ELANTAN

Main information

  • Trade name:
  • ELANTAN Tablets 10 Milligram
  • Dosage:
  • 10 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ELANTAN Tablets 10 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0891/011/001
  • Authorization date:
  • 05-06-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Elantan10mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains10mgisosorbidemononitrate.

Alsocontains154mglactose(asmonohydrate).

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

White,circular,flat,bevelled-edgetabletswithscoreline,marked‘E/10’ononeside.

Thescorelineisonlytofacilitatebreakingforeaseofswallowingandnottodivideintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheprophylaxisandlongtermmanagementofanginapectoris.

4.2Posologyandmethodofadministration

Fororaladministration.

Adults

Onetablettobetakenasymmetrically(toallowanitratelowperiod)twoorthreetimesaday.Thedosagemaybe

increasedupto120mgperday.Dosageregimeshouldbedesignedaccordingtotheclinicalresponseofthepatient.

Tabletsshouldbetakenaftermeals,unchewedwithalittlefluid.

Thelowesteffectivedoseshouldbeused.

Elderly

Thereisnoevidencetosuggestthatanadjustmentofthedosageisnecessary.

Children

ThesafetyandefficacyofElantanhasyettobeestablishedinchildren.

TreatmentwithElantan,aswithanyothernitrate,shouldnotbestoppedsuddenly.Boththefrequencyanddosage

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4.3Contraindications

Elantan10shouldnotbeusedincasesofacutemyocardialinfarctionwithlowfillingpressure,acutecirculatoryfailure

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

pericarditis,cardiactamponade,lowcardiacfillingpressures,aortic/mitralvalvestenosisanddiseasesassociatedwith

araisedintra-cranialpressuree.g.followingaheadtraumaandincludingcerebralhaemorrhage.

Thisproductshouldnotbegiventopatientswithaknownsensitivitytoisosorbidemononitrate,thelistedingredients

orothernitrates.

Elantan10shouldnotbeusedinpatientswithmarkedanaemia,severehypotension,closedangleglaucomaor

hypovolaemia.

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

hypotensiveeffectsofnitrates,andtheirco-administrationwithnitratesornitricoxidedonorsistherefore

contraindicated(seesection4.5).

4.4Specialwarningsandprecautionsforuse

Thisproductmaygiverisetosymptomsofposturalhypotensionandsyncopeinsomepatients.Severepostural

hypotensionwithlight-headednessanddizzinessisfrequentlyobservedaftertheconsumptionofalcohol.

Elantan10shouldbeusedwithcautioninpatientswhohavearecenthistoryofmyocardialinfarction,orwhoare

sufferingfromhypothyroidism,hypothermia,malnutritionandsevereliverorrenaldisease.

Symptomsofcirculatorycollapsemayariseafterfirstdose,particularlyinpatientswithlabilecirculation.

Hypotensioninducedbynitratesmaybeaccompaniedbyparadoxicalbradycardiaandincreasedangina.

Elantantabletscontainlactoseandthereforeshouldnotbeusedinpatientswithrarehereditaryproblemsofgalactose

intolerance,theLapplactasedeficiencyorglucose-galactosemalabsorption.

Intheeventofanacuteanginaattack,asublingualtreatmentsuchasaGTNsprayortabletshouldbeusedinsteadof

Elantantablets.

Ifthetabletsarenottakenasindicated(seesection4.2)tolerancetothemedicationcoulddevelop.Thelowesteffective

doseshouldbeused.

TreatmentwithElantan,aswithanyothernitrate,shouldnotbestoppedsuddenly.Boththedosageandfrequency

shouldbetaperedgradually(seesection4.2).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofdrugswithbloodpressureloweringproperties,e.g.beta-blockers,calciumchannel

blockers,vasodilators,alprostadil,aldesleukin,angiotensinIIreceptorantagonistsetcand/oralcoholmaypotentiatethe

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AnybloodpressureloweringeffectofElantanwillbeincreasedifusedtogetherwithphosphodiesterasetype-5

inhibitors,whichareusedforerectiledysfunction(seespecialwarningsandcontraindications).Thismightleadtolife

threateningcardiovascularcomplications.PatientswhoareonElantan10therapythereforemustnotuse

phosphodiesterasetype-5inhibitors.

ReportssuggestthatconcomitantadministrationofElantan10mayincreasethebloodlevelofdihydroergotamineand

itshypertensiveeffect.

4.6Fertility,pregnancyandlactation

Safetyinpregnancyhasnotbeenestablishedforisosorbidemononitrateanditisnotknownwhethernitratesare

excretedinhumanmilk.ThereforeElantanshouldonlybeusedinpregnancyandduringlactationif,intheopinionof

thephysician,thepossiblebenefitsoftreatmentoutweighthehazards.

4.7Effectsonabilitytodriveandusemachines

Dizzinesstirednessorblurredvisionmayoccuratthestartoftreatment.Ifaffecteddonotdriveoroperatemachinery.

Thiseffectmaybeincreasedbyalcohol.

4.8Undesirableeffects

Averycommon(>10%)adversereactiontoElantan10isthrobbingheadache.Theevidenceofheadachediminishes

graduallywithtimeandcontinueduse.

Atthestartortherapyorwhenthedosageisincreased,hypotensionand/orlightheadednessintheuprightpositionare

commonlyobserved(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.

Severehypotensiveresponseshavebeenreportedfororganicnitratesandincludenausea,vomiting,restlessness,pallor

andexcessiveperspiration.Uncommonlycollapsemayoccur(sometimesaccompaniedbybradyarrhythmiaand

syncope).Uncommonlyseverehypotensionmayleadtoenhancedanginasymptoms.

Afewreportsofheartburnmostlikelyduetoanitrateinducedsphincterrelaxationhavebeenrecorded.

Tachycardiaandparoxysmalbradycardiahavebeenreportedwithnitrates.

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.

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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

Isosorbide-5-mononitrateisrapidlyabsorbedandpeakplasmalevelsoccurapprox.1hourfollowingoraldosing.

Isosorbide-5-mononitrateiscompletelybioavailableafteroraldosesandisnotsubjecttopre-systemicelimination

processes.

Isosorbide-5-mononitrateiseliminatedfromtheplasmawithahalf-lifeofabout5.1hours.Itismetabolisedto

isosorbide-5-MN-2-glucuronideexcretedunchangedintheurine.

Aftermultipleoraldosingplasmaconcentrationsaresimilartothosethatcanbepredictedfromsingledosekinetic

parameters.

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

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Carcinogenicity:

Neitherthelongtermtoxicitystudiesinratsanddogsnoraspecialcarcinogenicitystudy,performedinratsover125

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

beconcludedthatcarcinogenicriskinhumansislow.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Microcrystallinecellulose

Potatostarch

Talc

Colloidalanhydroussilica

Aluminiumstearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

5years.

6.4Specialprecautionsforstorage

Nospecialprecautions.

6.5Natureandcontentsofcontainer

CartonsofblisterstripsofPP/ALorPP/PP.

Aluminiumfoilthickness16µmor20µm.

Packsizes:28,30,50,56,60,84,90or100tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

UCBPharmaIrelandLimited

UnitedDrugHouse

MagnaDrive

MagnaBusinessPark

CitywestRoad

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA0891/011/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11October1991

Dateoflastrenewal:11October2006

10DATEOFREVISIONOFTHETEXT

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