BOOTS NICASSIST

Main information

  • Trade name:
  • BOOTS NICASSIST
  • Dosage:
  • 1 Milligram
  • Pharmaceutical form:
  • Lozenges
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BOOTS NICASSIST
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/057/001
  • Authorization date:
  • 11-07-2003
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BootsNicAssist1mgcompressedlozenges.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachpieceoflozengecontains:

Activesubstance:1mgnicotine(correspondingto3.072mgnicotinebitartratedihydrate).

Excipient(s):aspartame(0.01g),maltitol(0.9g)andsodium(9.8mg).

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Compressedlozenge.

White,mintflavoured,roundbiconvexlozenge.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Reliefofnicotinewithdrawalsymptoms,innicotinedependencyasanaidtosmokingcessation.

Patientcounsellingandsupportnormallyimprovethesuccessrate.

4.2Posologyandmethodofadministration

Adultsandelderly

UsersshouldstopsmokingcompletelyduringtreatmentwithBootsNicAssistlozenge.

BootsNicAssist1mglozengeisrecommendedinsmokerswithalowtomoderatenicotinedependency.

BootsNicAssist1mglozengeisnotrecommendedinthecaseofsmokerswithastrongorverystrongnicotine

dependency.

Theoptimaldosageformisselectedaccordingtothefollowingtable:

Ifanadverseeventoccurswiththeuseofthehighdoseform(2mglozenge),useofthelowdoseform(1mglozenge)

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Theinitialdosageshouldbeindividualisedonthebasisofthepatientsnicotinedependence.Onepieceoflozengeto

suckwhentheuserfeelstheurgetosmoke.

Initially,1lozengeshouldbetakenevery1-2hours.Theusualdosageis8-12lozengesperday.Themaximumdaily

doseis30lozenges.

Directionsforuse:

1.Onelozengetobesuckeduntilthetastebecomesstrong.

2.Thelozengeshouldthenbelodgedbetweenthegumandcheek.

3.Whenthetastefades,suckingofthelozengeshouldcommenceagain

4.Thesuckingroutinewillbeadaptedindividuallyandshouldberepeateduntilthelozengedissolvescompletely

(about30minutes)

Thetreatmentdurationisindividual.Normally,treatmentshouldcontinueforatleast3months.After3months,the

usershouldgraduallyreducethenumberoflozenges.Treatmentshouldbediscontinuedwhenthedosehasbeen

reducedto1-2lozengesperday.UseofnicotinemedicinalproductslikeBootsNicAssist1mglozengebeyond6

monthsisgenerallynotrecommended.Someex-smokersmayneedtreatmentwiththelozengelongertoavoid

returningtosmoking.

Patientswhohavebeenusingoralnicotinereplacementtherapybeyond9monthsareadvisedtoseekadditionalhelp

andinformationfromhealthcareprofessionals.

Counsellingmayhelpsmokerstoquit.

Concomitantuseofacidicbeveragessuchascoffeeorsodamaydecreasethebuccalabsorptionofnicotine.Acidic

beveragesshouldbeavoidedfor15minutespriortosuckingthelozenge.

Childrenandadolescents(<18years)

BootsNicAssistlozengeshouldnotbeusedbypeopleunder18yearsofagewithoutrecommendationfroma

physician.Thereisnoexperienceintreatingadolescentsundertheageof18withBootsNicAssistlozenge.

4.3Contraindications

Hypersensitivitytonicotineortoanyoftheexcipients

BootsNicAssistlozengeshouldnotbeusedbynon-smokers.

4.4Specialwarningsandprecautionsforuse

Dependentsmokerswitharecentmyocardialinfarction,unstableorworseninganginaincludingPrinzmetal’sangina,

severecardiacarrhythmias,uncontrolledhypertensionsorrecentcerebrovascularaccidentshouldbeencouragedtostop

smokingwithnon-pharmacologicalinterventions(suchascounselling).Ifthisfails,BootsNicAssist1mglozenges

maybeconsideredbutasdataonsafetyinthispatientgrouparelimited,initiationshouldonlybeunderclosemedical

supervision.

BootsNicAssist1mglozengesshouldbeusedwithcautioninpatientswithhypertension,stableanginapectoris,

cerebrovasculardisease,occlusiveperipheralarterialdisease,heartfailure,diabetesmellitus,hyperthyroidismor

pheochromocytomaandseverehepaticand/orrenalimpairment.

Patientsshouldinitiallybeencouragedtostopsmokingwithnon-pharmacologicalinterventions(suchascounselling).

Swallowednicotinemayexacerbatesymptomsinsubjectssufferingfromactiveoesophagitis,oralandpharyngeal

inflammation,gastritisorpepticulcer.

Dosesofnicotinethataretoleratedbyadultsmokersduringtreatmentmayproduceseveresymptomsofpoisoningin

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Specialwarningsaboutexcipients

BootsNicAssist1mglozengescontainsweeteners,includingaspartameandmaltitol.

EachBootsNicAssist1mglozengecontainsaspartame(E951),asourceofphenylalanineequivalentto5mg/doseand

maybeharmfulforpeoplewithphenylketonuria.

BecauseBootsNicAssist1mglozengecontainsmaltitol(E965),asourceoffructose:

-patientswithrarehereditaryconditionsoffructoseintoleranceshouldnottakethismedicine,

-patientsmayexperienceamildlaxativeeffect.

Calorificvalue2.3kcal/gmaltitol.

BootsNicAssist1mglozengecontains9.8mgofsodiumperpiece.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

DrugInteractions:NoinformationisavailableoninteractionsbetweenNicotinelllozengeandothermedicinal

products.

SmokingCessation:SmokingbutnotnicotineisassociatedwithincreasedCYP1A2activity.Afterstoppingsmoking

theremaybereducedclearanceofsubstratesforthisenzymeandincreasedplasmalevelsofsomemedicinalproducts

ofpotentialclinicalimportancebecauseoftheirnarrowtherapeuticwindowe.g.theophylline,tacrine,olanzapineand

clozapine.

TheplasmaconcentrationsofotheractivesubstancesmetabolisedbyCYP1A2e.g.caffeine,paracetamol,phenazone,

phenylbutazone,pentazocine,lidocaine,benzodiazepines,warfarin,oestrogenandvitaminB12mayalsoincrease.

Howevertheclinicalsignificanceofthiseffectfortheseactivesubstancesisunknown.

Smokingmayleadtoreducedanalgesiceffectsofpropoxyphene,reduceddiureticresponsetofurosemide(frusemide),

reducedeffectofpropranololonbloodpressureandheartrateandreducedresponderratesinulcerhealingwithH2-

antagonists.

Smokingandnicotinemayraisethebloodlevelsofcortisolandcatecholamines,i.e.mayleadtoareducedeffectof

nifedipineoradrenergicantagonistsandtoanincreasedeffectofadrenergicagonists.

Increasedsubcutaneousabsorptionofinsulinwhichoccursuponsmokingcessationmaynecessitateareductionin

insulindose.

4.6Fertility,pregnancyandlactation

Pregnancy

Inpregnantwomen,completecessationoftobaccosmokingshouldalwaysberecommendedwithoutnicotine

replacementtherapy.

Nevertheless,inthecaseoffailureinhighlydependentpregnantsmokers,tobaccowithdrawalvianicotinereplacement

therapymayberecommended.Indeed,foetalriskisprobablylowerthanthatexpectedwithtobaccosmoking,dueto:

-lowermaximalplasmanicotineconcentrationthanwithinhalednicotine

-noadditionalexposuretopolycyclichydrocarbonsandcarbonmonoxide

-improvedchancesofquittingsmokingbythethirdtrimester.

Smokingcontinuedduringthethirdtrimestermayleadtointra-uterinegrowthretardationorevenprematurebirthor

stillbirth,dependingonthedailyamountoftobacco.

Tobaccowithdrawalwithorwithoutnicotinereplacementtherapyshouldnotbeundertakenalonebutaspartofa

medicallysupervisedsmokingcessationprogram.

Inthethirdtrimesternicotinehashaemodynamiceffects(e.g.changesinfoetalheartrate)whichcouldaffectthefoetus

closetodelivery.Therefore,afterthesixthmonthofpregnancy,thelozengeshouldonlybeusedundermedical

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Lactation

Nicotineisexcretedinbreastmilkinquantitiesthatmayaffectthechildevenintherapeuticdoses.Thelozenge,like

smokingitself,shouldthereforebeavoidedduringbreast-feeding.Shouldsmokingwithdrawalnotbeachieved,useof

thelozengebybreastfeedingsmokersshouldonlybeinitiatedafteradvicefromaphysician.Wherenicotine

replacementtherapyisusedwhilstbreast-feeding,thelozengeshouldbetakenjustafterbreast-feedingandnotduring

thetwohoursbeforebreast-feeding.

4.7Effectsonabilitytodriveandusemachines

Thereisnoevidenceofanyrisksassociatedwithdrivingoroperatingmachinerywhenthelozengeisusedfollowing

therecommendeddose.Neverthelessoneshouldtakeintoconsiderationthatsmokingcessationcancausebehavioural

changes.

4.8Undesirableeffects

BootsNicAssistlozengecancauseadversereactionssimilartothoseassociatedwithnicotineadministeredby

smoking.Thesecanbeattributedtothepharmacologicaleffectsofnicotine,whicharedose-dependent.Nondose-

dependentadversereactionsareasfollows:hypersensitivity,angioneuroticoedemaandanaphylacticreactions.

Mostoftheadversereactionswhicharereportedbypatientsoccurgenerallyduringthefirst3-4weeksafterinitiation

oftherapy.

Nicotinefromlozengesmaysometimescauseaslightirritationofthethroatandincreasedsalivationatthestartofthe

treatment.Excessiveswallowingofnicotinewhichisreleasedinthesalivamay,atfirst,causehiccups.Thosewhoare

pronetoindigestionmaysufferinitiallyfromminordegreesofdyspepsiaorheartburn;slowersuckingwillusually

overcomethisproblem.

Excessiveconsumptionoflozengesbysubjectswhohavenotbeeninthehabitofinhalingtobaccosmoke,could

possiblyleadtonausea,faintnessandheadache.

Increasedfrequencyofaphthousulcermayoccurafterabstinencefromsmoking.

Adversereactionsarelistedbelow,bysystemorganclassandfrequencey.Frequenciesaredefinedas:verycommon( ≥

1/10),common( ≥1/100to<1/10),uncommon(≥1/1,000to<1/100),rare(≥1/10,000,<1/1000)orveryrare

(<1/10,000).

Nervoussystemdisorders:

Common:Dizziness,headache

Gastrointestinaldisorders:

Common:Nausea,flatulence,hiccups,gastritis,drymouth,stomatitisandoesophagitis.

Cardiacdisorders:

Uncommon:Palpitations

Rare: atrialarrhythmia

Immunesystemdisorders:

Rare: Hypersensitivity,angioneuroticoedemaandanaphylacticreactions.

Certainsymptomswhichhavebeenreportedsuchasdizziness,headacheandinsomniamaybeascribedtowithdrawal

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Coldsoresmaydevelopinconnectionwithsmokingcessation,butanyrelationwiththenicotinetreatmentisunclear.

Thepatientmaystillexperiencenicotinedependenceaftersmokingcessation.

4.9Overdose

Inoverdose,symptomscorrespondingtoheavysmokingmaybeseen.

Theacutelethaloraldoseofnicotineisabout0.5–0.75mgperkgbodyweight,correspondinginanadultto40–60

mg.Evensmallquantitiesofnicotinearedangerousinchildren,andmayresultinseveresymptomsofpoisoningwhich

mayprovefatal.Ifpoisoningissuspectedinachild,adoctormustbeconsultedimmediately.

OverdosewithBootsNicAssist1mglozengemayonlyoccurifmanypiecesaresuckedsimultaneously.Nicotine

toxicityafteringestionwillmostlikelybeminimisedasaresultofearlynauseaandvomitingthatoccurfollowing

excessivenicotineexposure.

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

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

prostration,circulatorycollapse,comaandterminalconvulsions.

Treatmentofoverdose:

Treatmentofoverdoseshouldbeimmediateassymptomsmaydeveloprapidly.Emesisisusuallyspontaneous.

Administrationoforalactivatedcharcoalandgastriclavageshouldbeconsideredassoonaspossibleandwithin1hour

ofingestion.Monitorvitalsignsandtreatsymptomatically.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:N07BA01

Pharmacotherapeuticgroup:Drugsusedinnicotinedependence

Nicotine,theprimaryalkaloidintobaccoproductsandanaturallyoccurringautonomoussubstance,isanicotine

receptoragonistintheperipheralandcentralnervoussystemsandhaspronouncedCNSandcardiovasculareffects.On

consumptionoftobaccoproducts,nicotinehasproventobeaddictive,resultingincravingandotherwithdrawal

symptomswhenadministrationisstopped.Thiscravingandthesewithdrawalsymptomsincludeastrongurgeto

smoke,dysphoria,insomnia,irritability,frustrationoranger,anxiety,concentrationdifficulties,agitationandincreased

appetiteorweightgain.Thelozengereplacespartofthenicotinethatwouldhavebeenadministratedviatobaccoand

reducestheintensityofthewithdrawalsymptomsandsmokingurge.

5.2Pharmacokineticproperties

Theabsorbedamountofnicotinedependsontheamountreleasedintothemouthandabsorbedthroughthebuccal

mucosa.

ThemainpartofnicotineinBootsNicAssist1mglozengeisabsorbedthroughthebuccalmucosa.Aproportion,bythe

swallowingofnicotine-containingsaliva,reachesthestomachandintestinewhereitisinactivated.Duetothefirst-pass

effectintheliver,thesystemicbioavailabilityofnicotineislow.Consequently,inthetreatmentwithBootsNicAssist

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Distributionvolumeafterintravenousadministrationofnicotineisapproximately2-31/kgandthehalf-lifeis2hours.

Nicotineismetabolisedprincipallyintheliverandtheplasmaclearanceisapproximately1.2l/min;nicotinealso

metabolisesinthekidneyandlungs.Nicotinecrossestheblood-brainbarrier.

Morethan20metaboliteshavebeenidentified,allbelievedtobelessactivethannicotine.Themainmetaboliteis

cotininewhichhasahalf-lifeof15-20hoursandwithapproximately10timeshigherplasmaconcentrationthan

nicotine.Nicotine’splasma-proteinbindingislessthan5%.Changesinnicotinebindingfromtheuseofconcomitant

medicinalproductsorduetoaltereddiseasestatearenotexpectedtohavesignificanteffectonnicotinekinetics.The

mainmetaboliteinurineiscotinine(15%ofthedose)andtrans-3-hydroxycotinine(45%ofthedose).

About10%ofthenicotineisexcretedunchanged.Upto30%maybeexcretedwithurineinincreaseddiuresisandthe

acidityunderpH5.

ThepeakvaluefortheplasmaconcentrationofBootsNicAssist1mglozengeafterasingledoseisapproximately4ng

permlandthemaximalconcentrationatsteadystateisapproximately10.6ngperml(averageplasmaconcentrationof

nicotineaftersmokingonecigaretteis15-30ngperml).Peakplasmaconcentrationisreachedafterabout45minutes

followingsuckingofasinglelozengeandafterabout30minutesatsteadystate.

5.3Preclinicalsafetydata

Nicotinewaspositiveinsomeinvitrogenotoxicitytestsbuttherearealsonegativeresultswiththesametestsystems.

Nicotinewasnegativeinstandardin-vivotests.

Animalexperimentshaveshownthatnicotineinducespost-implantationlossandreducesthegrowthoff o etuses.

Theresultsofcarcinogenicityassaysdidnotprovideanyclearevidenceofatumorigeniceffectofnicotine.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Maltitol(E965)

Sodiumcarbonateanhydrous

Sodiumhydrogencarbonate

Polyacrylatedispersion30percent

Xanthangum

Colloidalanhydroussilica

Levomenthol

Peppermintoil

Aspartame(E951)

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

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6.5Natureandcontentsofcontainer

12,36,72,96,144or204lozengesinopaqueblistersconsistingofaluminiumfoilandPVC/PE/PVDC/PE/PVC-film.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLtd

TradingasNovartisConsumerHealth

WimblehurstRoad

Horsham

WestSussexRH125AB

England

8MARKETINGAUTHORISATIONNUMBER

PA0030/057/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11 th

July2003

Dateoflastrenewal:16 th

December2008

10DATEOFREVISIONOFTHETEXT

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