BRICANYL TURBOHALER 500 Mcg/Dose Powder for Inhalation

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
TERBUTALINE SULFATE
Available from:
IMED Healthcare Ltd.
INN (International Name):
TERBUTALINE SULFATE
Dosage:
500 Mcg/Dose
Pharmaceutical form:
Powder for Inhalation
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization number:
PPA1463/032/001
Authorization date:
2014-05-28

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BricanylTurbohaler500microgramspermetereddose,inhalationpowder.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmetereddosecontains500microgramsofTerbutalineSulphate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Inhalationpowder

ProductimportedfromtheUK:

Multi-dosebreath-actuatedmetereddosepowderinhaler.Whitetooffwhitesphericalparticleswhichbreakintoafine

powderoninhalation.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Terbutalineisaselectivebeta

-adrenergicagonistrecommendedforthereliefandpreventionofbronchospasmin

bronchialasthmaandinchronicbronchitisandotherbronchopulmonarydisordersinwhichbronchospasmisa

complicatingfactor.

4.2Posologyandmethodofadministration

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

benecessaryinany24hourperiod.

Elderly:Dosageasforadults.

InstructionsforuseandcleaningareprovidedinthePatientInformationLeaflet,whichcanbefoundineachpack.

4.3Contraindications

Bricanylpreparationsarecontra-indicatedinpatientswithahistoryofsensitivitytoterbutalinesulphate.

4.4Specialwarningsandprecautionsforuse

Patientsshouldbeinstructedinproperuseandtheirinhalationtechniquecheckedregularly.

Witheachinhalationafractionofthedelivereddosewillbedepositedintheoralcavity.Tominimizeunnecessary

systemicexposuretoterbutaline,thepatientsshouldbeadvisedto,whenpossible,rinsetheirmouthaftereachuse.

Ifapreviouslyeffectivedosageregimennolongergivesthesamesymptomaticrelief,thepatientshouldurgentlyseek

furthermedicaladvice.Considerationshouldbegiventotherequirementsforadditionaltherapy(includingincreased

dosagesofanti-inflammatorymedication).Severeexacerbationsofasthmashouldbetreatedasanemergencyinthe

usualmanner.

Asforallbeta

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Cardiovasculareffectsmaybeseenwithsympathomimeticdrugs,includingBricanyl.

Thereissomeevidencefrompost-marketingdataandpublishedliteratureofrareoccurrencesofmyocardialischaemia

associatedwithbetaagonists.Patientswithunderlyingsevereheartdisease(e.g.ischaemicheartdisease,arrhythmiaor

severeheartfailure)whoarereceivingBricanylshouldbewarnedtoseekmedicaladviceiftheyexperiencechestpain

orothersymptomsofworseningheartdisease.Attentionshouldbepaidtoassessmentofsymptomssuchasdyspnoea

andchestpain,astheymaybeofeitherrespiratoryorcardiacorigin.

Duetothepositiveinotropiceffectofbeta

-agonists,thesedrugsshouldnotbeusedinpatientswithhypertrophic

cardiomyopathy.

Duetothehyperglycaemiceffectsofbeta

-agonists,additionalbloodglucosemeasurementsareinitiallyrecommended

whenBricanyltherapyiscommencedindiabeticpatients.

Potentiallyserioushypokalaemiamayresultfrombeta

-agonisttherapy,mainlywithparenteralornebulised

administration.Particularcautionisadvisedinacutesevereasthmaasthiseffectmaybeaugmentedbyhypoxia.The

hypokalaemiceffectmaybepotentiatedbyconcomitanttreatmentwithxanthinederivatives,corticosteroidsand/or

diuretics(SeeSection4.5).Itisrecommendedthatserumpotassiumlevelsaremonitoredinsuchsituations.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

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

totallyinhibittheeffectofbeta

-stimulants.Therefore,Bricanylpreparationsandnon-selective-blockersshouldnot

normallybeadministeredconcurrently.Bricanylshouldbeusedwithcautioninpatientsreceivingother

sympathomimetics.

Hypokalaemiamayresultfrombeta

-agonisttherapyandmaybepotentiatedbyconcomitanttreatmentwithxanthine

derivatives,corticosteroidsanddiuretics(seeSection4.4,SpecialWarningsandPrecautionsforuse).

Therearesomedatawhichindicatethatthereisariskofinteractionbetweenmonoamineoxidaseinhibitors,tricyclic

antidepressantsandterbuatline.

4.6Fertility,pregnancyandlactation

Althoughnoteratogeniceffectshavebeenobservedinanimalsorinpatients,Bricanylshouldonlybeadministered

withcautionduringthefirsttrimesterofpregnancy.

Terbutalineissecretedviabreastmilkbutanyeffectontheinfantisunlikelyattherapeuticdoses.

Transienthypoglycaemiahasbeenreportedinnewbornpreterminfantsaftermaternalbeta

-agonisttreatment.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Thefrequencyofadversereactionsislowattherecommendeddose.Terbutalinegivenbyinhalationisunlikelyto

producesignificantsystemiceffectswhengiveninrecommendeddoses.Mostoftheadversereactionsare

characteristicofsympathomimeticamines.Themajorityoftheseeffectshavereversedspontaneouslywithinthefirst1-

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*Reportedspontaneouslyinpost-marketingdataandthereforefrequencyregardedasunknown

**Drugsforinhalationmaythroughunspecifiedmechanismscausebronchospasm.

4.9Overdose

Possiblesymptomsandsigns:

Headache,anxiety,tremor,nausea,toniccramp,palpitations,tachycardiaandarrhythmia.Afallinbloodpressure

Frequency

Classification AdverseDrugReaction

SystemOrganClass

(SOC) Preferredterm(PT)

VeryCommon

1/10 NervousSystemDisorders Tremor

Headache

Common<1/10

and1/100 CardiacDisorders Tachycardia

Palpitations

Musculoskeletaland

ConnectiveTissueDisorders Musclespasms

MetabolismandNutrition

Disorders Hypokalaemia

Unknown* CardiacDisorders Arrhythmias,e.g.atrial

fibrillation,supraventricular

tachycardiaand

extrasystoles

Myocardialischaemia

GastrointestinalDisorders Nausea

PsychiatricDisorders Sleepdisorederand

Behaviouraldisturbances,

suchasagitationand

restlessness

NervousSystemDisorders Psychomotorhyperactivity

Respiratory,Thoracicand

MediastinalDisorders Bronchospasm**

SkinandSubcutaneous

TissueDisorders Urticaria

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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:Selectivebeta

-agonist,terbutaline,

ATCcode:R03AC03.

Terbutalinesulphateisanadrenergicagonistwhichpredominantlystimulatesbeta

-receptors,thusproducing

relaxationofbronchialsmoothmuscle,inhibitionofthereleaseofendogenousspasmogens,inhibitionsofoedema

causedbyendogenousmediatorsandincreasedmucociliaryclearance.

Inhaledterbutalineactswithinafewminutesandhasadurationforupto6hours.TreatmentwithBricanylTurbohaler

iseffectiveevenduringanacuteasthmaattack.

5.2Pharmacokineticproperties

About20-30%ofthemetereddoseisdepositedinthelungsatanormalinhalationflowrate.Terbutalineismetabolized

mainlybyconjugationwithsulphuricacidandexcretedasthesulphateconjugate.Noactivemetabolitesareformed.

5.3Preclinicalsafetydata

Themajortoxiceffectofterbutaline,observedintoxicologicalstudies,isfocalmyocardialnecrosis.Thistypeof

cardiotoxicityisawell-knownclass-effect,andtheeffectofterbutalineissimilartoorlesspronouncedthanthatof

otherbeta-receptoragonists.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

None

6.2Incompatibilities

Notapplicable

6.3Shelflife

Theshelf-lifeexpirydateofthisproductisthedateshownontheinhalerandouterpackageoftheproductonthe

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6.4Specialprecautionsforstorage

Donotstoreabove30 °

Replacethecoverproperlyafteruse

6.5Natureandcontentsofcontainer

BricanylTurbohalerconsistsofanumberofassembledplasticdetails,themainpartsbeingthedosingmechanism,the

drugsubstancestore,thedesiccantstoreandthemouthpiece.Theinhalerisprotectedbyanoutertubularcoverscrewed

ontoabottomplate.

Eachoverlabelledinhalercontains100metereddoses

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

IMEDHealthcareLtd

NewRoad

Buncrana

Co.Donegal

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1463/32/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12thMarch2010

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 22/10/2012 CRN 2119162 page number: 5

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