CARDOX SR

Main information

  • Trade name:
  • CARDOX SR
  • Dosage:
  • 60 Milligram
  • Pharmaceutical form:
  • Prolonged Release Capsules
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CARDOX SR
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0549/003/003
  • Authorization date:
  • 13-10-1992
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0549/003/003

CaseNo:2043622

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

EthypharmSA

17-21rueSt.Matthieu,78550Houdan,France

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CardoxSR60mgProlonged-releaseCapsules.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom22/04/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 23/04/2008 CRN 2043622 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CardoxSR60mgProlonged-releaseCapsules.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains:Isosorbidemononitrate60.00mg.

Excipients:alsoincludeslactosemonohydrate180mgpercapsule,andsucrose57.75mgpercapsule.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Prolonged-releaseCapsules,hard.(Prolonged-releaseCapsules).

Size1,opaquewhite,hardgelatincapsulescontainssphericaloff-whitemicrogranules.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheprophylaxisofanginapectorisandasanadjunctforthetreatmentofchronicheartfailure.

4.2Posologyandmethodofadministration

Dosagerecommendations:

Dosagemaybetakenwithorwithoutfood,andshouldbeswallowedandnotchewed.

Prophylaxisofangina

Adults:theusualadultdoseis40mgperday,takenasasingledoseorindivideddoses.Ifthedoseisdivided,inorder

toavoidtolerance,thefirstdoseshouldbetakenatthesametimeeachday,followed7hourslaterbytheseconddose.

Thedailydosemaybeincreasedto60mg.

Children:safetyandefficacyinchildrenhavenotbeenestablished.

Elderly:thereisnoevidenceofaneedforroutinedosageadjustmentintheelderly,butspecialcaremaybeneededin

thosewithincreasedsusceptibilitytohypotensionormarkedhepaticorrenalinsufficiency.

Congestiveheartfailure

Adults:40mgor60mgeverytwelvehours.Cardox™SRcapsulescanbeusedinadditiontoafirst-linediuretic

therapy.

Children:safetyandefficacyinchildrenhavenotbeenestablished.

Elderly:thereisnoevidenceofaneedforroutinedosageadjustmentintheelderly,butspecialcaremaybeneededin

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4.3Contraindications

Thisproductshouldnotbegiventopatientswithaknownsensitivitytoisosorbidemononitrate,othernitratesortoany

oftheexcipients.

Thisproductshouldnotbeadministeredconcomitantlywithsildenafil,oranyotherphosphodiesterasetype-5inhibitor

(Seesection4.5).

Isosorbide-5-mononitratesshouldnotbeusedinpatientswithacutemyocardialinfarctionwithlowfillingpressure,

markedanaemia,headtrauma,cerebralhaemorrhage,severehypotensionorhypovolaemia.

4.4Specialwarningsandprecautionsforuse

Isosorbide-5-mononitrateshouldbeusedwithcautioninpatientswhoarepredisposedtoclosedangleglaucoma.

Isosorbide-5-mononitrateshouldbeusedwithcautioninpatientssufferingfromhypothyroidism,hypothermia,

malnutrition,severeliverorrenaldisease.

Cardox™SRcapsulesarenotindicatedforreliefofacuteanginaattacks;intheeventofanacuteattack,sublingualor

buccalglyceryltrinitratetablets/spraysshouldbeused.

Thismedicinalproductcontainssucroseandlactose.Patientswithrarehereditaryproblemsofgalactoseintolerance,

theLapplactasedeficiency,glucose-galactosemalabsorptionorsucrase-isomaltaseinsufficiencyshouldnottakethis

medicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Someoftheeffectsofalcoholmaybepotentiatedbythisagent.

Thehypotensiveeffectsofotherdrugssuchasalprostadil,aldesleukinandangiotensinIIreceptorantagonistsmaybe

potentiated.Inparticular,thehypotensiveeffectsofnitratesarepotentiatedbyconcurrentco-administrationof

phosphodiesterasetype-5inhibitorse.g.sildenafil(seeSection4.3);theseeffectsarepotentiallylifethreatening.

Vasodilatators,antihypertensivesanddiureticsmaypotentiatethehypotensioncausedbynitratesparticularlyinthe

elderly.

Thereisnoevidenceofinteractionwithfood.

4.6Pregnancyandlactation

Thisproductshouldnotbeusedduringpregnancyorlactationunlessconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Sinceposturalhypotensionwithsymptomssuchasdizzinesshasbeenreported,patientsshouldbeadvisedtobecareful

whendrivingoroperatingmachineryiftheysufferfromthesesymptoms.

4.8Undesirableeffects

Side-effectsincludingcutaneousvasodilatation,posturalhypotensionanddryskinrashesmayoccuroccasionally.

Headachemayoccurattheonsettreatmentbutmaybeminimisedbycommencingwithlowdosesandgradually

increasingthedose.

Usingtherecommendeddosageschedulesthereisnoevidenceofdevelopmentofnitratetolerance.

4.9Overdose

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:C01DA14Vasodilatorusedincardiacdiseases.

Nitratecompoundsrelaxsmoothmusclecausingdilatationoftheveinsandarteries,andtoalesserextentofthe

arterioles.Theresultisaverymarkedreductionofpreload,accompaniedbyloweringofrightheartpressuresandleft

ventricularend-diastolicpressure.

Theend-diastolicvolumeandpressureandtheejectionfractionarereducedbutthereflexincreaseofheartrate

preventsanyreductionofcardiacoutput.Myocardialoxygenconsumptionmaythusfallbymorethan50%inparallel

withthereductionofleftventricularpreload.Athigherdoses,afterloadisalsodecreasedbyarterialandarteriolar

dilatation;thisalsohelpstoimprovecardiacfunction.

Nitratecompoundsexertadilatoryandantispasmodiceffectonthecoronaryvessels;theyareeffectiveagainstboth

spontaneousandinducedspasms.

5.2Pharmacokineticproperties

Inman,isosorbide-5-mononitrateisabsorbedcompletelyandrapidlyfollowingoraladministration.

Isosorbide-5-mononitrateisnotsubjecttothe«hepaticfirst-pass»effect,andprovidesalowdegreeofinter-individual

variationofbloodlevels.

Comparedwithanimmediate-releasedosageform,thepeakplasmaconcentrationobtainedislowerandoccurslater,

whiletheapparenteliminationhalf-lifeisunchanged;thereislessfluctuationbetweenCmaxandCmin,whereas

bioavailabilityisequivalenttoanimmediate-releaseformulation.

Theslowcontinuousdiffusionoftheactiveingredientfromtheprolongedreleasemicrogranulesmakesitpossible,at

steadystate,tomaintainplasmaconcentrationsabovetheputativeeffectivelevelof100ng/mlforaperiodofabout12

hoursforthe20mgcapsules,16hoursforthe40mgcapsulesand20hoursforthe60mgcapsules.

5.3Preclinicalsafetydata

Isosorbide-5-mononitrateproducesveryfewtoxiceffectsandislesstoxicthanisosorbidedinitrate.Afterchronic

administrationathighdoses(60mg/kg),signsoftoxicityhavebeendetectedincanineliverandkidneys.Tests

conductedhaveshownnoevidenceofateratogenicormutagenicpotential.Theprolongedreleasemicrogranulesin

Cardox™SRcapsuleshaveprovedtobelesstoxicaftersingledosesthanisosorbide-5-mononitratealone

(Bibliographicdata).

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

LactoseMonohydrate

Sucroseandmaizestarchmicrogranules

Shellac

EudragitL100

EudragitRS100

Talc

Gelatin

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years

6.4Specialprecautionsforstorage

Storebelow25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Blisterpacks(20µmaluminium/250µmPVC)-boxedincardboardcartoncontaining28,30,56or60capsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

EthypharmSA

17-21rueSaint-Matthieu

78550Houdan

France

8MARKETINGAUTHORISATIONNUMBER

PA549/3/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13 th

October1992

Dateoflastrenewal:13 th

October2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 23/04/2008 CRN 2043622 page number: 5