BRICANYL TURBOHALER

Main information

  • Trade name:
  • BRICANYL TURBOHALER
  • Dosage:
  • 500 Mcg/Acutuation
  • 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:
  • PPA1500/060/001
  • Authorization date:
  • 20-08-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BricanylTurbohaler500microgramspermetereddose,Inhalationpowder.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmetereddosecontains500microgramsofTerbutalineSulphate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Inhalationpowder

ProductimportedfromtheUKandfromHungary:

Multi-dosebreath-actuatedmetereddosepowderinhaler.

Whitetooffwhitesphericalparticleswhichbreakintoafinepowderoninhalation

4CLINICALPARTICULARS

4.1TherapeuticIndications

Terbutalineisaselectivebeta

-adrenergicagonistrecommendedforthereliefandpreventionofbronchospasmin

bronchialasthmaandinchronicbronchitisandotherbronchopulmonarydisordersinwhichbronchospasmisa

complicatingfactor.

4.2Posologyandmethodofadministration

AdultsandChildren:

Oneinhalation(500micrograms)(metereddose)asrequired.Notmorethan4inhalationsshouldbenecessaryinany

24hourperiod.

Elderly:

Dosageasforadults.

InstructionsforuseandcleaningareprovidedinthePatientInformationLeaflet,whichcanbefoundineachpack.

4.3Contraindications

Bricanylpreparationsarecontra-indicatedinpatientswithahistoryofsensitivitytoterbutalinesulphate.

4.4Specialwarningsandprecautionsforuse

Patientsshouldbeinstructedinproperuseandtheirinhalationtechniquecheckedregularly.

Ifapreviouslyeffectivedosageregimennolongergivesthesamesymptomaticrelief,thepatientshouldurgentlyseek

furthermedicaladvice.

Considerationshouldbegiventotherequirementsforadditionaltherapy(includingincreaseddosagesofanti-

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Severeexacerbationsofasthmashouldbetreatedasanemergencyintheusualmanner.

Asforallbeta

-agonistscautionshouldbeobservedinpatientswiththyrotoxicosis.

Cardiovasculareffectsmaybeseenwithsympathomimeticdrugs,includingBricanyl.Thereissomeevidencefrom

post-marketingdataandpublishedliteratureofrareoccurrencesofmyocardialischaemiaassociatedwithbetaagonists.

Patientswithunderlyingsevereheartdisease(e.g.ischaemicheartdisease,arrhythmiaorsevereheartfailure)whoare

receivingBricanylshouldbewarnedtoseekmedicaladviceiftheyexperiencechestpainorothersymptomsof

worseningheartdisease.Attentionshouldbepaidtoassessmentofsymptomssuchasdyspnoeaandchestpain,asthey

maybeofeitherrespiratoryorcardiacorigin.

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).

4.6Fertility,pregnancyandlactation

Althoughnoteratogeniceffectshavebeenobservedinanimalsorinpatients,Bricanylshouldonlybeadministered

withcautionduringthefirsttrimesterofpregnancy.

Terbutalineissecretedviabreastmilkbutanyeffectontheinfantisunlikelyattherapeuticdoses.

Transienthypoglycaemiahasbeenreportedinnewbornpreterminfantsaftermaternalbeta

-agonisttreatment.

4.7Effectsonabilitytodriveandusemachines

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4.8Undesirableeffects

Thefrequencyofadversereactionsislowattherecommendeddose.Terbutalinegivenbyinhalationisunlikelyto

producesignificantsystemiceffectswhengiveninrecommendeddoses.Mostoftheadversereactionsare

characteristicofsympathomimeticamines.Themajorityoftheseeffectshavereversedspontaneouslywithinthefirst1-

2weeksoftreatment.

*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

≥1/100 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-lifeexpirydateofthisproductisthedateshownontheinhalerandoutercartonoftheproductonthemarket

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6.4Specialprecautionsforstorage

Donotstoreabove30 ˚C

Replacethecoverproperlyafteruse

6.5Natureandcontentsofcontainer

ProductimportedfromtheUK:

AnouteroverlabelledcardboardcartoncontainingawhiteTurbohalerconsistingofanoutercoverscrewedontoa

bottomplate.Insideistheinhalerwithitsmainparts:amouthpiece,adosingmechanism,andasubstancestore.

Thereisoneinhalerpercarton.Eachinhalercontains100metereddoses.

ProductimportedfromHungary:

AnouteroverlabelledcardboardcartoncontainingawhiteTurbohalerconsistingofanoutercoverscrewedontoa

bottomplate.Insideistheinhalerwithitsmainparts:amouthpiece,adosingmechanism,andasubstancestore.

Thereisoneinhalerpercarton.Eachinhalercontains200metereddoses.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

ProfindWholesaleLtd

Unit625,KilshaneAvenue

NorthwestBusinessPark

Dublin15

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1500/60/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:20 th

August2010

10DATEOFREVISIONOFTHETEXT

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