ANTAROL

Main information

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

Documents

Localization

  • Available in:
  • ANTAROL Tablets 10 mg Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0073/073/001
  • Authorization date:
  • 01-11-1982
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AntarolTablets10mg.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontains10 mg ofPropranololHydrochloride.

Forexcipients, see6.1

3PHARMACEUTICALFORM

Film-coatedtablet.

Pink, film-coatedtabletsembossed P/10 on onefaceand theAntigenlogo on thereverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thecontrolofhypertension.

Themanagementofanginapectoris.

Thelong-termprophylaxisafterrecovery fromacutemyocardialinfarction.

Thecontrolofcardiacdysrhythmias.

Theprophylaxisofmigraine.

Asan adjunctin thecontrolofthesymptomsofanxiety, essentialtremor, tachycardia(including thatwith

thyrotoxicosis).

Themanagementofphaeochromocytoma(Antarolshould only bestarted inthepresenceofeffectivealpha

blockade).

Theprophylaxisofuppergastrointestinalbleeding in patientswith portalhypertension and oesophagealvarices.

4.2Posologyandmethodofadminstration

AntarolTabletsarefororaladministration.

Adults:

Hypertension:Astartingdoseof80mgtwiceadaymaybeincreasedatweeklyintervalsaccordingtoresponse.The

usualdoserangeis160-320mgperday.Withconcurrentdiureticorotherantihypertensivedrugs,afurtherreduction

ofblood pressureisobtained.

Angina,anxiety,migraineandessentialtremor:Astartingdoseof40mgtwoorthreetimesdailymaybeincreasedby

thesameamountatweekly intervalsaccording to patientresponse.

Anadequateresponseinanxiety,migraineandessentialtremorisusuallyseenintherange80-160mg/dayandin

anginain therange120-240mg/day.

Dysrhythmias,anxiety,tachycardiaandthyrotoxicosis:Adosagerangeof10-40mgthreeorfourtimesadayusually

achievestherequired response.

Post-myocardialinfarction:Treatmentshouldstartbetweendays5and21aftermyocardialinfarction,withaninitial

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given as80mg twiceaday.

Phaeochromocytoma:(Usedonlywithanalpha-receptorblockingdrug).Pre-operative:60mgdailyforthreedaysis

recommended.Non-operablemalignantcases:30mgdaily.

Portalhypertension/oesophagealvarices:Dosageshouldbetitratedtoachieveapproximately25%reductioninresting

heartrate.Dosingshouldbeginwith40mgtwicedailyincreasingto80mgtwicedailydependingonheartrate

response.Ifnecessary, thedosemay beincreased incrementally to amaximumof160mg twicedaily.

Elderly:

Someolderpatientstendtobemoresusceptibletotheeffectsofbetablockade;reduceddosagesshouldbeused

initially.

Children:

Theusualdoserangeis0.25to 0.5mg/kg threeorfourtimesdaily.

4.3Contraindications

Second and third degreeAVblock.

Severebradycardia.

Uncontrolled ordigitalis/diureticrefractory heartfailure.

Cardiogenicshock

Usein patientswith asthmaorahistory ofasthma.

Metabolicacidosis(e.g. diabeticketoacidosis).

Prolonged fasting.

Severeperipheralarterialdisease.

4.4Special warningsandprecautionsforuse

Suddenwithdrawalofbeta-adrenoceptorblockingagentsfrompatientswithischaemicheartdiseasemayresultinthe

appearanceofanginalattacksofincreasedfrequencyandseverityorindeteriorationincardiacstate.Discontinuation

oftherapy should begradual.

Propranololshouldonlybeusedwithcautioninpatientswithcontrolledcongestivecardiacfailure.Evidenceof

recrudescenceofthecondition should beregarded asasignalto discontinuetherapy.

Whenpropranololisadministeredtopatientswithrenalfailure,theintervalbetweendosesmayneedtobeincreasedor

thedosagereducedtoavoidaccumulationofthedrug. Inpatientswithsignificanthepaticorrenalimpairmentcare

should betaken when starting treatmentand selecting theinitialdose.

Someocularchanges(conjunctivitisand‘dryeye’)and/orskinrashes(includingapsoriasiformtype)havebeen

reportedinassociationwiththeuseofbeta-adrenoceptorblockers. Untiltheirsignificanceisknown,itis

recommended thatconsideration begiven to discontinuing such therapy iftheseeffectsappear.

Theinitialtreatmentofseveremalignanthypertensionshouldbesodesignedastoavoidsuddenreductionindiastolic

bloodpressurewithimpairmentofautoregulatorymechanisms. Cautionmustbeexercisedwhenusinganaesthetic

agentswith“Antarol”.Theanaesthetistshouldbeinformedandthechoiceofanaestheticshouldbeanagentwithas

littlenegativeinotropicactivity aspossible.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Propranololshould onlybeused with caution in patientswho arereceiving concomitantmyocardialdepressantssuch as

chloroform,oranti-arrhythmicagentssuchaslignocaine,quinidine,procainamide,orbeta-adrenoceptorstimulants

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Adrenergicneuroneblockingagentssuchasguanethidineandreserpine,diureticsandotherantihypertensiveagents,

including thevasodilatorgroupwillhavean additiveeffecton thehypotensiveaction ofthedrug.

Propranololmaymaskthesymptomsofthyrotoxicosisandofhypoglycaemiabyinhibitionofsympatheticnerve

functions.Itmayalsoaffectcarbohydratemetabolismperse.Theeffectsofhypoglycaemicagentsmaybeincreased

particularly by thenon-cardioselectivebeta-blockers.

Ifpropranololandclonidinearegivenconcomitantly,theclonidineshouldnotbediscontinueduntilseveraldaysafter

withdrawalofthebeta-blocker.

Intheeventthatapatientreceivingpropranololrequiresanaesthesia,theanaesthetistshouldbeinformedoftheuseof

themedication priorto theuseofageneralanaestheticto permithistaking thenecessary precautions.

Concurrentusewith verapamilshould beavoided, astheeffectsofbeta-blockersand verapamilmay beadditivewith

respecttoboth conduction and contraction.

4.6Pregnancyandlactation

Propranololshould notbegiven during pregnancy orlactation unlessconsidered essentialby thephysician.

4.7Effectsonabilitytodriveandusemachines

Symptomssuch aslight-headednessand fatiguehaveoccasionally been reported in association with useofbeta-

blockersand patientsshould beadvised notto driveorto operatemachinery ifaffected.

4.8Undesirableeffects

Possibleside-effectsincludenausea,vomiting,diarrhoea,bradycardia,hypotension,coldextremities,depressionand

sleepdisturbances. Bronchospasmmayoccur,particularlyinsusceptibleindividuals. Someocularchanges

(conjunctivitisand‘dryeye’)and/orskinrasheshavebeenreportedinassociationwiththeuseofbeta-adrenoceptor

blockers.

(SeeSpecialwarningsand precautionsforuse).

4.9Overdose

Ifoverdosageisrecent, thestomach should beemptied by gastricaspiration/lavage.Excessivebradycardiaand

hypotension may respondto atropine1-2mg intravenously, ifnecessary followed by abolusdoseofglucagon 10mg

intravenously.Ifrequired, thismay berepeated orfollowed by an intravenousinfusion ofglucagon attherateof1-

10mg/hourdepending on response.Ifthereisno responseto glucagon, orifglucagon isnotavailable, abeta-

adrenoceptorstimulantsuch asisoprenaline25microgramsinitially ororciprenaline0.5mg may begiven by slow

intravenousinjection.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Propranololisabeta-adrenergicreceptorblocking agent.

5.2Pharmacokineticproperties

Propranololisalmostcompletelyabsorbedfromthegastro-intestinaltractandundergoesextensivefirst-pass

metabolismintheliver.Plasmahalf-lifeisabout3to6hours.Metabolitesareexcretedintheurinewithsome

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5.3Preclinical safetydata

No furtherrelevantinformation otherthan thatwhich isincluded in othersectionsoftheSummary ofProduct

Characteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore:

Lactosemonohydrate

Maizestarch

Povidone

Colloidalanhydroussilica

Magnesiumstearate

Film-coating:

Methylcellulose

Ethylcellulose

Diethylphthalate

Opaspray K-I-1340 containing hypromellose, titaniumdioxide(E171)and carmine(E120)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.

Storein theoriginalcontainer.

6.5Natureandcontentsofcontainer

Polypropylenetabletcontainerswith tamperevidentpolypropylenecaps.

Pack size:100, 250, 500and 1,000 tablets.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Antigen PharmaceuticalsLtd.

Roscrea

County Tipperary

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation 1 st

November1982

Dateoflastrenewal: 1 st

November2002

10DATEOFREVISIONOFTHETEXT

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