BRICANYL TURBOHALER

Main information

  • Trade name:
  • BRICANYL TURBOHALER
  • Dosage:
  • 500 Mcg/ Dose
  • Pharmaceutical form:
  • Powder for Inhalation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRICANYL TURBOHALER
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1473/029/001
  • Authorization date:
  • 02-10-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BricanylTurbohaler500microgramspermetereddose,inhalationpowder

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmetereddosecontains500microgramsofTerbutalineSulphate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Inhalationpowder

ProductimportedfromtheUK:

Whitetooffwhitesphericalparticleswhichbreakintoafinepowderoninhalation,containedinaplasticmulti-dose

breath-actuatedmetereddosepowderinhaler.

4CLINICALPARTICULARS

Terbutalineisaselective2-adrenergicagonistrecommendedforthereliefandpreventionofbronchospasmin

bronchialasthmaandinchronicbronchitisandotherbronchopulmonarydisordersinwhichbronchospasmisa

complicatingfactor.

4.2Posologyandmethodofadministration

AdultsandChildren:Oneinhalation(500micrograms)(metereddose)asrequired.Notmorethan4inhalationsshould

benecessaryinany24hourperiod.

Elderly:Dosageasforadults.

InstructionsforuseandcleaningareprovidedinthePatientInformationLeaflet,whichcanbefoundineachpack.

4.3Contraindications

Bricanylpreparationsarecontra-indicatedinpatientswithahistoryofsensitivitytoterbutalinesulphate.

4.4Specialwarningsandprecautionsforuse

Patientsshouldbeinstructedinproperuseandtheirinhalationtechniquecheckedregularly.

Careshouldbetakeninpatientssufferingfrommyocardialinsufficiencyorthyrotoxicosis.

Duetothehyperglycaemiceffectsof2-stimulants,additionalbloodglucosemeasurementsareinitiallyrecommended

whenBricanyltherapyiscommencedindiabeticpatients.

Cardiovasculareffectsmaybeseenwithsympathomimeticdrugs,includingBricanyl.Thereissomeevidencefrom

post-marketingdataandpublishedliteratureofrareoccurrencesofmyocardialischaemiaassociatedwithbetaagonists.

Patientswithunderlyingsevereheartdisease(e.g.ischaemicheartdisease,arrhythmiaorsevereheartfailure)whoare

receivingBricanylshouldbewarnedtoseekmedicaladviceiftheyexperiencechestpainorothersymptomsof

worseningheartdisease.Attentionshouldbepaidtoassessmentofsymptomssuchasdyspnoeaandchestpain,asthey

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Potentiallyserioushypokalaemiamayresultfrom

-agonisttherapy,mainlywithparenteralornebulised

administration.Particularcautionisadvisedinacutesevereasthmaasthiseffectmaybeaugmentedbyhypoxia.The

hypokalaemiceffectmaybepotentiatedbyconcomitanttreatmentwithxanthinederivatives,corticosteroidsand/or

diuretics.Itisrecommendedthatserumpotassiumlevelsaremonitoredinsuchsituations.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Beta-blockingagents(includingeyedrops),especiallythenon-selectiveonessuchaspropranolol,maypartiallyor

totallyinhibittheeffectof2-stimulants.Therefore,Bricanylpreparationsandnon-selective-blockersshouldnot

normallybeadministeredconcurrently.Bricanylshouldbeusedwithcautioninpatientsreceivingother

sympathomimetics.

Hypokalaemiamayresultfrom2-agonisttherapyandmaybepotentiatedbyconcomitanttreatmentwithxanthine

derivatives,corticosteroidsanddiuretics(seeSection4.4,SpecialWarningsandPrecautionsforuse).

4.6Fertility,pregnancyandlactation

Althoughnoteratogeniceffectshavebeenobservedinanimalsorinpatients,Bricanylshouldonlybeadministered

withcautionduringthefirsttrimesterofpregnancy.

Terbutalineissecretedviabreastmilkbutanyeffectontheinfantisunlikelyattherapeuticdoses.

Transienthypoglycaemiahasbeenreportedinnewbornpreterminfantsaftermaternal2-agonisttreatment.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Thefrequencyofside-effectsislow.Side-effectswhichhavebeenrecordedsuchastremor,headache,nausea,tonic

cramp,mouthandthroatirritation,tachycardiaandpalpitationsareallcharacteristicofsympathomimeticamines.A

fewpatientsfeeltense;thisisalsoduetotheeffectsonskeletalmuscleandnottodirectCNSstimulation.Whenever

theseside-effectshaveoccurred,themajorityhaveusuallybeenspontaneouslyreversiblewithinthefirstweekof

treatment.Aswithother

-agonists,tremorisdoserelated.

Sleepdisturbancesandbehaviouraldisturbances,suchasagitation,hyperactivityandrestlessness,havebeenobserved.

Tachycardia,withorwithoutperipheralvasodilation,hasbeenrarelyreportedduring

-agonisttherapy.Cardiac

arrhythmias,includingatrialfibrillation,supraventriculartachycardiaandextrasystoles,havebeenreportedin

associationwith

-agonists,usuallyinsusceptiblepatients.Myocardialischaemiamayoccur;theincidenceis

unknown*(seesection4.4).

Potentiallyserioushypokalaemiamayresultfrom -agonisttherapy.(SeealsoSection4.4,SpecialWarningsand

Precautionsforuse.)

Inrarecases,throughunspecifiedmechanisms,paradoxicalbronchospasmmayoccur,withwheezingimmediatelyafter

inhalation.Thisshouldbeimmediatelytreatedwitharapid-onsetbronchodilator.Bricanyltherapyshouldbe

discontinuedand,afterassessment,analternativetherapyinitiated.

Hypersensitivityreactions,includingangioedema,urticaria,exanthema,bronchospasm,hypotensionandcollapse,have

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*reportedspontaneouslyinpost-marketingdatathereforefrequencyregardedasunknown

4.9Overdose

i)Possiblesymptomsandsigns:Headache,anxiety,tremor,nausea,toniccramp,palpitations,tachycardiaand

arrhythmia.Afallinbloodpressuresometimesoccurs.Laboratoryfindings:Hypokalaemia,hyperglycaemiaand

metabolicacidosissometimesoccur.

ii)Treatment:

Mildandmoderatecases:Reducethedose.

Severecases:Gastriclavage,administrationofactivatedcharcoal(wheresuspectedthatsignificantamountshavebeen

swallowed).Determinationofacid-basebalance,bloodsugarandelectrolytes,particularlyserumpotassiumlevels.

Monitoringofheartrateandrhythmandbloodpressure.Metabolicchangesshouldbecorrected.Acardioselective-

blocker(e.g.metoprolol)isrecommendedforthetreatmentofarrhythmiascausinghaemodynamicdeterioration.The

-blockershouldbeusedwithcarebecauseofthepossibilityofinducingbronchoconstriction:usewithcautionin

patientswithahistoryofbronchospasm.Ifthe2-mediatedreductioninperipheralvascularresistancesignificantly

contributestothefallinbloodpressure,avolumeexpandershouldbegiven.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmaco-therapeuticgroup:Selective2-agonist,terbutaline,

ATCcode:R03AC03.

Terbutalinesulphateisanadrenergicagonistwhichpredominantlystimulates2-receptors,thusproducingrelaxation

ofbronchialsmoothmuscle,inhibitionofthereleaseofendogenousspasmogens,inhibitionsofoedemacausedby

endogenousmediatorsandincreasedmucociliaryclearance.

Inhaledterbutalineactswithinafewminutesandhasadurationforupto6hours.TreatmentwithBricanylTurbohaler

iseffectiveevenduringanacuteasthmaattack.

5.2Pharmacokineticproperties

About20-30%ofthemetereddoseisdepositedinthelungsatanormalinhalationflowrate.Terbutalineismetabolized

mainlybyconjugationwithsulphuricacidandexcretedasthesulphateconjugate.Noactivemetabolitesareformed.

5.3Preclinicalsafetydata

Themajortoxiceffectofterbutaline,observedintoxicologicalstudies,isfocalmyocardialnecrosis.Thistypeof

cardiotoxicityisawell-knownclass-effect,andtheeffectofterbutalineissimilartoorlesspronouncedthanthatof

otherbeta-receptoragonists.Terbutalinehasbeenusedextensivelyovermanyyearsforthereliefofbronchospasm

withoutidentifyinganyareasofconcern.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

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6.2Incompatibilities

Notapplicable

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

Replacethecoverproperlyafteruse

6.5Natureandcontentsofcontainer

BricanylTurbohalerconsistsofanumberofassembledplasticdetails,themainpartsbeingthedosingmechanism,the

drugsubstancestore,thedesiccantstoreandthemouthpiece.Theinhalerisprotectedbyanoutertubularcoverscrewed

ontoabottomplate.

Eachoverlabelledinhalercontains100metereddoses.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

McDowellPharmaceuticals

4AltonaRoad

Lisburn

BT275QB

NorthernIreland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1473/29/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:2ndOctober2009

10DATEOFREVISIONOFTHETEXT

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