ARTEXAL

Main information

  • Trade name:
  • ARTEXAL Tablets 5 Milligram
  • Dosage:
  • 5 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ARTEXAL Tablets 5 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0568/001/001
  • Authorization date:
  • 13-04-1988
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0568/001/001

CaseNo:2066568

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

LesLaboratoiresServier

22,rueGarnier,92200Neuilly-sur-Seine,France

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Artexal5mgTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom31/08/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 05/09/2009 CRN 2066568 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Artexal5mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Tertatololhydrochloride5mgpertablet.

Excipients:containsLactoseMonohydrate37.0mg

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Filmcoatedtablet.

White,oblong,film-coatedtabletsscoredononeface.

Thetabletcanbedividedintoequalhalves.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asabetaadrenoceptorblockerforthetreatmentofessentialhypertension.

4.2Posologyandmethodofadministration

Oraladministration

AdultsOnly:

Theusualdailydoseis5mginsingleordivideddoses.

Hypertension:

Theusualdailydoseis5mgasasingledose.Thiscanbeincreasedto10mgdailyifrequiredforcontrol,butshould

onlybedoneaftertheeffectsoftheinitialdosehavebeenachieved(1to2weeks).Tertatololmaybecombinedwitha

diureticifrequired,orotherantihypertensiveagents.

4.3Contraindications

Hypersensitivitytotertatololhydrochlorideortoanyoftheexcipients.

2ndor3rddegreeatrioventricularblock.

Severebradycardia.

Uncontrolledordigitalis/diuretic-refractoryheartfailure.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 05/09/2009 CRN 2066568 page number: 2

Cardiogenicshock.

Renalfailurewithcreatinineclearancebelow10ml/min.

Useinhepaticinsufficiencyinabsenceofclinicalstudies.

4.4Specialwarningsandprecautionsforuse

Suddenwithdrawalofbeta-adrenoceptorblockingagentsinpatientswithischaemicheartdiseasemayresultin

theappearanceofanginalattacksofincreasedfrequencyorseverityordeteriorationincardiacstate.

Discontinuationoftherapyshouldbegradual.

Thebeta-blockershouldonlybeusedwithcautioninpatientswithcontrolledcongestivecardiacfailureorwitha

familyhistoryofasthma.Evidenceofdevelopmentofeitherconditionshouldberegardedasasignalto

discontinuetherapy.

Thebeta-blockercanbeadministeredtopatientswithobstructiverespiratorydisordersprovidedthatadequate

supervisionismaintainedtopermitanynecessaryadjustmentofdosageofthebronchodilatoremployed.

Theinitialtreatmentofseveremalignanthypertensionshouldbesodesignedastoavoidsuddenreductionin

diastolicbloodpressurewithimpairmentofautoregulatorymechanisms.

Whenthisagentisadministeredtopatientsinrenalfailurethedosagemayrequireadjustment.Inpatientswith

hepaticdysfunction,dosageshouldbereducedandiftheprothrombintimeislessthan70%thedrugshouldbe

discontinued.

Somecasesofocularchanges(conjunctivitisand'dryeye')and/orskinrashes(includingapsoriasiformtype)

havebeenreportedinassociationwiththeuseofbeta-adrenoceptorblockers.Untiltheirsignificanceisknownit

isrecommendedthatconsiderationbegiventodiscontinuingsuchtherapyiftheseeffectsappear.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Intheeventthatapatientreceivingthebeta-blockerrequiresanaesthesiatheanaesthetistshouldbeinformedof

theuseofthemedicationpriortotheuseofageneralanaesthetictopermithistakingthenecessaryprecautions.

Thebeta-blockershouldonlybeusedwithgreatcautioninpatientswhoarereceivingconcomitantmyocardial

depressantssuchashalogenatedhydrocarbonanaesthetics,lignocaine,procainamide,beta-adrenoceptor

stimulantssuchasisoprenaline,orverapamiloralpha-adrenoceptorstimulantssuchasnoradrenaline.

Adrenergic-neuroneblockingagentssuchasguanethidine,reserpine,diureticsandotheranti-hypertensive

agents,includingthevasodilatorgroup,willhaveanadditiveeffectonthehypotensiveactionofthedrug.

Thebeta-blockermaymasksomeofthesymptomsofthyrotoxicosisandofhypoglycaemiabyinhibitionof

sympatheticnervefunctions.Theeffectsofhypoglycaemicagentsmaybeincreased,particularlybythenon-

cardioselectivebeta-blockers.Thetachycardiaofhypoglycaemiamaybemodified.

Ifthebeta-blockerandclonidinearegivenconcurrentlytheclonidineshouldnotbediscontinueduntilseveral

daysafterwithdrawalofthebeta-blocker.

Careshouldbetakeninprescribinga-adrenoceptorblockerinconjunctionwithantidysrhythmics,particularly

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 05/09/2009 CRN 2066568 page number: 3

4.6Pregnancyandlactation

Pregnancy

Althoughthedrugcrossestheplacentalbarrierandispresentincordblood,thereisnoevidenceuptothepresenttime

offoetalabnormalities.Nonethelessthepossibilitycannotbeexcludedandthedrugshouldonlybeusedifconsidered

essentialandwiththepatientunderclosesupervision.

Lactation

Thedrugisexcretedinbreastmilk.Theriskofhypoglycaemiaandbradycardiaoccurringhasnotbeenevaluated.

Consequently,andasaprecaution,breast-feedingisinadvisablethroughouttreatment.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandusemachinehavebeenperformed.

4.8Undesirableeffects

Thefollowingundesirableeffectscouldbeobservedduringtreatmentandrankedunderthefollowingfrequency:very

common(1/10);common(1/100,<1/10);uncommon(1/1000,<1/100);rare(1/10000,<1/1000),veryrare

(<1/10000),includingisolatedreports.

Metabolismandnutritiondisorders:

Veryrare: Hypoglycaemia

Psychiatricdisorders

Rare: insomniaandnightmares

Cardiacdisorders

Common: bradycardia,severeattimes

Uncommon: heartfailure

Veryrare: slowingdownofatrioventricularconductionorincreaseinexistingatrioventricularblock

Vasculardisorders

Common: coldextremities

Uncommon: dropinbloodpressure

Veryrare: aggravationofexistingintermittentclaudication,Raynaud'ssyndrome

Respiratory,thoracicandmediastinaldisorders

Common: bronchospasm

Gastrointestinaldisorders

Uncommon: gastrointestinaldisorders(gastralgia,nauseaandvomiting)

Skinandsubcutaneoustissuedisorders

Uncommon: miscellaneousskinreactions,includingpsoriasiformeruptions

Reproductivesystemandbreastdisorders

Uncommon: impotence

Generaldisordersandadministrationsiteconditions

Common: asthenia

Effectsonlaboratoryparameters:

Inrarecases,antinuclearantibodieshavebeenobserved.Theseareonlyveryrarelyaccompaniedbyclinicalsignssuch

assystemiclupuserythematosuswhichsubsidewhentreatmentisdiscontinued.

4.9Overdose

Thefollowingshouldbeadministeredincasesofbradycardiaoranexcessivedropinbloodpressure:

atropine,1to2mgI.V.,

glucagon10mg,toberepeatedasrequired,

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 05/09/2009 CRN 2066568 page number: 4

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:C07AA16BetaBlockingagents,non-selective

Non-selective-adrenoceptorblocker.

SomeclinicalstudieshaveshownthatARTEXAL ®

maintainsorimprovesrenalhaemodynamics,particularlyrenal

plasmaflowandglomerularfiltration,inpatientswithandwithoutrenalfailure.

5.2Pharmacokineticproperties

Tertatololiswellabsorbedafteroraldosingandexcretedunchanged(andashydroxymetabolite)throughthekidneys

withaplasmaeliminationhalflifeofabout3hours.

5.3Preclinicalsafetydata

Nofindingsinthepreclinicaltestingwhichcouldbeofrelevancefortheprescriber.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Stearicacid

Sodiumstarchglycollate

Microcrystallinecellulose

Whitebeeswax

Glycerol

Calciumhydrogenphosphatedihydrate

Hypromellose

Lactosemonohydrate

SodiumLaurilsulfate

Titaniumdioxide

Macrogol6000

Colloidalanhydroussilica

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Storebelow25°C.

6.5Natureandcontentsofcontainer

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 05/09/2009 CRN 2066568 page number: 5

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

LesLaboratoiresServier

22,rueGarnier

92200Neuilly-sur-Seine

France

8MARKETINGAUTHORISATIONNUMBER

PA568/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13 th

April1988

Dateoflastrenewal:13 th

April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 05/09/2009 CRN 2066568 page number: 6