BOOTS NICOTINE CHEWING GUM

Main information

  • Trade name:
  • BOOTS NICOTINE CHEWING GUM
  • Dosage:
  • 4 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:
  • PA0030/040/002
  • Authorization date:
  • 14-06-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BootsNicotineMedicatedChewingGum4mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onepieceofmedicatedchewing-gumcontains4mgNicotine(as20mgNicotine-polacrilin(1:4)).

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Medicatedchewinggum

Eachpieceofuncoatedchewing-gumisoff-whiteincolourandrectangularinshape.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BootsNicotineChewingGumtreatmentisindicatedforthereliefofnicotinewithdrawalsymptoms,innicotine

dependencyasanaidtosmokingcessation.BootsNicotineChewingGum4mgisforusewhensevere

withdrawalsymptomsareexperienced.

4.2Posologyandmethodofadministration

AdultsandElderly:UsersshouldstopsmokingcompletelyduringtreatmentwithBootsNicotineChewingGum.

OnepieceofBootsNicotineChewingGumtobechewedwhentheuserfeelstheurgetosmoke.

Normally,8-12piecesperday,uptoamaximumof15piecesperday.

Thecharacteristicsofchewinggumasapharmaceuticalformaresuchthatindividuallydifferentnicotinelevels

canresultintheblood.Therefore,dosagefrequencyshouldbeadjustedaccordingtoindividualrequirements

withinthestatedmaximumlimit.

Directionsforuse:

1.Onepieceofgumshouldbecheweduntilthetastebecomesstrong.

2.Thechewinggumshouldberestedbetweenthegumandcheek.

3.Whenthetastefades,chewingshouldcommenceagain.

4.Thechewingroutineshouldberepeatedfor30minutes.

Afterthreemonths,theusershouldgraduallycutdownthenumberofpieceschewedeachdayuntiltheyhave

stoppedusingtheproduct.

BootsNicotineMedicatedChewingGumissugar-free.

Childrenandyoungadults:

BootsNicotineChewingGumshouldnotbeusedbypeopleunder18yearsofagewithoutrecommendations

fromaphysician.

Concomitantuseofacidicbeveragessuchascoffeeorsodamayinterferewiththebuccalabsorptionofnicotine.

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4.3Contraindications

BootsNicotineChewingGumshouldnotbeusedbynon-smokers.Furthermore,peopleshouldnotusethegum

andsmokeconcomitantly.

Useiscontra-indicated,inpatientswithacutemyocardialinfarction,unstableorworseninganginapectoris,

severecardiacarrhythmiasandrecentcerebrovascularaccident.

4.4Specialwarningsandprecautionsforuse

Swallowednicotinemayexacerbatesymptomsinsubjectssufferingfromactiveoesophagitis,oralorpharyngeal

inflammation,gastritisorpepticulcer.

Usewithcautioninpatientswithhypertension,stableanginapectoris,cerebrovasculardisease,occlusive

peripheralarterialdisease,heartfailure,hyperthyroidism,diabetesmellitus,andrenalorhepaticimpairment.

Counsellingmayhelpsmokerstoquit.

Dosesofnicotinethataretoleratedbyadultsmokersduringtreatmentmayproduceseveresymptomsof

poisoninginsmallchildrenandmayprovefatal(pleaseseeSection4.9).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

DrugInteractions:

NoinformationisavailableoninteractionsbetweenBootsNicotineChewingGumandotherdrugs.

SmokingCessation:

Thisisdifferentinthecaseofsmokingwhereinteractionswithothermedicationsmayoccurduetoamultitudeof

othersubstancescontainedinthesmoke.Presumablyduetothepolycyclicaromatichydrocarbonscontainedinthe

smoke,themetabolismofdifferentmedicinalproductsmaybespeededupbyenzymeinduction:e.g.caffeine,

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

oestrogenandvitaminB12.

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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offoetalgrowth.Studiesinratsproducedevidenceofdecreasedfertility,prolongedpregnancy,andbehavioural

disordersintheoffspring.Inmicetheoffspringofanimalsexposedtoveryhighdosesofnicotineshowed

skeletaldefectsintheperipheralpartsofthelimbs.

Overall,therearenoclearcutgroundsforbelievingthatnicotineattheconcentrationsreachedbytreatmentwith

nicotinegumhasanyteratogenicpotentialand/orinhibitoryeffectsonfertility.

4.7Effectsonabilitytodriveandusemachines

Smokingcessationcancausebehaviouralchanges.Thereisnoevidenceofanyrisksassociatedwithdrivingor

operatingmachinerywhenthegumisusedfollowingtherecommendeddose.

4.8Undesirableeffects

Inprinciple,BootsNicotineChewingGumcancauseadversereactionssimilartothoseassociatedwithnicotine

administeredbysmoking.

Nicotinefromgummaysometimescauseaslightirritationofthethroatandincreasesalivationatthestartof

treatment.Excessiveswallowingofdissolvednicotinemay,atfirst,causehiccupping.Thosewithatendencyto

indigestionmaysufferinitiallyfromminorindigestionorheartburn.Slowerchewingwillusuallyovercomethis

problem.Excessiveconsumptionofgumbysubjectswhohavenotbeeninthehabitofinhalingtobaccosmoke

couldpossiblyleadtonausea,faintnessorheadaches.

4.9Overdose

Inoverdose,symptomscorrespondingtoheavysmokingmaybeseen.

Theacutelethaloraldoseofnicotineisabout0.5-0.75mgperkgbodyweight,correspondinginanadultto40-

60mg.Evensmallquantitiesofnicotinearedangerousinchildren,andmayresultinseveresymptomsof

poisoningwhichmayprovefatal.Ifpoisoningissuspectedinachild,adoctormustbeconsultedimmediately.

OverdosewithBootsNicotineChewingGummayonlyoccurifmanypiecesarechewedsimultaneously.Riskof

overdoseissmallasnauseaorvomitingusuallyoccursatanearlystage.Riskofpoisoningbyswallowingthe

gumissmall.Sincethereleaseofnicotinefromthegumisslow,verylittlenicotineisabsorbedfromthe

stomachandintestine,andifanyis,itwillbeinactivatedintheliver.

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

vomiting,diarrhoea,abdominalpain,hearingandvisualdisturbances,headache,tachycardiaandcardiac

arrhythmia,dyspnoea,prostration,circulatorycollapse,comaandterminalconvulsions.

Treatmentofoverdosage:

Intheeventofoverdosage,vomitingshouldbeinducedwithsyrupofipecacuanhaorgastriclavagecarriedout

(wideboretube).Asuspensionofactivatedcharcoalshouldthenbepassedthroughthetubeandleftinthe

stomach.Artificialrespirationwithoxygenshouldbeinstitutedifneededandcontinuedforaslongasnecessary.

Othertherapy,includingtreatmentofshock,ispurelysymptomatic.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Nicotinegummimicsthepharmacologicaleffectsofnicotinefromsmoking,andmaythereforebeusedtohelp

providerelieffromnicotinewithdrawalsymptoms.Inadditiontoeffectsonthecentralnervoussystem,nicotine

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5.2Pharmacokineticproperties

Whenthegumischewed,nicotineissteadilyreleasedintothemouthandisrapidlyabsorbedthroughthebuccal

mucosa.Aproportion,bytheswallowingofnicotinecontainingsaliva,reachesthestomachandintestinewhere

itisinactivated.

Thepeakplasmaconcentrationofthe2mggumafterasingledoseisapproximately4.8nanogramspermland

followingsteadystateadministrationisapproximately14nanogramsperml(averageplasmaconcentrationof

nicotinewhensmokingacigaretteis15-30nanogramsperml).

Forachewinggumof4mgithasbeencalculatedthatamaximumplasmaconcentrationofapproximately

10nanog/mlisreachedafterapproximately30minutes.

Nicotineiseliminatedmainlyviahepaticmetabolism;smallamountsofnicotineareeliminatedinunchanged

formviathekidneys.Theplasmahalf-lifeisapproximatelythreehours.Nicotinecrossestheblood-brainbarrier,

theplacentaandisdetectableinbreastmilk.

5.3Preclinicalsafetydata

NoanimalstudieshavebeenundertakenonBootsNicotineChewingGum.

Thetoxicityofnicotineasaconstituentoftobaccohasbeenwelldocumented.Acutetoxiceffectsinclude

convulsions,cardiacinsufficiency,andparalysisoftherespiratorysystem.

Athighdosesincatsanddogs,nicotinehasbeenshowntopotentiatehistamine-inducedpepticulcer.

Nicotinehasnogenotoxicactivityinmostofthemutagenicitytestsystems.Thewell-knowncarcinogenicityof

tobaccosmokingismainlycausedbypyrolysisproducts.Applicationofnicotinechewinggum,however,avoids

thehightemperaturerequiredfortheformationofthesecarcinogenicproducts.

AllexcipientsusedinBootsNicotineChewingGumareoffoodgrade.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Gumbase

Calciumcarbonate

Sorbitol(E420)

Purifiedwater

Glycerol(E422)

Sodiumcarbonateanhydrous

Sodiumhydrogencarbonate

Polacrilin

Levomenthol

Peppermintoil

Eucalyptusoil

Butylhydroxytoluene(E321)

Acesulfamepotassium

Saccharin

Sodiumsaccharin

Talc

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

18months.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

ThechewinggumispackedinPVC/aluminiumblisterpackseachcontaining12piecesofgum.Theblistersare

packedinboxescontaining12,24,36,48,60,72and96piecesofgum.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLtd

WimblehurstRoad

Horsham

WestSussexRH125AB

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA30/40/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14June2000

Dateoflastrenewal:14June2005

10DATEOFREVISIONOFTHETEXT

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