EMCORETIC

Main information

  • Trade name:
  • EMCORETIC Tablets
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EMCORETIC Tablets
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0654/008/001
  • Authorization date:
  • 27-11-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

EmcoreticTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontains5 mg Bisoprololfumarateand 12.5 mg Hydrochlorothiazide.

Forexcipients, see6.1

3PHARMACEUTICALFORM

Film-coatedtablet.

Circular, biconvex, pink, film-coatedtablets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Managementofhypertension.

4.2Posologyandmethodofadminstration

MethodofAdministration:Oral.

Adults:Onetabletdaily.

In patientswith moderateto severeimpairmentofrenal(creatinineclearance<20ml/min)orliverfunction thedose

should bereduced.

Elderly:Asforadults.

Children:Thereisno paediatricexperiencewith bisoprololand itisnotthereforerecommended forchildren.

4.3Contraindications

Itshould notbeused in casesofuntreated ordecompensated cardiacfailure, cardiogenicshock, sinoatrialblock,

second orthird degreeAVblock, marked bradycardia(heartratelessthan 50 beats/min), acutemyocardialinfarction,

severeasthma, patientswith aknown hypersensitivity to hydrochlorothiazide, severerenalorhepaticfailure,

hypokalaemiaorhyponatraemia.

4.4Special warningsandspecialprecautionsforuse

Emcoreticcan beadministered with caution to patientswith obstructiverespiratory disordersprovided thatadequate

supervision ismaintained.Ifincreased airwaysresistancedevelopsconsideration mustbegiven to discontinuation of

the-blocker, depending on thedegreeofairwaysresistanceand thebenefitderived from-blockade.

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disturbances,such asRaynaud’sphenomenon.

In patientswith ischaemicheartdisease, treatmentshould notbewithdrawn abruptly.

Sincebisoprololisahighly selective-adrenoceptorantagonist, itmay beused with caution in patientswith amedical

history ofchronicobstructiveairwaysdisease.However, in somepatientsan increasein airwaysresistancemay

occur.Thisbronchospasmcan usually bereversed by commonly used bronchodilatorssuch assalbutamol.

Dueto thelowaffinity ofbisoprololfor-receptors, itdoesnotappearto haveahypoglycaemiceffect.However, it

should beused with caution in diabeticpatientssincethesymptomsofhypoglycaemia(in particular, tachycardia)may

bemasked and hydrochlorothiazidemay impairglucosetolerancefurther.

Careshould betaken in patientswith apredisposition to goutorhyperuricaemia.

Allpatientstreatedwith diureticsshould receiveperiodicmonitoring forsignsoffluid orelectrolyteimbalance.

Hypokalaemiacan beinduced asaresultofthiazidetherapy and potassiumlevelsshould bechecked, particularly in

olderpatients, thosereceiving digitalispreparationsforheartfailure, thoseon dietslowin potassiumand patients

suffering fromgastro-intestinalcomplaints.Thelowdoseofhydrochlorothiazidereducestheprobability ofa

significantelectrolyteimbalanceoccurring.

Priorto anaesthesia, theanaesthetistshouldbeinformed ifthepatientistaking thisproduct.In casesofsevere

ischaemicheartdisease, therisk/benefitofcontinuing treatmentshould beevaluated.Careshould betaken when using

volatileanaestheticsbecauseofan increased hypotensiveeffect.Hydrochlorothiazidemay increasetheresponsiveness

to agentsofthetubocurarinetype.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Bisoprololmay potentiatetheeffectofotherconcurrently administered antihypertensivedrugs.Concomitanttreatment

with reserpine,-methyldopaand clonidinemay causean exaggerated decreasein heartrateand blood pressure.In

particular, ifclonidineisto bediscontinued, thisshould notbedoneuntiltreatmentwith

bisoprolol/hydrochlorothiazidehasbeen discontinued forseveraldays.

Itshould also beused with carewhen myocardialdepressants, inhibitorsofAVconduction suchascalciumantagonists

oftheverapamiland diltiazemtype, orclassIantidysrhythmicagentssuch asdisopyramideareused concurrently.

Theintravenousadministration ofcalciumantagonistsand antiarrhythmicagentsisnotrecommended during therapy.

Lithiumshould notgenerally beadministered withdiureticssuch aslithiumclearancemay besignificantly reduced.

Theconcurrentuseofrifampicin can reducetheelimination halflifeofbisoprolol, although an increasein doseis

generally notnecessary.Theeffectsofinsulin ororalhypoglycaemicagentsmay bepotentiated when used

concurrently with bisoprolol.

4.6Pregnancyandlactation

No teratogeniceffectshavebeen demonstrated with bisoprololin animalstudies, butthiazidediureticsarenot

generally recommended foruseduring pregnancy.Beta-blockersadministered in latepregnancy may cause

bradycardiaorhypotension in thefoetus/neonate.Likeotherantihypertensivetherapy, thebenefitsofuseduring

pregnancy should beweighed againstthepossiblehazard to motherand foetus.Whilstclinically relevantlevelsof

bisoprololmay notappearin breastmilk, hydrochlorothiazidedoesappearin themilk and iftreatmentisessentialthen

thepatientsshould stop breastfeeding.

4.7Effectsonabilitytodriveandusemachines

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4.8Undesirableeffects

Itisusually welltolerated with reported sideeffectsgenerally attributableto itspharmacologicaleffects.These

includelassitude, dizziness, mild headache, perspiration, aggravation ofintermittentclaudication orRaynaud’sdisease,

paresthesiaoftheextremities.Occasionally, amarked decreasein blood pressureand pulserateoradisturbanceof

AVconduction may beobserved.Dry eyesand sleep disturbancesnoted with other-blockershavenotbeen reported

forpatientstreated with thisproductbutmay, rarely, occur.

Diureticscan affectblood sugar.

4.9Overdose

In thecaseofoverdosageoraprecipitousdrop in pulserateand/orblood pressure, treatmentmustbediscontinued.If

necessary, thefollowing antidotesshould beadministeredaloneorconsecutively:intravenousatropine0.5-2.0 mg,

intravenousorciprenaline0.5 mg by slowintravenousinjection;also glucagon may begiven atadoselevelof1 to 5

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Bisoprololisapotent, highly-antagonistdevoid ofintrinsicsympathomimeticactivity and withoutrelevant

membranestabilising activity.

Aswithother-antagonists, themodeofaction in hypertension isnotclearbutitisknown thatbisoprololmarkedly

depressesplasmarenin levelsand reducesheartrate.

In patientswith angina, theblockageof-receptorsreducesheartaction and thusreducesoxygen demand.Hence

bisoprololiseffectivein eliminating orreducing thesymptoms.

Hydrochlorothiazideisathiazidediureticwhich hasan antihypertensiveaction.Thediureticeffectistheresultof

inhibition ofactiveNatransportfromkidney tubulesto blood, preventing theresorption ofNa.Italso appearsto

decreaseperipheralresistanceresulting fromrelaxation ofvascularsmooth muscle, possibly caused by its

phosphodiesteraseinhibiting activity.

Thecombination ofa-adrenoceptorantagonistand thiazidediureticiswellestablished in thetreatmentof

hypertension and showsgreatertherapeuticefficacy than eitheractiveingredientalonein mild to moderateessential

hypertension.

5.2Pharmacokineticproperties

Bisoprololisabsorbed almostcompletely fromthegastrointestinaltract.Togetherwith thevery smallfirstpasseffect

in theliver, thisresultsin ahigh bioavailability ofapproximately 90%.Thedrug iscleared equally by theliverand

kidney.

Thelong plasmahalf-life(10-12 hours)provides24 hoursefficacy following aoncedaily dosage.About95%ofthe

drug substanceisexcreted through thekidney, halfofthisisasunchanged bisoprolol.Thereareno activemetabolites

in man.

Hydrochlorothiazideisrelatively wellabsorbed forthegastrointestinaltractwith peak plasmalevelsobtained after

about2 hours.Elimination isbiphasicwith an elimination half-lifeof9-13 hours.Itismainly excreted unchanged in

theurine.

When administered together, thereareno significantpharmacokineticinteractionsbetween bisoprololand

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5.3Preclinical safetydata

Thereareno additionaldatafromanimalstudieswhich provideany furtherrelevantinformation forusein humans.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Dibasiccalciumphosphateanhydrous

Microcrystallinecellulose

Colloidalanhydroussilica

Maizestarch

Magnesiumstearate

Hypromellose

Dimeticone

Titaniumdioxide

Iron oxidered (E172)

Iron oxideblack (E172)

Polyethyleneglycol400

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

4 years.

6.4Special precautionsforstorage

Do notstoreabove30°C.

6.5Natureandcontentsofcontainer

HDPEbottleswith polyethylenescrewcap containing 100 tablets.

Carton with ACLAR/PE/PVC/Aluminiumfoilblisterscontaining 28 tablets.

Carton with ACLAR/PE/PVC/Aluminiumfoilblisterscontaining 2 tablets(professionalsample).

6.6Instructionsforuseandhandling

None.

7MARKETINGAUTHORISATIONHOLDER

MerckLimited

HarrierHouse

High Street

WestDrayton

Middlesex

UB7 7QG

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8MARKETINGAUTHORISATIONNUMBER

PA654/8/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 27 th

November1992

Dateoflastrenewal:27 th

November2002

10DATEOFREVISIONOFTHETEXT

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