CLICKHALER SALBUTAMOL

Main information

  • Trade name:
  • CLICKHALER SALBUTAMOL
  • Dosage:
  • 95mcg/actu %v/v
  • Pharmaceutical form:
  • Powder for Inhalation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLICKHALER SALBUTAMOL
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0486/001/001
  • Authorization date:
  • 17-04-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0486/001/001

CaseNo:2029180

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

InnovataBiomedLtd

1MereWay,Ruddington,Nottingham,NG116JS,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ClickhalerSalbutamolinhalationpowder,95micrograms/inhalation

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom27/08/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 29/09/2008 CRN 2029180 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ClickhalerSalbutamolinhalationpowder,95micrograms/inhalation

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmeteredactuationof3mgofinhalationpowdercontains114microgramsofsalbutamolsulphate(95micrograms

salbutamolbase)anddelivers110microgramsofsalbutamolsulphate(90microgramsofsalbutamolbase).

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Inhalationpowder.

Aplasticinhalerdeviceincorporatinganactuatingandmeteringmechanismenclosedwithinanaluminiumfoilheat

sealedbag.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ClickhalerSalbutamolisindicatedforthesymptomatictreatmentofbronchospasminbronchialasthmaandother

conditionswithassociatedreversibleairwaysobstruction.Appropriateanti-inflammatorytherapyshouldbeconsidered

inlinewithcurrentpractice.

ClickhalerSalbutamolmaybeusedwhennecessarytorelieveattacksofacutedyspnoeaduetobronchoconstriction.

ClickhalerSalbutamolmayalsobeusedbeforeexertiontopreventexercise-inducedbronchospasmorbeforeexposure

toaknownunavoidableallergenchallenge.

4.2Posologyandmethodofadministration

Adults:Forthereliefofacutebronchospasmandformanagingintermittentepisodesofasthma,oneinhalationmaybe

administeredasasingledose;thismaybeincreasedtotwoinhalationsifnecessary.Iftheresponseisinadequate,

higherdosesthantwoinhalationscanbeused.Themaximumrecommendeddoseistwoinhalationsthreeorfour

timesaday.

Topreventexercise-inducedbronchospasmoneortwoinhalationsshouldbetaken15minutesbeforeexertion.

Oneortwoinhalationsmayalsobetakenbeforeforeseeablecontactwithallergens.

Elderly:asforadults

Children:Oneinhalationistherecommendeddoseforthereliefofacutebronchospasm,inthemanagementofepisodic

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Ondemanduseshouldnotexceedfourtimesdaily.Thebronchodilatoreffectofeachadministrationofinhaled

salbutamollastsforatleastfourhoursexceptinpatientswhoseasthmaisbecomingworse.Suchpatientsshouldbe

warnednottoincreasetheirusageoftheinhaler,butshouldseekmedicaladvicesincetreatmentwith,oranincreased

doseofaninhaledand/orsystemicglucocorticosteroidisindicated.

Astheremaybeadverseeffectsassociatedwithexcessivedosing,thedosageorfrequencyofadministrationshould

onlybeincreasedonmedicaladvice.

ThefollowinginstructionsforuseareincludedinthePatientInformationLeaflet:

Removemouthpiececoverfromtheinhaler

Shaketheinhalerwell

Holdtheinhaleruprightwiththumbonthebaseandfingeronthepushbutton.Pressthedosingbuttondown

firmly-onceonly

Breatheoutasfarasiscomfortable.

Note:donotblowintothedeviceatanytime.

Placemouthpieceinyourmouth.Closelipsfirmlyaroundit(donotbiteit)

Breatheinthroughyourmouthsteadilyanddeeply,todrawthemedicineintoyourlungs.

Holdyourbreath,taketheinhalerfromyourmouthandcontinueholdingyourbreathforabout5seconds.

Forthesecondpuff,keeptheinhaleruprightandrepeatsteps2-7.

Replacethemouthpiececover.

4.3Contraindications

ClickhalerSalbutamoliscontraindicatedinpatientswithhypersensitivity(allergy)toanyoftheactivesubstancesor

theexcipients(seesection6.1ListofExcipients).

4.4Specialwarningsandprecautionsforuse

Bronchodilatorsshouldnotbetheonlyormaintreatmentinpatientswithmoderatetosevereorunstableasthma.

Severeasthmarequiresregularmedicalassessmentincludinglungfunctiontestingaspatientsareatriskofsevere

attacksandevendeath.Physiciansshouldconsiderusingthemaximumrecommendeddoseofinhaledcorticosteroid

and/ororalcorticosteroidtherapyinthesepatients.Increasinguseofbronchodilators,inparticularshort-actinginhaled

beta-2-agoniststorelievesymptoms,indicatesdeteriorationofasthmacontrol.Ifpatientsfindthatshort-acting

bronchodilatortreatmentbecomeslesseffectiveortheyneedmoreinhalationsthanusual,theyshouldbewarnedbythe

prescriberoftheneedforconsultingimmediately.Inthissituation,patientsshouldbereassessedandconsideration

giventotheneedforincreasedanti-inflammatorytherapy(eg.higherdosesofinhaledcorticosteroidsoracourseof

oralcorticosteroids).

Salbutamolshouldbeadministeredcautiously,especiallywithsystemictherapy,topatientssufferingfrom

thyrotoxicosis,myocardialinsufficiency,hypertension,knownaneurysms,decreasedglucosetolerance,manifest

diabetes,phaeochromocytomaandconcomitantuseofcardiacglycosides.Cautionshouldalsobeappliedinpatients

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Cardiovasculareffectsmaybeseenwithsympathomimeticdrugs,includingsalbutamol.Thereissomeevidencefrom

post-marketingdataandpublishedliteratureofrareoccurrencesofmyocardialischemiaassociatedwithsalbutamol.

Patientswithunderlyingsevereheartdisease(e.g.ischemicheartdisease,arrhythmiaorsevereheartfailure)whoare

receivingsalbutamolshouldbewarnedtoseekmedicaladviceiftheyexperiencechestpainorothersymptomsof

worseningheartdisease.Attentionshouldbepaidtoassessmentofsymptomssuchasdyspnoeaandchestpain,asthey

maybeofeitherrespiratoryorcardiacorigin.

Salbutamolandnon-selectivebeta-blockingdrugs,suchaspropranolol,shouldnotusuallybeprescribedtogether.

Potentiallyserioushypokalaemiahasresultedfromsystemicß

-agonisttherapy.Particularcautionisadvisedinacute

severeasthmaasthiseffectmaybepotentiatedbyconcomitanttreatmentwithxanthinederivatives,steroids,diuretics

andbyhypoxia.Itisrecommendedthatserumpotassiumlevelsaremonitoredinsuchsituations.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Salbutamolandnon-selectivebeta-blockingdrugs,suchaspropranolol,shouldnotusuallybeprescribedtogether.

Cautionisalsoadvisedinpatientsusingcardiacglycosides.

Potentiallyserioushypokalaemiahasresultedfromsystemicß2-agonisttherapy.Particularcautionisadvisedinacute

severeasthmaasthiseffectmaybepotentiatedbyconcomitanttreatmentwithxanthinederivatives,steroids,diuretics

andbyhypoxia.

Patientsshouldbeinstructedtodiscontinuesalbutamolatleast6hoursbeforeintendedanaesthesiawithhalogenated

anaesthetics,whereverpossible.

4.6Pregnancyandlactation

Pregnancy:Administrationofsalbutamolduringpregnancyshouldonlybeconsiderediftheexpectedbenefittothe

motherisgreaterthananypossiblerisktothefetus.Aswiththemajorityofdrugsthereislittlepublishedevidenceof

itssafetyintheearlystagesofpregnancy,butinanimalstudies,therewasevidenceofsomeharmfuleffectsinthefetus

atveryhighdoselevels.

Lactation:Salbutamolmaybesecretedinbreastmilk.Itisnotknownwhethersalbutamolhasaharmfuleffectonthe

neonateandsoitsuseshouldberestrictedtosituationswhereitisfeltthattheexpectedbenefittothemotherislikely

tooutweighanypotentialrisktotheneonate.

4.7Effectsonabilitytodriveandusemachines

Individualreactions,especiallyathigherdoses,maybesuchthatpatients’abilitytodriveorusemachinesmaybe

affected,particularlysoatthebeginningoftreatmentandinconjunctionwithalcohol.

Thepossiblesideeffectsofsalbutamolsuchastransientmusclecrampsandtremormaynecessitatecautionwhenusing

machines.

4.8Undesirableeffects

Thesideeffectsaredosedependentandduetothedirectmechanismofß2-agonists.

Hypersensitivityreactionsincludeangioedemaandurticaria,bronchospasm,hypotensionandcollapseandhavebeen

reportedveryrarely.

Bloodandthelymphaticsystemdisorders:potentiallyserioushypokalaemiamayresultfromsystemicß2-agonist

therapy.Specialprecautionsshouldbetakeninpatientsusingß2-agonistswithhypokalaemiabecauseoftheincreased

riskoftachycardiaandarrhythmias.Hypokalaemiamaybepotentiatedbyconcomitanttherapywithcorticosteroids,

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Psychiatricdisorders:nervousness,feelingoftenseness.Aswithotherß2agonists,hyperactivityinchildrenhasbeen

reportedrarely.

Nervoussystemdisorders:mildtremor,headache,dizziness.

Cardiacdisorders: tachycardia,angioedema,hypotension,cardiacarrhythmias(includingatrialfibrillation,

supraventriculartachycardiaandextrasystoles)andmyocardialischemia(seeSection4.4)havebeenreportedin

associationwithß2agonists,usuallyinsusceptiblepatients.

Respiratory,thoracicandmediastinaldisorders:aswithotherinhalationtherapy,thepotentialforparadoxical

bronchospasmshouldbekeptinmind.Ifitoccurs,thepreparationshouldbediscontinuedimmediatelyandalternative

therapyinstituted.

Gastrointestinaldisorders:nausea

Skinandsubcutaneoustissuedisorders:urticaria.

Musculoskeletal,connectivetissueandbonedisorders:therehavebeenrarereportsoftransientmusclecramps

Generaldisordersandadministrationsiteconditions:oralandpharyngealirritationcanoccur.

4.9Overdose

Anoverdoseshouldbetreatedsymptomatically.

Thepreferredantidoteforoverdosagewithsalbutamolisacardioselectivebeta-blockingagentbutbeta-blockingdrugs

shouldbeusedwithcautioninpatientswithahistoryofbronchospasm.

Ifhypokalaemiaoccurspotassiumreplacementviatheoralrouteshouldbegiven.Inpatientswithsevere

hypokalaemiaintravenousreplacementmaybenecessary.

Increasedserumlactatelevels,andrarely,lacticacidosis,havebeenreportedfollowingtherapywithsalbutamol,

particularlyafterhighdoseadministration.Symptomsincludedeep,rapidbreathing,coldandbluecolouredfingers

andtoes,inabilitytoconcentrateandgeneralmalaise.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:R03AC02

Salbutamolisabeta-adrenergicstimulantwhichhasaselectiveactiononbronchialß2-adrenoceptorsattherapeutic

doses.Followinginhalation,salbutamolexertsastimulatingactiononß2receptorsonbronchialsmoothmuscles,and

thusensuresrapidbronchodilationwhichbecomessignificantwithinafewminutesandpersistsfor4to6hours.

Thedrugalsocausesvasodilationleadingtoareflexchronotropiceffectandwidespreadmetaboliceffects,including

hypokalaemia.

5.2Pharmacokineticproperties

Followingtreatmentwithsalbutamolbyinhalation,onlyapproximately10%orlessofthedrugisdepositedinthe

airwaysandtheremainderisswallowed.Pre-systemicmetabolismofsalbutamolisconsiderableandoccursprimarily

inthegastrointestinaltractandbyconjugationtoformaninactivesulphateester.Thesystemicclearanceforsalbutamol

is30l/hr.Salbutamoliseliminatedboththroughexcretionofunchangeddruginurineandthroughmetabolismmainly

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Theeliminationhalf-lifevariesbetween3and7hours.Salbutamoliswellabsorbedfromthegastrointestinaltract.

5.3Preclinicalsafetydata

Preclinicaldatarevealnospecialhazardforhumansbasedonconventionalstudiesofsafetypharmacology,repeated

dosetoxicityandgenotoxicity.Findingsconcerningteratogenicityinrabbitsathighsystemicexposureandthe

inductionofbenignmesovarianleiomyomasinratsarenotconsideredofclinicalconcern.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate(whichcontainsmilkprotein)

6.2Incompatibilities

Notapplicable

6.3ShelfLife

2yearsinunopenedfoilpouch.6monthswhenremovedfromfoilpatch.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Aplasticinhalerdeviceincorporatinganactuatingandmeteringmechanismenclosedwithinanaluminiumfoilheat

sealedbag.Eachdevicecontains750mgofpowder–sufficientfor200actuations.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Instructionsforuseareincludedinthepatientinformationleaflet.ThesearealsoincludedinSection4.2.

7MARKETINGAUTHORISATIONHOLDER

InnovataBiomedLtd

1MereWay

Ruddington

Nottingham

NG116JS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:17 th

April1998

Dateoflastrenewal:8 th

May2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 29/09/2008 CRN 2029180 page number: 7