BUTOVENT PULVINAL

Main information

  • Trade name:
  • BUTOVENT PULVINAL
  • Dosage:
  • 200 Microgram
  • Pharmaceutical form:
  • Inhalation Powder, Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BUTOVENT PULVINAL
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0584/002/001
  • Authorization date:
  • 13-07-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ButoventPulvinal200 micrograms/doseinhalationpowder

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each actuation provides200 microgramsofsalbutamol.

Forexcipientseesection 6.1.

3PHARMACEUTICALFORM

Inhalation powder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

In adultsand children over12 years:

Symptomatictreatmentofasthmaattacks.

Symptomatictreatmentofexacerbationsofasthmaorofchronicobstructive

bronchitiswith areversiblecomponent.

Prevention ofexercise-induced asthma.

4.2Posologyandmethodofadminstration

Posology

Adultsand children over12 years:

Treatmentofasthmaattacksand exacerbations:

assoon assymptomsoccur:1 to 2 inhalations.

Ifthesymptomspersist, thedosemay berepeated afewminuteslater.

Prevention ofexercise-induced asthma:1 to 2 inhalations15 to 30 minutesbeforeexercise.

Thelowesteffectivedosesofinhaled salbutamolarerecommendedto beused in thetreatmentofasthma. In thelong

termtreatmentitisrecommended instead ofregularuse, to useinhaled salbutamolwhen needed.

Thedaily doseshould notexceed 8 inhalationsper24hours(seesection 4.4).

Methodofadministration.

Inhalation fromthedevicethrough themouthpiece.

Thephysicianshould ensurethatthepatientcorrectlyusesthepowderinhalerinaccordancewiththeinstructions

forusereported intheleaflet.

Inhalation powdersaresuitableforusein patientswho showpoorhand/lung synchronisation.

Thisdeviceisa“high resistance”inhalerthatrequiresapeak inspiratory flowrateofatleast28 l/min to insurea

satisfactorylung disposition ofthepowder. Thereforethismedicinalproductisnotsuitableforpatientswith alowpeak

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within apatient.

When othersalbutamolinhalersarereplaced by ButoventPulvinalinhaler, itshould betaken into accountthatthe

obtained dosecan vary between differentinhalersand thereforethedosemay haveto beadjusted.

Thedrug isdelivered into thebronchiwhen thepatientbreathesin deeply and naturally through themouthpieceofthe

device.Theinhalation mustbefollowed by apnoea.

Thepatientmustbeadvised:

neverto breatheoutinto thePulvinal device

to re-tighten thecap firmly afteruse

neverto wash thePulvinal device,butto wipeitwith aclean, dry cloth.

4.3Contraindications

Thisproductiscontra-indicated in patientswith known hypersensitivity to any oftheingredients.

4.4Special warningsandspecialprecautionsforuse

Specialwarnings

Patientsshould beadvised thatanimmediatemedicalexamination isnecessary ifthepreviously usualeffectivedoseis

failing to quickly providethereliefusually observed. Ifpatientrapidly increasestheuseofinhaled short-acting

agoniststo relievesymptoms, worsening ofasthmaisto befeared (especially ifpeak inspiratory flowratevaluefalls

and/orbecomesirregular)and patientmay beatrisk ofsevereattacks. Patientsshould thereforebewarned oftheneed

foranimmediateexamination, withoutfirstexceeding theprescribed maximumdoses. Therapy should subsequently be

reassessed.

In asthmaticadults, adailyanti-inflammatory medication isrequired assoon asthepatientrequiresinhaled

-agonists

morethan onceaweek. Thepatientshould bethen warned that, even ifhisasthmacontrolisachieved, thetreatment

should notbediscontinued withoutany medicaladvice.

Salbutamolorotherbronchodilatating drugsshould notbegiven astheonly treatmentto patientswith moderateto

severeorunstableasthma.

Sportsmen and athletesarewarned thatthismedicinalproductcontainsan activeingredientwhich may produce

positiveresultin anti-doping testssearchingforprohibited substances.

Specialprecautionsforuse

In theeventofbronchialinfection orabundantbronchorrhoea,appropriatetreatmentisnecessary to optimisethe

deposition oftheproductwithin therespiratory tract.

Atusualdoses, when administered by theinhaled routewith thisdevice, salbutamolshould begiven with caution in

patientssuffering fromthyrotoxicosis, coronary failure, congestivecardiomyopathy, ventricularrhythmdisorders,

arterialhypertension ordiabetesmellitus.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thismedicinalproductshallbeused with caution in caseofassociation with otheradrenergictreatments,

dueto therisk ofonsetofcardiovascularundesirableevents

Monoamineoxidaseinhibitors, tricyclicantidepressants:risk ofincreasedcardiovasculareffects

Beta-blockers, such aspropranolol:antagonisteffecton theaction carried outby salbutamol

and theotherbeta-mimetics

Thesimultaneousadministration ofxanthines,corticosteroidsorpotassiumexcretingdiuretics

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4.6Pregnancyandlactation

Pregnancy:Dataon alargenumberofexposed pregnanciesindicateno adverseeffectsofsalbutamolon pregnancy.

Administration ofsalbutamolduring pregnancy should only beconsidered onlyiftheexpected benefitto themotheris

greaterthan any possiblerisk to thefoetus.

When administered during pregnancy, an acceleration in thefoetalheartratemay beobserved togetherwith

tachycardiain themother. Thisconditionexceptionally persistsafterbirth. Similarly, thevaluesofpost-natalglycaemia

areonly exceptionally altered.

When administered beforelabour, theperipheralvasodilating effectsandthepotentialinhibiting effecton uterine

contractionsof

-agonistsshould betaken into account.

Lactation:

-agonistspassinto maternalmilk. Datawith respectto passageofsalbutamolinto breastmilkare

insufficient. Thepotentialrisk forthechildisunknown.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Theundesirableeffectsobserved with inhaled salbutamoladministration given attherapeuticdosesarelinked to a

sympathomimeticactivity. They areoften mild and generally disappearon continuation oftreatment.

Frequent(>1%):

heartand circulatory effects:peripheralvasodilation mightbethecauseofamild reflex tachycardia

musculareffects:tremors

Lessfrequent(1-0.1%):

systemiceffects:headache, hypersensitivity reactions(angioedema, urticaria, hypotension and collapse)

Seldom(<0.1%):

respiratory effects:bronchospasm(seeWarningsand PrecautionsforUse), mouth and

throatirritation thatcan beprevented by rinsing themouth afterproductinhalation

metabolic:hypokalaemia

muscular:muscularcramps

centralnervoussystem:restlessness, vertigo

4.9Overdose

Theuseofthisdrug atdosesmuch higherthan therecommended dosesindicatesaworsening ofasthma, requiring

promptexamination to re-assessthetreatment.

Theexpected symptomswith overdosearethoseofexcessivebeta-adrenergicstimulation and/oroccurrenceor

exaggeration ofany ofthesymptomslisted undersection4.8.“UndesirableEffects”.Particularly hypokalaemiamay

occurathigh doses.

Theuseofthisdrug atdosesmuch higherthan therecommended dosesreflectsadeterioration oftherespiratory

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmatherapeuticgroup:Antiasthmatics, ATCcode:R03AC02.

Short-acting inhaledß

-agonistbronchodilator. Salbutamolisan agonistoftheß-adrenoceptorswith amuch more

selectiveaction onß

receptors.

Afterinhalation, salbutamolexercisesastimulating action on theß

receptorsofthebronchialsmooth muscle, thus

ensuring rapid bronchodilation, significantwithin afewminutesand lasting for4 to 6 hours.

5.2Pharmacokineticproperties

Afterinhalation theplasmaconcentrationsobserved attheusualdosesarenegligible(10-50 timeslowerthan those

observed perosorby injection).

Aportion oftheinhaled dosereachesthelowerpartoftheairwaysand, afterpulmonary resorption, ismainly excreted

by renalroutepartially unchanged and partially asmetabolites.

Theremainingportionoftheinhaleddoseisswallowed and then absorbed fromthegastrointestinalsysteminto

circulation, whereitundergoessignificantfirst-passmetabolism.

5.3Preclinical safetydata

Pre-clinicaldatarevealno specialhazard forhumansbased on conventionalstudiesofsafety pharmacology, repeated

dosetoxicityand genotoxicity.

Cleftpalatehasbeen reported inmicebutnotin ratsorrabbitsaftersubcutaneousadministration.

Findingsconcerning teratogenicity in rabbitsathigh systemicexposurelevelsand theinduction ofbenign mesovarian

leiomyomasin ratsarenotconsidered ofclinicalconcern.

Thereisno evidenceofcarcinogenicity, mutagenicity orteratogenicity in humans.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate.

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2 years.

6.4Special precautionsforstorage

Keepthedry powderinhalertightly closed.

6.5Natureandcontentsofcontainer

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6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ChiesiFarmaceuticiS.p.A

26/AViaPalermo

43100 PARMA

Italy

8MARKETINGAUTHORISATIONNUMBER

PA584/2/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 13 th

July 2001

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