Nicotinell Haleon depotplaster
Innledning |
Bruksområder |
Forsiktighetsregler |
Bruksmåte |
Bivirkninger |
Oppbevaring |
Ytterligere informasjon |
Informasjon til pasienter |
Helsepersonell
Les nøye gjennom dette pakningsvedlegget før du begynner å bruke dette legemidlet. Det inneholder informasjon som er viktig for deg.
Bruk alltid dette legemidlet nøyaktig som beskrevet i dette pakningsvedlegget eller slik apoteket har fortalt deg.
- Ta vare på dette pakningsvedlegget. Du kan få behov for å lese det igjen.
- Spør på apoteket dersom du trenger mer informasjon eller råd.
- Kontakt lege eller apotek dersom du opplever bivirkninger, inkludert mulige bivirkninger som ikke er nevnt i dette pakningsvedlegget. Se avsnitt 4.
I dette pakningsvedlegget finner du informasjon om:
- Hva Nicotinell depotplaster er og hva det brukes mot
- Hva du må vite før du bruker Nicotinell depotplaster
- Hvordan du bruker Nicotinell depotplaster
- Mulige bivirkninger
- Hvordan du oppbevarer Nicotinell depotplaster
- Innholdet i pakningen og ytterligere informasjon
1. Hva Nicotinell depotplaster er og hva det brukes mot
Voksne over 18 år: Nicotinell depotplaster er et hjelpemiddel som brukes ved røykeavvenning for å motvirke abstinenssymptomene (røykesug).
Nikotinen tas langsomt opp gjennom huden. Konsentrasjonen av nikotin i blodet er maksimal etter 8-10 timer. Hvert plaster skal sitte på i 24 timer for å gi en jevn tilførsel av nikotin. Dersom du vanligvis ikke lider av røykesug om morgenen, kan plasteret tas av ved sengetid. Ved gradvis å gå ned i styrke kan kroppens nikotinbehov reduseres, og kan til slutt bli borte.
2. Hva du må vite før du bruker Nicotinell depotplaster
Bruk ikke Nicotinell depotplaster dersom:
- du er allergisk overfor nikotin eller noen av de andre innholdsstoffene i dette legemidlet (listet opp i avsnitt 6)
- du er gravid
Advarsler og forsiktighetsregler
Snakk med lege før du bruker Nicotinell depotplaster dersom:
- du har eller har hatt alvorlig hjerte- eller karsykdom, magesår, diabetes, epilepsi eller nedsatt lever- eller nyrefunksjon. Dette gjelder også ved kroniske hudsykdommer.
Nicotinell depotplaster inneholder nikotin og kan være forbundet med en viss tilvenningsfare.
Plasteret inneholder nikotin, også etter bruk, og må oppbevares utilgjengelig for barn. Erfaringer mangler for bruk av preparatet til personer under 18 år.
Graviditet, amming og fertilitet
Snakk med lege eller apotek før du tar dette legemidlet dersom du er gravid eller ammer, tror du kan være gravid eller planlegger å bli gravid.
Enhver form for nikotintilførsel i forbindelse med graviditet og amming bør unngås. Skadelige effekter av sigarettrøyking som lav fødselsvekt og økt risiko for spontanabort er kjent. Det kan være en risiko for fosterskadelige effekter ved bruk av Nicotinell depotplaster under graviditet. Enhver form for nikotin kan skade ditt ufødte barn. Nikotin går lett over i morsmelk og det er mulig at barn som ammes påvirkes. Bruk derfor ikke Nicotinell depotplaster under graviditet og amming.
Enhver form for nikotintilførsel i forbindelse med graviditet og amming bør unngås. Skadelige effekter av sigarettrøyking som lav fødselsvekt og økt risiko for spontanabort er kjent. Det kan være en risiko for fosterskadelige effekter ved bruk av Nicotinell depotplaster under graviditet. Enhver form for nikotin kan skade ditt ufødte barn. Nikotin går lett over i morsmelk og det er mulig at barn som ammes påvirkes. Bruk derfor ikke Nicotinell depotplaster under graviditet og amming.
Kjøring og bruk av maskiner
Nicotinell depotplaster antas ikke å påvirke evnen til å kjøre bil eller bruke maskiner.
3. Hvordan du bruker Nicotinell depotplaster![](data:image/jpeg;base64,iVBORw0KGgoAAAANSUhEUgAAAbkAAACQCAIAAAAa4oI1AAAAAXNSR0IArs4c6QAA/8pJREFUeF7s
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)
Behandling med Nicotinell depotplaster i kombinasjon med Nicotinell medisinsk tyggegummi
Behandling med Nicotinell depotplaster i kombinasjon med Nicotinell 1 mg sugetabletter
Bruk alltid dette legemidlet nøyaktig slik legen din eller apoteket har fortalt deg. Kontakt lege eller apotek hvis du er usikker.
Nicotinell depotplaster kan brukes alene eller i kombinasjon med Nicotinell 2 mg medisinsk tyggegummi eller Nicotinell 1 mg sugetablett.
Bruk av Nicotinell depotplaster hos barn og ungdomNicotinell depotplaster skal ikke brukes av personer under 18 år uten at legen har anbefalt det.
Dosering for voksne over 18 år:Behandling med kun Nicotinell depotplasterDosen er ett plaster én gang daglig. Plasteret skal sitte på hele døgnet eller i den tiden du er våken. Bruk av plasteret døgnet rundt er nødvendig dersom du kjenner røyksug allerede om morgenen. Styrke velges med utgangspunkt i tidligere røykevaner. De som røyker mer enn 20 sigaretter per dag anbefales å starte behandlingen med ett plaster Nicotinell depotplaster 21 mg/24 timer. For de som røyker mindre enn 20 sigaretter per dag er det passende å starte behandlingen med Nicotinell depotplaster 14 mg/24 timer. Nicotinell depotplaster 7 mg/24 timer benyttes ved dosereduksjon i slutten av behandlingen.
Ved tilfredsstillende effekt etter 3-4 ukers behandling skal du bytte til nærmeste lavere styrke. Deretter senkes dosen ytterligere et trinn til laveste styrke eller du fortsetter med laveste styrke i ytterligere 3-4 uker. Behandling med Nicotinell depotplaster bør ikke pågå i mer enn 3 måneder.
BruksanvisningDet er viktig at du slutter helt å røyke før du begynner med Nicotinell depotplaster, og du må være sterkt motivert for å slutte å røyke. Plasteret byttes 1 gang i døgnet. Dersom du ikke føler røykesug om morgenen, kan plasteret fjernes før sengetid. Du kan bade og dusje som vanlig mens du bruker plasteret. Plasteret skal ikke deles.
- Klipp langs den stiplede linjen på den barnesikre pakningen.
- Fjern den smale siden av aluminiumsfolien. Hold i det hudfargede plasteret og trekk av resten av folien. Unngå å ta på limet.
- Plasteret settes på et rent, tørt og helst hårfritt sted på kroppen, for eksempel brystet, ryggen, overarmen eller hoften.
- Press plasteret mot huden med flat hånd i ca. 15 sekunder. Plasteret må ikke løsnes eller flyttes fordi det da vil klebe dårligere.
- Hvis plasteret løsner bør det kastes, og et nytt plaster bør settes på et annet sted på kroppen. Vent til huden er helt tørr ved bytte av plaster etter badstue, bading, eller fysisk aktivitet.
- Nicotinell depotplaster bør ikke settes på samme sted to ganger etter hverandre. Det bør gå en uke før plasteret igjen settes på samme sted. Huden skal ikke være irritert (rød) eller skadet.
- Vask hendene etterpå slik at du ikke får overført nikotin til f.eks. øynene.
Program 1 |
Program 2 |
Program 3 |
|
Styrke: 21 mg/24 timer
Hvert depotplaster avgir nikotin, ca. 21 mg/24 timer |
Styrke: 14 mg/24 timer
Hvert depotplaster avgir nikotin, ca. 14 mg/24 timer |
Styrke: 7 mg/24 timer
Hvert depotplaster avgir nikotin, ca. 7 mg/24 timer |
|
Du som røyker mer enn 20 sigaretter per dag |
| ||
3-4 uker |
3-4 uker |
3-4 uker |
Sammenlagt 9-12 uker |
Du som røyker mindre enn 20 sigaretter per dag |
| ||
|
3-8 uker |
3-4 uker |
Sammenlagt maks. 9-12 uker |
Dersom du ikke har lyktes med behandling med kun Nicotinell tyggegummi eller du ønsker å redusere bruken av tyggegummi pga. lokale bivirkninger, kan du bruke Nicotinell depotplaster sammen med Nicotinell 2 mg tyggegummi.
MERK: Les pakningsvedlegget for Nicotinell 2 mg medisinsk tyggegummi før bruk.
Innledende kombinasjonsbehandling:
Start behandlingen med ett plaster 21 mg/24 timer sammen med den innledende dosen til Nicotinell 2 mg tyggegummi. Bruk antall tyggigummi etter behov. I de fleste tilfeller er 5-6 tyggegummier tilstrekkelig. Du bør ikke bruke mer enn 24 tyggegummier per dag. Vanligvis bør behandlingen vare i 6-12 uker. Deretter reduseres nikotindosen gradvis.
Start behandlingen med ett plaster 21 mg/24 timer sammen med den innledende dosen til Nicotinell 2 mg tyggegummi. Bruk antall tyggigummi etter behov. I de fleste tilfeller er 5-6 tyggegummier tilstrekkelig. Du bør ikke bruke mer enn 24 tyggegummier per dag. Vanligvis bør behandlingen vare i 6-12 uker. Deretter reduseres nikotindosen gradvis.
Reduksjon av nikotindose:
Dette kan gjøres på to måter. Enten brukes plaster med lavere styrke, det vil si 14 mg/24 timer i 3-6 uker etterfulgt av 7 mg/24 timer i ytterligere 3-6 uker sammen med den innledende dosen til Nicotinell 2 mg tyggegummi. Deretter reduseres antall 2 mg tyggegummi gradvis i inntil 12 måneder. Eventuelt kan bruk av plaster avbrytes og antall 2 mg tyggegummi reduseres gradvis i inntil 12 måneder.
Dette kan gjøres på to måter. Enten brukes plaster med lavere styrke, det vil si 14 mg/24 timer i 3-6 uker etterfulgt av 7 mg/24 timer i ytterligere 3-6 uker sammen med den innledende dosen til Nicotinell 2 mg tyggegummi. Deretter reduseres antall 2 mg tyggegummi gradvis i inntil 12 måneder. Eventuelt kan bruk av plaster avbrytes og antall 2 mg tyggegummi reduseres gradvis i inntil 12 måneder.
Anbefalt dosering:
Periode |
Plaster |
2 mg tyggegummi |
Innledende behandling | ||
Første 6-12 uker |
1 plaster 21 mg/24 timer |
Ved behov, 5-6 tyggegummier per dag er anbefalt |
Reduksjon av nikotindose – alternativ 1 | ||
Neste 3-6 uker |
1 plaster 14 mg/24 timer |
Fortsett å bruke tyggegummi ved behov |
Påfølgende 3-6 uker |
1 plaster 7 mg/24 timer |
Fortsett å bruke tyggegummi ved behov |
Inntil 12 måneder |
--- |
Reduser gradvis antall tyggegummier |
Reduksjon av nikotindose – alternativ 2 | ||
Inntil 12 måneder |
--- |
Fortsett med gradvis reduksjon av antall tyggegummier |
Dersom du ikke har lyktes med behandling med kun Nicotinell depotplaster, kan du bruke Nicotinell 1 mg sugetabletter sammen med Nicotinell depotplaster.
MERK: Les pakningsvedlegget for Nicotinell 1 mg sugetabletter før bruk.
For å øke sjansen for å lykkes med å slutte å røyke, bør du slutte å røyke helt når du begynner å bruke depotplaster i kombinasjon med Nicotinell 1 mg sugetabletter, og heller ikke røyke under hele behandlingsperioden.
Bruk av Nicotinell depotplaster sammen med Nicotinell 1 mg sugetablett anbefales for røykere med moderat til svært sterk avhengighet, det vil si mer enn 20 sigaretter per dag. Det anbefales sterkt at kombinasjonsbehandlingen utføres med veiledning og støtte fra helsepersonell.
Innledende kombinasjonsbehandling:
Start behandlingen med ett plaster 21 mg/24 timer sammen med den innledende dosen av Nicotinell 1 mg sugetablett. I de fleste tilfeller er 5-6 sugetabletter tilstrekkelig. Ikke bruk mer enn 15 sugetabletter på én dag. Vanligvis vil behandlingen vare i 6-12 uker. Deretter bør du gradvis redusere nikotindosen.
Start behandlingen med ett plaster 21 mg/24 timer sammen med den innledende dosen av Nicotinell 1 mg sugetablett. I de fleste tilfeller er 5-6 sugetabletter tilstrekkelig. Ikke bruk mer enn 15 sugetabletter på én dag. Vanligvis vil behandlingen vare i 6-12 uker. Deretter bør du gradvis redusere nikotindosen.
Les bruksanvisningen for plasteret ovenfor.
Reduksjon av nikotindose etter de første 6-12 ukene:
Dette kan gjøres på to måter.
Dette kan gjøres på to måter.
Alternativ 1: Bruk plaster med en lavere styrke, det vil si plaster på 14 mg/24 timer i 3-6 uker etterfulgt av 7 mg/24 timer i ytterligere 3-6 uker sammen med den innledende dosen av Nicotinell 1 mg sugetablett. Deretter bør antall sugetabletter reduseres gradvis. Lengre behandlingstid enn 6 måneder er vanligvis ikke anbefalt. Enkelte tidligere røykere kan imidlertid ha behov for lengre behandling for å unngå tilbakefall, men behandlingen bør ikke overskride 9 måneder.
Alternativ 2: Avbryt behandling med plaster og reduser gradvis antallet 1 mg sugetabletter. Lengre behandlingstid enn 6 måneder er vanligvis ikke anbefalt. Enkelte tidligere røykere kan imidlertid ha behov for lengre behandling for å unngå tilbakefall, men behandlingen bør ikke overskride 9 måneder.
Anbefalt dosering:
Periode |
Plaster |
1 mg sugetabletter |
Innledende behandling (etterfulgt av alternativ 1 eller 2, se under) | ||
Første 6-12 uker |
1 plaster 21 mg/24 timer |
Ved behov, 5-6 sugetabletter per dag er anbefalt |
Reduksjon av nikotindose – alternativ 1 | ||
Neste 3-6 uker |
1 plaster 14 mg/24 timer |
Fortsett å bruke sugetabletter ved behov |
Påfølgende 3-6 uker |
1 plaster 7 mg/24 timer |
Fortsett å bruke sugetabletter ved behov |
Inntil 9 måneder totalt |
--- |
Reduser gradvis antall sugetabletter |
Reduksjon av nikotindose – alternativ 2 | ||
Inntil 9 måneder totalt |
--- |
Fortsett med gradvis reduksjon av antall sugetabletter |
Kontakt lege eller apotek dersom du fortsatt bruker plaster eller sugetabletter etter 9 måneder.
Dersom du bruker for mye av Nicotinell depotplaster
Kontakt lege, sykehus eller Giftinformasjonen (tlf. 22 59 13 00) hvis du har fått i deg for mye legemiddel eller hvis barn har fått i seg legemiddel ved et uhell.
Nikotin er giftig og for rask absorpsjon kan selv små doser gi alvorlige virkninger. Selv små mengder nikotin er farlig og kan være livstruende hos barn. Symptomer på overdose av nikotin kan være blekhet, svette, kvalme, svimmelhet, diaré, hodepine, skjelving, forvirring, krampe og tungpustethet. Fjern plasteret i slike tilfeller.
Dersom du har glemt å ta Nicotinell depotplaster
Du må ikke ta en dobbel dose som erstatning for en glemt dose.
4. Mulige bivirkninger
Som alle legemidler kan Nicotinell depotplaster forårsake bivirkninger, men ikke alle får det. Kontakt lege eller apotek dersom noen av bivirkningene blir plagsomme eller du merker bivirkninger som ikke er nevnt i pakningsvedlegget.
Plasteret kan i prinsippet gi samme bivirkninger som nikotin tilført ved røyking, men mindre markert. Vanligst er ulike former for hudreaksjoner der plasteret er festet, som kløe og rødhet. De fleste bivirkninger er milde og forsvinner i løpet av 24 timer.
Vanlige (kan forekomme hos opptil 1 av 10 personer): kvalme, hodepine, svimmelhet, søvnproblemer, kløe, rødhet, hevelse.
Mindre vanlige (kan forekomme hos opptil 1 av 100 personer): hjertebank
Svært sjeldne (kan forekomme hos opptil 1 av 10 000 personer): kontakteksem, allergisk dermatitt.
Mindre vanlige (kan forekomme hos opptil 1 av 100 personer): hjertebank
Svært sjeldne (kan forekomme hos opptil 1 av 10 000 personer): kontakteksem, allergisk dermatitt.
Enkelte CNS bivirkninger (bivirkninger på sentralnervesystemet) kan vanskelig skilles fra abstinenssymptomer ved røykeslutt. Munnsår kan oppstå når man slutter å røyke, men sammenhengen med nikotinbehandling er uklar.
Melding av bivirkninger
Kontakt lege, apotek eller sykepleier dersom du opplever bivirkninger. Dette gjelder også bivirkninger som ikke er nevnt
i pakningsvedlegget. Du kan også melde fra om bivirkninger direkte via meldeskjema som finnes på nettsiden til Statens legemiddelverk:
www.legemiddelverket.no/pasientmelding. Ved å melde fra om bivirkninger
bidrar du med informasjon om sikkerheten ved bruk av dette legemidlet.
5. Hvordan du oppbevarer Nicotinell depotplaster
Oppbevares utilgjengelig for barn.
Oppbevares ved høyst 25ºC, beskyttet mot varme.
Oppbevares ved høyst 25ºC, beskyttet mot varme.
Bruk ikke dette legemidlet etter utløpsdatoen som er angitt på pakningen. Utløpsdatoen henviser til den siste dagen i måneden.
Bruk ikke dette legemidlet hvis du oppdager synlige tegn på forringelse.
Legemidler skal ikke kastes i avløpsvann eller sammen med husholdningsavfall. Spør på apoteket hvordan du skal kaste legemidler som du ikke lenger bruker. Disse tiltakene bidrar til å beskytte miljøet.
Øvrig informasjonBeskyttelsesfolien tas av umiddelbart før bruk.
Brukte plastre brettes sammen (med den hudfargede siden utover) og kastes slik at de ikke blir tilgjengelig for barn.
Brukte plastre brettes sammen (med den hudfargede siden utover) og kastes slik at de ikke blir tilgjengelig for barn.
6. Innholdet i pakningen og ytterligere informasjon
Sammensetning av Nicotinell depotplaster
- Virkestoff er nikotin.
- Andre hjelpestoffer er kopolymer av akryl-metakrylestre. Limet består av fraksjonert kokosnøttolje, kopolymer basert på akrylestre og vinylacetat.
Hvordan Nicotinell depotplaster ser ut og innholdet i pakningen
Plasteret består av en ytre hudfarget film, et lag som inneholder nikotin og en beskyttelsesfolie som skal tas av før bruk. Plastrene finnes i tre ulike styrker som avgir henholdsvis:
- 21 mg nikotin
- 14 mg nikotin
- 7 mg nikotin
Størrelsen på plastrene øker med økende mengde nikotin.
Innehaver av markedsføringstillatelsen og tilvirkerInnehaver
Haleon Denmark ApS
Delta Park 37
2665 Vallensbæk Strand
Danmark
Telefon: 800 58 630
E-mail: mystory.nd@haleon.com
TilvirkerDelta Park 37
2665 Vallensbæk Strand
Danmark
Telefon: 800 58 630
E-mail: mystory.nd@haleon.com
LTS Lohmann Therapie-Systeme AG, Andernach, Tyskland
Haleon Denmark ApS, Delta Park 37, 2665 Vallensbæk Strand , Danmark
Haleon Denmark ApS, Delta Park 37, 2665 Vallensbæk Strand , Danmark
Dette pakningsvedlegget ble sist oppdatert: 14.04.2023
Detaljert informasjon om dette legemidlet er tilgjengelig på nettstedet til www.felleskatalogen.no