BRICANYL TURBOHALER 500 MICROGRAMS PER METERED DOS

Main information

  • Trade name:
  • BRICANYL TURBOHALER 500 MICROGRAMS PER METERED DOS
  • Dosage:
  • 500 Microgram
  • Pharmaceutical form:
  • Powder for Inhalation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRICANYL TURBOHALER 500 MICROGRAMS PER METERED DOS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/055/001
  • Authorization date:
  • 12-01-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BricanylTurbohaler500microgramspermetereddose,inhalationpowder.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmetereddosecontains500microgramsTerbutalineSulphate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Inhalationpowder.

ProductimportedfromGreece,PortugalandUK:

Multi-dosebreath-actuatedmetereddosepowderinhaler.Whitetooff-whitesphericalparticleswhichbreakintoafine

powderoninhalation.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Terbutalineisaselective2-adrenergicagonistrecommendedforthereliefandpreventionofbronchospasmin

bronchialasthmaandinchronicbronchitisandotherbronchopulmonarydisordersinwhichbronchospasmisa

complicatingfactor.

4.2Posologyandmethodofadministration

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

benecessaryinany24hourperiod.

Elderly:Dosageasforadults.

InstructionsforuseandcleaningareprovidedinthePatientInformationLeaflet,whichcanbefoundineachpack.

4.3Contraindications

Bricanylpreparationsarecontra-indicatedinpatientswithahistoryofsensitivitytoterbutalinesulphate.

4.4Specialwarningsandprecautionsforuse

Patientsshouldbeinstructedinproperuseandtheirinhalationtechniquecheckedregularly.

Ifapreviouslyeffectivedosageregimennolongergivesthesamesymptomaticrelief,thepatientshouldurgentlyseek

furthermedicaladvice.Considerationshouldbegiventotherequirementsforadditionaltherapy(includingincreased

dosagesofanti-inflammatorymedication).Severeexacerbationsofasthmashouldbetreatedasanemergencyinthe

usualmanner.

Asforallbetal-agonistscautionshouldbeobservedinpatientswiththyrotoxicosis.

Cardiovasculareffectsmaybeseenwithsympathomimeticdrugs,includingBricanyl.Thereissomeevidencefrom

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Patientswithunderlyingsevereheartdisease(e.g.Ischaemicheartdisease,arrhythmiaorsevereheartfailure)whoare

receivingBricanylshouldbewarnedtoseekmedicaladviceiftheyexperiencechestpainorothersymptomsof

worseningheartdisease.Attentionshouldbepaidtoassessmentofsymptomssuchasdyspnoeaandchestpain,asthey

maybeofeitherrespiratoryorcardiacorigin.

Duetothepositiveinotropiceffectof~2-agonists,thesedrugsshouldnotbeusedinpatientswith,hypertrophic

cardiomyopathy.

Duetothehyperglycaemiceffectsofbeta2-agonists,additionalbloodglucosemeasurementsareinitiallyrecommended

whenBricanyltherapyiscommencedindiabeticpatients.

Potentiallyserioushypokalaemiamayresultfrom~2-agonisttherapy,mainlywithparenteralornebulised

administration.Particularcautionisadvisedinacutesevereasthmaasthiseffectmaybeaugmentedbyhypoxia.The

hypokalaemiceffectmaybepotentiatedbyconcomitanttreatmentwith

xanthinederivatives,corticosteroidsand/ordiuretics.Itisrecommendedthatserumpotassiumlevelsaremonitoredin

suchsituations.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

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

totallyinhibittheeffectof2-stimulants.Therefore,Bricanylpreparationsandnon-selective-blockersshouldnot

normallybeadministeredconcurrently.Bricanylshouldbeusedwithcautioninpatientsreceivingother

sympathomimetics.

Hypokalaemiamayresultfrom

-agonisttherapyandmaybepotentiatedbyconcomitanttreatmentwithxanthine

derivatives,corticosteroidsanddiuretics(seeSection4.4,SpecialWarningsandPrecautionsforuse).

Therearesomedatawhichindicatethatthereisariskofinteractionbetweenmonoamineoxidaseinhibitors,tricyclic

antidepressantsandterbutaline.

4.6Fertility,pregnancyandlactation

Althoughnoteratogeniceffectshavebeenobservedinanimalsorinpatients,Bricanylshouldonlybeadministered

withcautionduringthefirsttrimesterofpregnancy.

Terbutalineissecretedviabreastmilkbutanyeffectontheinfantisunlikelyattherapeuticdoses.

Transienthypoglycaemiahasbeenreportedinnewbornpreterminfantsaftermaternal

-agonisttreatment.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Thefrequencyofadversereactionsislowattherecommendeddose.Terbutalinegivenbyinhalationisunlikelyto

producesignificantsystemiceffectswhengiveninrecommendeddoses.Mostoftheadversereactionsarecharacteristic

ofsympathomimeticamines.Themajorityoftheseeffectshavereversedspontaneouslywithinthefirst1-2weeksof

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*Reportedspontaneouslyinpost-marketingdataandthereforefrequencyregardedasunknown

**Drugsforinhalationmaythroughunspecifiedmechanismscausebronchospasm.

4.9Overdose

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

arrhythmia.Afallinbloodpressuresometimesoccurs.Laboratoryfindings:Hypokalaemia,hyperglycaemiaand

metabolicacidosissometimesoccur.

ii)Treatment:

FrequencyClassification AdverseDrugReaction

SystemOrganClass(SOC) Preferredterm(PT)

VeryCommon>1/10

NervousSystemDisorders Tremor

Headache

Common<1/10and>1/100

CardiacDisorders Tachycardia

Palpitations

MusculoskeletalandConnective

TissueDisorders MuscleSpasms

MetabolismandNutrition

Disorders Hypokalaemia

Unknown*

CardiacDisorders Arrhythmias,e.g.atrial

fibrillation,supraventricular

tachycardiaandextrasystoles

Myocardialischaemia

GastrointestinalDisorders Nausea

PsychiatricDisorders SleepdisorderandBehavioural

disturbances,suchasagitation

andrestlessness

NervousSystemDisorders Psychomotorhyperactivity

Respiratory,Thoracic

MediastinalDisorders Bronchospasm**

SkinandSubcutaneousTissue

Disorders Urticaria

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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

None

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

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6.5Natureandcontentsofcontainer

BricanylTurbohalerconsistsofanumberofassembledplasticdetails,themainpartsbeingthedosingmechanism,the

drugsubstancestore,thedesiccantstoreandthemouthpiece.Theinhalerisprotectedbyanoutertubularcoverscrewed

ontoabottomplate.

Eachinhalercontains100or200metereddoses.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

Middlesex

HA40NU

UnitedKingdom.

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1328/55/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation12 th

January2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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