CLARITYN RAPIDE

Main information

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

Documents

Localization

  • Available in:
  • CLARITYN RAPIDE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0277/053/003
  • Authorization date:
  • 26-11-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Clarityn 10mg RapideTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each orallyophilisatecontains10 mg loratadine.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

OralLyophilisate.

Round, whitetablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Clarityn RapideTabletsareindicated forthesymptomatictreatmentofallergicrhinitisand chronicidiopathic

urticaria.

4.2Posologyandmethodofadminstration

Adultsand children 12 yearsofageand over:

10mg oncedaily (oneorallyophilisateoncedaily).

Theorallyophilisatemaybetaken withoutregard to mealtime.

Children under2 to 12 yearsofagewith:

Bodyweightmorethan 30kg:10mg oncedaily (oneorallyophilisateoncedaily).

The10mg strength orallyophilisateisnotappropriateforchildren with abodyweightlessthan 30kg.

Efficacy and safety ofClarityn RapideTabletsin children under2 yearsofagehasnotbeen established.

Patientswith severeliverimpairmentshould beadministered alowerinitialdosebecausethey may havereduced

clearanceofloratadine.An initialdoseof10mg every otherday isrecommended foradultsand children weighing

morethan 30kg.

No dosageadjustmentsarerequired in theelderly orin patientswith renalinsufficiency.

4.3Contraindications

Clarityn RapideTabletsarecontraindicated inpatientswho arehypersensitiveto theactivesubstanceorto any of

theexcipientsin theseformulations.

4.4Special warningsandprecautionsforuse

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Theadministration ofClarityn RapideTabletsshould bediscontinued atleast48 hoursbeforeskin testssince

antihistaminesmay preventorreduceotherwisepositivereactionsto dermalreactivity index.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

When administered concurrently with alcohol, Clarityn RapideTabletshaveno potentiating effectsasmeasured by

psychomotorperformancestudies.

Dueto thewidetherapeuticindex ofloratadineno clinically relevantinteractionsareexpected and nonewere

observed in theconducted clinicaltrials(see5.2).

4.6Pregnancyandlactation

Loratadinewasnotteratogenicin animalstudies.Thesafeuseofloratadineduring pregnancy hasnotbeen

established.TheuseofClaritynRapideTabletsduring pregnancy isthereforenotrecommended.

Loratadineisexcreted in breastmilk, thereforetheuseofloratadineisnotrecommended in breast-feeding women.

4.7Effectsonabilitytodriveandusemachines

In clinicaltrialsthatassessed driving ability, no impairmentoccurred inpatientsreceiving loratadine.However,

patientsshould beinformedthatvery rarely somepeopleexperiencedrowsiness, which may affecttheirability to

driveorusemachines.

4.8Undesirableeffects

In clinicaltrialsin apaediatricpopulation children aged 2 through 12years, common adversereactionsreported in

excessofplacebo wereheadache(2.7%), nervousness(2.3%)and fatigue(1%).

In clinicaltrialsinvolving adultsand adolescentsin arangeofindicationsincluding ARand CIU, atthe

recommended doseof10mg daily, adversereactionswith loratadinewerereported in 2%ofpatientsin excessof

thosetreated with placebo.Themostfrequentadversereactionsreported in excessofplacebo weresomnolence

(1.2%), headache(0.6%), increased appetite(0.5%)and insomnia(0.1%).Otheradversereactionsreported very

rarely during thepost-marketing period arelisted in thefollowing table.

4.9Overdose

Overdosagewith loratadineincreased theoccurrenceofanticholinergicsymptoms.Somnolence, tachycardiaand

headachehavebeen reported with overdoses.

In theeventofoverdosage,treatment, which should bestarted immediately, isgeneralsymptomaticand supportive.

Immunedisorders Anaphylaxis

Nervoussystemdisorders Dizziness

Cardiacdisorders Tachycardia, palpitation

Gastrointestinaldisorders Nausea, dry mouth, gastritis

Hepato-biliary disorders Abnormalhepaticfunction

Skin and subcutaneoustissuedisorders Rash, alopecia

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Administration ofactivatedcharcoalasaslurry with watermay beattempted.Gastriclavageshould be

considered.Loratadineisnotremoved by haemodialysisand itisnotknown ifloratadineisremoved by peritoneal

dialysis. Medicalmonitoring ofthepatientisto becontinued afteremergency treatment.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:antihistamines–H

antagonist, ATCcode:R06AX13

Loratadine, theactiveingredientin Clarityn RapideTablets, isatricyclicantihistaminewith selective, peripheral

-receptoractivity.

Loratadinehasno clinically significantsedativeoranticholinergicpropertiesin themajority ofthepopulation and

when used attherecommended dosage.

During long-termtreatmenttherewereno clinically significantchangesin vitalsigns, laboratory testvalues,

physicalexaminationsorelectrocardiograms.

Loratadinehasno significantH

-receptoractivity, doesnotinhibitnorepinephrineuptakeand haspractically no

influenceon cardiovascularfunction oron intrinsiccardiacpacemakeractivity.

5.2Pharmacokineticproperties

Afteroraladministration, loratadineisrapidly and wellabsorbed, and undergoesextensivefirstpassmetabolism,

mainly by CYP3A4 and CYP2D6. Themajormetabolite-desloratadine(DL)-ispharmacologically activeand

responsibleforalargepartoftheclinicaleffect.Loratadineand DLachievemaximumplasmaconcentrations

)between 1-1.5 hoursand 1.5-3.7 hoursafteradministration, repectively.

Increasein plasmaconcentrationsofloratadinehasbeen reported afterconcomitantusewith ketoconazole,

erythromycin and cimetidinein controlled trials, butwithoutclinically significantchanges(including

electrodiographic).

Loratadineishighly bound (97%to 99%)and itsactivemetabolitemoderately bound (73%to 76%)to plasma

proteins.

In healthy subjects, plasmadistribution half-livesofloratadineand itsactivemetaboliteareapproximately 1 and 2

hours, respectively.Themean elimination half-livesin healthy adultssubjectswere8.4 hours(range=3 to 20

hours)forloratadineand 28 hours(range=8.8 to 92 hours)forthemajoractivemetabolite.

Approximately 40%ofthedoseisexcreted in urineand 42%in thefaecesovera10 day period and mainly in the

formofconjugated metabolites.Approximately 27%ofthedoseiseliminated in theurineduring thefirst24

hours.Lessthan 1%oftheactivesubstanceisexcreted unchanged in activeform, asloratadineorDL.

Thebioavailability parametersofloratadineand oftheactivemetabolitearedoseproportional.

Thepharmacokineticprofileofloratadineand itsmetabolitesiscomparableinhealthy adultvolunteersand in healthy

geriatricvolunteers.

Concomitantingestion offood can delay slightly theabsorption ofloratadinebutwithoutinfluencing theclinical

effect.

In patientswith chronicrenalimpairment, both theAUCand peak plasmalevels(C

)increased forloratadine

and itsmetaboliteascompared to theAUCsand peak plasmalevels(C

)ofpatientswith normalrenalfunction.

Themean elimination half-livesofloratadineand itsmetabolitewerenotsignificantly differentfromthatobserved

in normalsubjects.Haemodialysisdoesnothavean effecton thepharmacokineticsofloratadineoritsactive

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In patientswith chronicalcoholicliverdisease, theAUCand peak plasmalevels(C

)ofloratadineweredouble

whilethepharmacokineticprofileof

Theactivemetabolitewasnotsignificantly changed fromthatin patientswith normalliverfunction.The

elimination half-livesforloratadineand itsmetabolitewere24 hoursand 37 hours, respectively, and increased with

increasing severity ofliverdisease.

Loratadineand itsactivemetaboliteareexcreted in thebreastmilk oflactating women.

5.3Preclinical safetydata

Preclinicaldatarevealno specialhazard based on conventionalstudiesofsafety, pharmacology, repeated dose

toxicity, genotoxicity and carcinogenicpotential.

In reproductivetoxicity studies, no teratogeniceffectswereobserved.However, prolonged parturition and reduced

viability ofoffspring wereobserved in ratsatplasmalevels(AUC)10 timeshigherthan thoseachieved with

clinicaldoses.

No evidenceofmucousmembraneirritation wasobserved afterdaily administration ofup to 12 tablets(120mg)of

orallyophilisatesinto thehamstercheek pouch forfivedays.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Gelatin

Mannitol

AnhydrousCitricAcid

MintFlavour

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

24 monthsoverall.Thepack should beused within 6 monthsoffirstuse.

6.4Special precautionsforstorage

Do notstoreabove25°C.Storein theoriginalpackage.

6.5Natureandcontentsofcontainer

Blisterstripscontaining 10 tabletscontained in an outercard carton.

Pack sizesof30 tablets.

6.6Instructionsforuseandhandling

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7MARKETINGAUTHORISATIONHOLDER

Schering-Plough Ltd

ShirePark

Welwyn Garden City

HertfordshireAL7 1TW

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

PA277/53/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26 th

November1999

Dateoflastrenewal:19 th

August2002

10DATEOFREVISIONOFTHETEXT

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