ASMASAL CLICKHALER

Main information

  • Trade name:
  • ASMASAL CLICKHALER
  • Dosage:
  • 95 Microgram
  • Pharmaceutical form:
  • Powder for Inhalation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1638/011/001
  • Authorization date:
  • 27-05-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AsmasalClickhalerinhalationpowder,95micrograms/inhalation.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmeteredactuationof3mgofinhalationpowdercontains114microgramsofsalbutamolsulphate(95micrograms

salbutamolbase)anddelivers110microgramsofsalbutamolsulphate(90microgramsofsalbutamolbase).

Excipient::LactoseMonohydrate2.886mgperactuation.

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Inhalationpowder.

Aplasticinhalerdeviceincorporatinganactuatingandmeteringmechanismenclosedwithinanaluminiumfoilheat

sealedbag.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AsmasalClickhalerisindicatedforthesymptomatictreatmentofbronchospasminbronchialasthmaandother

conditionswithassociatedreversibleairwaysobstruction.Appropriateanti-inflammatorytherapyshouldbeconsidered

inlinewithcurrentpractice.

AsmasalClickhalermaybeusedwhennecessarytorelieveattacksofacutedyspnoeaduetobronchoconstriction.

AsmasalClickhalermayalsobeusedbeforeexertiontopreventexercise-inducedbronchospasmorbeforeexposureto

aknownunavoidableallergenchallenge.

4.2Posologyandmethodofadministration

Adults:Forthereliefofacutebronchospasmandformanagingintermittentepisodesofasthma,oneinhalationmaybe

administeredasasingledose;thismaybeincreasedtotwoinhalationsifnecessary.Iftheresponseisinadequate,

higherdosesthantwoinhalationscanbeused.Themaximumrecommendeddoseistwoinhalationsthreeorfour

timesaday.

Topreventexercise-inducedbronchospasmoneortwoinhalationsshouldbetaken15minutesbeforeexertion.

Oneortwoinhalationsmayalsobetakenbeforeforeseeablecontactwithallergens.

Elderly:asforadults

Children:Oneinhalationistherecommendeddoseforthereliefofacutebronchospasm,inthemanagementof

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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

AsmasalClickhaleriscontra-indicatedinpatientswithintoleranceorhypersensitivitytotheactiveingredientorthe

excipient.

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.

Potentiallyserioushypokalaemiahasresultedfromsystemicß2-agonisttherapy.Particularcautionisadvisedinacute

severeasthmaasthiseffectmaybepotentiatedbyconcomitanttreatmentwithxanthinederivatives,steroids,

diureticsandbyhypoxia.Itisrecommendedthatserumpotassiumlevelsaremonitoredinsuchsituations.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Salbutamolandnon-selectivebeta-blockingdrugs,suchaspropranolol,shouldnotusuallybeprescribedtogether.

Cautionisalsoadvisedinpatientsusingcardiacglycosides.

Potentiallyserioushypokalaemiahasresultedfromsystemicß2-agonisttherapy.Particularcautionisadvisedinacute

severeasthmaasthiseffectmaybepotentiatedbyconcomitanttreatmentwithxanthinederivatives,steroids,diuretics

andbyhypoxia.

Patientsshouldbeinstructedtodiscontinuesalbutamolatleast6hoursbeforeintendedanaesthesiawithhalogenated

anaesthetics,whereverpossible.

4.6Fertility,pregnancyandlactation

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

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Bloodandthelymphaticsystemdisorders:potentiallyserioushypokalaemiamayresultfromsystemicß2-agonist

therapy.Specialprecautionsshouldbetakeninpatientsusingß2-agonistswithhypokalaemiabecauseoftheincreased

riskoftachycardiaandarrhythmias.Hypokalaemiamaybepotentiatedbyconcomitanttherapywithcorticosteroids,

diureticsandxanthines.

Psychiatricdisorders:nervousness,feelingoftenseness.Aswithotherß2agonists,hyperactivityinchildrenhasbeen

reportedrarely.

Nervoussystemdisorders:mildtremor,headache,dizziness.

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

supraventriculartachycardiaandextrasystoles)andmyocardialischemia(seesection4.4,Specialwarningsand

precautionsforuse)havebeenreportedinassociationwithß2agonists,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

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5.2Pharmacokineticproperties

Followingtreatmentwithsalbutamolbyinhalation,onlyapproximately10%orlessofthedrugisdepositedinthe

airwaysandtheremainderisswallowed.Pre-systemicmetabolismofsalbutamolisconsiderableandoccursprimarily

inthegastrointestinaltractandbyconjugationtoformaninactivesulphateester.Thesystemicclearanceforsalbutamol

is30l/hr.Salbutamoliseliminatedboththroughexcretionofunchangeddruginurineandthroughmetabolismmainly

viasulphateconjugation.Theeliminationhalf-lifevariesbetween3and7hours.Salbutamoliswellabsorbedfromthe

gastrointestinaltract.

5.3Preclinicalsafetydata

Preclinicaldatarevealnospecialhazardforhumansbasedonconventionalstudiesofsafetypharmacology,repeated

dosetoxicityandgenotoxicity.Findingsconcerningteratogenicityinrabbitsathighsystemicexposureandthe

inductionofbenignmesovarianleiomyomasinratsarenotconsideredofclinicalconcern.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate(whichcontainsmilkprotein).

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3yearsinunopenedfoilpouch.6monthswhenremovedfromfoilpouch.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Aplasticinhalerdeviceincorporatinganactuatingandmeteringmechanismenclosedwithinanaluminiumfoilheat

sealedbag.Eachdevicecontains750mgofpowder-sufficientfor200actuations.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Instructionsforuseareincludedinthepatientinformationleaflet.Thesearealsoincludedinseesection4.2,Posology

andmethodofadministration.

7MARKETINGAUTHORISATIONHOLDER

RPHPharmaceuticalsAB

Lagervagen7

13650Haninge

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8MARKETINGAUTHORISATIONNUMBER

PA1638/011/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Firstdateofauthorisation: 17April1998

Dateoflastrenewal: 08May2007

10DATEOFREVISIONOFTHETEXT

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