EMCOR 5MG FILM-COATED TABLETS.

Main information

  • Trade name:
  • EMCOR 5MG FILM-COATED TABLETS.
  • Dosage:
  • 5 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EMCOR 5MG FILM-COATED TABLETS.
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/087/001A
  • Authorization date:
  • 06-12-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Emcor5mgFilm-coatedtablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontains5mgbisoprololfumarate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedTablet.

ProductimportedfromtheNetherlands,Spain,andHungary:

Paleyellow,heart-shapedtablets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthemanagementofhypertensionandthemanagementofangina.

4.2Posologyandmethodofadministration

Routeofadministration:oral

RecommendedDosage:

Adults:

Theusualdoseis10mgdailywithamaximumrecommendeddoseof20mgperday.Insomepatients5mgperday

maybeadequate.Inpatientswithfinalstageimpairmentofrenal(creatinineclearance<20ml/min)orliverfunction,

thedoseshouldnotexceed10mgbisoprololoncedaily.Experienceoftheuseofbisoprololinrenaldialysispatientsis

limited,however,thereisnoevidencethatthedosageregimenneedstobealtered.

Elderly:

Nodosageadjustmentisnormallyrequiredbut5mgperdaymaybeadequateinsomepatients;asforotheradults,

dosagemayhavetobereducedincasesofsevererenalorhepaticdysfunction.

Useinchildren:

Thereisnopaediatricexperiencewithbisoprolol,thereforeitsusecannotberecommendedforchildren.

Inpatientswithischaemicheartdisease,treatmentshouldnotbewithdrawnabruptly;gradualdosagereductionover1-

2weeksisrecommended.

4.3Contraindications

Bisoprololiscontra-indicatedinpatientswith:

acuteheartfailureorduringepisodesofheartfailuredecompensationrequiringi.v.inotropictherapy

cardiogenicshock

secondorthirddegreeAVblock(withoutapacemaker)

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sinoatrialblock

markedbradycardia(heartratelessthen60beats/minpriortostartoftherapy)

hypotension(systolicbloodpressure<100mmHg)

severebronchialasthmaorseverechronicobstructivepulmonarydisease

latestagesofperipheralarterialocclusivediseaseandRaynaud’ssyndrome

untreatedphaeochromocytoma(seesection4.4,Specialwarningsandprecautionsforuse)

metabolicacidosis

hypersensitivitytobisoprololortoanyoftheexcipeints

4.4Specialwarningsandprecautionsforuse

Bisoprololmustbeusedwithcautionin:

heartfailure(thetreatmentofstablechronicheartfailurewithbisoprololhastobeinitiatedwithaspecial

titrationphase[fordetails,seeSPCforbisoprololindicatedforthetreatmentofstablechronicheartfailure])

bronchialasthma,obstructiveairwaysdiseases

concomitanttreatmentwithinhalationanaesthetics(seesection4.5,Interactionwithothermedicinalproducts

andotherformsofinteraction)

diabetesmellituswithlargefluctuationsinbloodglucosevalues;symptomsofhypoglycaemiacanbemasked

strictfasting

ongoingdesensitisationtherapy

AVblockoffirstdegree

Prinzmetal’sangina

Peripheralarterialocculusivedisease(intensificationofcomplaintsmayoccurparticularlyduringthestartof

therapy.

Inbronchialasthmaorotherchronicobstructivelungdiseases,whichmaycausesymptoms,bronchodilatingtherapy

mayhavetobegivenconcomitantly.Occasionallyanincreaseoftheairwayresistancemayoccurinpatientswith

asthma,thereforethedoseof

-stimulantsmayhavetobeincreased.

Aswithother -blockers,bisoprololmayincreaseboththesensitivitytowardsallergensandtheseverityof

anaphylacticreactions.Adrenalinetreatmentdoesnotalwaysgivetheexpectedtherapeuticeffect.

Patientswithpsoriasisorwithahistoryofpsoriasisshouldonlybegiven-blockers(e.g.bisoprolol)aftercarefully

balancingthebenefitsagainsttherisks.

Inpatientswithphaeochromocytomabisoprololmustnotbeadministereduntilafteralpha-receptorblockade.

Undertreatmentwithbisoprololthesymptomsofathyrotoxicosismaybemasked.

Thecessationoftherapywithbisoprololshouldnotbedoneabruptlyunlessclearlyindicated.Forfurtherinformation,

(seesection4.2,Posologyandmethodofadministration)

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Combinationsnotrecommended.

Calciumantagonistssuchasverapamilandtoalesserextentdiltiazem:

Negativeinfluenceoncontractility,atrio-ventricularconductionandbloodpressure.Intravenousadministrationof

verapamilinpatientsonbeta-blockertreatmentmayleadtoprofoundhypotensionandatrioventricularblock.

Clonidine:Increasedriskof“reboundhypertension”aswellasexaggerateddecreaseinheartrateandcardiac

conduction.

Monoamineoxidaseinhibitors(exceptMAO-Binhibitors):Enhancedhypotensiveeffectof-blockersbutalsoriskof

hypertensivecrisis.

Combinationstobeusedwithcaution

Calciumantagonistssuchasdihydropyridinederivatives(e.g.nifedipine):increasedriskofhypotension.Inpatients

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antiarrhythmicdrugs(e.g.disopyramide,quinidine):Effectonatrialconductiontimemaybepotentiatedandnegative

inotropiseffectmaybeincreased.

Class-IIIantiarrhythmicdrugs(e.g.amiodarone):Effectonatrialconductiontimemaybepotentiated.

Parasympathomimeticdrugs(includingtacrine):Atrio-ventricularconductiontimemaybeincreased.

Other-blockers,includingeyedrops,haveadditiveeffects.

Insulinandoralantidiabeticdrugs:Intensificationofbloodsugarloweringeffect.Blockadeof-adrenoceptorsmay

masksymptomsofhypoglycaemia.

Anaestheticagents:Attenuationofthereflextachycardiaandincreaseoftheriskofhypotension.Continuationof-

blockadereducestheriskofarrhythmiaduringinductionandintubation.Theanaesthesiologistshouldbeinformed

whenthepatientisreceivingbisoprolol.

Digitalisglycosides:Reductionofheartrate,increaseofatrio-ventricularconductiontime.

Prostaglandinsynthetaseinhibitingdrugs:Decreasedhypotensiveeffects.

Ergotaminederivatives:Exacebationofperipheralcirculatorydisturbances.

Sympathomimeticagents:Combinationwithbisoprololmayreducetheeffectofbothagents.Higherdosesof

epinephrinemaybenecessaryfortreatmentofallergicreactions.

Tricyclicantidepressants,barbiturates,phenothiazinesaswellasotherantihypertensiveagents:Increasedblood

pressureloweringeffect.

Rifampicin:Slightreductionofthehalf-lifeofbisoprololpossibleduetotheinductionofhepaticdrug-metabolising

enzymes.Normallynodosageadjustmentnecessary.

Moxisylyte:Possiblycausessevereposturalhypertension.

Combinationtobeconsidered

Mefloquine:increasedriskofbradycardia.

4.6Fertility,pregnancyandlactation

Pregnancy

Bisoprololhaspharmacologicaleffectsthatmaycasueharmfuleffectsonpregnancyand/orthefoetus/newborn.In

general,-blockersreduceplacentalperfusion,whichhasbeenassociatedwithgrowthretardation,intrauterinedeath,

abortionorearlylabour.Adverseeffects(e.g.hypoglycaemiaandbradycardia)mayoccurinthefoetusandnewborn

infant.Iftreatmentwith-adrenoceptorblockersisnecessary,

-selectiveadrenoceptorblockersarepreferable.

Bisoprololshouldnotbeusedduringpregnancyunlessclearlynecessary.Iftreatmentwithbisoprololisconsidered

necessary,theuteroplacentalbloodflowandthefoetalgrowthshouldbemonitored.Incaseharmfuleffectson

pregnancyorthefoetusalternativetreatmentshouldbeconsidered.Thenewborninfantmustbecloselymonitored.

Symptomsofhypoglycaemiaandbradycardiaaregenerallytobeexpectedwithinthefirst3days.

Lactation

Itisnotknownwhetherthisdrugisexcretedinhumanmilk.Therefore,breastfeedingisnotrecommendedduring

administrationofbisoprolol.

4.7Effectsonabilitytodriveandusemachines

Inastudyorcoronaryheartdiseasepatients,bisoprololdidnotimpairdrivingperformance.However,dueto

individualvariationsinreactionstothedrug,theabilitytodriveavehicleortooperatemachinerymaybeimpaired.

Thisshouldbeconsideredparticularlyatthestartoftreatmentanduponchangeofmedicationaswellasinconjunction

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4.8Undesirableeffects

*Thesesymptomsespeciallyoccuratthebeginingoftherapy.Theyaregenerallymildandoftendisappearwithin1-2

weeks.

4.9Overdose

Themostcommonsignsexpectedwithoverdosageofa-blockerarebradycardia,hypotension,bronchospasm,acute

cardiacinsufficiencyandhypoglycaemia.Todateafewcasesofoverdose(maximum:2000mg)withbisoprololhave

beenreported.Bradycardiaand/orhypotensionwerenoted.Allpatientsrecovered.Thereisawideinterindividual

variationinsensitivitytoonesinglehighdoseofbisoprolol.

Ingeneral,ifoverdoseoccurs,bisoprololtreatmentshouldbestoppedandsupportiveandsymptomatictreatment

shouldbeprovided.Limiteddatasuggestthatbisoprololishardlydialysable.Basedontheexpectedpharmacological

Common

(>1%and<10%) Circ:Feelingofcoldnessornumbnessinthe

extremities

CNS: Tirdeness*, exhaustion*, dizziness*,

headache*

GI:Nausea,vomiting,diarrhoea,constipation

Uncommon

(>0.1%and<1%) General:Muscularweaknessandcramps

Circ:Bradycardia,AVstimulusdisturbances,

worsening of heart failure, orthostatic

hypotension

CNS:Sleepdisturbances,depression

Airways: Bronchospasm in patients with

bronchialasthmaorhistoryofobstructive

airwaysdisease.

Rare

(>0.01%and<0.1%) CNS:Nightmares,hallucinations

Skin:Hypersensitivityreactions(itching,flush,

rash)

Liver:increasedliverenzymes(ALAT,ASAT),

hepatitis

Metabolism:Increasedtriglycerides

Urogenital:Potencydisorders

Ear-nose-throat:hearingimpairment,allergic

rhinitis

Eyes:reducedtearflow(tobeconsideredif

patientsuseslenses)

Singlecases

(<0.01%) Eyes:conjunctivitis,visualdisturbances

Skin: -blockersmayprovokeorworsen

psoriasisorinducepsoriasis-likerash,alopecia

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clinicallywarranted.

Bradycardia:Administerintravenousatropine.Iftheresponseisinadequate,isoprenalineoranotheragentwith

positivechronotropicpropertiesmaybegivencautiously.Undersomecircumstances,transvenouspacemakerinsertion

maybenecessary.

Hypotension:Intravenousfluidsandvasopressorsshouldbeadministered.

Intravenousglucagonmaybeuseful.

AVblock(secondorthirddegree):Patientsshouldbecarefullymonitoredandtreatedwithisoprenalineinfusionor

transvenouscardiacpacemakerinsertion.

Acuteworseningofheatfailure:Administeri.v.diuretics,inotropicagents,vasodilatingagents.

Bronchospasm:Administerbronchodilatortherapysuchasisoprenaline,

-sympathomimeticdrugsand/or

aminophylline.

Hypoglycaemia:Administeri.v.glucose.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Bisoprololisapotent,highlybeta-1-selective-adrenoreceptorblockingagentdevoidofintrinsicsympathomimetic

activityandwithoutrelevantmembranestabilisingactivity.Aswithotherbeta-1-blockingagents,themodeofaction

inhypertensionisnotclearbutitisknownthatbisoprololmarkedlydepressesplasmareninactivity.

Inpatientswithangina,theblockadeofbeta-1-receptorsreducesheartactionandthusreducesoxygendemand.Hence

bisoprololiseffectiveineliminatingorreducingthesymptoms.

5.2Pharmacokineticproperties

Bisoprololisabsorbedalmostcompletelyfromthegastrointestinaltract.Togetherwiththeverysmallfirstpasseffect

intheliver,thisresultsinahighbioavailabilityofapproximately90%.Thedrugisclearedequallybytheliverand

kidney.Theplasmaeliminationhalf-life(10-12hours)provides24hoursefficacyfollowingaoncedailydosage.

About95%ofthedrugsubstanceisexcretedthroughthekidney,halfofthisisasunchangedbisoprolol.Thereareno

activemetabolitesinman.

5.3Preclinicalsafetydata

Nothingstated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore

silica,colloidalanhydrous

Magnesiumstearate

Crospovidone

Microcrystallinecellulose(E460)

Maizestarch

Anhydrouscalciumhydrogenphosphate

Tabletcoating

Ironoxideyellow(E172)

Dimeticone

Macrogol400

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Hypromellose.

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Blisterpacksof30tabletsinanover-labelledcardboardcarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA465/87/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:06December2002

Dateoflastrenewal:06December2007

10DATEOFREVISIONOFTHETEXT

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