CARDILATE 20MG

Main information

  • Trade name:
  • CARDILATE 20MG
  • Dosage:
  • 20 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CARDILATE 20MG
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0282/070/002
  • Authorization date:
  • 26-06-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0282/070/002

CaseNo:2069219

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NortonHealthcareLimitedT/AIVAXPharmaceuticalsUK

RegentHouse,5-7BroadhurstGardens,SwissCottage,LondonNW63RZ,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Cardilate20mgProlonged-ReleaseTablet

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom08/09/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/09/2009 CRN 2069219 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cardilate20mgProlonged-ReleaseTablet

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activeingredient:Nifedipine20mg.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Prolonged-ReleaseTablet

Round,biconvex,red-brownishcoatedtabletsembossedwithnotchand‘20’.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Cardilateisindicatedforthetreatmentofmildtomoderatehypertensionandforprophylaxisofchronicstableangina

pectoris.

4.2Posologyandmethodofadministration

Adults:

Cardilateissuitableforlong-termtreatmentofhypertensionandforprophylaxisofchronicstableanginapectoris.

Dosagemustbedeterminedforeachpatientonthebasisofdiseaseseverityandthepatient’sindividualresponse.

TherecommendedstartingdoseofCardilateis10mgevery12hourswithsubsequenttitrationofdosageaccordingto

response.Thedosemaybeadjustedto40mgevery12hours.

Tabletsmustbeswallowedwholewithaglassofwaterandmustnotbebrokenorchewed.Thetabletsshouldbetaken

beforeorafterfood.Nifedipineshouldnotbetakenwithgrapefruitjuice(seeSection4.5).Recommendedintervals

betweendosesofCardilateis12hours.

ElderlyandSpecialPopulations:

Thepharmacokineticsofnifedipinearealteredintheelderly,sothatlowermaintenancedosesmayberequired

comparedtoyoungerpatients.Cardilatecanbegiventopatientswithimpairedrenalfunctionwithoutadjustmentof

dosage.

Ifhepaticfunctionisimpaired,dosagerequirementofnifedipineshouldbeestablishedbeforeuseofCardilate.

Treatmentshouldbecommencedatadoseof5or10mgnifedipinetwicedailywithcarefulmonitoringofbloodlevels

todeterminetheappropriatedoseregimen.

Children:

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4.3Contraindications

Cardilateshouldnotbegiventopatientswithknownhypersensitivitytonifedipineorothertabletconstituents,norto

thoseincardiogenicshock.

Cardilateiscontraindicatedinwomenofchild-bearingpotentialandthosebreast-feedingtheirbabies.

Cardilateiscontra-indicatedinpatientswithadvancedaorticstenosis,unstableanginaorwithporphyria.

Cardilateshouldnotbeusedforthetreatmentofacuteattacksofangina.

Itisalsocontraindicatedduringorwithinonemonthofamyocardialinfarct,andforsecondarypreventionafter

myocardialinfarction.

Efficacyandsafetyinmalignanthypertensionhasnotbeenestablished.

4.4Specialwarningsandprecautionsforuse

Cardilateshouldbeadministeredtopatientswithlowcardiacreserveorwithseverehypotensionwithcaution.Patients

atriskofhypotensivecrisisshouldbeginanytherapyunderclosemedicalsupervision.

Inpatientsonhaemodialysiswithmalignanthypertensionandirreversiblerenalfailurewithhypovolaemia,nifedipine

shouldbegivenwithcaution.Anexaggeratedfallinbloodpressureduetovasodilationmayoccur.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Cardilatecanbeadministeredconcomitantlywithotheranti-hypertensivesincludingbeta-receptorblockers.Thesemay

haveadditiveantihypertensiveeffectsandposturalhypotensionmaythereforeoccur.Cardilatewillnotpreventthe

possibilitythattheremightbeareboundeffectwhenotherantihypertensivetreatmentisstopped.

Concomitanttherapywithcimetidinemaypotentiatetheantihypertensiveactionofnifedipine.Nifedipine

administrationmaysuppressserumlevelsofquinidine.Thereforeoncombinationtherapymonitoringofquinidine

levelsisrecommended.InitialreportsthatNifedipinemaycauseanincreaseinplasmadigoxinlevelsduetoreduced

renaldrugclearanceareunsupported.

Cardilateshouldnotbeadministeredconcomitantlywithrifampicin,sinceeffectiveplasmalevelsofnifedipinemaynot

beachievedowingtoenzymeinduction.

Cardilatemaymodifyinsulinandglucoseresponses,requiringadjustmentintherapyoftreateddiabetics.

Aswithotherdihydropyridines,Cardilateshouldnotbetakenwithgrapefruitjuiceasitsmetabolismmaybeinhibited.

4.6Pregnancyandlactation

Cardilateiscontraindicatedinpregnantwomenandwomenofchild-bearingpotentialbecausefetalrisks,observedin

animalexperimentsandduringhumanuse,faroutweighthepotentialbenefits.

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4.7Effectsonabilitytodriveandusemachines

Infrequently,Cardilatemaycauseheadaches,dizziness,nauseaandtirednesstosuchadegreethatreactiontimeis

affected.Theseeffectscanbeaggravatedbyconcurrentalcohol.Ifthisoccurs,thepatientshouldnotbeallowedto

driveoroperatemachines.

4.8Undesirableeffects

Cardilatemaycauseheadaches,facialreddeninganddizzinessandlegoedema.Theseeffectsaresecondaryto

vasodilation.Lesscommonside-effectsincluderash,nausea,lethargyandurinaryfrequency.Rarely,gingival

hyperplasiamayoccur;thismayresolvewhentreatmentisdiscontinued.

Chestpainduetomyocardialischaemiamayoccur1-4hoursafteringestionofCardilate.A‘steal’effecthasnotbeen

observeduptonowwithCardilate,buttreatmentshouldbediscontinuedinpatientsinwhichthisdoesoccur.Casesof

hypersensitivitytonifedipineresultinginjaundicehavebeenreported.

Exacerbationofanginapectorismayoccuratthestartoftreatmentwithsustainedreleaseformulationsofnifedipine.

Theoccurrenceofmyocardialinfarctionhasbeendescribed,althoughitisnotpossibletodistinguishsuchanevent

fromthenaturalcourseofischaemicheartdisease.

4.9Overdose

Toxiceffectsarisefromthethreemainactionsofnifedipineinoverdose:dilatationofvascularsmoothmuscles

(predominanteffect);decreasedmyocardialcontractility;anddepressionofAVnodalconduction.

Hypotensionandtachycardiaorbradycardiaarethemostlikelymanifestationsofoverdose.Othertoxiceffectsinclude

nausea,vomiting,drowsiness,dizziness,confusion,lethargy,flushing,comaandconvulsions.Cardiaceffectsmay

includeheartblock,AVdissociationandasystole;metabolicdisturbancesincludehyperglycaemia,acidosis,hypo-or

hyperkalaemiaandhypocalcaemia;pulmonaryoedemahasbeenreported.

Primarytreatmentinvolvesremovalofnifedipinebygastriclavageoripecacandadministrationofactivatedcharcoal

(50gadults;10-15gchildren).Cardilateisamodifiedreleaseproduct;thereforeactivatedcharcoalshouldberepeatedat

4-hourlyintervals(25gadults;10gchildren).Thepatientshouldbecloselymonitoredandtreatedaccordingto

predominatingsigns:

Forhypotension:Thefeetshouldberaisedandplasmaexpandersgivenintravenously(calciumchlorideshouldnotbe

giventoacidoticpatients).Ifthisfails,dopaminemaybetried(largedosesmaybeneeded).Glucagonmayalsobeof

value.

Forbradycardia:Treatmentwithatropine,isoprenalineandcardiacpacingshouldbegivenasrequired.

Thevalueofextracorporealmethodsofremovalofnifedipinehavenotbeenestablished.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Nifedipineinhibitstheinfluxofcalciumintomyocardialcells,thesmoothmusclecellsofthecoronaryarteriesandthe

peripheralcapillaries.Nifedipinebringsaboutasubstantialimprovementintheoxygensupplytothemyocardium

whilereducingoxygendemand.Ithasbeenshowntoexhibitanti-anginalproperties.Highbloodpressureisnormalised

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5.2Pharmacokineticproperties

Absorption:

Nifedipineisabsorbedrapidlyandalmostcompletelyfollowingoraladministration.Nifedipinecanbedetectedin

plasma30-60minutesafteradministrationofCardilateandreachesmaximalconcentrationbetween0.75and5hours.

Distribution:

Nifedipineismorethan90%serumproteinbound.Animalstudieswithlabellednifedipinehaveshownthatdistribution

ofthefractionnotproteinboundisthroughoutallorgansandtissues,withhigherconcentrationsinmyocardiumthanin

skeletalmuscle.Neithernifedipinenotitsmetabolitesarestoredselectivelyinanytissue.

Metabolism:

Nifedipineisconvertedalmostcompletelytoinactivemetabolites.

Elimination:

70to80%ofadministerednifedipineisexcretedasmetabolitesbythekidneyswithaneliminationhalf-lifeof

approximately10hours.

Eliminationmayberetardedbyrenalfailureorinsufficiency.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

TabletCore:

Microcrystallinecellulose

Carboxymethylsodiumstarch

Mannitol(E421)

Colloidalanhydroussilica

Polyvidone

Magnesiumstearate

Sodiumlaurisulfate

Tabletcoating:

Hypromellose

Macrogol6000

Macrogol400

Redferricoxide(E172)

Titaniumdioxide(E171)

Talc

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

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6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

ThermoformedblisterpacksofPVC/redtransparentPVdC/aluminiuminboxesof20,30,60,90or100tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NortonHealthcareLtd

T/AIVAXPharmaceuticalsUK

RegentHouse

5-7BroadhurstGardens

SwissCottage

London,NW63RZ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA282/70/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26June1998

Dateoflastrenewal:26June2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 08/09/2009 CRN 2069219 page number: 6