ASMABEC CLICKHALER 100 MICROGRAMS. INHALATION POW

Main information

  • Trade name:
  • ASMABEC CLICKHALER 100 MICROGRAMS. INHALATION POW
  • Dosage:
  • 100 mcg Microgram
  • Pharmaceutical form:
  • Powder for Inhalation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASMABEC CLICKHALER 100 MICROGRAMS. INHALATION POW
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1638/010/002
  • Authorization date:
  • 19-08-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AsmabecClickhaler100micrograms,Inhalationpowder

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmeteredactuationof2.6mgcontains100microgramsofbeclometasonedipropoinateanddelivers90micrograms

ofbeclometasonedipropionate.

Excipients:includes2.5mgoflactosemonohydrateperdose.

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Inhalationpowder.

Whitefree-flowingpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BeclometasoneDipropionateisindicatedforthecontrolofpersistentasthma.

4.2Posologyandmethodofadministration

Posology

ForoptimumresultsAsmabecClickhalershouldbeusedregularly.

Theinitialdoseshouldbeappropriatetotheseverityofthediseaseandthemaintenancedosetitratedtothelowestdose

atwhicheffectivecontrolofasthmaisachieved.

Adults:

Theinitialdoseforpatientswithmildasthmais200to400microgramsperday;thismaybeincreasedto800

microgramsperdayifrequired.

Forpatientswithmoderateasthmaandsevereasthmatheinitialdosecanbe800to1600microgramsperday,increased

to2000microgramsinseverecases.Thenormalmaximumdailyforadultsis2000micrograms.

Themaintenancedoseisnormally200to400microgramstwicedaily.Ifnecessarythedosemaybeincreasedto1600

to2000microgramsperdaydividedintotwotofourdosesandbereducedlaterwhenasthmaisstabilised.

Specialpopulation

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Paediatricpopulation

Childrenaged6-12years:

Upto100micrograms2to4timesdailyaccordingtotheclinicalresponse.

Normallythemaximumdailydoseinchildrenis400mg.Howeversomecasesofsevereasthmamaynotbecontrolled

andhigherdosesmayberequiredinlinewithinternationalguidelines.Oncetheasthmaiscontrolled,thedoseof

AsmabecClickhalershouldbereducedtotheminimumtomaintaincontrol.

Childrenagedunder6years:

AsmabecClickhalerisnotrecommendedforchildrenunder6yearsofage.

WhentransferringapatienttoAsmabecClickhalerfromotherdevices,treatmentshouldbeindividualisedtakinginto

considerationtheactiveingredientandmethodofadministration.

Methodofadministration

Theproductisintendedfororalinhalationonly.

Itisimportanttoinstructthepatientto:

Removemouthpiececoverfromtheinhaler

Shaketheinhalerwell

Holdtheinhaleruprightwiththumbonthebaseandfingeronthepushbutton.

Pressthedosingbuttondownfirmly-onceonly.

Breatheoutasfarasiscomfortable.

Note:donotblowintothedeviceatanytime.

Placemouthpieceinyourmouth.Closelipsfirmlyaroundit(donotbiteit).

Breatheinthroughyourmouthsteadilyanddeeply,todrawthemedicineintoyourlungs.

Holdyourbreath,taketheinhalerfromyourmouthandcontinueholdingyourbreathforabout5seconds.

Forthesecondpuff,keeptheinhaleruprightandrepeatsteps2-7.

Replacethemouthpiececover.

ThepatientshouldbetoldtorefertothedetailedinstructionsontheuseandcleaningoftheClickhalerinthePatient

InformationLeafletwhichispackedwitheachClickhaler.

4.3Contraindications

AsmabecClickhaleriscontra-indicatedinpatientswithhypersensitivity(allergy)tobeclometasonedipropionateorto

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4.4Specialwarningsandprecautionsforuse

Patientsshouldbeinstructedintheproperuseoftheinhaler.Theyshouldalsobemadeawareoftheprophylactic

natureoftherapywithAsmabecClickhalerandthattheyshoulduseitregularly,everyday,evenwhentheyare

asymptomatic.Beclometasonedipropionateisnotsuitableforthetreatmentofanacuteasthmaattack.

Increasinguseofbronchodilators,inparticularshort-actinginhaled

-agonists,torelievesymptomsindicates

deteriorationofasthmacontrol.Ifpatientsfindthatshort-actingreliefbronchodilatortreatmentbecomeslesseffective,

ortheyneedmoreinhalationsthanusual,medicalattentionmustbesought.Inthissituationpatientsshouldbe

reassessedandconsiderationgiventotheneedforincreasedanti-inflammatorytherapy(e.g.higherdosesofinhaled

corticosteroidsoracourseoforalcorticosteroids).Severeexacerbationsofasthmamustbetreatedinthenormalway.

Systemiceffectsofinhaledcorticosteroidsmayoccur,particularlyathighdosesprescribedforprolongedperiods.

Theseeffectsaremuchlesslikelytooccurthanwithoralcorticosteroids.PossiblesystemiceffectsincludeCushing's

syndrome,Cushingoidfeatures,adrenalsuppression,growthretardationinchildrenandadolescents,decreaseinbone

mineraldensity,cataract,glaucoma,andmorerarely,arangeofpsychologicalorbehaviouraleffectsincluding

psychomotorhyperactivity,sleepdisorders,anxiety,depressionoraggression(particularlyinchildren).Itisimportant

thereforethatthedoseofinhaledcorticosteroidistitratedtothelowestdoseatwhicheffectivecontrolofasthmais

maintained.

Itisrecommendedthattheheightofchildrenreceivingprolongedtreatmentwithinhaledsteroidsisregularly

monitored.Ifgrowthisslowed,therapyshouldbereviewedwiththeaimofreducingthedoseofinhaledcorticosteroid

ifpossible,tothelowestdoseatwhicheffectivecontrolofsymptomsisachieved.

Dosesinexcessof1500microgramsperdaymayinduceadrenalsuppression.Insuchpatientstherisksofdeveloping

adrenalsuppressionshouldbebalancedagainstthetherapeuticadvantages,andprecautionsshouldbetakentoprovide

systemicsteroidcoverinsituationsofstressorelectivesurgery.

Thetransfertoinhaledbeclometasonedipropionateofpatientswhohavebeentreatedwithsystemicsteroidsforlong

periodsoftime,orathighdose,needsspecialcareandsubsequentmanagementasrecoveryfromimpaired

adrenocorticalfunctionisslow.Withthesepatientsadrenocorticalfunctionshouldbemonitoredregularlyandtheir

doseofsystemicsteroidreducedcautiously.Gradualwithdrawalofthesystemicsteroidshouldcommenceafterabout

oneweek.Reductionsindosage,appropriatetothelevelofmaintenancesystemicsteroid,shouldbeintroducedatnot

lessthanweeklyintervals.

Somepatientsmayfeelunwellinanon-specificwayduringwithdrawalofthesystemicsteroid.Theyshouldbe

encouragedtoperseverewiththeinhaledbeclometasonedipropionate,unlessthereareobjectivesignsofadrenal

insufficiency.

Patientswhohavebeentransferredfromoralsteroidswhoseadrenocorticalfunctionisimpairedshouldcarryasteroid

warningcardindicatingthattheymayneedsupplementarysystemicsteroidsduringperiodsofstress,eg.worsening

asthmaattacks,chestinfections,majorintercurrentillness,surgery,traumaetc.

Replacementofsystemicsteroidtreatmentwithinhaledtherapysometimesunmasksallergiessuchasallergicrhinitis

oreczemapreviouslycontrolledbythesystemicdrug.

Inthecaseofmassivemucussecretionintherespiratorytract,de-obstructionandashortcourseoforalsteroidsmaybe

necessarytoensureefficacyoftheinhaledbeclometasone.

Specialcareisnecessaryinpatientswithactiveorquiescentpulmonarytuberculosisandinpatientswithviral,bacterial

andfungalinfectionsoftheeye,mouthorrespiratorytract.

Inthecaseofbacterialinfectionoftherespiratorytractadequateantibioticco-medicationmayberequired.

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Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Duetotheverylowplasmaconcentrationachievedafterinhaleddosing,clinicallysignificantdruginteractionsarein

generalunlikely.Careshouldbetakenwhenco-administeringknownstrongCYP3A4inhibitors(e.g.ketoconazole,

itrazonazole,nelfinavir,ritonavir)asthereisapotentialforincreasedsystemicexposuretobeclomethasone.

4.6Fertility,pregnancyandlactation

Pregnancy:

Thereareinsufficientdataregardingthesafetyofbeclometasonedipropionateduringhumanpregnancy.Systemic

administrationofrelativelyhighdosesofcorticosteroidstopregnantanimalscancauseabnormalitiesoffoetal

developmentincludingcleftpalateandintra-uterinegrowthretardation.Theremaythereforebeaverysmallriskof

sucheffectsinthehumanfoetus.Becausebeclometasonedipropionateisdelivereddirectlytothelungsbytheinhaled

routeitavoidsthehighlevelofexposurethatoccurswhencorticosteroidsaregivenbysystemicroutes.

Theuseofbeclometasonedipropionateinpregnancyrequiresthatthepossiblebenefitsofthedrugbeweighedagainst

thepossiblehazards.Itshouldbenotedthatthedrughasbeeninwidespreaduseformanyyearswithoutapparentill

consequence.

Lactation:

Itisreasonabletoassumethatbeclometasonedipropionateissecretedinmilk,butatthedosagesusedfordirect

inhalationthereislowpotentialforsignificantlevelsinbreastmilk.

Theuseofbeclometasonedipropionateinmothersbreastfeedingtheirbabiesrequiresthatthetherapeuticbenefitsof

thedrugbeweighedagainstthepotentialhazardstothemotherandbaby.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Infectionsandinfestations:candidiasisofthemouthandthroat.Thismaybetreatedwhilststillcontinuingwith

AsmabecClickhaler.

Immunesystemdisorders:easybruisingoftheskin,veryrarelyhypersensitivityincludingrashandangioedemamay

occur.

Endocrinedisorders:decreaseinbonemineraldensity,adrenalsuppression,Cushing’ssyndrome,growthretardationin

childrenandadolescents

Psychiatricdisorders:psychomotorhyperactivity,sleepdisorders,anxiety,depression,aggression,behavioural

changes(predominantlyinchildren).

Eyedisorders:cataractandglaucoma

Respiratory,thoracicandmediastinaldisorders:hoarseness,paradoxicalbronchospasm.Ifbronchospasmoccursthe

preparationshouldbediscontinuedimmediatelyandifnecessaryalternativetherapyinstituted.

Itisrecommendedtorinseoutthemouththoroughlywithwaterimmediatelyafterinhalationinordertoreducethe

risksofcandidiasisandhoarseness.

Systemiceffectsofinhaledcorticosteroidsmayoccur,particularlyathighdosesprescribedforprolongedperiods(see

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4.9Overdose

AcuteInhalationofalargeamountofthedrugoverashortperiodmayleadtotemporarysuppressionofadrenal

function.Noemergencyactionisrequired.Treatmentwithbeclometasonedipropionatebyinhalationshouldbe

continuedatadosesufficienttocontrolasthma;adrenalfunctionrecoversinafewdaysandcanbeverifiedby

measuringplasmacortisol.

ChronicUseofexcessivedosesofinhaledbeclometasonedipropionateoveraprolongedperiodmaycauseadrenal

suppressionandadegreeofatrophyoftheadrenalcortex.Transfertoamaintenancedoseofasystemicsteroidmaybe

requireduntiltheconditionisstabilised.Treatmentwithinhaledbeclometasonedipropionateshouldthenbecontinued

atadosesufficienttocontrolasthma.

Ifhigherthanapproveddosesarecontinuedoverprolongedperiods,significantadrenalsuppressionandadrenalcrisis

arepossible.Presentingsymptomsofadrenalcrisismayinitiallybenon-specificandincludeanorexia,abdominalpain,

weightloss,tiredness,headache,nausea,vomiting.

Hypoglycaemiawithdecreasedconsciousnessand/orconvulsionsisatypicalsymptom.Situationswhichcould

potentiallytriggeracuteadrenalcrisisincludeexposuretotrauma,surgery,infectionoranyrapidreductionindosage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otheranti-asthmatics,inhalants,glucocorticoids.

ATCcode:R03BA01.

Beclometasonedipropionategivenbyinhalationhasaglucocorticoidanti-inflammatoryactionwithinthelungs.

Theexactmechanismresponsibleforthisanti-inflammatoryeffectisunknown.

5.2Pharmacokineticproperties

Absorptionfromthegastrointestinaltractisslowandbioavailabilityislow,suggestingthatmostoftheabsorbeddrug

ismetabolisedduringitsfirstpassagethroughtheliver.Sincethedoseoforalbeclometasonedipropionateneededto

suppressplasmacortisolisgreaterthanthatrequiredbyinhalation,thissuggeststhattheportionabsorbedfromthe

lungsismainlyresponsibleforanysystemiceffects.

5.3Preclinicalsafetydata

Studiesinanumberofanimalspecies,includingrats,rabbitsanddogs,haveshownnounusualtoxicityduringacute

experiments.Theeffectsofbeclometasonedipropionateinproducingsignsofglucocorticoidexcessduringchronic

administrationbyvariousroutesaredoserelated.Teratogenicitytestinghasshowncleftpalateinmice,aswithother

glucocorticoids.Beclometasonedipropionateisnon-genotoxicanddemonstratesnooncogenicpotentialinlifetime

studieswithrats

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate(whichcontainsmilkproteins).

6.2Incompatibilities

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6.3Shelflife

3years.

6monthswhenremovedfromthefoilpouch.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Storeintheoriginalpackageinordertoprotectfrommoistureandlight.

6.5Natureandcontentsofcontainer

Aplasticinhalerdeviceincorporatingameteringpumpandamouthpieceenclosedwithina

polyester/aluminium/polyethyleneheat-sealedsachet.Each100micrograminhalercontains200actuations.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

RPHPharmaceuticalsAB

Lagervägen7

13650Jordbro

Sweden

8MARKETINGAUTHORISATIONNUMBER

PA1638/10/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:07September1999

Dateoflastrenewal:29October2008

10DATEOFREVISIONOFTHETEXT

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