ELANTAN LA

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/103/001
  • Authorization date:
  • 03-07-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA1328/103/001

CaseNo:2061479

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

B&SHealthcare

Unit4,BradfieldRoad,Ruislip,Middlesex,HA40NU,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ElantanLA25mgProlongedReleaseCapsules,hard

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom03/07/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 07/07/2009 CRN 2061479 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ElantanLA25mgProlongedReleaseCapsules,hard

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachprolongedreleasehardcapsulecontains25mgisosorbidemononitrate

Excipient:containslactosemonohydrateandsucrose

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Prolongedreleasecapsule,hard

ProductimportedfromUK:

Hardcapsulewithbrowncapandwhitebody,containingwhitetooffwhitepellets

4CLINICALPARTICULARS

4.1TherapeuticIndications

Intheprophylaxisofanginapectoris

4.2Posologyandmethodofadministration

Fororaladministration

Adults

Onecapsuletobetakeninthemorning.

Forpatientswithhighernitraterequirement,thedosemaybeincreasedtotwocapsulestakensimultaneously.The

lowesteffectivedoseshouldbeused.

Elderly

Thereisnoevidencetosuggestthatanadjustmentofthedosageisnecessary.

Children

ThesafetyandefficacyofElantanLA25hasyettobeestablishedinchildren.

Attenuationofeffecthasoccurredinsomepatientsbeingtreatedwithprolongedreleasepreparations.Insuchpatients

intermittenttherapymaybemoreappropriate(seesection4.4).

TreatmentwithElantanLA25,aswithanyothernitrate,shouldnotbestoppedsuddenly.Bothdosageandfrequency

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4.3Contraindications

ElantanLA25shouldnotbeusedincasesofacutemyocardialinfarctionwithlowfillingpressure,acutecirculatory

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

constrictivepericarditis,cardiactamponade,lowcardiacfillingpressures,aortic/mitralvalvestenosis,anddiseases

associatedwitharaisedintra-cranialpressuree.g.followingaheadtraumaandincludingacerebralhaemorrhage.

ThisproductshouldnotbegiventopatientswithaknownsensitivitytoIsosorbidemononitrate,thelistedingredients

orothernitrates.

ElantanLA25shouldnotbeusedinpatientswithmarkedanaemia,severehypotension,closedangleglaucomaor

hypovolaemia.

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

hypotensiveeffectsofnitrates,andtheirco-administrationwithnitratesornitricoxidedonorsistherefore

contraindicated(seesection4.5).

4.4Specialwarningsandprecautionsforuse

Thecapsulesshouldbeusedwithcautioninpatientswhohavearecenthistoryofmyocardialinfarctionorwhoare

sufferingfromhypothyroidism,hypothermia,malnutrition,severeliverorsevererenaldisease.

Symptomsofcirculatorycollapsemayariseafterfirstdose,particularlyinpatientswithlabilecirculation.

Thisproductmaygiverisetoposturalhypotensionandsyncopeinsomepatients.Severeposturalhypotensionwith

light-headednessanddizzinessisfrequentlyobservedaftertheconsumptionofalcohol.

Hypotensioninducedbynitratesmaybeaccompaniedbyparadoxicalbradycardiaandincreasedangina.

ElantanLA25capsulescontainlactoseandthereforeshouldnotbeusedinpatientswithrarehereditaryproblemsof

galactoseintolerance,theLapplactasedeficiencyorglucose-galactosemalabsorption.

ElantanLA25capsulesalsocontainsucroseandthereforepatientswithrarehereditaryproblemsoffructose

intolerance,glucose-galactosemalabsorptionorsucrase-isomaltaseinsufficiencyshouldnottakethismedicine.

Intheeventofanacuteanginaattack,asublingualtreatmentsuchasaGTNsprayortabletshouldbeusedinsteadof

ElantanLA25capsules.

Ifthesecapsulesarenottakenasindicated(seesection4.2.)tolerancetothemedicationcoulddevelop.Insome

patientsbeingtreatedwithprolongedreleasepreparations,attenuationofeffectisobserved.Insuchpatients,

intermittenttherapymaybemoreappropriate.Thelowesteffectivedoseshouldbeused.

TreatmentofElantanLA25,aswithanyothernitrate,shouldnotbestoppedsuddenly.Boththedosageandfrequency

shouldbetaperedgradually(Seesection4.2).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofdrugswithbloodpressureloweringproperties,e.g.beta-blockers,calciumchannel

blockers,vasodilators,alprostadil,aldesleukin,angiotensinIIreceptorantagonistsetcand/oralcoholmaypotentiatethe

hypotensiveeffectofElantanLA25.Thismayalsooccurwithneurolepticsandtricyclicantidepressants.

AnybloodpressureloweringeffectofElantanLA25willbeincreasedifusedtogetherwithphosphodiesterasetype-5

inhibitorswhichareusedforerectiledysfunction(seespecialwarningsandcontraindications,sections4.4and4.3

respectively).Thismightleadtolifethreateningcardiovascularcomplications.PatientswhoareonElantanLA25

therapythereforemustnotusephosphodiesterasetype-5inhibitors.

ReportssuggestthatconcomitantadministrationofElantanLA25mayincreasethebloodlevelofdihydroergotamine

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4.6Pregnancyandlactation

Safetyinpregnancyhasnotbeenestablishedforisosorbidemononitrateanditisnotknownwhethernitratesare

excretedinhumanmilk.ThereforeElantanLA25shouldonlybeusedinpregnancyandduringlactationif,inthe

opinionofthephysician,thepossiblebenefitsoftreatmentoutweighthehazards.

4.7Effectsonabilitytodriveandusemachines

Dizziness,tirednessorblurredvisionmayoccuratthestartoftreatment.Ifaffecteddonotdriveoroperatemachinery.

Thiseffectmaybeincreasedbyalcohol.

4.8Undesirableeffects

Averycommon>10%)adversereactiontoElantanLA25isthrobbingheadache.Theevidenceofheadachediminishes

graduallywithtimeandcontinueduse.

Atthestartoftherapyorwhenthedosageisincreased,hypotensionand/orlightheadednessinuprightpositionare

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

reflextachychardiaandafeelingofweakness.

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-inducedsphincterrelaxationhavebeenreported.

Tachycardiaandparoxysmalbradycardiahavebeenreported.

4.9Overdose

Symptomsandsigns:

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

visionandsyncope.Ariseinintracranialpressurewithconfusionandneurologicaldeficitscansometimesoccur.

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

circulatoryfailure,raisedintracranialpressure)occursrarely.

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,

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:C01DA14–Vasodilatorusedincardiacdiseases

Isosorbidemononitrateisanorganicnitrate,which,incommonwithothercardioactivenitrates,isavasodilator.

Itproducesdecreasedleftandrightventricularend-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:

Thesestudiesincludedfertilityandbreedingstudyovertwogenerationsinrats;teratologystudiesinratsandrabbits;

andaratperi-postnatalstudy.Thedosagelevelsusedweregenerallyhighandproducedmaternaltoxiceffectsatthe

highestdose.Noteratogeniceffectsofisosorbidemononitratewereobserved.

Mutagenicity:

Isosorbidemononitratewastestedindifferentstudiesinbothinvitroandinvivo(Amestest,Humanperipheral

lymphocytes,bonemarrowofratsandhamsters,V79test,SCEtest)onpossiblemutageniceffects.Asalltestswere

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Carcinogenicity:

Neitherthelongtermtoxicitystudiesinratsanddogsnoraspecialcarcinogenicitystudy,performedinratsover125

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

beconcludedthatcarcinogenicriskinhumansislow.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Talc

Ethylcellulose

Macrogol20,000

Hyprolose

Surcose

Cornstarch

Gelatin

Titaniumdioxide(E171)

Ironoxidered(E172)

Ironoxideblack(E172)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelflifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions

6.5Natureandcontentsofcontainer

Over-labelledcardboardcartoncontaining2blisterstrips(14capsulesperstrip).

Packsize:28capsules

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7ParallelProductAuthorisationHolder

B&SHealthcare

Unit4,BradfieldRoad

Ruislip

Middlesex

HA40NU

UnitedKingdom

8ParallelProductAuthorisationNumber

PPA1328/103/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:3 rd

July2009

Irish Medicines Board

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