BOOTS NICOTINE TRANSDERMAL PATCH 24HOUR

Main information

  • Trade name:
  • BOOTS NICOTINE TRANSDERMAL PATCH 24HOUR
  • Dosage:
  • 21mg 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:
  • PA0030/040/006
  • Authorization date:
  • 14-06-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BootsNicotineTransdermalPatch21mg/24hour

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachpatchcontains52.5mgS(-)nicotine,averageabsorptionrate21mgin24hours.

Drugreleasingsurfacearea–30cm 2

Forexcipients,see6.1.

3PHARMACEUTICALFORM

TransdermalPatch

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

printed‘CGEME’onthepatchsurface.Itisprotectedbyarectangularmetallicreleaselinerbackingtobediscarded

beforeapplication.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thetreatmentofnicotinedependence,asanaidtosmokingcessation.

4.2Posologyandmethodofadministration

Adults

UsersshouldstopsmokingcompletelyduringtreatmentwiththeBootsNicotinePatch21mg/24Hour.

Forindividualssmoking20cigarettesormoreaday,itisrecommendedthattreatmentbestartedwithBootsNicotine

Patches21mg/24Hour(step1)daily,appliedtoadrynon-hairyareaoftheskinonthetrunkorupperarm.Those

smokinglessthanthisarerecommendedtostartwithBootsNicotinePatches14mg/24Hour(step2).Sizesof30cm 2

20cm 2

and10cm 2

areavailabletopermitgradualwithdrawalofnicotinereplacement,usingtreatmentperiodsof3-4

weeksforeachsize.Thesizeofpatchmaybeadjustedaccordingtoindividualresponse,maintainingorincreasingthe

doseifabstinenceisnotachievedorifwithdrawalsymptomsareexperienced.

Totaltreatmentperiodsofmorethan3monthsanddailydosesabove30cm 2

havenotbeenevaluated.Thetreatmentis

designedtobeusedcontinuouslyfor3monthsbutnotbeyond.

However,ifabstinenceisnotachievedattheendofthe3monthtreatmentperiod,furthertreatmentsmaybe

recommendedfollowingare-evaluationofthepatient’smotivation.

Thedosagemustnotbeadjustedbycuttingapatch.

TheBootsNicotinePatch21mg/24Hourshouldbeusedassoonasithasbeenremovedfromthechild-resistantpouch.

Followingremovalofthemetallicbacking,theBootsNicotinePatch21mg/24Hourshouldbeappliedtotheskinand

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Eachpatchshouldberemovedafter24hoursanddisposedofsafely(see“Warnings”).Adifferentsiteofapplication

shouldbechoseneachdayandseveraldaysshouldbeallowedtoelapsebeforeanewpatchisappliedtothesamearea

ofskin.

Childrenandyoungadults

TheBootsNicotinePatch21mg/24Hourshouldnotbeadministeredtopersonsunder18yearsofagewithout

recommendationfromaphysician.Thereisnoexperienceintreatingadolescentsundertheageof18withtheBoots

NicotinePatch21mg/24Hour.

Elderly

ExperienceintheuseoftheBootsNicotinePatch21mg/24Hourinsmokersovertheageof65yearsislimited.The

BootsNicotinePatch21mg/24Hourdoesnotappeartoposesafetyproblemsinthisagegroup.

Potentialforabuseanddependence

Transdermalnicotineislikelytohaveaverylowabusepotentialbecauseofitsslowonsetofaction,lowfluctuationsin

bloodconcentrations,inabilitytoproducehighbloodconcentrationsofnicotine,andtheinfrequent(oncedaily)use.

Moreover,gradualweaningfromBootsNicotinePatches21mg/24Hourisinstitutedwithinthetreatmentschedule,and

theriskofdependenceaftertherapyisminimal.TheeffectsofabruptwithdrawalfromBootsNicotinePatches

21mg/24Hourarelikelytobesimilartothoseobservedwithtobaccowithdrawalfromcomparablenicotine

concentrations.

4.3Contraindications

TheBootsNicotinePatches21mg/24Hourshouldnotbeadministeredtonon-smokersoroccasionalsmokers.The

systemisalsocontra-indicatedinacutemyocardialinfarction,unstableorworseninganginapectoris,severecardiac

arrhythmias,recentcerebrovascularaccident,diseasesoftheskinwhichmaycomplicatepatchtherapy,andknown

hypersensitivitytonicotineoranyofthecomponentsofthepatch.

4.4Specialwarningsandprecautionsforuse

Warnings:Nicotineisatoxicdrugandmilligramdosesarepotentiallyfatalifrapidlyabsorbed.TreatmentwithBoots

NicotinePatches21mg/24Hourshouldbediscontinuedifsymptomsofnicotineoverdosageappear.Mildintoxication

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

Dosesofnicotinethataretoleratedbyadultsmokersduringtreatmentcanproduceseveresymptomsofpoisoningin

smallchildrenandmayprovefatal.Bothbeforeandafteruse,theBootsNicotinePatch21mg/24Hourcontainsa

significantamountofnicotine.Subjectsmustbecautionedthatthepatchesmustnotbehandledcasuallyorleftwhere

theymightbeinadvertentlymisusedorconsumedbychildren.Usedpatchesmustbedisposedofwithcarebyfolding

theminhalfwiththeadhesivesidesinwards,andensuringthattheydonotfallintothehandsofchildrenunderany

circumstances.

Precautions:UsersshouldstopsmokingcompletelyduringtherapywithBootsNicotinePatches21mg/24Hour.They

shouldbeinformedthatiftheycontinuetosmokewhileusingBootsNicotinePatches21mg/24Hour,theymay

experienceincreasedadverseeffectsduetothehazardsofsmoking,includingcardiovasculareffects.

Insubjectswiththeconditionslistedbelow,BootsNicotinePatch21mg/24Hourshouldonlybeusedfollowinga

carefulrisk-benefitassessment,andonlyincaseswheresubjectshavefounditimpossibletostopsmokingwithoutuse

ofBootsNicotinePatches21mg/24Hour:Hypertension,stableanginapectoris,cerebrovasculardisease,occlusive

peripheralarterialdisease,heartfailure,hyperthyroidism,diabetesmellitus,renalorhepaticimpairmentandpeptic

ulcer.

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Contactsensitisationwasreportedinafewpatientsusingtransdermalnicotineinclinicaltrials.Patientswhodevelop

contactsensitisationtonicotineshouldbecautionedthataseverereactioncouldoccurfromsmokingorexposureto

othernicotinecontainingproducts.

WhentheBootsNicotinePatch21mg/24Hourisusedasrecommended,thereareminimalrisksfordrivingvehiclesor

operatingmachinery.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

NoinformationisavailableoninteractionsbetweenBootsNicotinePatches21mg/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

assessmentoftheriskbenefitoftheBootsNicotinePatch21mg/24Hourshouldbemade.

Teratogenicitystudieswithnicotineinseveralanimalspecieshavedemonstratednon-specificretardationoffoetal

growth.Studiesinpregnantratshaveindicatedthepresenceofbehaviouraldisordersintheoffspring,andinthemouse

theunbornoffspringofanimalstreatedwithapproximately120timesthehumantransdermaldoseshowedskeletal

defectsintheperipheralpartsofthelimbs.Embryoimplantationinratsandrabbitsmaybeinhibitedordelayedby

nicotine.Overall,therearenoclearcutgroundsforbelievingthatnicotineattheconcentrationsreachedbytreatment

withtheBootsNicotinePatch21mg/24Hourhasanyteratogenicpotentialand/orinhibitoryeffectsonfertility.

4.7Effectsonabilitytodriveandusemachines

WhentheBootsNicotinePatch21mg/24Hourisusedasrecommended,thereareminimalrisksfordrivingvehiclesor

operatingmachinery.

4.8Undesirableeffects

Inprinciple,theBootsNicotinePatch21mg/24Hourcancauseadversereactionssimilartothoseassociatedwith

nicotineadministeredbysmoking.Sincethemaximumplasmaconcentrationsofnicotinethatareproducedbythe

patcharelowerthanthoseproducedbysmokingandfluctuateless,nicotine-relatedadversereactionsoccurringduring

treatmentwiththepatchcanbeexpectedtobelessmarkedthanduringsmoking.

Someofthesymptomslistedbelowarehardtodifferentiatefromrecognisedtobaccowithdrawalsymptomswhen

comparisonwithplaceboismade.Theplacebousedcontainedabout13%ofthenicotineofamatchingBootsNicotine

Patch21mg/24Hour(tomatchcolourandodourforblindingpurposes).

ThemainunwantedeffectofBootsNicotinePatch21mg/24Hourisapplicationsitereaction.Thisledtopremature

discontinuationofthepatchesinabout6%ofclinicaltrialparticipants.Skinreactionsconsistedoferythemaorpruritus

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Themajorityofthesereactionsweremild.Mostoftheskinreactionsresolvedwithin48hours,butinmoresevere

casestheerythemaandinfiltrationlastedfrom1to3weeks.Thetimeofonsetofimportantskinreactionswasbetween

3and8weeksfromthestartoftherapy.Inisolatedcasestheskinreactionsextendedbeyondtheapplicationsites.

Isolatedcasesofurticaria,angioneuroticoedemaanddyspnoeawerereported.

Thefollowingaretheadverseevents/withdrawalsymptomsmostcommonlyreportedinthreedouble-blindclinical

trialsirrespectiveofcasualassociationtostudydrug.

Otherunwantedexperiencesreported(irrespectiveofcausalassociationwithBootsNicotinePatches21mg/24Hour)

withanincidenceof1%-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.

ApplicationofseveralBootsNicotinePatches21mg/24Hourcouldresultinseriousoverdosage.Slowerabsorption

aftercutaneousexposuretonicotinefavoursthedevelopmentoftolerancetotoxiceffects.

RapidsystemicdeliveryofnicotinefromBootsNicotinePatches21mg/24Hourwouldnotbeexpectedonchewing

andswallowing,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,theBootsNicotinePatch21mg/24Hourshouldberemovedimmediately.

Theskinsurfacemaybewashedwithwateranddried(nosoapshouldbeused).Theskinwillcontinuetodeliver

nicotineintothebloodstreamforseveralhoursafterremovalofthesystem,possiblybecauseofadepotofnicotinein

Boots

Nicotine

Patch 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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Othertreatmentmeasuresforacutenicotinepoisoningincludeartificialrespirationinthecaseofrespiratoryparalysis,

maintainingnormalbodytemperature,andtreatmentofhypotensionandcardiovascularcollapse.

EachBootsNicotinePatch21mg/24Hourissealedinachild-resistantsachetandtheproductmustbekeptoutofthe

reachofchildrenatalltimes(see“Warnings”).Evendosesofnicotinewhicharetoleratedbyadultsduringtreatment

withBootsNicotinePatches21mg/24Hourcouldproduceseveresymptomsofpoisoninginsmallchildrenfollowing

accidentalapplication,andmayprovefatal.

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.TheBootsNicotinePatch21mg/24

HourprovidesforaconvenientoncedailyadministrationbyexploitingthefactthatS(-)-nicotineisreadilyabsorbed

throughtheskinintothesystemiccirculation.Placebo-controlled,double-blindstudieshaveshownthatnicotine

replacementwiththeBootsNicotinePatch21mg/24Hourproducessmokingabstinenceratesstatisticallysignificantly

betterthanplacebo,withorwithoutgroupsupport.Therewasalsoastrongtrendtowardsreductionofwithdrawal

symptoms.

ApplicationoftheBootsNRT14mg/24HourPatchtosmokersabstinentovernightresultedinsmallincreasesinmean

heartrateandsystolicbloodpressureandadecreaseinstrokevolume.Theeffectsweresmallerinmagnitudethan

thoseproducedbycigarettesmoking.

5.2Pharmacokineticproperties

FollowingsingleapplicationoftheBootsNicotinePatch21mg/24Hourtotheskinofhealthyabstinentsmokersthere

isaninitial1-2hoursdelayfollowedbyaprogressiveriseinnicotineplasmaconcentrations,withaplateauattainedat

about8-10hoursafterapplication.

Inthemajorityofsubjectstheareaundertheplasmaconcentrationcurve(AUC0-24hours)variesapproximatelyin

proportiontothedrugreleasingareaofthepatch.TheBootsNicotinePatch21mg/24Hourisdesignedtodeliver

approximately0.7mg/cm 2

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

NicotinePatch21mg/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

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Acrylateestersvinylacetateco-polymers

Fractionatedcoconutoil

Methacrylicacidestersco-polymers

Aluminisedpolyesterbackingfilm

Aluminisedandsiliconisedpolyesterfilmreleaseliner

6.2Incompatibilities

Noneknown.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

EachBootsNicotinePatch21mg/24Hourissealedinachildresistantsachetcomposedofheat-sealed

paper/aluminium/polyamide/polyacrylnitrile.

Thesachetsarepackedinacardboardcarton:

BootsNicotinePatch21mg/24Hour:Packsof2,3,7and21patches

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLtd.

Tradingas:

NovartisConsumerHealth

WimblehurstRoad

Horsham

WestSussexRH125AB

England

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14June2000

Dateoflastrenewal:14June2005

10DATEOFREVISIONOFTHETEXT

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