CATAPRES TABLETS 300 MICROGRAMS. 0.3 Milligram Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CLONIDINE HYDROCHLORIDE
Available from:
Boehringer Ingelheim Limited
INN (International Name):
CLONIDINE HYDROCHLORIDE
Dosage:
0.3 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization number:
PA0007/014/002
Authorization date:
2013-02-27

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CatapresTablets300micrograms

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontainsclonidinehydrochloride300micrograms.

Forexcipientssee6.1.

3PHARMACEUTICALFORM

Tablet

White,round,flat,bevel-edgedtabletsimpressedwiththemotif03CononesideandtheBoehringerIngelheim

symbolonthereverse. 03C

4CLINICALPARTICULARS

4.1TherapeuticIndications

Cataprestabletsareindicatedforthetreatmentofhypertensionthathasfailedtorespondadequatelytootheranti-

hypertensives.

4.2Posologyandmethodofadministration

Adultsonly:

Theusualinitialdosageis0.05to0.10mgthreetimesdailywithsubsequentgradualincrementstothelevelofoptimal

controlgenerallyinthedailydoserangeof0.3to1.2mgindivideddosesalthoughhigherlevelsmayberequired.

Shouldclonidinebeaddedtootheranti-hypertensivetherapydosageofthelattershouldbegraduallyreducedasthe

clonidineisintroduced.

PatientsundergoinganaesthesiashouldcontinuetheirCataprestreatmentbefore,duringandafteranaesthesiausingoral

orintravenousadministrationaccordingtoindividualcircumstances.

PaediatricPopulation:

Thereisinsufficientevidencefortheapplicationofclonidineinchildrenandadolescentsyoungerthan18years.

Thereforetheuseofclonidineisnotrecommendedinpaediatricsubjectsunder18years.

4.3Contraindications

Catapresshouldnotbeusedinchildren(pleaserefertosection4.4SpecialWarningsandPrecautionsforUse)orin

patientswithknownhypersensitivitytotheactiveingredientorothercomponentsoftheproductandinpatientswith

severebradyarrhythmiaresultingfromeithersicksinussyndromeorAVblockof2ndor3rddegree.

Incaseofrarehereditaryconditionsthatmaybeincompatiblewithanexcipientoftheproduct(pleaserefertoSection

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4.4Specialwarningsandprecautionsforuse

Clonidineshouldonlybeusedwithcautioninpatientswithdepressionorahistorythereof,withRaynaud’sdisease,or

otherperipheralvascularocclusivedisease.Theproductshouldonlybeusedwithcautioninpatientswith

cerebrovascularorcoronaryinsufficiency.Catapresshouldalsobeusedwithcautioninpatientswithmildtomoderate

bradyarrhythmiasuchaslowsinusrhythm,andwithpolyneuropathyorconstipation.

Aswithotherantihypertensivedrugs,treatmentwithCatapresshouldbemonitoredparticularlycarefullyinpatients

withheartfailure.

InhypertensioncausedbyphaeochromocytomanotherapeuticeffectofCataprescanbeexpected.

Clonidine,theactiveingredientofCatapres,anditsmetabolitesareextensivelyexcretedintheurine.Dosagemustbe

adjustedaccordingtotheindividualantihypertensiveresponse,whichcanshowhighvariabilityinpatientswithrenal

insufficiency;carefulmonitoringisrequired.Sinceonlyaminimalamountofclonidineisremovedduringroutine

haemodialysis,thereisnoneedtogivesupplementalclonidinefollowingdialysis.

Suddenwithdrawalofclonidineshouldbeavoidedbecauseofpossiblereboundhypertension.Casesofagitation,

restlessness,palpitations,nervousness,tremor,headacheandabdominalsymptomshavealsobeenreported.Patients

shouldbeinstructednottodiscontinuetherapywithoutconsultingtheirphysician.Whendiscontinuingtherapythe

physicianshouldreducethedosegradually.However,ifwithdrawalsymptomsshouldneverthelessoccur,thesecan

usuallybetreatedwithreintroductionofclonidineorwithalphaandbetaadrenoceptorblockingagents.

Iflong-termtreatmentwithabeta-receptorblockerhastobeinterruptedthenthebeta-receptorblockershouldfirstbe

phasedoutgradually,followedbygradualwithdrawalofclonidine.

PatientswhowearcontactlensesshouldbewarnedthattreatmentwithCatapresmaycausedecreasedlacrimination.

Theuseandthesafetyofclonidineinchildrenandadolescentshaslittlesupportingevidenceinrandomizedcontrolled

trialsandthereforecannotberecommendedforuseinthispopulation.

Inparticular,whenclonidineisusedoff-labelconcomitantlywithmethylphenidateinchildrenwithADHD,serious

adversereactions,includingdeath,havebeenobserved.Therefore,clonidineinthiscombinationisnotrecommended.

Thisproductcontains72.1mgoflactosepertablet.Patientswithrarehereditaryproblemsofgalactoseintolerance,the

Lapplactasedeficiencyorglucose-galactosemalabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thereductioninbloodpressureinducedbyclonidinecanbefurtherpotentiatedbyconcurrentadministrationofother

hypotensiveagents.Thiscanbeoftherapeuticuseinthecaseofotherantihypertensiveagentssuchasdiuretics,

vasodilators,beta-receptorblockers,calciumantagonistsandACE-inhibitors,buttheeffectofalpha

-blockersis

unpredictable.

Theantihypertensiveeffectofclonidinemaybereducedorabolishedandorthostatichypotensionmaybeprovokedor

aggravatedbyconcomitantadministrationoftricyclicantidepressantsorneurolepticswithalpha-receptorblocking

properties.

Substanceswhichraisebloodpressureorinduceasodiumion(Na +

)andwaterretainingeffectsuchasnon-steroidal

anti-inflammatoryagentscanreducethetherapeuticeffectofclonidine.

Substanceswithalpha

-receptorblockingproperties,suchasmirtazapine,mayabolishthealpha

-receptormediated

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Concomitantadministrationofsubstanceswithanegativechronotropicordromotropiceffectsuchasbeta-receptor

blockersordigitalisglycosidescancauseorpotentiatebradycardicrhythmdisturbances.

Itcannotberuledoutthatconcomitantadministrationofabeta-receptorblockerwillcauseorpotentiateperipheral

vasculardisorders.

Basedonobservationsinpatientsinastateofalcoholicdeliriumithasbeensuggestedthathighintravenousdosesof

clonidinemayincreasethearrhythmogenicpotential(QT-prolongation,ventricularfibrillation)ofhighintravenous

dosesofhaloperidol.Causalrelationshipandrelevanceforantihypertensivetreatmenthavenotbeenestablished.

Theconcomitantuseofothercentralnervoussystemdepressantswillincreasethedepressanteffectofthedrug.

4.6Fertility,pregnancyandlactation

Thisproductshouldonlybeusedinpregnancyifconsideredessentialbythephysician.Carefulmonitoringofmother

andchildisrecommended.

Clonidinepassestheplacentalbarrierandmaylowertheheartrateofthefoetus.Postpartumatransientriseinblood

pressureinthenew-borncannotbeexcluded.

DuringpregnancytheoralformsofCatapresshouldbepreferred.Intravenousinjectionofclonidineshouldbeavoided.

Thereisnoadequateexperienceregardingthelong-termeffectsofprenatalexposure.

TheuseofCatapresduringlactationisnotrecommendedduetoalackofsupportinginformation.

4.7Effectsonabilitytodriveandusemachines

Thisproductmaycausedrowsiness.Patientsreceivingitshouldnotdriveoroperatemachineryunlessithasbeen

shownnottoaffectphysicalormentalability.

4.8Undesirableeffects

Mostadverseeffectsaremildandtendtodiminishwithcontinuedtherapy.

Adverseeventshavebeenrankedunderheadingsoffrequencyusingthefollowingconvention:

Verycommon 1/10

Common 1/100,<1/10

Uncommon 1/1000,<100

Rare 1/10000,<1/1000

Veryrare <1/10000

Notknown Cannotbeestimatedfromtheavailabledata

Endocrinedisorders:

Gynaecomastia rare

Psychiatricdisorders:

Confusionalstate notknown

Delusionalperception uncommon

Depression common

Hallucination uncommon

Libidodecreased notknown

Nightmare uncommon

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Fluidretentionoccursoccasionally.Twocasesofhepatitishavealsobeenreported.

4.9Overdose

Symptoms:

Manifestationsofintoxicationareduetoageneralisedsympatheticdepressionandincludepupillaryconstriction,

lethargy,bradycardia,hypotension,hypothermia,somnolenceincludingcomaandrespiratorydepressionincluding

apnoea.Paradoxicalhypertensioncausedbystimulationofperipheralalpha

-receptorsmayoccur.Transient

Nervoussystemdisorders:

Dizziness verycommon

Headache common

Paraesthesia uncommon

Sedation verycommon

Eyedisorders:

Accommodationdisorder notknown

Lacrimationdecreased rare

Cardiacdisorders:

Atrioventricularblock rare

Bradyarrhythmia notknown

Sinusbradycardia uncommon

Vasculardisorders:

Orthostatichypotension verycommon

Raynaud’sphenomenon uncommon

Respiratory,thoracicandmediastinaldisorders:

Nasaldryness rare

Gastrointestinaldisorders:

Colonicpseudo-obstruction rare

Constipation common

Drymouth verycommon

Nausea common

Salivaryglandpain common

Vomiting common

Skinandsubcutaneoustissuedisorders:

Alopecia rare

Pruritus uncommon

Rash uncommon

Urticaria uncommon

Reproductivesystemandbreastdisorders:

Erectiledysfunction common

Generaldisordersandadministrationsiteconditions:

Fatigue common

Malaise uncommon

Investigations:

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Treatment:

Gastriclavageshouldbeperformedwhereappropriate.Inmostcasesallthatisrequiredaregeneralsupportive

measures.Wherebradycardiaissevereatropinewillincreasetheheartrate.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Clonidineactsprimarilyonthecentralnervoussystem,resultinginreducedsympatheticoutflowandadecreasein

peripheralresistance,renalvascularresistance,heartrateandbloodpressure.Renalbloodflowandglomerular

filtrationrateremainessentiallyunchanged.Normalposturalreflexesareintactandthereforeorthostaticsymptomsare

mildandinfrequent.Duringlongtermtherapy,cardiacoutputtendstoreturntocontrolvalues,whileperipheral

resistanceremainsdecreased.Slowingofthepulseratehasbeenobservedinmostpatientsgivenclonidine,butthe

drugdoesnotalternormalhaemodynamicresponsetoexercise.

Theefficacyofclonidineinthetreatmentofhypertensionhasbeeninvestigatedinfiveclinicalstudiesinpaediatric

patients.Theefficacydataconfirmsthepropertiesofclonidineinreductionofsystolicanddiastolicbloodpressure.

However,duetolimiteddataandmethodologicalinsufficiencies,nodefinitiveconclusioncanbedrawnontheuseof

clonidineforhypertensivechildren.

TheefficacyofclonidinehasalsobeeninvestigatedinafewclinicalstudieswithpaediatricpatientswithADHD,

Tourettesyndromeandstuttering.Theefficacyofclonidineintheseconditionshasnotbeendemonstrated.

Therewerealsotwosmallpaediatricstudiesinmigraine,neitherofwhichdemonstratedefficacy.Inthepaediatric

studiesthemostfrequentadverseeventsweredrowsiness,drymouth,headache,dizzinessandinsomnia.Theseadverse

eventsmighthaveseriousimpactondailyfunctioninginpaediatricpatients.

Overall,thesafetyandefficacyofclonidineinchildrenandadolescentshavenotbeenestablished(seesection4.2).

5.2Pharmacokineticproperties

Thepharmacokineticsofclonidineisdose-proportionalintherangeof100-600micrograms.Clonidine,theactive

ingredientofCatapres,iswellabsorbedandnofirstpasseffectexists.Peakplasmaconcentrationsarereachedwithin

1-3hafteroraladministration.Clonidineisrapidlyandextensivelydistributedintotissuesandcrossestheblood-brain

barrieraswellastheplacentalbarrier.Theplasmaproteinbindingis30-40%.

Themeanplasmahalf-lifeofclonidineisabout13hoursrangingbetween10and20hours.Itcanbeprolongedin

patientswithseverelyimpairedrenalfunctionupto41hours.

About70%ofthedoseadministeredisexcretedwiththeurinemainlyintheformofunchangedparentdrug(40-60%

ofthedose).Themainmetabolitep-hydroxy-clonidineispharmacologicallyinactive.Approximately20%ofthetotal

amountisexcretedwiththefaeces.Thepharmacokineticsofclonidinearenotinfluencedbyfoodnorbytheraceofthe

patient.

Theantihypertensiveeffectisreachedatplasmaconcentrationsbetweenabout0.2and1.5ng/mlinpatientswith

normalexcretoryfunction.Afurtherriseintheplasmalevelswillnotenhancetheantihypertensiveeffect.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Calciumhydrogenphosphate(anhydrous)

Maizestarch

Colloidalsilica(anhydrous)

Povidone

Solublestarch

Stearicacid

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

Keeptheblistersintheoutercarton.

6.5Natureandcontentsofcontainer

OpaquePVC250µm/PVDC40g/m 2

blisterswithaluminiumliddingfoil20µmcontaining100tablets.

Notallpacksizesaremarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

BoehringerIngelheimLimited

EllesfieldAvenue

Bracknell

BerkshireRG128YS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1979

Dateoflastrenewal:01November2005

10DATEOFREVISIONOFTHETEXT

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Date Printed 24/02/2012 CRN 2081080 page number: 7

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