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:
  • PPA0465/049/001B
  • Authorization date:
  • 15-06-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Clarityn10mgTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachClarityntabletcontains10mgofloratadine.

Excipients:Lactose

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

ProductsourcedfromtheUK:

White,ovaloidtablets,plainononeside,withabreaklineontheotherside,withalogoabovethebreaklineand‘10’

belowthebreakline.

ProductsourcedfromGreece:

White,circularflatbevelededgedtablets,plainononeside,withabreaklineontheotherside,with‘10’abovethe

breaklineandalogbelowthebreakline.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Clarityntabletsareindicatedforthereliefofsymptomsassociatedwithallergicrhinitis,suchassneezing,nasal

dischargeanditchingandocularitchingandburning.Nasalandocularsignsandsymptomsarerelievedrapidlyafter

oraladministration.

Clarityntabletsarealsoindicatedforreliefofsymptomsandsignsofchronicurticariaandotherdermatologic

disorders.

4.2Posologyandmethodofadministration

Claritynisfororaladministration.Thetabletsshouldbetakenonanemptystomach.

AdultsandChildren12yearsandabove:onetablet(10mg)daily

Patientswithseverliverimpairment:onetablet(10mg)everyotherday

Childrenunder12:notrecommended

4.3Contraindications

Clarityntabletsarecontra-indicatedinpatientswhohaveshownhypersensitivityoridiosyncrasytoloratadineorany

othercomponent.

4.4Specialwarningsandprecautionsforuse

Specialprecautions:

Duringclinicalstudiestheincidenceofanticholinergicactivityassociatedwith10mgClarityntabletswas

comparabletothatassociatedwithplacebo.However,cautionshouldbeobservedinpatientswithprostatic

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Patientswithliverimpairmentshouldbegivenalowerinitialdosebecausetheyhavereducedclearanceof

loratadine(seesection5.2,PharmacokineticProperties).

PatientsalsotakinganyCNSdepressantsshouldbecarefullymonitored(Seesection4.5,Interactionwithother

medicinalproductsandotherformsofinteractions).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Whenadministeredconcurrentlywithalcohol(bloodlevel0.8g/l)ortherapeuticdosesofdiazepam,clinicalstudies

haveshownthatClarityntabletsandplaceboarecomparableintheireffectonpsychomotorperformance,i.e.no

potentiationisobserved.However,ingeneral,cautionshouldbetakenbypatientsreceivingCNSdepressantsuntilit

hasbeendemonstratednottoaffectperformance.

Claritynshouldbeco-administeredwithcautionwithdrugsknowntoinhibithepaticmetabolism,e.g.cimetidine,until

definitiveinteractionstudiescanbecompleted.

Antihistaminesshouldbediscontinuedaboutfourdayspriortoskintestingprocedures,sincethesedrugsmayprevent

ordiminishotherwisepositivereactionstodermalreactivityindicators.

ALCOHOL:Thereis,asyet,nodefinitiveproofthatpotentiationofthepossiblesedativeeffectsofloratadineoccurs

whentakenconcurrentlywithalcohol(seeabove).Neverthelessitisadvisablethatalcohol,asaCNSdepressant,

shouldnotbemixedinanysignificantquantitieswithClarityntablets.

4.6Fertility,pregnancyandlactation

Therewasnoevidenceofteratogenicityinstudiesperformedinanimals.Thereare,however,noadequateandwell-

controlledstudiesinpregnantwomen.Clarityntabletsshould,therefore,onlybeusedduringpregnancyifconsidered

essential.

Sinceloratadineanditsmetabolite(descarboethoxyloratadine)passeasilyintobreastmilk,ingeneral,adecision

shouldbemadewhethertodiscontinuenursingordiscontinuethedrug.CautionshouldbeexercisedwhenClarityn

tabletsareadministeredtoanursingwoman.

4.7Effectsonabilitytodriveandusemachines

Ingeneraloneofthemainside-effectsoftheantihistaminesissedation.Loratadineanditsmetabolites,however,do

notreadilycrosstheblood-brainbarrier(seesection5.2,PharmacokineticProperties)sothatsedativeeffectsarenot

expected.Rarely,though,casesofdrowsinessand/orsedationhavebeenreportedandinordertoprotectsensitive

individuals(includingtheelderlyandthosewithsignificantrenalorhepaticimpairment-seesection5.2,

PharmacokineticProperties)patientsshouldbeadvisedtotakecareaftertakingClaritynwhenfirstdrivingor

operatingmachinery.

4.8Undesirableeffects

Themainside-effectsusuallyassociatedwithantihistaminescanbetracedtotheirpenetrationoftheCNS(sedation)

andmildanticholinergicaction(various).However,loratadineanditsmetabolitesdonotreadilypenetratetheCNS.In

addition,duringcontrolledclinicalstudieswith10mgClarityntablettreatment,sedationandanticholinergicadverse

eventswerecomparabletothoseassociatedwithplacebo.Fatigue,nauseaandheadachewerereportedrarely.

Subsequentpostmarketingstudiesinvolvingover10,000patientshaveshownanincidenceofspontaneousreportsof

drowsinessand/orsedationoflessthan0.3%.

4.9Overdose

Intheeventofoverdose,generalsymptomaticandsupportivemeasuresshouldbeinstitutedpromptlyandmaintained

foraslongasnecessary.Treatmentofoverdosewouldreasonablyconsistofemesis(ipecacsyrup),exceptinpatients

withimpairedconsciousness,followedbytheadministrationofactivatedcharcoaltoabsorbanyremainingdrug.If

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mayalsobeofvalueforrapiddilutionofbowelcontents.Loratadineisnoteliminatedbyhaemodialysis.After

emergencytreatmentthepatientshouldcontinuetobeundermedicalsupervision.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Loratadineisalong-actingtricyclicantihistaminewithselectiveperipheralhistamineH-receptorantagonisticactivity.

5.2Pharmacokineticproperties

StudieshaveshownconsiderablevariationinthepharmacokineticsdataforClarityn,probablyduetotheextensive

first-passmetabolism.However,followingoraladministrationloratadineisrapidlyabsorbedandundergoesextensive

metabolismtodescarboethoxyloratadine(anactivemetabolite).Approximately80%ofthetotaldoseadministeredcan

befoundequallydistributedbetweenurineandfaecesintheformofmetabolicproductsafter10days.Studieshave

shownmeaneliminationhalf-livesare8.4hours(range3-20hours)forloratadineand28hours(range8.8-92hours)for

descarboethoxyloratadine.

Aftera10mgoraldosethedrugexhibitsandantihistaminiceffectbeginningwithin1-3hours,reachingamaximum8-

12hoursandlastinginexcessof24hours.Twenty-eightdaysofcontinuousdosingshowednobuildupoftoleranceto

thiseffect.Loratadine,dosedoncedaily,reachessteady-statebythefifthdose.

Thetimetopeakplasmaconcentrationofloratadineanddescarboethoxyloratadineisdelayedbyfoodsothatitis

preferablethatClarityntabletsbeadministeredonanemptystomach.

Instudiesinvolvinggeriatricpatientspeakplasmalevelsofloratadineanddescarboethoxyloratadineweresignificantly

higher(approx.50%increase).Theeliminationhalf-lifeofloratadinewassignificantlylongerbutthatforitsactive

metabolitereduced.

Patientswithchronicrenalimpairmentshowedpeakplasmalevelsofloratadineincreasedbyapprox.73%andthe

activemetabolitebyapprox.120%.Elimininationhalf-liveswerenotsignificantlychanged.Patientswithchronic

alcoholicliverdiseaseshoweddoublepeakplasmalevelsofloratadinebutthosefortheactivemetabolitewerenot

significantlychanged.Eliminationhalf-livesweresignificantlyincreased.

Loratadineisabout97%anddescarboethoxyloratadineis73-77%boundtoplasmaproteins.Animalstudieshave

shownthatneitherloratadineoritsmetabolitesreadilycrosstheblood-brainbarrier.Trialsgiving2-4timeshigher

dosesthanthatrecommended(10mg)haveshownadose-relatedincreaseintheincidenceofsomnolence.Therefore,

somepatients,particularlythosewithhepaticorrenalimpairmentandtheelderly,mayexperiencesomnolence.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactose

Maizestarch

Magnesiumstearate(E572)

6.2Incompatibilities

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6.3ShelfLife

Theshelf-lifeexpirydateforthisproductisthedateshownonthecontainerandouterpackageoftheproductas

marketedinthecountryoforigin.

6.4Specialprecautionsforstorage

Storebelow25ºC.

6.5Natureandcontentsofcontainer

Blistersof7,15,20,21or30tabletsinacardboardcarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PCOManufacturingLimited

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

Ireland

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA465/49/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:15June1998

Dateoflastrenewal:15June2008

10DATEOFREVISIONOFTHETEXT

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