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:
  • PPA1659/050/002
  • Authorization date:
  • 11-11-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ElantanLA25mgProlonged-releaseCapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachprolongedreleasecapsulecontains25mgisosorbidemononitrate.

Containssucroseandlactose

Forafulllistexcipients,seesection6.1.

3PHARMACEUTICALFORM

Prolonged-releaseCapsules

ProductimportedfromtheUK:

Hardcapsulewithbrowncapandwhitebody,containingwhitetooff-whitepellets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Intheprophylaxisofanginapectoris.

4.2Posologyandmethodofadministration

Fororaladministration.

Adults

Onecapsuletobetakeninthemorning.

Forpatientswithhighernitraterequirement,thedosemaybeincreasedtotwocapsulestakensimultaneously.The

lowesteffectivedoseshouldbeused.

Elderly

Thereisnoevidencetosuggestthatanadjustmentofthedosageisnecessary.

Children

ThesafetyandefficacyofElantanLA25hasyettobeestablishedinchildren.

Attenuationofeffecthasoccurredinsomepatientsbeingtreatedwithprolongedreleasepreparations.Insuchpatients

intermittenttherapymaybemoreappropriate(seesection4.4).

TreatmentwithElantanLA,aswithanyothernitrate,shouldnotbestoppedsuddenly.Bothdosageandfrequency

shouldbetaperedgradually(seesection4.4).

4.3Contraindications

ElantanLA25shouldnotbeusedincasesofacutemyocardialinfarctionwithlowfillingpressure,acutecirculatory

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

constrictivepericarditis,cardiactamponade,lowcardiacfillingpressures,aortic/mitralvalvestenosisanddiseases

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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,severeliverdiseaseorsevererenaldisease.

Symptomsofcirculatorycollapsemayariseafterfirstdose,particularlyinpatientswithlabilecirculation.

Thisproductmaygiverisetoposturalhypotensionandsyncopeinsomepatients.Severeposturalhypotensionwith

light-headednessanddizzinessisfrequentlyobservedaftertheconsumptionofalcohol.

Hypotensioninducedbynitratesmaybeaccompaniedbyparadoxicalbradycardiaandincreasedangina.

ElantanLAcapsulescontainlactoseandthereforeshouldnotbeusedinpatientswithrarehereditaryproblemsof

galactoseintolerance,theLapplactasedeficiencyorglucose-galactosemalabsorption.

ElantanLAcapsulesalsocontainsucroseandthereforepatientswithrarehereditaryproblemsoffructoseintolerance,

glucose-galactosemalabsorptionorsucrase-isomaltaseinsufficiencyshouldnottakethismedicine.

Intheeventofanacuteanginaattack,asublingualtreatmentsuchasaGTNsprayortabletshouldbeusedinsteadof

ElantanLAcapsules.

Ifthesecapsulesarenottakenasindicated(seesection4.2.)tolerancetothemedicationcoulddevelop.Insome

patientsbeingtreatedwithprolongedreleasepreparations,attenuationofeffectisobserved.Insuchpatients,

intermittenttherapymaybemoreappropriate.Thelowesteffectivedoseshouldbeused.

TreatmentofElantanLA,aswithanyothernitrate,shouldnotbestoppedsuddenly.Boththedosageandfrequency

shouldbetaperedgradually(seesection4.2).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofdrugswithbloodpressureloweringproperties,e.g.beta-blockers,calciumchannel

blockers,vasodilators,alprostadil,aldesleukin,angiotensinIIreceptorantagonistsetcand/oralcoholmaypotentiatethe

hypotensiveeffectofElantanLA.Thismayalsooccurwithneurolepticsandtricyclicantidepressants.Anyblood

pressureloweringeffectofElantanLA25willbeincreasedifusedtogetherwithPhosphodiesterasetype-5inhibitors,

whichareusedforerectiledysfunction(seespecialwarningsandcontraindicationssections4.4&4.3respectively).

Thismightleadtolifethreateningcardiovascularcomplications.PatientswhoareonElantanLA25therapytherefore

mustnotusePhosphodiesterasetype-5inhibitors.

ReportssuggestthatconcomitantadministrationofElantanLAmayincreasethebloodlevelofdihydroergotamineand

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4.6Fertility,pregnancyandlactation

Safetyinpregnancyhasnotbeenestablishedforisosorbidemononitrateanditisnotknownwhethernitratesare

excretedinhumanmilk.ThereforeElantanshouldonlybeusedinpregnancyandduringlactationif,intheopinionof

thephysician,thepossiblebenefitsoftreatmentoutweighthehazards.

4.7Effectsonabilitytodriveandusemachines

Dizziness,tirednessorblurredvisionmayoccuratthestartoftreatment.Ifaffecteddonotdriveoroperatemachinery.

Thiseffectmaybeincreasedbyalcohol.

4.8Undesirableeffects

Averycommon(>10%)adversereactiontoElantanLA25isthrobbingheadache.Theevidenceofheadache

diminishesgraduallywithtimeandcontinueduse.

Atthestartoftherapyorwhenthedosageisincreased,hypotensionand/orlightheadednessinuprightpositionare

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

tachycardiaandafeelingofweakness.

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

sometimesseverely.Insinglecases,exfoliativedermatitismayoccur.

Severehypotensiveresponsehavebeenreportedfororganicnitratesandincludenausea,vomiting,restlessness,pallor

andexcessiveperspiration.Uncommonlycollapsemayoccur(sometimesaccompaniedbybradyarrhythmiaand

syncope).Uncommonlyseverehypotensionmayleadtoenhancedanginasymptoms.

Afewreportsofheartburnmostlikelyduetonitrate-inducedsphincterrelaxationhavebeenreported.Tachycardiaand

paroxysmalbradycardiahavebeenreported.

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,phenytoinorpropofol

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:CO1DA14–Vasodilatorusedincardiacdiseases.

Isosorbidemononitrateisanorganicnitrate,which,incommonwithothercardioactivenitratesisavasodilator.It

producesdecreasedleftandrightventricularend-diastolicpressurestoagreaterextentthanthedecreaseinsystemic

arterialpressure,therebyreducingafterloadandespeciallythepreloadtotheheart.

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

tothoseobtainedinhealthy

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

highestdose.Noteratogeniceffectsofisosorbidemononitratewereobserved.

Mutagenicity:

Isosorbidemononitratewastestedindifferentstudiesinbothinvitroandinvivo(Amestest,Humanperipheral

lymphocytes,bonemarrowofratsandhamsters,V79test,SCEtest)onpossiblemutageniceffects.Asalltestswere

negativethemutagenicrisksinhumansisconsideredlow.

Carcinogenicity:

Neitherthelongtermtoxicitystudiesinratsanddogsnoraspecialcarcinogenicitystudy,performedinratsover125

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

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

PurifiedTalc

Ethylcellulose

Macrogol20000

Hydroxypropylcellulose

Sucrose

Cornstarch

Gelatin

Titaniumdioxide

Ironoxidered(E172)

Ironoxideblack(El72)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelf-lifeexpirydateofthisproductshallbethedateshownontheblisterandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

BlistersofPVC/aluminiumorofpolypropyleneandaluminium,inanover-labelledoutercartoncontainingcalendar

packscontaining28capsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

IPSHealthcareLimited

SterlingHouse

501MiddletonRoad

Chadderton

Oldham

LancashireOL99LY

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11 th

November2011

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