BOOTS NICOTINE TRANSDERMAL PATCH 24HOUR

Main information

  • Trade name:
  • BOOTS NICOTINE TRANSDERMAL PATCH 24HOUR
  • Dosage:
  • 7 Milligram
  • Pharmaceutical form:
  • Transdermal Patch
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BOOTS NICOTINE TRANSDERMAL PATCH 24HOUR
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/040/004
  • Authorization date:
  • 14-06-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BootsNicotineTransdermalPatch7mg/24hour

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachpatchcontains17.5mgS(-)nicotine,averageabsorptionrate7mgin24hours.

Drugreleasingsurfacearea–10cm 2

Forexcipients,see6.1.

3PHARMACEUTICALFORM

TransdermalPatch

Transdermaltherapeuticsystem,consistingofaround,flat,matrix-typeself-adhesiveyellowish-ochrecolouredpatch

printed‘CGCWC’onthepatchsurface.Itisprotectedbyarectangularmetallicreleaselinerbackingtobediscarded

beforeapplication.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thetreatmentofnicotinedependence,asanaidtosmokingcessation.

Routeofadministration:transdermal.

4.2Posologyandmethodofadministration

Adults

UsersshouldstopsmokingcompletelyduringtreatmentwiththeBootsNicotinePatch7mg/24Hour.

Forindividualssmoking20cigarettesormoreaday,itisrecommendedthattreatmentbestartedwithBootsNicotine

Patch21mg/24Hour(step1)daily,appliedtoadrynon-hairyareaoftheskinonthetrunkorupperarm.Those

smokinglessthanthisarerecommendedtostartwithBootsNicotinePatch14mg/24Hour(step2).Sizesof30cm 2

20cm 2

and10cm 2

areavailabletopermitgradualwithdrawalofnicotinereplacement,usingtreatmentperiodsof3-4

weeksforeachsize.Thesizeofpatchmaybeadjustedaccordingtoindividualresponse,maintainingorincreasingthe

doseifabstinenceisnotachievedorifwithdrawalsymptomsareexperienced.Totaltreatmentperiodsofmorethan3

monthsanddailydosesabove30cm 2

havenotbeenevaluated.Thetreatmentisdesignedtobeusedcontinuouslyfor3

monthsbutnotbeyond.However,ifabstinenceisnotachievedattheendofthe3monthtreatmentperiod,further

treatmentsmayberecommendedfollowingare-evaluationofthepatient’smotivationbythedoctor.

Thedosagemustnotbeadjustedbycuttingapatch.

TheBootsNicotinePatch7mg/24Hourshouldbeusedassoonasithasbeenremovedfromthechild-resistantpouch.

Followingremovalofthemetallicbacking,theBootsNicotinePatch7mg/24Hourshouldbeappliedtotheskinand

heldinpositionfor10-20secondswiththepalmofthehand.Eachpatchshouldberemovedafter24hoursand

disposedofsafely(see“Warnings”).Adifferentsiteofapplicationshouldbechoseneachdayandseveraldaysshould

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Childrenandyoungadults:

TheBootsNicotinePatch7mg/24Hourshouldnotbeadministeredtopersonsunder18yearsofagewithout

recommendationfromaphysician.Thereisnoexperienceintreatingadolescentsundertheageof18withtheBoots

NicotinePatch7mg/24Hour.

Elderly

ExperienceintheuseoftheBootsNicotinePatch7mg/24Hourinsmokersovertheageof65yearsislimited.The

BootsNicotinePatch7mg/24hourdoesnotappeartoposesafetyproblemsinthisagegroup.

Potentialforabuseanddependence

Transdermalnicotineislikelytohaveaverylowabusepotentialbecauseofitsslowonsetofaction,lowfluctuationsin

bloodconcentrations,inabilitytoproducehighbloodconcentrationsofnicotine,andtheinfrequent(oncedaily)use.

Moreover,gradualweaningfromBootsNicotinePatchesisinstitutedwithinthetreatmentschedule,andtheriskof

dependenceaftertherapyisminimal.TheeffectsofabruptwithdrawalfromBootsNicotinePatch24hourpatchesare

likelytobesimilartothoseobservedwithtobaccowithdrawalfromcomparablenicotineconcentrations.

4.3Contraindications

TheBootsNicotinePatch7mg/24hourshouldnotbeadministeredtonon-smokersoroccasionalsmokers.Thesystem

isalsocontra-indicatedinacutemyocardialinfarction,unstableorworseninganginapectoris,severecardiac

arrhythmias,recentcerebrovascularaccident,diseasesoftheskinwhichmaycomplicatepatchtherapy,andknown

hypersensitivitytonicotineoranyofthecomponentsofthepatch.

4.4Specialwarningsandprecautionsforuse

Warnings:Nicotineisatoxicdrugandmilligramdosesarepotentiallyfatalifrapidlyabsorbed.TreatmentwithBoots

NicotinePatch7mg/24Hourshouldbediscontinuedifsymptomsofnicotineoverdosageappear.Mildintoxication

producesnausea,vomiting,abdominalpain,diarrhoea,headache,sweatingandpallor(see‘Overdosage’).

Dosesofnicotinethataretoleratedbyadultsmokersduringtreatmentcanproduceseveresymptomsofpoisoningin

smallchildrenandmayprovefatal.Bothbeforeandafteruse,theBootsNicotinePatch7mg/24hourcontainsa

significantamountofnicotine.Subjectsmustbecautionedthatthepatchesmustnotbehandledcasuallyorleftwhere

theymightbeinadvertentlymisusedorconsumedbychildren.Usedpatchesmustbedisposedofwithcarebyfolding

theminhalfwiththeadhesivesidesinwards,andensuringthattheydonotfallintothehandsofchildrenunderany

circumstances.

Precautions:UsersshouldstopsmokingcompletelyduringtherapywithBootsNicotinePatch7mg/24Hour.They

shouldbeinformedthatiftheycontinuetosmokewhileusingBootsNicotinePatch7mg/24hour,theymayexperience

increasedadverseeffectsduetothehazardsofsmoking,includingcardiovasculareffects.

Insubjectswiththeconditionslistedbelow,BootsNicotinePatch7mg/24hourshouldonlybeusedfollowingacareful

risk-benefitassessment,andonlyincaseswheresubjectshavefounditimpossibletostopsmokingwithoutuseof

BootsNicotinePatch7mg/24hour:hypertension,stableanginapectoris,cerebrovasculardisease,occlusiveperipheral

arterialdisease,heartfailure,hyperthyroidism,diabetesmellitus,renalorhepaticimpairmentandpepticulcer.

Discontinuationoftreatmentmaybeadvisableincasesofsevereorpersistentskinreactions.

Contactsensitisationwasreportedinafewpatientsusingtransdermalnicotineinclinicaltrials.Patientswhodevelop

contactsensitisationtonicotineshouldbecautionedthataseverereactioncouldoccurfromsmokingorexposureto

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

NoinformationisavailableoninteractionsbetweenBootsNicotinePatch7mg/24hourandotherdrugs.

Cessationofsmoking,withorwithoutnicotinereplacement,mayaltertheindividual’sresponsetoconcomitant

medicationandmayrequireadjustmentofdose.Smokingisthoughttoincreasethemetabolismthroughenzyme

inductionandthustolowerthebloodconcentrationsofdrugssuchasantipyrine,caffeine,oestrogens,

desmethyldiazepam,imipramine,lignocaine,oxazepam,pentazocine,phenacetin,theophylline,andwarfarin.Cessation

ofsmokingmayresultinincreasedconcentrationsofthesedrugs.

Otherreportedeffectsofsmokingincludereducedanalgesicefficacyofpropoxyphene,reduceddiureticresponseto

frusemideandreducedpharmacologicalresponsetopropranolol,aswellasreducedratesofulcerhealingwithH

antagonists.

Bothsmokingandnicotinecanincreaselevelsofcirculatingcortisolandcatecholamines.Dosagesofnifedipine,

adrenergicagonists,oradrenergicblockingagentsmayneedtobeadjusted.

4.6Pregnancyandlactation

Patientsshouldbeadvisedtogiveupsmokingwithoutuseofnicotinereplacementtherapy.Shouldthisfail,amedical

assessmentoftheriskbenefitoftheBootsNicotinePatch7mg/24hourshouldbemade.

Teratogenicitystudieswithnicotineinseveralanimalspecieshavedemonstratednon-specificretardationoffoetal

growth.Studiesinpregnantratshaveindicatedthepresenceofbehaviouraldisordersintheoffspring,andinthemouse

theunbornoffspringofanimalstreatedwithapproximately120timesthehumantransdermaldoseshowedskeletal

defectsintheperipheralpartsofthelimbs.Embryoimplantationinratsandrabbitsmaybeinhibitedordelayedby

nicotine.Overall,therearenoclearcutgroundsforbelievingthatnicotineattheconcentrationsreachedbytreatment

withtheBootsNicotinePatch7mg/24hourhasanyteratogenicpotentialand/orinhibitoryeffectsonfertility.

4.7Effectsonabilitytodriveandusemachines

WhentheBootsNicotinePatch7mg/24hourisusedasrecommended,thereareminimalrisksfordrivingvehiclesor

operatingmachinery.

4.8Undesirableeffects

Inprinciple,theBootsNicotinePatch7mg/24hourcancauseadversereactionssimilartothoseassociatedwith

nicotineadministeredbysmoking.Sincethemaximumplasmaconcentrationsofnicotinethatareproducedbythe

BootsNicotinePatch7mg/24hourarelowerthanthoseproducedbysmokingandfluctuateless,nicotine-related

adversereactionsoccurringduringtreatmentwiththeBootsNicotinePatch7mg/24hourcanbeexpectedtobeless

markedthanduringsmoking.

Someofthesymptomslistedbelowarehardtodifferentiatefromrecognisedtobaccowithdrawalsymptomswhen

comparisonwithplaceboismade.Theplacebousedcontainedabout13%ofthenicotineofamatchingBootsNicotine

Patch7mg/24Hour(tomatchcolourandodourforblindingpurposes).

ThemainunwantedeffectofBootsNicotinePatch7mg/24hourisapplicationsitereaction.Thisledtopremature

discontinuationofBootsNicotinePatch7mg/24hourinabout6%ofclinicaltrialparticipants.Skinreactionsconsisted

oferythemaorpruritusatthepatchsite.Oedema,burningsensation,blisters,rash,orpinchingsensationatthe

applicationsitewasalsonoted.Themajorityofthesereactionsweremild.Mostoftheskinreactionsresolvedwithin

48hours,butinmoreseverecasestheerythemaandinfiltrationlastedfrom1to3weeks.Thetimeofonsetof

importantskinreactionswasbetween3and8weeksfromthestartoftherapy.Inisolatedcasestheskinreactions

extendedbeyondtheapplicationsites.Isolatedcasesofurticaria,angioneuroticoedemaanddyspnoeawerereported.

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trialsirrespectiveofcausalassociationtostudydrug.

Otherunwantedexperiencesreported(irrespectiveofcausalassociationwithBootsNicotinePatch7mg/24hour)with

anincidenceof1%-5.9%andmorefrequentlythanplacebo,included:abdominalpain,vomiting,dyspepsia,allergy,

motordysfunction,chestpain,vividdreams,bloodpressurechanges,generalisedrash,somnolence,impaired

concentrationandfatigue.

4.9Overdose

Thetoxicityofnicotinecannotbedirectlycomparedwiththatofsmoking,becausetobaccosmokecontainsadditional

toxicsubstances(egcarbonmonoxide,andtar).

Chronicsmokerscantoleratedosesofnicotinethat,inanon-smoker,wouldbemoretoxic,becauseofthedevelopment

oftolerance.

ApplicationofseveralBootsNicotinePatchescouldresultinseriousoverdosage.Slowerabsorptionaftercutaneous

exposuretonicotinefavoursthedevelopmentoftolerancetotoxiceffects.

RapidsystemicdeliveryofnicotinefromBootsNicotinePatch7mg/24hourwouldnotbeexpectedonchewingand

swallowing,owingtotheslowreleaseofnicotinefromthepatchandfirst-passmetabolism.

Acutetoxiceffects:

Signsandsymptomsofoverdosagewouldbethesameasthoseofacutenicotinepoisoning.Innon-smokingchildren

andadults,theseincludepallor,sweating,nausea,salivation,vomiting,abdominalcramps,diarrhoea,headache,

dizziness,hearingandvisiondisturbances,tremor,mentalconfusion,muscleweakness,convulsions,prostration,

absenceofneurologicalreaction,andrespiratoryfailure.Lethaldosesmayproduceconvulsions,anddeathfollowsasa

resultofperipheralorcentralrespiratoryparalysis,or,lessfrequently,cardiacfailure.

Theacutelethaloraldoseofnicotineinnon-smokingadultsisapproximately60mg.

Management:

Ifthepatientshowssignsofoverdosage,theBootsNicotinePatch7mg/24hourshouldberemovedimmediately.The

skinsurfacemaybewashedwithwateranddried(nosoapshouldbeused).Theskinwillcontinuetodelivernicotine

intothebloodstreamforseveralhoursafterremovalofthesystem,possiblybecauseofadepotofnicotineintheskin.

Othertreatmentmeasuresforacutenicotinepoisoningincludeartificialrespirationinthecaseofrespiratoryparalysis,

maintainingnormalbodytemperature,andtreatmentofhypotensionandcardiovascularcollapse.

EachBootsNicotinePatch7mg/24hourissealedinachild-resistantsachetandtheproductmustbekeptoutofthe

reachandsightofchildrenatalltimes(see“Warnings”).Evendosesofnicotine,whicharetoleratedbyadultsduring

BootsNicotine24

HourPatch Placebo

(N=401) (N=391)

Applicationsitereaction 34.9% 17.6%

Headache 29.7% 29.2%

Coldandflu-likesymptoms 12.0% 8.4%

Dysmenorrhoea(%offemalesubjects) 6.6% 8.8%

Insomnia 6.5% 5.4%

Nausea 6.2% 4.6%

Myalgia 6.0% 4.1%

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followingaccidentalapplication,andmayprovefatal.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Modeofaction:S(-)-nicotineisthemostpharmacologicallyactiveformofnicotine,themajoralkaloidoftobacco.

S(-)-nicotineactsprimarilyoncholinergicreceptorsofthenicotinictypeintheperipheralandcentralnervoussystem.

Formanyeffects,lowdosesofS(-)-nicotinehaveastimulantaction,andhighdosesadepressanteffect.

IntermittentadministrationofS(-)-nicotineaffectsneurohormonalpathways,andresultsinthereleaseofacetylcholine,

noradrenaline,dopamine,serotinin,vasopressin,beta-endorphin,growthhormone,cortisolandACTH.These

neuroregulatorsmaybeinvolvedinthereportedbehaviouralandsubjectiveeffectsofsmoking.

Nicotinereplacementisanestablishedtherapyasanaidtosmokingcessation.TheBootsNicotinePatch7mg/24Hour

providesforaconvenientoncedailyadministrationbyexploitingthefactthatS(-)-nicotineisreadilyabsorbedthrough

theskinintothesystemiccirculation.Placebo-controlled,double-blindstudieshaveshownthatnicotinereplacement

withtheBootsNicotinePatch7mg/24Hourproducessmokingabstinenceratesstatisticallysignificantlybetterthan

placebo,withorwithoutgroupsupport.Therewasalsoastrongtrendtowardsreductionofwithdrawalsymptoms.

ApplicationofBootsNicotinePatch7mg/24hourtosmokersabstinentovernightresultedinsmallincreasesinmean

heartrateandsystolicbloodpressureandadecreaseinstrokevolume.Theeffectsweresmallerinmagnitudethan

thoseproducedbycigarettesmoking.

5.2Pharmacokineticproperties

FollowingsingleapplicationoftheBootsNicotinePatch7mg/24hourtotheskinofhealthyabstinentsmokersthereis

aninitial1-2hoursdelayfollowedbyaprogressiveriseinnicotineplasmaconcentrations,withaplateauattainedat

about8-10hoursafterapplication.

Inthemajorityofsubjectstheareaundertheplasmaconcentrationcurve(AUC0-24hours)variesapproximatelyin

proportiontothedrugreleasingareaofthepatch.TheBootsNicotinePatch7mg/24hourisdesignedtodeliver

approximately0.7mg/cm 2

/24hours.Incomparisonwithani.v.infusion,76.8%ofthenicotinereleasedfromtheBoots

NicotinePatch7mg/24hourissystemicallyavailable.Steadystateplasmaconcentrationsafterrepeateddaily

administrationarewithintherangeobservedduringmoderatecigarettesmoking.

Absorptionofnicotineover24hoursvariesbyafactoroftwobetweendifferentindividuals;howeverwithin-individual

variabilityissmallindicatingconsistentperformanceofthetransdermalsystem.

S(-)-nicotineisdistributedwidelyinthebodywithavolumeofdistributionofapproximately180litres.Itcrossesthe

blood-brainbarrier,placentaandisdetectableinbreastmilk.Plasmaproteinbindingisonly5%.Totalplasma

clearanceofnicotinerangesfrom0.92to2.43litres/min.Itiseliminatedmainlyviahepaticmetabolism.Onlysmall

amountsofnicotineareeliminatedinunchangedformviathekidneys,aprocesswhichispHdependent,being

negligibleunderalkalineconditions.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Acrylateestersvinylacetateco-polymers

Fractionatedcoconutoil

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Aluminisedpolyesterbackingfilm

Aluminisedandsiliconisedpolyesterfilmreleaseliner

6.2Incompatibilities

Noneknown.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

EachBootsNicotinePatch7mg/24hourissealedinachildresistantsachetcomposedofheat-sealed

paper/aluminium/polyamide/polyacrylnitrile.

Thesachetsarepackedinacardboardcarton.

BootsNicotinePatch7mg/24hour:Packsof7patches.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLtd.

Tradingas:

NovartisConsumerHealth

WimblehurstRoad

Horsham

WestSussexRH125AB

England

8MARKETINGAUTHORISATIONNUMBER

PA30/40/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14June2000

Dateoflastrenewal:14June2005

10DATEOFREVISIONOFTHETEXT

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