ATECOR

Main information

  • Trade name:
  • ATECOR Film Coated Tablet 25 Milligram
  • Dosage:
  • 25 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ATECOR Film Coated Tablet 25 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1151/055/001
  • Authorization date:
  • 07-03-2008
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA1151/055/001

CaseNo:2069197

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ImbatLimited

UnitL2,NorthRingBusinessPark,Santry,Dublin9

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ATECOR,25Milligram

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom26/08/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 04/09/2009 CRN 2069197 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Atecor25mgFilm-CoatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains25mgAtenolol.

Excipients:lactose

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet

ProductimportedfromGermany:

White,round,biconvex,film-coatedtabletwithascorelineononefaceandplainonthereverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asabeta-adrenoceptorblockerAtecorisindicatedforthetreatmentofessentialhypertension,anginapectorisand

cardiacdysrhythmias.Atecorisalsoindicatedinearlyinterventionintheacutephaseofmyocardialinfarctionandfor

thelong-termprophylaxisafterrecoveryfrommyocardialinfarction.

4.2Posologyandmethodofadministration

RouteofAdministration:Oral.

RecommendedDosageSchedule:

Adults:

Hypertension:

Theusualdailydoseis50mgasasingledose.Thiscanbeincreasedto100mgdailyifrequiredforcontrolbutshould

onlybedoneaftertheeffectsoftheinitialdosehavebeenachieved(1to2weeks).Atenololmaybecombinedwitha

diureticifrequiredorotherantihypertensiveagents.

Angina:

Theusualdailydoseis100mggivenorallyoncedailyor50mggiventwicedaily.

Dysrhythmias:

Formaintenancecontroltheusualdailydoseis50–100mgtwicedaily.

MyocardialInfarction:

Wherebeta-blockadeisappropriateforpatientspresentinglaterafterinfarction,Atenolol100mgdailymaybe

givenforlongtermprophylaxis.

Elderly:

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Children:

ThereisnopaediatricexperiencewithAtecorandforthisreasonitisnotrecommendedforuseinchildren.

Renalfailure:

Atenololisexcretedviathekidneysandthereforedosageshouldbeadjustedincasesofsevereimpairmentofrenal

function.

Nosignificantaccumulationofatenololoccursinpatientswhohaveacreatinineclearancegreaterthan

35ml/min/1.73m(normalrangeisbetween100-150ml./min/1.73m).Forpatientswithacreatinineof15-

35ml/min/1.73m(equivalenttoserumcreatinineof300-600micromol/litre)theintravenousdoseshouldbe10mgonce

everytwodaysandtheoraldoseshouldbe50mgdaily.Forpatientswithacreatinineclearanceof<15ml/min/1.73m

(equivalenttoaserumcreatinineof>600micromol/litre)theintravenousdoseshouldbe25mgdaily

or50mgonalternatedays.Patientsonhaemodialysisshouldbegiven50mgorallyaftereachdialysis:thisshouldbe

doneunderhospitalsupervisionasmarkedfallsinbloodpressurecanoccur.

4.3Contraindications

Atecoriscontra-indicatedinpatientswithseconddegreeorthirddegreeatrioventricularblock.

Atecorshouldnotbeusedifthereisseverebradycardia.Atecorshouldnotbeusedinuncontrolledordigitalis/diuretic

refractoryheartfailureorincardiogenicshockormetabolicacidosis.

Atecorshouldnotbeusedinpatientswithaknownhypersensitivitytotheactivesubstanceoranyexcipients.

4.4Specialwarningsandprecautionsforuse

Suddenwithdrawalofbeta-adrenoceptorblockingagentsinpatientswithischaemicheartdiseasemayresultinthe

appearanceofanginalattacksofincreasedfrequencyorseverityordeteriorationincardiacstate.Discontinuationof

therapyshouldbegradual.Thebeta-blockershouldonlybeusedwithcautioninpatientswithcontrolledcongestive

cardiacfailureorwithafamilyhistoryofasthma.Evidenceofrecrudescenceofeitherconditionshouldberegardedas

asignaltodiscontinuetherapy.

Thebeta-blockercanbeadministeredtopatientswithobstructiverespiratorydisordersprovidedthatadequate

supervisionismaintainedtopermitanynecessaryadjustmentofdosageofthebronchodilatoremployed.Ifincreased

airwaysresistancedevelopsconsiderationmustbegiventodiscontinuationofthebeta-blocker,dependingonthe

degreeofairwaysresistanceandthebenefitderivedfrombeta-blockade.

Theinitialtreatmentofseveremalignanthypertensionshouldbesodesignedastoavoidsuddenreductionindiastolic

bloodpressurewithimpairmentofautoregulatorymechanisms.

Whenthisagentisadministeredtopatientsinrenalfailuretheintervalbetweendosesmayneedtobeincreasedorthe

dosagereducedtoavoidaccumulationofthedrug.

Somecasesofocularchanges(conjunctivitisand‘dryeye’)and/orskinrashes(includingapsoriasiformtype)have

beenreportedinassociationwiththeuseofbeta-adrenoceptorblockers.Untiltheirsignificanceisknownitis

recommendedthatconsiderationbegiventodiscontinuingsuchtherapyiftheseeffectsappear.

Usewithcautionindiabetesmellitusassymptomsofhypoglycaemiacouldbemasked.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorption,shouldnottakethismedicine.

Atenololshouldnotbegiventopatientswithpheochromocytomawithoutconcomitantalpha-adrenoreceptorblocking

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Intheeventthatapatientreceivingthebeta-blockerrequiresanaesthesiatheanaesthetistshouldbeinformedoftheuse

ofthemedicationpriortotheuseofageneralanaesthetictopermithistakingthenecessaryprecautions.

Thebeta-blockershouldonlybeusedwithgreatcautioninpatientswhoarereceivingconcomitantmyocardial

depressantssuchaschloroform,lignocaine,procainamide,beta-adrenoceptorstimulantssuchasisoprenaline,or

calciumantagonistssuchasverapamil,nifedipineanddiltiazem.Thesimultaneoususeofcalciumchannelblockers

mayresultinhypotension,bradycardiaandcardiacfailure.Alpha-adrenoceptorstimulantssuchasnoradrenaline,may

counteracttheeffectofthebeta-blocker.

Adrenergic-neuroneblockingagentssuchasguanethidine,reserpine,diureticsandotherantihypertensiveagents,

includingthevasodilatorgroup,willhaveanadditiveeffectonthehypotensiveactionofthedrug.

Thebeta-blockermaymasksomeofthesymptomsofthyrotoxicosisandofhypoglycaemiabyinhibitionof

sympatheticnervefunctions.Theeffectsofhypoglycaemicagentsmaybeincreased,particularlybythe

noncardioselectivebetablockers.Thetachycardiaofhypoglycaemiamaybemodified.

Ifthebeta-blockerandclonidinearegivenconcurrentlytheclonidineshouldnotbediscontinueduntilseveraldays

afterwithdrawalofthebeta-blocker.

Careshouldbetakeninprescribingabeta-adrenoceptorblockerinconjunctionwithClassIantidysrhythmicssuchas

disopyramide.

4.6Pregnancyandlactation

Atenololhasbeengiveninpregnancy-associatedhypertensionafter20weeksgestation.Althoughthedrugcrossesthe

placentalbarrierandispresentincordblood,thereisnoevidenceuptothepresenttimeoffoetalabnormalities.

Nonethelessthepossibilitycannotbeexcludedandthedrugshouldonlybeusedifconsideredessentialandwiththe

patientunderclosesupervision.

Thedrugisexcretedinbreastmilk.Thisshouldbekeptinmindifitisintendedforuseinnursingmothers.

Thepossibilityoffoetalinjurycannotbeexcludedandtheuseofthedruginwomenwhoare,ormaybecomepregnant

orwhoarenursingthenewborninfant,requiresthatanticipatedbenefitsbeweighedagainstpossiblerisks.

Neonatesborntomotherswhoarereceivingatenololatparturitionorbreastfeedingmaybeatriskofhypoglycaemia.

4.7Effectsonabilitytodriveandusemachines

TheuseofAtecorisunlikelytoresultinanyimpairmentoftheabilityofpatientstodriveoroperatemachinery,butsee

section4.8.Alsopatientsshouldbestabilisedontreatmentbeforedrivingoroperatingmachinery.

4.8Undesirableeffects

Thefollowingundesiredeffects,listedbybodysystem,havebeenreportedforatenolol.

Cardiovascular:bradycardia,syncope,hypotension,Raynaudsphenomenaandcoldextremities.

CNS:headache,hallucinations,depression,sleepdisorders,dizziness.

Dermatology:psoriasiformskinreactions,skinrashes.

Gastrointestinal:gastrointestinalupset[nausea,diarrhoeaorconstipation]rarecasesofhepatictoxicityincluding

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Haematological:thrombocytopenia,purpura.

Neurological:paraesthesia,peripheralneuropathy.

Ocular:visualdisturbances,dryeyes.

Respiratory:bronchospasm.

Others:alopecia,fatigue,hypo-or-hyperglycemia.

4.9Overdose

Thesymptomsofoverdosagemayincludebradycardia,hypotension,acutecardiacinsufficiencyandbronchospasm.

Generaltreatmentshouldinclude:closesupervision;treatmentinanintensivecareward,theuseofgastriclavage,

activatedcharcoalandalaxativetopreventabsorptionofanydrugstillpresentinthegastrointestinaltract,theuseof

plasmaorplasmasubstitutestotreathypotensionandshock.

Thepossibleuseofhaemodialysisorhaemoperfusionmaybeconsidered.

Excessivebradycardiacanbecounteredwithatropine1-2mgintravenouslyand/oracardiacpacemaker.Ifnecessary,

thismaybefollowedbyabolusdoseofglucagon10mgintravenously.Ifrequired,thismayberepeatedorfollowedby

anintravenousinfusionofglucagon1-10mg/hourdependingonresponse.Ifnoresponsetoglucagonoccurs,orif

glucagonisunavailable,abeta-adrenoceptorstimulantsuchasdobutamine2.5to10micrograms/kg/minuteby

intravenousinfusionmaybegiven.Dobutamine,becauseofitspositiveinotropiceffectcouldalsobeusedtotreat

hypotensionandacutecardiacinsufficiency.Itislikelythatthesedoseswouldbeinadequatetoreversethecardiac

effectsofbeta-blockadeifalargeoverdosehasbeentaken.Thedoseofdobutamineshouldthereforebeincreasedif

necessarytoachievetherequiredresponseaccordingtotheclinicalconditionofthepatient.

Bronchospasmcanusuallybereversedbybronchodilators.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:Betablockingagents.

CO7AB03:Betablockingagents,selective.

Atecor(Atenolol)isabeta-adrenoceptorblockingdrug,whichiscardioselective(i.e.actspreferentiallyon

betaadrenergicreceptorsintheheart).Itiswithoutintrinsicsympathomimeticandmembranestabilisingactivities.

Humanstudiesindicatethatitcrossesthebloodbrain–barrieronlytoanegligibleextent.

ItisprobablytheactionofAtecorinreducingcardiacrateandcontractilitywhichmakesiteffectiveineliminatingor

reducingthesymptomsofpatientswithangina.Aswithotherbeta-adrenoceptorblockingdrugs,itsmodeofactionin

thetreatmentofhypertensionisunclear.

EarlyinterventionwithAtecorinacutemyocardialinfarctionreducesinfarctsizeanddecreasesmorbidity.Fewer

patientswithathreatenedinfarctionprogresstofrankinfarction,theincidenceofventriculararrhythmiasisdecreased

andmarkedpainreliefmayresultinreducedneedofopiateanalgesics.Earlymortalitymayalsobedecreased.Atecor

isanadditionaltreatmenttostandardcoronarycare.

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Atecorfacilitatescompliancewithanti-hypertensivetherapybyitsacceptabilitytopatientsandsimplicityofdosing.

Thenarrowdoserangeandearlypatientresponseensurethattheeffectofthedruginindividualpatientsisquickly

demonstrated.Atecorisfullycompatiblewithdiureticsandotherhypotensiveagents(see4.4SpecialWarningsand

SpecialPrecautionsforUse).

Sinceitactspreferentiallyonbeta-receptorsintheheart,Atecormaywithcarebeusedsuccessfullyinthetreatmentof

patientswithrespiratorydiseasewhocannottoleratenon-selectivebeta-blockers.

5.2Pharmacokineticproperties

Atenololiswellabsorbedafteroraldosingandexcretedunchangedthroughthekidneyswithahalf-lifeof6-9hours.

Theatenololbloodlevelsareconsistentandsubjecttolittlevariability.Thereisnosignificanthepaticmetabolismof

atenololandmorethan90%oftheabsorbedreachesthesystemiccirculationunaltered.Atenololpenetratestissue

poorlyduetoitslowlipidsolubilityanditsconcentrationinbraintissueislow.Plasmaproteinbindingislow

(approximately3%).Atenololiseffectiveforatleast24hoursafterasingleoraldailydose.

5.3Preclinicalsafetydata

Therearenopreclinicalsafetydataofrelevancetotheprescriber,whichareadditionaltothosealreadyincludedin

othersectionsofthisSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

TabletCore:

Maizestarch

SodiumLaurilsulfate

Heavymagnesiumcarbonate

Magnesiumstearate

Gelatin

FilmCoating:

Lactose

Hypromellose

Titaniumdioxide(E171)

Macrogol6000

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelflifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.

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6.5Natureandcontentsofcontainer

Cardboardoutercontainingblisterstrips.Packsize30.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

ImbatLimited

UnitL2

NorthRingBusinessPark

Santry

Dublin9

8ParallelProductAuthorisationNumber

PPA1151/55/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:7thMarch2008

10DATEOFREVISIONOFTHETEXT

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