BOOTS NICOTINE TRANSDERMAL PATCH 24HOUR

Main information

  • Trade name:
  • BOOTS NICOTINE TRANSDERMAL PATCH 24HOUR
  • Dosage:
  • 14mg 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:
  • PA0030/040/005
  • Authorization date:
  • 14-06-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BootsNicotineTransdermalPatch14mg/24hour

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachpatchcontains35mgS(-)nicotine,averageabsorptionrate14mgin24hours.

Drugreleasingsurfacearea–20cm 2

Forexcipients,see6.1.

3PHARMACEUTICALFORM

TransdermalPatch

Transdermaltherapeuticsystem,consistingofaround,flat,matrix-typeself-adhesiveyellowish-ochrecolouredpatchprinted‘CG

FEF’onthepatchsurface.

Itisprotectedbyarectangularmetallicreleaselinerbackingtobediscardedbeforeapplication.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thetreatmentofnicotinedependence,asanaidtosmokingcessation.

4.2Posologyandmethodofadministration

Adults

UsersshouldstopsmokingcompletelyduringtreatmentwiththeBootsNicotinePatch14mg/24Hour.

Forindividualssmoking20cigarettesormoreaday,itisrecommendedthattreatmentbestartedwithBootsNicotinePatches

21mg/24Hour(step1)daily,appliedtoadrynon-hairyareaoftheskinonthetrunkorupperarm.Thosesmokinglessthanthis

arerecommendedtostartwithBootsNicotinePatches14mg/24Hour(step2).Sizesof30cm 2

,20cm 2

and10cm 2

areavailableto

permitgradualwithdrawalofnicotinereplacement,usingtreatmentperiodsof3-4weeksforeachsize.Thesizeofpatchmaybe

adjustedaccordingtoindividualresponse,maintainingorincreasingthedoseifabstinenceisnotachievedorifwithdrawal

symptomsareexperienced.Totaltreatmentperiodsofmorethan3monthsanddailydosesabove30cm 2

havenotbeenevaluated.

Thetreatmentisdesignedtobeusedcontinuouslyfor3monthsbutnotbeyond.

However,ifabstinenceisnotachievedattheendofthe3monthtreatmentperiod,furthertreatmentsmayberecommended

followingare-evaluationofthepatient’smotivation.

Thedosagemustnotbeadjustedbycuttingapatch.

TheBootsNicotinePatch14mg/24Hourshouldbeusedassoonasithasbeenremovedfromthechild-resistantpouch.Following

removalofthemetallicbacking,theBootsNicotinePatch14mg/24Hourshouldbeappliedtotheskinandheldinpositionfor10-

20secondswiththepalmofthehand.Eachpatchshouldberemovedafter24hoursanddisposedofsafely(see“Warnings”).A

differentsiteofapplicationshouldbechoseneachdayandseveraldaysshouldbeallowedtoelapsebeforeanewpatchisapplied

tothesameareaofskin.

Children

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fromaphysician.Thereisnoexperienceintreatingadolescentsundertheageof18withtheBootsNicotinePatch14mg/24Hour.

Elderly

ExperienceintheuseoftheBootsNicotinePatch14mg/24Hourinsmokersovertheageof65yearsislimited.TheBoots

NicotinePatch14mg/24Hourdoesnotappeartoposesafetyproblemsinthisagegroup.

Potentialforabuseanddependence

Transdermalnicotineislikelytohaveaverylowabusepotentialbecauseofitsslowonsetofaction,lowfluctuationsinblood

concentrations,inabilitytoproducehighbloodconcentrationsofnicotine,andtheinfrequent(oncedaily)use.Moreover,gradual

weaningfromBootsNicotinePatches14mg/24Hourisinstitutedwithinthetreatmentschedule,andtheriskofdependenceafter

therapyisminimal.TheeffectsofabruptwithdrawalfromBootsNicotinePatches14mg/24Hourarelikelytobesimilartothose

observedwithtobaccowithdrawalfromcomparablenicotineconcentrations.

4.3Contraindications

TheBootsNicotinePatches14mg/24Hourshouldnotbeadministeredtonon-smokersoroccasionalsmokers.Thesystemisalso

contra-indicatedinacutemyocardialinfarction,unstableorworseninganginapectoris,severecardiacarrhythmias,recent

cerebrovascularaccident,diseasesoftheskinwhichmaycomplicatepatchtherapy,andknownhypersensitivitytonicotineorany

ofthecomponentsofthepatch.

4.4Specialwarningsandprecautionsforuse

Warnings:Nicotineisatoxicdrugandmilligramdosesarepotentiallyfatalifrapidlyabsorbed.TreatmentwithBootsNicotine

Patches14mg/24Hourshouldbediscontinuedifsymptomsofnicotineoverdosageappear.Mildintoxicationproducesnausea,

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

Dosesofnicotinethataretoleratedbyadultsmokersduringtreatmentcanproduceseveresymptomsofpoisoninginsmall

childrenandmayprovefatal.Bothbeforeandafteruse,theBootsNicotinePatch14mg/24Hourcontainsasignificantamount

ofnicotine.Subjectsmustbecautionedthatthepatchesmustnotbehandledcasuallyorleftwheretheymightbeinadvertently

misusedorconsumedbychildren.Usedpatchesmustbedisposedofwithcarebyfoldingtheminhalfwiththeadhesivesides

inwards,andensuringthattheydonotfallintothehandsofchildrenunderanycircumstances.

Precautions:UsersshouldstopsmokingcompletelyduringtherapywithBootsNicotinePatches14mg/24Hour.Theyshouldbe

informedthatiftheycontinuetosmokewhileusingBootsNicotinePatches14mg/24Hour,theymayexperienceincreased

adverseeffectsduetothehazardsofsmoking,includingcardiovasculareffects.

Insubjectswiththeconditionslistedbelow,BootsNicotinePatches14mg/24Hourshouldonlybeusedfollowingacarefulrisk-

benefitassessment,andonlyincaseswheresubjectshavefounditimpossibletostopsmokingwithoutuseofBootsNicotine

Patches14mg/24Hour:hypertension,stableanginapectoris,cerebrovasculardisease,occlusiveperipheralarterialdisease,heart

failure,hyperthyroidism,diabetesmellitus,renalorhepaticimpairmentandpepticulcer.

Discontinuationoftreatmentmaybeadvisableincasesofsevereorpersistentskinreactions.

Contactsensitisationwasreportedinafewpatientsusingtransdermalnicotineinclinicaltrials.Patientswhodevelopcontact

sensitisationtonicotineshouldbecautionedthataseverereactioncouldoccurfromsmokingorexposuretoothernicotine

containingproducts.

WhentheBootsNicotinePatch14mg/24Hourisusedasrecommended,thereareminimalrisksfordrivingvehiclesoroperating

machinery.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

NoinformationisavailableoninteractionsbetweenBootsNicotinePatches14mg/24Hourandotherdrugs.

Cessationofsmoking,withorwithoutnicotinereplacement,mayaltertheindividual’sresponsetoconcomitantmedicationand

mayrequireadjustmentofdose.Smokingisthoughttoincreasethemetabolismthroughenzymeinductionandthustolowerthe

bloodconcentrationsofdrugssuchasantipyrine,caffeine,oestrogens,desmethyldiazepam,imipramine,lignocaine,oxazepam,

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Otherreportedeffectsofsmokingincludereducedanalgesicefficacyofpropoxyphene,reduceddiureticresponsetofrusemideand

reducedpharmacologicalresponsetopropranolol,aswellasreducedratesofulcerhealingwithH

-antagonists.

Bothsmokingandnicotinecanincreaselevelsofcirculatingcortisolandcatecholamines.Dosagesofnifedipine,adrenergic

agonists,oradrenergicblockingagentsmayneedtobeadjusted.

4.6Pregnancyandlactation

Patientsshouldbeadvisedtogiveupsmokingwithoutuseofnicotinereplacementtherapy.Shouldthisfail,amedicalassessment

oftheriskbenefitoftheBootsNicotinePatch14mg/24Hourshouldbemade.

Teratogenicitystudieswithnicotineinseveralanimalspecieshavedemonstratednon-specificretardationoffoetalgrowth.

Studiesinpregnantratshaveindicatedthepresenceofbehaviouraldisordersintheoffspring,andinthemousetheunborn

offspringofanimalstreatedwithapproximately120timesthehumantransdermaldoseshowedskeletaldefectsintheperipheral

partsofthelimbs.Embryoimplantationinratsandrabbitsmaybeinhibitedordelayedbynicotine.Overall,therearenoclearcut

groundsforbelievingthatnicotineattheconcentrationsreachedbytreatmentwiththeBootsNicotinePatch14mg/24Hourhas

anyteratogenicpotentialand/orinhibitoryeffectsonfertility.

4.7Effectsonabilitytodriveandusemachines

WhentheBootsNicotinePatch14mg/24Hourisusedasrecommended,thereareminimalrisksfordrivingvehiclesoroperating

machinery.

4.8Undesirableeffects

Inprinciple,BootsNicotinePatches14mg/24Hourcancauseadversereactionssimilartothoseassociatedwithnicotine

administeredbysmoking.SincethemaximumplasmaconcentrationsofnicotinethatareproducedbytheBootsNicotinePatch

14mg/24Hourarelowerthanthoseproducedbysmokingandfluctuateless,nicotine-relatedadversereactionsoccurringduring

treatmentwiththeBootsNicotinePatch14mg/24Hourcanbeexpectedtobelessmarkedthanduringsmoking.

Someofthesymptomslistedbelowarehardtodifferentiatefromrecognisedtobaccowithdrawalsymptomswhencomparison

withplaceboismade.Theplacebousedcontainedabout13%ofthenicotineofamatchingBootsNicotinePatch14mg/24Hour

(tomatchcolourandodourforblindingpurposes).

ThemainunwantedeffectofBootsNicotinePatches14mg/24Hourisapplicationsitereaction.Thisledtopremature

discontinuationofBootsNicotinePatches14mg/24Hourinabout6%ofclinicaltrialparticipants.Skinreactionsconsistedof

erythemaorpruritusatthepatchsite.Oedema,burningsensation,blisters,rash,orpinchingsensationattheapplicationsitewas

alsonoted.Themajorityofthesereactionsweremild.Mostoftheskinreactionsresolvedwithin48hours,butinmoresevere

casestheerythemaandinfiltrationlastedfrom1to3weeks.Thetimeofonsetofimportantskinreactionswasbetween3and8

weeksfromthestartoftherapy.Inisolatedcasestheskinreactionsextendedbeyondtheapplicationsites.Isolatedcasesof

urticaria,angioneuroticoedemaanddyspnoeawerereported.

Thefollowingaretheadverseevents/withdrawalsymptomsmostcommonlyreportedinthreedouble-blindclinicaltrials

irrespectiveofcausalassociationtostudydrug.

BootsNicotinePatch

14mg/24Hour 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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Otherunwantedexperiencesreported(irrespectiveofcausalassociationwithBootsNicotinePatches14mg/24Hour)withan

incidenceof1%-5.9%andmorefrequentlythanplacebo,included:abdominalpain,vomiting,dyspepsia,allergy,motor

dysfunction,chestpain,vividdreams,bloodpressurechanges,generalisedrash,somnolence,impairedconcentrationandfatigue.

4.9Overdose

Thetoxicityofnicotinecannotbedirectlycomparedwiththatofsmoking,becausetobaccosmokecontainsadditionaltoxic

substances(egcarbonmonoxide,andtar).

Chronicsmokerscantoleratedosesofnicotinethat,inanon-smoker,wouldbemoretoxic,becauseofthedevelopmentof

tolerance.

ApplicationofseveralBootsNicotinePatches14mg/24Hourcouldresultinseriousoverdosage.Slowerabsorptionafter

cutaneousexposuretonicotinefavoursthedevelopmentoftolerancetotoxiceffects.

RapidsystemicdeliveryofnicotinefromBootsNicotinePatches14mg/24Hourwouldnotbeexpectedonchewingand

swallowing,owingtotheslowreleaseofnicotinefromthepatchandfirst-passmetabolism.

Acutetoxiceffects:

Signsandsymptomsofoverdosagewouldbethesameasthoseofacutenicotinepoisoning.Innon-smokingchildrenandadults,

theseincludepallor,sweating,nausea,salivation,vomiting,abdominalcramps,diarrhoea,headache,dizziness,hearingandvision

disturbances,tremor,mentalconfusion,muscleweakness,convulsions,prostration,absenceofneurologicalreaction,and

respiratoryfailure.Lethaldosesmayproduceconvulsions,anddeathfollowsasaresultofperipheralorcentralrespiratory

paralysis,or,lessfrequently,cardiacfailure.

Theacutelethaloraldoseofnicotineinnon-smokingadultsisapproximately60mg.

Management:

Ifthepatientshowssignsofoverdosage,theBootsNicotinePatch14mg/24Hourshouldberemovedimmediately.Theskin

surfacemaybewashedwithwateranddried(nosoapshouldbeused).Theskinwillcontinuetodelivernicotineintotheblood

streamforseveralhoursafterremovalofthesystem,possiblybecauseofadepotofnicotineintheskin.

Othertreatmentmeasuresforacutenicotinepoisoningincludeartificialrespirationinthecaseofrespiratoryparalysis,maintaining

normalbodytemperature,andtreatmentofhypotensionandcardiovascularcollapse.

EachBootsNicotinePatch14mg/24Hourissealedinachild-resistantsachetandtheproductmustbekeptoutofthereachof

childrenatalltimes(see“Warnings”).EvendosesofnicotinewhicharetoleratedbyadultsduringtreatmentwithBootsNicotine

Patches14mg/24Hourcouldproduceseveresymptomsofpoisoninginsmallchildrenfollowingaccidentalapplication,andmay

provefatal.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Modeofaction:S(-)-nicotineisthemostpharmacologicallyactiveformofnicotine,themajoralkaloidoftobacco.S(-

)-nicotineactsprimarilyoncholinergicreceptorsofthenicotinictypeintheperipheralandcentralnervoussystem.For

manyeffects,lowdosesofS(-)-nicotinehaveastimulantaction,andhighdosesadepressanteffect.Intermittent

administrationofS(-)-nicotineaffectsneurohormonalpathways,andresultsinthereleaseofacetylcholine,

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

neuroregulatorsmaybeinvolvedinthereportedbehaviouralandsubjectiveeffectsofsmoking.

Nicotinereplacementisanestablishedtherapyasanaidtosmokingcessation.TheBootsNicotinePatch14mg/24Hourprovides

foraconvenientoncedailyadministrationbyexploitingthefactthatS(-)-nicotineisreadilyabsorbedthroughtheskinintothe

systemiccirculation.Placebo-controlled,double-blindstudieshaveshownthatnicotinereplacementwiththeBootsNicotine

Patch14mg/24Hourproducessmokingabstinenceratesstatisticallysignificantlybetterthanplacebo,withorwithoutgroup

support.Therewasalsoastrongtrendtowardsreductionofwithdrawalsymptoms.

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rateandsystolicbloodpressureandadecreaseinstrokevolume.Theeffectsweresmallerinmagnitudethanthoseproducedby

cigarettesmoking.

5.2Pharmacokineticproperties

FollowingsingleapplicationoftheBootsNicotinePatch14mg/24Hourtotheskinofhealthyabstinentsmokersthere

isaninitial1-2hoursdelayfollowedbyaprogressiveriseinnicotineplasmaconcentrations,withaplateauattainedat

about8-10hoursafterapplication.

Inthemajorityofsubjectstheareaundertheplasmaconcentrationcurve(AUC0-24hours)variesapproximatelyin

proportiontothedrugreleasingareaofthepatch.TheBootsNicotinePatch14mg/24Hourisdesignedtodeliver

approximately0.7mg/cm 2

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

NicotinePatch14mg/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

Methacrylicacidestersco-polymers

Aluminisedpolyesterbackingfilm

Aluminisedandsiliconisedpolyesterfilmreleaseliner

6.2Incompatibilities

Noneknown.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

EachBootsNicotinePatch14mg/24Hourissealedinachildresistantsachetcomposedofheat-sealed

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Thesachetsarepackedinacardboardcarton:

BootsNicotinePatches14mg/24Hour:Packsof2,3,7and21patches

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLtd.

Tradingas:

NovartisConsumerHealth

WimblehurstRoad

Horsham

WestSussexRH125AB

England

8MARKETINGAUTHORISATIONNUMBER

PA30/40/5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14June2000

Dateoflastrenewal:14June2005

10DATEOFREVISIONOFTHETEXT

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