CLAREEZE ALLERGY 10 MG TABLETS

Main information

  • Trade name:
  • CLAREEZE ALLERGY 10 MG TABLETS
  • Dosage:
  • 10 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLAREEZE ALLERGY 10 MG TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1427/003/001
  • Authorization date:
  • 19-10-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ClareezeAllergy10mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains10mgLoratadine.

Alsocontains75mglactosemonohydrate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet.

Whiteoralmostwhite,8mmround,flattablets,withabreakline.

Thebreaklineisonlytofacilitatebreakingforeaseofswallowingandnottodivideintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ClareezeAllergy10mgTabletsisindicatedforthesymptomatictreatmentofallergicrhinitisandchronicidiopathic

urticaria.

4.2Posologyandmethodofadministration

4.2.1 Dosage

OralUse.Thetabletmaybetakenwithoutregardtomealtime.

Adults:10mgoncedaily(onetabletoncedaily)

Children:6yearsandabove:10mgoncedaily(onetabletoncedaily)

Donotgivetochildrenunder6yearsandanychild(olderthan6years)whoweighlessthan30kg.

Patientswithsevereliverimpairmentshouldbeadministeredalowerinitialdosebecausetheymayhavereduced

clearanceofLoratadine.Aninitialdoseof10mgeveryotherdayisrecommendedforadultsandchildrenweighing

morethan30kg.

Nodosageadjustmentsarerequiredintheelderlyorinpatientswithrenalinsufficiency.

4.3Contraindications

ClareezeAllergy10mgTabletsiscontraindicatedinpatientswhoarehypersensitivetotheactivesubstanceortoanyof

theexcipientsinthisformulation

4.4Specialwarningsandprecautionsforuse

ClareezeAllergy10mgTabletsshouldbeadministeredwithcautioninpatientswithsevereliverimpairment(see

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TheadministrationofClareezeAllergy10mgTabletsshouldbediscontinuedatleast48hoursbeforeskintestssince

antihistaminesmaypreventorreduceotherwisepositivereactionstodermalreactivityindex.

Thismedicinalproductcontainslactose:thuspatientswithrarehereditaryproblemsofgalactoseintolerance,theLapp

lactasedeficiencyorglucose-galactosemalabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Whenadministeredconcomitantlywithalcohol,ClareezeAllergy10mgTabletshasnopotentiatingeffectsasmeasured

bypsychomotorperformancestudies.

DuetothewidetherapeuticindexofLoratadinenoclinicallyrelevantinteractionsareexpectedandnonewere

observedintheconductedclinicaltrials(seesection5.2,Pharmacokineticproperties).

4.6Fertility,pregnancyandlactation

Loratadinewasnotteratogenicinanimalstudies.ThesafeuseofLoratadineduringpregnancyhasnotbeen

established.TheuseofClareezeAllergy10mgTabletsduringpregnancyisthereforenotrecommended.

Loratadineisexcretedinbreastmilk,thereforetheuseofLoratadineisnotrecommendedinbreast-feedingwomen.

4.7Effectsonabilitytodriveandusemachines

Inclinicaltrialsthatassesseddrivingability,noimpairmentoccurredinpatientsreceivingLoratadine.However,

patientsshouldbeinformedthatveryrarelysomepeopleexperiencedrowsiness,whichmayaffecttheirabilitytodrive

orusemachines.

4.8Undesirableeffects

Inclinicaltrialsinapaediatricpopulationchildrenaged2through12years,commonadversereactionsinexcessof

placebowereheadache(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

OverdosewithLoratadineincreasedtheoccurrenceofanticholinergicsymptoms.Somnolence,tachycardia,and

headachehavebeenreportedwithoverdoses.

Immunedisorders Anaphylaxis

Nervoussystemdisorders Dizziness

Cardiacdisorders Tachycardia,palpitation

Gastrintestinaldisorders Nausea,drymouth,gastritis

Hepato-biliarydisorders Abnormalhepaticfunction

Skinandsubcutaneoustissue

disorders Rash,alopecia

Generaldisordersand

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asnecessary.Administrationofactivatedcharcoalasaslurrywithwatermaybeattempted.Gastriclavagemaybe

considered.LoratadineisnotremovedbyhaemodialysisanditisnotknownifLoratadineisremovedbyperitoneal

dialysis.Medicalmonitoringofthepatientistobecontinuedafteremergencytreatment.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:antihistamines–H

antagonist,ATCcode:R06AX13.

Loratadine,theactiveingredientinClareezeAllergy10mgTablets,isatricyclicantihistaminewithselective,

peripheralH

-receptoractivity.

Loratadinehasnoclinicallysignificantsedativeoranticholinergicpropertiesinthemajorityofthepopulationand

whenusedattherecommendeddosage.

Duringlong-termtreatmenttherewerenoclinicallysignificantchangesinvitalsigns,laboratorytestvalues,physical

examinationsorelectrocardiograms.

LoratadinehasnosignificantH

-receptoractivity.Itdoesnotinhibitnorepinephrineuptakeandhaspracticallyno

influenceoncardiovascularfunctionoronintrinsiccardiacpacemakeractivity.

5.2Pharmacokineticproperties

Afteroraladministration,Loratadineisrapidlyandwellabsorbedandundergoesanextensivefirstpassmetabolism,

mainlybyCYP3A4andCYP2D6.Themajormetabolite-desloratadine(DL)-ispharmacologicallyactiveand

responsibleforalargepartoftheclinicaleffect.LoratadineandDLachievemaximumplasmaconcentrations(T

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

IncreaseinplasmaconcentrationsofLoratadinehasbeenreportedafterconcomitantusewithketoconazole,

erythromycin,andcimetidineincontrolledtrials,butwithoutclinicallysignificantchanges(including

electrocardiographic).

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

Inhealthysubjects,plasmadistributionhalf-livesofLoratadineanditsactivemetaboliteareapproximately1and2

hours,respectively.Themeaneliminationhalf-livesinhealthyadultsubjectswere8.4hours(range3to20hours)for

Loratadineand28hours(range8.8to9.2hours)forthemajoractivemetabolite.

Approximately40%ofthedoseisexcretedintheurineand42%inthefaecesovera10dayperiodandmainlyinthe

formofconjugatedmetabolites.Approximately27%ofthedoseiseliminatedintheurineduringthefirst24hours.

Lessthan1%oftheactivesubstanceisexcretedunchangedinactiveform,asloratadineorDL.

ThebioavailabilityparametersofLoratadineandoftheactivemetabolitearedoseproportional.

ThepharmacokineticprofileofLoratadineanditsmetabolitesiscomparableinhealthyadultvolunteersandinhealthy

geriatricvolunteers.

ConcomitantingestionoffoodcandelayslightlytheabsorptionofLoratadinebutwithoutinfluencingtheclinical

effect.

Inpatientswithchronicrenalimpairment,boththeAUCandpeakplasmalevels(C

)increasedforLoratadineand

itsmetaboliteascomparedtotheAUCsandpeakplasmalevels(C

)ofpatientswithnormalrenalfunction.The

meaneliminationhalf-livesofLoratadineanditsmetabolitewerenotsignificantlydifferentfromthatobservedin

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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.

Noevidenceofmucousmembraneirritationwasobservedafterdailyadministrationofupto12tablets(120mg)ororal

lyophilisatesintothehamstercheekpouchforfivedays.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Cellulose,microcrystalline

Maizestarch

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

Blisterpacksmadefrom20µmaluminiumfoiland250µmPVCpackedintoacardboardoutercontainer.

Packsizes:30Tablets

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

ÉireceuticaLtd

Unit2

BlockE

NutgroveBusinessPark

Dublin14

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1427/003/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24August2001

Dateoflastrenewal:24August2006

10DATEOFREVISIONOFTHETEXT

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