BOOTS NICOTINE CHEWING GUM

Main information

  • Trade name:
  • BOOTS NICOTINE CHEWING GUM
  • Dosage:
  • 2 Milligram
  • Pharmaceutical form:
  • Unknown
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BOOTS NICOTINE CHEWING GUM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/040/001
  • Authorization date:
  • 14-06-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BootsNicotineMedicatedChewingGum2mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onepieceofmedicatedchewing-gumcontains2mgNicotine(as10mgnicotine-polacrilin(1:4)).

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Medicatedchewinggum

Eachpieceofuncoatedchewing-gumisoff-whiteincolourandrectangularinshape.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BootsNicotineChewingGumtreatmentisindicatedforthereliefofnicotinewithdrawalsymptoms,innicotine

dependencyasanaidtosmokingcessation.

4.2Posologyandmethodofadministration

AdultsandElderly:UsersshouldstopsmokingcompletelyduringtreatmentwithBootsNicotineChewingGum.One

pieceofBootsNicotineChewingGumtobechewedwhentheuserfeelstheurgetosmoke.

Normally,8-12piecesperday,uptoamaximumof25piecesperday.

Thecharacteristicsofchewinggumasapharmaceuticalformaresuchthatindividuallydifferentnicotinelevelscan

resultintheblood.Therefore,dosagefrequencyshouldbeadjustedaccordingtoindividualrequirementswithinthe

statedmaximumlimit.

Directionsforuse:

1.Onepieceofgumshouldbecheweduntilthetastebecomesstrong.

2.Thechewinggumshouldberestedbetweenthegumandcheek.

3.Whenthetastefades,chewingshouldcommenceagain.

4.Thechewingroutineshouldberepeatedfor30minutes.

Afterthreemonths,theusershouldgraduallycutdownthenumberofpieceschewedeachdayuntiltheyhavestopped

usingtheproduct.

BootsNicotineMedicatedChewingGumissugar-free.

Childrenandyoungadults:

BootsNicotineChewingGumshouldnotbeusedbypeopleunder18yearsofagewithoutrecommendationfroma

physician.

Concomitantuseofacidicbeveragessuchascoffeeorsodamayinterferewiththebuccalabsorptionofnicotine.Acidic

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4.3Contraindications

BootsNicotineChewingGumshouldnotbeusedbynon-smokers.Furthermore,peopleshouldnotusethegumand

smokeconcomitantly.

Useiscontra-indicated,inpatientswithacutemyocardialinfarction,unstableorworseninganginapectoris,severe

cardiacarrhythmiasandrecentcerebrovascularaccident.

4.4Specialwarningsandprecautionsforuse

Swallowednicotinemayexacerbatesymptomsinsubjectssufferingfromactiveoesophagitis,oralorpharyngeal

inflammation,gastritisorpepticulcer.

Usewithcautioninpatientswithhypertension,stableanginapectoris,cerebrovasculardisease,occlusiveperipheral

arterialdisease,heartfailure,hyperthyroidism,diabetesmellitus,andrenalorhepaticimpairment.

Counsellingmayhelpsmokerstoquit.

Dosesofnicotinethataretoleratedbyadultsmokersduringtreatmentmayproduceseveresymptomsofpoisoningin

smallchildrenandmayprovefatal(pleaseseeSection4.9).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

DrugInteractions:

NoinformationisavailableoninteractionsbetweenBootsNicotineChewingGumandotherdrugs.

SmokingCessation:

Thisisdifferentinthecaseofsmokingwhereinteractionswithothermedicationsmayoccurduetoamultitudeofother

substancescontainedinthesmoke.Presumablyduetothepolycyclicaromatichydrocarbonscontainedinthesmoke,

themetabolismofdifferentmedicinalproductsmaybespeededupbyenzymeinduction:e.g.caffeine,theophylline,

paracetamol,phenazone,phenylbutazone,pentazocine,lidocaine,benzodiazepines,imipramine,warfarin,oestrogen

andvitaminB12.

Uponsmokingcessationitmaybeexpectedthatthehithertoincreasedmetabolismofthesemedicinalproductsis

sloweddownornormalised.Unaltereddosageoftheproductsmayresultinanincreaseintheirbloodconcentration.

ThereforewhenprescribingBootsNicotineChewingGumapossibledoseadjustmentshouldbeconsideredinpatients

treatedwiththeabovementionedmedicinalproducts.

Otherreportedeffectsofsmokingincludeareductionoftheanalgesiceffectsofpropoxyphene,reduceddiuretic

responsetofrusemide,changeinthepharmacologicaleffectofpropranololandalteredresponderratesinulcerhealing

withH

-antagonists.

Smokingandnicotinemayraisethebloodlevelsofcortisolandcatecholamines.Doseadjustmentofnifedipine,

adrenergicagonistsoradrenergicantagonistsmaybenecessary.

Increasedsubcutaneousabsorptionofinsulinwhichoccursundersmokingcessationmaynecessitateareductionin

insulindose.

4.6Pregnancyandlactation

Patientsshouldbeadvisedtogiveupsmokingwithouttheuseofnicotinereplacementtherapy.Shouldthisfail,a

medicalassessmentoftheriskbenefitofBootsNicotineChewingGumshouldbemade.

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foetalgrowth.Studiesinratsproducedevidenceofdecreasedfertility,prolongedpregnancy,andbehaviouraldisorders

intheoffspring.Inmicetheoffspringofanimalsexposedtoveryhighdosesofnicotineshowedskeletaldefectsinthe

peripheralpartsofthelimbs.

Overall,therearenoclearcutgroundsforbelievingthatnicotineattheconcentrationsreachedbytreatmentwith

nicotinegumhasanyteratogenicpotentialand/orinhibitoryeffectsonfertility.

4.7Effectsonabilitytodriveandusemachines

Smokingcessationcancausebehaviouralchanges.Thereisnoevidenceofanyrisksassociatedwithdrivingor

operatingmachinerywhenthegumisusedfollowingtherecommendeddose.

4.8Undesirableeffects

Inprinciple,BootsNicotineChewingGumcancauseadversereactionssimilartothoseassociatedwithnicotine

administeredbysmoking.

Nicotinefromgummaysometimescauseaslightirritationofthethroatandincreasesalivationatthestartof

treatment.Excessiveswallowingofdissolvednicotinemay,atfirst,causehiccuping.Thosewithatendencyto

indigestionmaysufferinitiallyfromminorindigestionorheartburn.Slowerchewingwillusuallyovercomethis

problem.Excessiveconsumptionofgumbysubjectswhohavenotbeeninthehabitofinhalingtobaccosmokecould

possiblyleadtonausea,faintnessorheadaches.

4.9Overdose

Inoverdose,symptomscorrespondingtoheavysmokingmaybeseen.

Theacutelethaloraldoseofnicotineisabout0.5-0.75mgperkgbodyweight,correspondinginanadultto40-60

mg.Evensmallquantitiesofnicotinearedangerousinchildrenandmayresultinseveresymptomsofpoisoningwhich

mayprovefatal.Ifpoisoningissuspectedinachild,adoctormustbeconsultedimmediately.

OverdosewithBootsNicotineChewingGummayonlyoccurifmanypiecesarechewedsimultaneously.Riskof

overdoseissmallasnauseaorvomitingusuallyoccursatanearlystage.Riskofpoisoningbyswallowingthegumis

small.Sincethereleaseofnicotinefromthegumisslow,verylittlenicotineisabsorbedfromthestomachandintestine

andifanyis,itwillbeinactivatedintheliver.

Generalsymptomsofnicotinepoisoninginclude:weakness,perspiration,salivation,throatburn,nausea,vomiting,

diarrhoea,abdominalpain,hearingandvisualdisturbances,headache,tachycardiaandcardiacarrhythmia,dyspnoea,

prostration,circulatorycollapse,comaandterminalconvulsions.

Treatmentofoverdosage:

Intheeventofoverdosage,vomitingshouldbeinducedwithsyrupofipecacuanhaorgastriclavagecarriedout(wide

boretube).Asuspensionofactivatedcharcoalshouldthenbepassedthroughthetubeandleftinthestomach.Artificial

respirationwithoxygenshouldbeinstitutedifneededandcontinuedforaslongasnecessary.Othertherapy,including

treatmentofshock,ispurelysymptomatic.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Nicotinegummimicsthepharmacologicaleffectsofnicotinefromsmoking,andmaythereforebeusedtohelpprovide

relieffromnicotinewithdrawalsymptoms.Inadditiontoeffectsonthecentralnervoussystem,nicotineproduces

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5.2Pharmacokineticproperties

Whenthegumischewed,nicotineissteadilyreleasedintothemouthandisrapidlyabsorbedthroughthebuccal

mucosa.Aproportion,bytheswallowingofnicotinecontainingsaliva,reachesthestomachandintestinewhereitis

inactivated.

Thepeakplasmaconcentrationofthe2mggumafterasingledoseisapproximately4.8nanogramspermland

followingsteadystateadministrationisapproximately14nanogramsperml(averageplasmaconcentrationofnicotine

whensmokingacigaretteis15-30nanogramsperml).

Forachewinggumof4mgithasbeencalculatedthatamaximumplasmaconcentrationofapproximately10nanog/ml

isreachedafterapproximately30minutes.

Nicotineiseliminatedmainlyviahepaticmetabolism;smallamountsofnicotineareeliminatedinunchangedformvia

thekidneys.Theplasmahalf-lifeisapproximatelythreehours.Nicotinecrossestheblood-brainbarrier,theplacenta

andisdetectableinbreastmilk.

5.3Preclinicalsafetydata

NoanimalstudieshavebeenundertakenonBootsNicotineChewingGum.

Thetoxicityofnicotineasaconstituentoftobaccohasbeenwelldocumented.Acutetoxiceffectsincludeconvulsions,

cardiacinsufficiencyandparalysisoftherespiratorysystem.

Athighdosesincatsanddogs,nicotinehasbeenshowntopotentiatehistamine-inducedpepticulcer.

Nicotinehasnogenotoxicactivityinmostofthemutagenicitytestsystems.Thewell-knowncarcinogenicityoftobacco

smokingismainlycausedbypyrolysisproducts.Applicationofnicotinechewinggum,however,avoidsthehigh

temperaturerequiredfortheformationofthesecarcinogenicproducts.

AllexcipientsusedinBootsNicotineChewingGumareoffoodgrade.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Gumbase

Calciumcarbonate

Sorbitol(E420)

Glycerol(E422)

Sodiumcarbonateanhydrous

Sodiumhydrogencarbonate

Polacrilin

Purifiedwater

Levomenthol

Peppermintoil

Eucalyptusoil

Butyhydroxytoluene(E321)

Acesulfamepotassium

Saccharin

Sodiumsaccharin

Talc

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

ThechewinggumispackedinPVC/aluminiumblisterpackseachcontaining12piecesofgum.Theblistersarepacked

inboxescontaining12,24,36,48,60,72and96piecesofgum.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLtd

WimblehurstRd

Horsham

WestSussexRH125AB

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA30/40/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14June2000

Dateoflastrenewal:14June2005

10DATEOFREVISIONOFTHETEXT

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