimalstudies.Thesafeuseofloratadineduringpregnancyhasnotbeenestablished.

TheuseofClaritynTabletsduringpregnancyisthereforenotrecommended.

Loratadineisexcretedinbreastmilk,thereforetheuseofloratadineisnotrecommendedinbreast-feedingwomen.

4.7Effectsonabilitytodriveandusemachines

Inclinicaltrialsthatassesseddrivingability,noimpairmentoccurredinpatientsreceivingloratadine.However,

patientsshouldbeinformedthatveryrarelysomepeopleexperiencedrowsiness,whichmayaffecttheirabilitytodrive

orusemachines.

4.8Undesirableeffects

Inclinicaltrialsinapaediatricpopulationchildrenaged2through12years,commonadversereactionsreportedin

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

InclinicaltrialsinvolvingadultsandadolescentsinarangeofindicationsincludingARandCIU,attherecommended

doseof10mgdaily,adversereactionswithloratadinewerereportedin2%ofpatientsinexcessofthosetreatedwith

placebo.Themostfrequentadversereactionsreportedinexcessofplaceboweresomnolence(1.2%),headache(0.6%),

increasedappetite(0.5%)andinsomnia(0.1%).Otheradversereactionsreportedveryrarelyduringthepost-marketing

periodarelistedinthefollowingtable.

4.9Overdose

Overdosagewithloratadineincreasedtheoccurrenceofanticholinergicsymptoms.Somnolence,tachycardiaand

headachehavebeenreportedwithoverdoses.

Intheeventofoverdosage,generalsymptomaticandsupportivemeasuresaretobeinstitutedandmaintainedforas

longasnecessary.

Administrationofactivatedcharcoalasaslurrywithwatermaybeattempted.Gastriclavagemaybeconsidered.

Loratadineisnotremovedbyhaemodialysisanditisnotknownifloratadineisremovedbyperitonealdialysis.

Immunedisorders Anaphylaxis

Nervoussystemdisorders Dizziness

Cardiacdisorders Tachycardia,palpitation

Gastrointestinaldisorders Nausea,drymouth,gastritis

Hepato-biliarydisorders Abnormalhepaticfunction

Skinandsubcutaneoustissuedisorders Rash,alopecia

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:antihistamines–H

antagonist,ATCcode:R06AX13.

Loratadine,theactiveingredientinClaritynTablets,isatricyclicantihistaminewithselective,peripheralH

-receptor

activity.

Loratadinehasnoclinicallysignificantsedativeorantichlolinergicpropertiesinthemajorityofthepopulationand

whenusedattherecommendeddosage.

Duringlong-termtreatmenttherewerenoclinicallysignificantchangesinvitalsigns,laboratorytestvalues,physical

examinationsorelectrocardiograms.

LoratadinehasnosignificantH

-receptoractivity.Itdoesnotinhibitnorepinephrineuptakeandhaspracticallyno

influenceoncardiovascularfunctionoronintrinsiccardiacpacemakeractivity.

5.2Pharmacokineticproperties

Afteroraladministration,loratadineisrapidlyandwellabsorbedandundergoesanextensivefirstpassmetabolism,

mainlybyCYP3A4andCYP2D6.Themajormetabolite-desloratadine(DL)-ispharmacologicallyactiveand

responsibleforalargepartoftheclinicaleffect.LoratadineandDLachievemaximumplasmaconcentrations(T

between1-1.5hoursand1.5-3.7hoursafteradministrationrespectively.

Increaseinplasmaconcentrationsofloratadinehasbeenreportedafterconcomitantusewithketoconazole,

erythromycin, and cimetidine incontrolled trials, but without clinically significant changes (including

electrocardiographic).

Loratadineishighlybound(97%to99%)anditsactivemetabolitemoderatelybound(73%to76%)toplasmaproteins.

Inhealthysubjects,plasmadistributionhalf-livesofloratadineanditsactivemetaboliteareapproximately1and2

hours,respectively.Themeaneliminationhalf-livesinhealthyadultssubjectswere8.4hours(range=3to20hours)for

loratadineand28hours(range=8.8to92hours)forthemajoractivemetabolite.

Approximately40%ofthedoseisexcretedinurineand42%inthefaecesovera10dayperiodandmainlyintheform

ofconjugatedmetabolites.Approximately27%ofthedoseiseliminatedintheurineduringthefirst24hours.Less

than1%oftheactivesubstanceisexcretedunchangedinactiveform,asloratadineorDL.

Thebioavailabilityparametersofloratadineandoftheactivemetabolitearedoseproportional.

Thepharmacokineticprofileofloratadineanditsmetabolitesiscomparableinhealthyadultvolunteersandinhealthy

geriatricvolunteers.

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Inpatientswithchronicrenalimpairment,boththeAUCandpeakplasmalevels(C

)increasedforloratadineandits

metaboliteascomparedtotheAUCsandpeakplasmalevels(C

)ofpatientswithnormalrenalfunction.Themean

eliminationhalf-livesofloratadineanditsmetabolitewerenotsignificantlydifferentfromthatobservedinnormal

subjects.Haemodialysisdoesnothaveaneffectonthepharmacokineticsofloratadineoritsactivemetabolitein

subjectswithchronicrenalimpairment.

Inpatientswithchronicalcoholicliverdisease,theAUCandpeakplasmalevels(C

)ofloratadineweredouble

whilethepharmacokineticprofileoftheactivemetabolitewasnotsignificantlychangedfromthatinpatientswith

normalliverfunction.Theeliminationhalf-livesforloratadineanditsmetabolitewere24hoursand37hours,

respectively,andincreasedwithincreasingseverityofliverdisease.

Loratadineanditsactivemetaboliteareexcretedinthebreastmilkoflactatingwomen.

5.3Preclinicalsafetydata

Preclinicaldatarevealnospecialhazardbasedonconventionalstudiesofsafety,pharmacology,repeateddosetoxicity,

genotoxicityandcarcinogenicpotential.

Inreproductivetoxicitystudies,noteratogeniceffectswereobserved.However,prolongedparturitionandreduced

viabilityofoffspringwereobservedinratsatplasmalevels(AUC)10timeshigherthanthoseachievedwithclinical

doses.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

LactoseMonohydrate

MaizeStarch

MagnesiumStearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

Blisterstripcomprising20µmaluminiumfoilwithavinylheatcoatinganda250µmclear,transparent

polyvinylchloridefilm.

Packsizesof2,5,7,10,14,15,20,21,28,30,50,60or100tablets.

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6.6Specialprecautionsfordisposal

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

MerckSharp&DohmeIreland(HumanHealth)Limited

PelhamHouse

SouthCountyBusinessPark

Leopardstown

Dublin18

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1286/32/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18 th

November1988

Dateoflastrenewal:8 th

November2007

10DATEOFREVISIONOFTHETEXT

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