ELANTAN LA HARD

Main information

  • Trade name:
  • ELANTAN LA HARD
  • Dosage:
  • 50 Milligram
  • Pharmaceutical form:
  • Prolonged Release Capsules
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ELANTAN LA HARD
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0891/011/002
  • Authorization date:
  • 12-06-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0891/011/002

CaseNo:2086513

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

UCB(Pharma)IrelandLimited

UnitedDrugHouse,MagnaDrive,MagnaBusinessPark,CitywestRoad,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ElantanLA50mgProlongedReleaseCapsules,hard

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom28/07/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 28/07/2010 CRN 2086513 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ElantanLA50mgProlongedReleaseCapsules,hard.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachprolongedreleasehardcapsulecontains50mgisosorbidemononitrate.

Excipients:Eachprolongedreleasehardcapsulecontains13.42mglactosemonohydrateandapproximately16-24

mgsucrose.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Prolongedreleasecapsule,hard(prolongedreleasecapsule).

Size3hardgelatinopaquecapsules.Browncapsulecapandfleshcolouredbody,containingwhitetobeige

odourlesspellets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheprophylaxisandlongtermmanagementofanginapectoris.

4.2Posologyandmethodofadministration

Fororaladministration.

Adults

Onecapsuletobetakeninthemorning.

Thedosemaybeincreaseduptotwocapsulesperdayforpatientswithhighernitraterequirements.Thelowest

effectivedoseshouldbeused.

Elderly

Thereisnoevidencetosuggestthatanadjustmentofthedosageisnecessary.

Children

ThesafetyandefficacyofElantanLAhasyettobeestablishedinchildren.

Attenuationofeffecthasoccurredinsomepatientsbeingtreatedwithprolongedreleasepreparations.Insuchpatients

intermittenttherapymaybemoreappropriate(seesection4.4).

TreatmentwithElantanLA,aswithanyothernitrate,shouldnotbestoppedsuddenly.Bothdosageandfrequency

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4.3Contraindications

ElantanLA50shouldnotbeusedincasesofacutemyocardialinfarctionwithlowfillingpressure,acutecirculatory

failure(shock,vascularcollapse),orverylowbloodpressure,hypertrophicobstructivecardiomyopathy(HOCM),

constrictivepericarditis,cardiactamponade,lowcardiacfillingpressures,aortic/mitralvalvestenosisanddiseases

associatedwitharaisedintra-cranialpressuree.g.followingaheadtraumaandincludingcerebralhaemorrhage.

Thisproductshouldnotbegiventopatientswithaknownhypersensitivitytoisosorbidemononitrate,thelisted

ingredientsorothernitrates.

ElantanLA50shouldnotbeusedinpatientswithmarkedanaemia,severehypotension,closedangleglaucomaor

hypovolaemia.

Phosphodiesterasetype-5inhibitors(e.g.sildenafil,tadalafilandvardenafil)havebeenshowntopotentiatethe

hypotensiveeffectsofnitrates,andtheirco-administrationwithnitratesornitricoxidedonorsistherefore

contraindicated(seesection4.5).

4.4Specialwarningsandprecautionsforuse

Thisproductmaygiverisetoposturalhypotensionandsyncopeinsomepatients.Severeposturalhypotensionwith

light-headednessanddizzinessisfrequentlyobservedaftertheconsumptionofalcohol.

ElantanLA50shouldbeusedwithcautioninpatientswhohavearecenthistoryofmyocardialinfarctionorwhoare

sufferingfromhypothyroidism,hypothermia,malnutrition,severeliverdiseaseorsevererenaldisease.

Symptomsofcirculatorycollapsemayariseafterfirstdose,particularlyinpatientswithlabilecirculation.Hypotension

inducedbynitratesmaybeaccompaniedbyparadoxicalbradycardiaandincreasedangina.

ElantanLAcapsulescontainlactoseandthereforeshouldnotbeusedinpatientswithrarehereditaryproblemsof

galactoseintolerance,theLapplactasedeficiencyorglucose-galactosemalabsorption.

ElantanLAcapsulesalsocontainsucroseandthereforepatientswithrarehereditaryproblemsoffructoseintolerance,

glucose-galactosemalabsorptionorsucrase-isomaltaseinsufficientlyshouldnottakethismedicine.

Intheeventofacuteanginaattack,asublingualtreatmentsuchasaGTNsprayortabletshouldbeusedinsteadof

ElantanLAcapsules.

Ifthesecapsulesarenottakenasindicated(seesection4.2)tolerancetothemedicationcoulddevelop.Insomepatients

beingtreatedwithprolongedreleasepreparations,attenuationofeffectisobserved.Insuchpatients,intermittent

therapymaybemoreappropriate.Thelowesteffectivedoseshouldbeused.

TreatmentofElantanLA,aswithanyothernitrate,shouldnotbestoppedsuddenly.Boththedosageandfrequency

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofdrugswithbloodpressureloweringproperties,e.g.beta-blockers,calciumchannel

blockers,vasodilators,alprostadil,aldesleukin,angiotensinIIreceptorantagonistsetcand/oralcoholmaypotentiatethe

hypotensiveeffectofElantanLA.Thismayalsooccurwithneurolepticsandtricyclicantidepressants.

AnybloodpressureloweringeffectofElantanLAwillbeincreasedifusedtogetherwithphosphodiesterasetype-5

inhibitors,whichareusedforerectiledysfunction(seespecialwarningsandcontraindications).

Thismightleadtolifethreateningcardiovascularcomplications.PatientswhoareonElantanLA50therapytherefore

mustnotusephosphodiesterasetype-5inhibitors.

ReportssuggestthatconcomitantadministrationofElantanLA50mayincreasethebloodlevelofdihydroergotamine

anditshypertensiveeffect.

4.6Pregnancyandlactation

Safetyinpregnancyhasnotbeenestablishedforisosorbidemononitrateanditisnotknownwhethernitratesare

excretedinhumanmilk.ThereforeElantanshouldonlybeusedinpregnancyandduringlactationif,intheopinionof

thephysician,thepossiblebenefitsoftreatmentoutweighthehazards.

4.7Effectsonabilitytodriveandusemachines

Dizziness,tirednessorblurredvisionmayoccuratthestartoftreatment.Ifaffecteddonotdriveoroperatemachinery.

Thiseffectmaybeincreasedbyalcohol.

4.8Undesirableeffects

Averycommon(>10%)adversereactiontoElantanLA50isthrobbingheadache.Theevidenceofheadache

diminishesgraduallywithtimeandcontinueduse.

Atthestartoftherapyofwhenthedosageisincreased,hypotensionand/orlightheadednessintheuprightpositionare

observedcommonly(i.e.in1-10%ofpatients).Thesesymptomsmaybeassociatedwithdizziness,drowsiness,reflex

tachychardiaandafeelingofweakness.

Infrequently(i.e.in<1%ofpatients)nausea,vomiting,flushingandallergicskinreaction(e.g.rash)mayoccur

sometimesseverely.Insinglecases,exfoliativedermatitismayoccur.

Severehypotensiveresponseshavebeenreportedfororganicnitratesandincludenausea,vomiting,restlessness,pallor

andexcessiveperspiration.Uncommonlycollapsemayoccur(sometimesaccompaniedbybradyarrhythmiaand

syncope).Uncommonlyseverehypotensionmayleadtoenhancedanginasymptoms.

Afewreportsofheartburnmostlikelyduetonitrate-inducedsphincterrelaxationhavebeenrecorded.

Tachycardiaandparoxysmalbradycardiahavebeenreportedwithnitrates.

4.9Overdose

Symptomsandsigns:

Headache,hypotension,nausea,vomiting,sweating,tachycardia,vertigo,restlessness,warmflushedskin,blurred

visionandsyncope.Ariseinintracranialpressurewithconfusionandneurologicaldeficitscansometimesoccur.

Methaemoglobinaemia(cyanosis,hypoxaemia,restlessness,respiratorydepression,convulsions,cardiacarrhythmias,

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Management:

Consideroralactivatedcharcoalifingestionofapotentiallytoxicamounthasoccurredwithin1hour.Observeforat

least12hoursaftertheoverdose.Monitorbloodpressureandpulse.Correcthypotensionbyraisingthefootofthebed

and/orbyexpandingtheintravascularvolume.Othermeasuresasindicatedbythepatient’sclinicalcondition.Ifsevere

hypotensionpersistsdespitetheabovemeasuresconsideruseofinotropes.

Ifmethaemoglobinaemia(symptomsor>30%methaemoglobin),IVadministrationofmethyleneblue1-2mg/kgbody

weight.Iftherapyfailswithseconddoseafter1hourorcontraindicated,considerredbloodcellconcentratesor

exchangetransfusion.Incaseofcerebralconvulsions,diazepamorclonazepamIV,oriftherapyfails,phenobarbital,

phenytoinorpropofolanaesthesia.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:CO1DA14–Vasodilatorusedincardiacdiseases.

Isosorbidemononitrateisanorganicnitratewhichincommonwithothercardioactivenitratesisavasodilator.It

producesdecreasedleftandrightventricularend-diastolicpressurestoagreaterextentthanthedecreaseinsystemic

arterialpressure,therebyreducingafterloadandespeciallythepreloadoftheheart.

Isosorbidemononitrateinfluencestheoxygensupplytoischaemicmyocardiumbycausingtheredistributionofblood

flowalongcollateralchannelsandfromepicardialtoendocardialregionsbyselectivedilationoflargeepicardial

vessels.

Itreducestherequirementofthemyocardiumforoxygenbyincreasingvenouscapacitance,causingapoolingofblood

inperipheralveins,therebyreducingventricularvolumeandheartwalldistension.

5.2Pharmacokineticproperties

Isosorbidemononitrateisavasodilator,whichisrapidlyabsorbedfollowingoraladministration.Thesecapsuleshavea

bioavailabilityof80–90%whencomparedtotheimmediatereleaseisosorbidemononitratetablets.

Thecapsulescontainpelletswhichareformulatedtorelease30%ofthedoseimmediatelywhilst70%ofthedoseis

releasedslowly.

Isosorbidemononitrateisextensivelymetabolisedtonitricoxide(NO–whichistheactiveagent)andisosorbide

(inactive).Inpatientswithcirrhoticdiseaseorcardiacfailureorrenalfailure,pharmacokineticparametersweresimilar

tothoseobtainedinhealthyvolunteers.

5.3Preclinicalsafetydata

Acutetoxicity:

Studiesonacutetoxicityinmiceandratswithdifferentroutesofadministrationindicatealowacutetoxicity(LD

oralapproximately2000-2500mg/kgbodyweight(b.w.)).

Chronictoxicity:

Longtermtoxicityhasbeentestedinratsfor78weeksandindogsfor52weeks.Firsttoxicreactionsoccurredin

dosagesof90mg/kg(dog)and405mg/kg(rat),respectively.Thustakingintoaccounttherecommendeddosageof20

to30mg/dinhumans,thetherapeuticindexcanbestatedashigh.

Reproductionstudies:

Thesestudiesincludedafertilityandbreedingstudyovertwogenerationsinrats;teratologystudiesinratsandrabbits;

andaratperi-postnatalstudy.Thedosagelevelsusedweregenerallyhighandproducedmaternaltoxiceffectsatthe

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Mutagenicity:

Isosorbidemononitratewastestedindifferentstudiesinbothinvitroandinvivo(Amestest,Humanperipheral

lymphocytes,bonemarrowofratsandhamsters,V79test,SCEtest)onpossiblemutageniceffects.Asalltestswere

negativethemutagenicrisksinhumansisconsideredlow.

Carcinogenicity:

Neitherthelongtermtoxicitystudiesinratsanddogsnoraspecialcarcinogenicitystudy,performedinratsover125

weeks(males)and138weeks(females)indicatedneoplastigenicpropertiesofisosorbidemononitrate.Therefore,itcan

beconcludedthatcarcinogenicriskinhumansislow.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Hydroxypropylcellulose

Ethylcellulose

Talc

Macrogol20,000

Sucrose

Cornstarch

Gelatin

Titaniumdioxide(E171)

Ironoxideblackandred(E172)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

CartonsofblisterstripsofPVCandaluminiumorofpolypropyleneandaluminium.

Aluminiumfoilthickness16or20micrometres.

14capsulesperstrip.

Packsizes:calendarpackscontaining28capsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

UCB(Pharma)IrelandLimited

UnitedDrugHouse

MagnaDrive

MagnaBusinessPark

CitywestRoad

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA891/11/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24July1987

Dateoflastrenewal:24July2007

10DATEOFREVISIONOFTHETEXT

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