BRICANYL TURBOHALER

Main information

  • Trade name:
  • BRICANYL TURBOHALER
  • Dosage:
  • 500 Microgram
  • Pharmaceutical form:
  • Inhalation Powder, Capsule
  • 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:
  • PPA0465/088/001A
  • Authorization date:
  • 07-02-2003
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BricanylTurbohaler500microgramspermetereddose,Inhalationpowder.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmetereddosecontains500microgramsterbutalinesulfate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Inhalationpowder

Breathacutatedmetereddosepowderinhaler.Whitetooff-whitesphericalparticleswhichbreakintoafinepowderon

inhalation.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Terbutalineisaselective

-adrenergicagonistrecommendedforthereliefandpreventionofbronchospasmin

bronchialasthmaandinchronicbronchitis,emphysemaandotherbronchopulmonarydisordersinwhichbronchospasm

isacomplicatingfactor.

4.2Posologyandmethodofadministration

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

benecessaryinany24hourperiod.

Elderly:Dosageasforadults.

InstructionsforuseandcleaningareprovidedinthePatientInformationLeaflet,whichcanbefoundineachpack.

4.3Contraindications

Bricanylpreparationsarecontra-indicatedinpatientswithahistoryofsensitivitytoterbutalinesulfate.

4.4Specialwarningsandprecautionsforuse

Patientsshouldbeinstructedinproperuseandtheirinhalationtechniquecheckedregularly.Careshouldbetakenin

patientssufferingfrommyocardialinsufficiencyorthyrotoxicosis.

Duetothehyperglycaemiceffectsofß

-stimulants,additionalbloodglucosemeasurementsareinitiallyrecommended

whenBricanyltherapyiscommencedindiabeticpatients.

Ifpreviouslyeffectivedosageregimennolongergivesthesamesymptomaticrelief,thepatientshouldurgentlyseek

furthermedicaladvice.

Considerationshouldbegiventotherequirementsforadditionaltherapy(includingincreaseddosagesofanti-

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Duetothepositiveinotropiceffectofß

-agoniststherapy,mainlywithparentalornebulisedadministration.Particular

cautionisadvisedinacutesevereasthmaasthiseffectmaybeaugmentedbyhypoxia.Itisrecommendedthatserum

potassiumlevelsaremonitoredinsuchsituations.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Beta-blockingagents(includingeyedrop)especiallythenon-selectiveonessuchaspropranololmaypartiallyortotally

inhibittheeffectof

-stimulants.ThereforeBricanylpreparationsandnon-selective

-blockersshouldnotnormally

beadministeredconcurrently.Bricanylshouldbeusedwithcautioninpatientsreceivingothersympathomimetics.

Hypokalaemiamayresultfrom

-agoniststherapyandmaybepotentiatedbyconcomitanttreatmentwithxanthine

derivatives,corticosteroidsanddiuretics(seeSection4.4,SpecialWarningsandPrecautionsforuse).

4.6Fertility,pregnancyandlactation

AlthoughnoteratogeniceffectshavebeenobservedinanimalsorinpatientsBricanylshouldonlybeadministeredwith

cautionduringthefirsttrimesterofpregnancy.

Terbutalineissecretedviabreastmilkbuteffectontheinfantisunlikelyattherapeuticdoses.

Transienthypoglycaemiahasbeenreportedinnewbornpreterminfantsaftermaternalß

-agoniststreatment.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Thefrequencyofside-effectsislow.Side-effectswhichhavebeenrecordedsuchastremor,headache,nauseatonic

cramp,mouthandthroatirritation,tachycardiaandpalpitationsareallcharacteristicofsympathomimeticamines.A

fewpatientsfeeltense;thisisalsoduetoeffectsonskeletalmuscleandnottodirectCNSstimulation.Wheneverthese

side-effectshaveoccurred,themajorityhaveusuallybeenspontaneouslyreversiblewithinthefirstweekoftreatment.

Aswithotherß

-agonists,tremorisdoserelated.

Sleepdisturbancesandbehaviouraldisturbances,suchasagitation,hyperactivityandrestlessness,havebeenobserved.

Tachycardia,withorwithoutperipheralvasodilation,hasbeenrarelyreportedduringß

-agonisttherapy.Cardiac

arrhythmias,includingatrialfibrillation,supraventriculartachycardiaandextrasystoles,havebeenreportedin

associationwithß

-agonists,usuallyinsusceptiblepatients.

Potentiallyserioushypokalaemiamayresultfromß

-agonisttherapy.(SeealsoSection4.4SpecialWarningsand

Precautionsforuse.)

Inrarecases,throughunspecifiedmechanisms,paradoxicalbronchospasmmayoccur,withwheezingimmediatelyafter

inhalation.

Thisshouldbeimmediatelytreatedwithrapid-onsetbronchodilator.

Bricanyltherapyshouldbediscontinuedand,afterassessment,analternativetherapyinitiated.

Hypersensitivityreactions,includingangioedema,urticaria,exanthema,brochospasm,hypotensionandcollapse,have

beenveryrarelyreportedwithß

-agonisttherapy.

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Possiblesymptomsandsigns:Headache,anxiety,tremor,toniccramp,palpitationsandarrhythmia.Afallin

bloodpressuresometimesoccurs.Laboratoryfindings:Hypokalaemia,hyperglycaemiaandmetabolicacidosis

sometimesoccur.

Treatment:

Mildandmoderatecases:Reducethedose

Severecases:Gastriclavage,administrationofactivatedcharcoal(wheresuspectedthatsignificantamountshave

beenswallowed).Determinationofacid-basebalance,bloodsugarandelectrolytes,particularlyserumpotassium

levels.Monitoringofheartrateandrhythmandbloodpressure.Metabolicchangesshouldbecorrected.A

cardioselective-blocker(e.g.metoprolol)isrecommendedforthetreatmentofarrhythmiascausinghaemodynamic

deterioration.The-blockershouldbeusedwithcarebecauseofthepossibilityinducingbronchoconstriction:usewith

cautioninpatientswithahistoryofbrochospasm.Ifthe

-mediatedreductioninperipheralvascularresistance

significantlycontributestothefallinbloodpressure,avolumeexpandershouldbegiven.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Selective

-agonists,tebutaline,

ATCcode:RO3ACO3

Terbutalinesulfateisanadrenergicagonistwhichpredominantlystimulates

-receptors,thusproducingrelaxationof

bronchialsmoothmuscle,inhibitionofthereleaseofendogenousspasmogens,inhibitionsofoedemacausedby

endogenousmediatorsandincreasedmucociliaryclearance.

Inhaledterbutalineactswithinafewminutesandhasadurationforupto6hours.TreatmentwithBricanylTurbohaler

iseffectiveevenduringanacuteasthmaattack.

5.2Pharmacokineticproperties

About20-30%ofthemetereddoseisdepositedinthelungsatanormalinhalationflowrate.Terbutalineis

metabolisedmainlybyconjugationwithsulphuricacidandexcretedasthesulphateconjugate.Noactivemetabolites

areformed.

5.3Preclinicalsafetydata

Themajortoxiceffectofterbutaline,observedintoxicologicalstudies,isfocalmyocardialnecrosis.Thistypeof

cardiotoxicityisawellknownclass-effect,andtheeffectofterbutalineissimilartoorlesspronouncedthanthatof

otherbeta-receptoragonists.Terbutalinehasbeenusedextensivelyovermanyyearsforthereliefofbronchospasm

withoutidentifyinganyareasofconcern.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

None.

6.2Incompatibilities

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6.3Shelflife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandtheouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

Replacethecoverproperlyafteruse.

6.5Natureandcontentsofcontainer

BricanylTurbohalerconsistsofanumberofassembledplasticdetails,themainpartsbeingthedosingmechanism,the

drugsubstancestore,thedessicantstoreandthemouthpiece.Theinhalerisprotectedbyanoutertubularcover

screwedontoabottomplate.Eachinhalercontains100actuations.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA0465/088/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:07February2003

Dateoflastrenewal: 07February2008

10DATEOFREVISIONOFTHETEXT

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