BRICANYL TURBOHALER

Main information

  • Trade name:
  • BRICANYL TURBOHALER
  • Dosage:
  • 500 Microgram
  • 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:
  • PPA1659/043/001
  • Authorization date:
  • 26-08-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BricanylTurbohaler500microgramspermetereddose,inhalationpowder.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmetereddosecontains500microgramsTerbutalineSulphate.

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

InhalationPowder.

ProductimportedfromtheUK:

Multi-dosebreath-actuatedmetereddosepowderinhaler.Whitetooff-whitesphericalparticleswhichbreakintoafine

powderoninhalation.

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(includingincreased

dosagesofanti-inflammatorymedication).

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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).

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

sometimesoccurs.Laboratoryfindings:Hypokalaemia,hyperglycaemiaandmetabolicacidosissometimesoccur.

Treatment:

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 Sleepdisorderand

Behaviouraldisturbances,

suchasagitationand

restlessness

NervousSystemDisorders Psychomotorhyperactivity

Respiratory,Thoracicand

MediastinalDisorders Bronchospasm**

SkinandSubcutaneous

TissueDisorders 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: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-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

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6.5Natureandcontentsofcontainer

BricanylTurbohalerconsistsofanumberofassembledplasticdetails,themainpartsbeingthedosingmechanism,the

drugsubstancestore,thedesiccantstoreandthemouthpiece.Theinhalerisprotectedbyanoutertubularcover

screwedontoabottomplate.

Eachinhalercontains100metereddoses.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialinstructions.

7PARALLELPRODUCTAUTHORISATIONHOLDER

IPSHealthcareLimited

SterlingHouse

501MiddletonRoad

Chadderton

Oldham

LancashireOL99LY

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1659/043/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26 th

August2011

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