Otrason Haleon
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 som lege, apotek eller sykepleier 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, apotek eller sykepleier dersom du opplever bivirkninger, inkludert mulige bivirkninger som ikke er nevnt i dette pakningsvedlegget. Se avsnitt 4.
- Du må kontakte lege dersom du ikke føler deg bedre eller hvis du føler deg verre etter 7 dager.
I dette pakningsvedlegget finner du informasjon om:
- Hva Otrason er og hva det brukes mot
- Hva du må vite før du bruker Otrason
- Hvordan du bruker Otrason
- Mulige bivirkninger
- Hvordan du oppbevarer Otrason
- Innholdet i pakningen og ytterligere informasjon
1. Hva Otrason er og hva det brukes mot
Virkestoffet er flutikasonpropionat, et kortikosteroid som, når det brukes hver dag, har betennelsesdempende virkning. Det bidrar til å kontrollere kroppens reaksjoner på allergener ("triggere") i omgivelsene.
Til voksne over 18 år: korttidsbehandling av neseplager ved allergi, for eksempel pollenallergi.
2. Hva du må vite før du bruker Otrason
Bruk ikke Otrason:
- dersom du er allergisk overfor flutikasonpropionat eller noen av de andre innholdsstoffene i dette legemidlet (listet opp i avsnitt 6).
Advarsler og forsiktighetsregler
Rådfør deg med lege eller apotek før du bruker Otrason:
- dersom du bruker kortikosteroider (inkludert kremer mot eksem, astmainhalatorer, tabletter, injeksjoner, nesespray og øye- eller nesedråper).
- dersom du har en infeksjon i nesen eller bihulene, er forkjølet, har feber, nylig neseoperert, har en neseskade eller sår i nesen.
Snakk med legen din dersom plagene ikke er bedre etter 7 dager.
Skal ikke brukes sammenhengende i mer enn 3 måneder, såfremt ikke legen din har bedt deg om det.
Kontakt legen din dersom du opplever tåkesyn eller andre synsforstyrrelser, noe som kan skyldes grå stær eller grønn stær (glaukom).
Når nesespray med kortikosteroid blir brukt i høye doser over lengre tid, kan det oppstå bivirkninger som skyldes at legemidlet er tatt opp i kroppen. Det er mye mindre sannsynlig at disse bivirkningene forekommer ved bruk av nesespray enn ved bruk av orale kortikosteroider (via munnen), og de kan variere fra pasient til pasient og mellom ulike kortikosteroid-legemidler. Dette kan omfatte Cushings syndrom, cushingoide trekk, binyresuppresjon, veksthemming hos barn og ungdom, grå stær, grønn stær og sjeldnere redusert bentetthet, effekter på glukosemetabolismen og en rekke psykologiske og adferdsrelaterte effekter som psykomotorisk hyperaktivitet, søvnforstyrrelser, angst, depresjon eller aggresjon (spesielt hos barn).
Behandling med høyere enn anbefalte doser av nesespray med kortikosteroider kan føre til at din egen hormonproduksjon reduseres (binyresuppresjon). Hvis høyere enn anbefalte doser har blitt brukt, kan legen anbefale andre typer kortikosteroid-legemidler i perioder med stress eller før operasjon.
Andre legemidler og Otrason
Rådfør deg med lege eller apotek dersom du bruker, nylig har brukt eller planlegger å bruke andre legemidler. Dette gjelder også reseptpliktige legemidler, spesielt:
- kortikosteroider (inkludert kremer mot eksem, astmainhalatorer, tabletter, injeksjoner, nesespray og øye- eller nesedråper).
- ritonavir eller kobicistat (legemidler mot hiv)
- ketokonazol (mot soppinfeksjon).
Noen legemidler kan øke effekten av Otrason, og legen din vil kanskje overvåke deg nøye hvis du tar disse legemidlene (inkludert noen legemidler mot hiv: ritonavir, kobicistat).
Inntak av Otrason sammen med mat og drikke
Du kan bruke Otrason når som helst på døgnet, med eller uten mat.
Graviditet, amming og fertilitet
Rådfør deg med lege eller apotek før du tar dette legemidlet dersom du er gravid eller ammer, tror at du kan være gravid eller planlegger å bli gravid. Det finnes ingen data på effekten av dette legemidlet på fertiliteten.
Kjøring og bruk av maskiner
Det er lite sannsynlig at Otrason påvirker din evne til å kjøre eller bruke verktøy eller maskiner.
Otrason inneholder benzalkoniumklorid
Dette legemidlet inneholder 0,02 mg benzalkoniumklorid i hver sprayløsning. Dette tilsvarer 0,2 mg benzalkoniumklorid i hver 1 ml løsning. Benzalkoniumklorid kan forårsake irritasjon og hevelser på innsiden av nesen, spesielt ved langvarig bruk.
3. Hvordan du bruker Otrason
Bruk alltid dette legemidlet nøyaktig som beskrevet i dette pakningsvedlegget eller som lege, apotek eller sykepleier har fortalt deg. Rådfør deg med lege, apotek eller sykepleier hvis du er usikker.
Voksne over 18 år: 2 spray i hvert nesebor 1 gang daglig. Når plagene er under kontroll, kan dosen reduseres til 1 spray i hvert nesebor 1 gang daglig.
Kontakt lege etter 7 dagers behandling hvis plagene blir verre eller ikke blir bedre.
Otrason skal ikke brukes sammenhengende i mer enn 3 måneder. Kontakt lege dersom du har symptomer på allergi som må behandles i mer enn 3 måneder.
Bruk av Otrason hos barn og ungdomOtrason skal ikke brukes sammenhengende i mer enn 3 måneder. Kontakt lege dersom du har symptomer på allergi som må behandles i mer enn 3 måneder.
Skal ikke brukes hos barn og ungdom under 18 år.
Hvordan du skal bruke OtrasonKun til bruk i nesen.
Skal ikke svelges.
Skal ikke sprayes i øynene.
Før du bruker en ny sprayflaske:Skal ikke svelges.
Skal ikke sprayes i øynene.
Otrason har en hette som beskytter dysen og holder den ren. Ta av denne hetten før du bruker sprayen (Bilde 1).
Før du begynner å bruke en ny flaske med Otrason, eller dersom du har ikke brukt sprayen på noen dager, skal du klargjøre sprayen for å være sikker på å få ut riktig dose.
Hold flasken med tommelen på undersiden, og hold pekefinger og langfinger på hver sin side av dysen. Mens du holder tommelen stille, presser du ned med fingrene flere ganger inntil det dannes en fin dusj (Bilde 2).
Når du gjør dette, må du ikke rette dysen mot deg selv eller noen andre.
Dersom sprayen likevel ikke fungerer, bør du rengjøre den som beskrevet under avsnittet "Rengjøring av sprayen". Ikke prøv å stikke opp eller forstørre det lille sprayhullet med en nål eller andre spisse gjenstander, siden det vil ødelegge spraymekanismen.
Bilde 1
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)
Bruk av sprayen:- Puss nesen godt.
- Rist flasken forsiktig og fjern hetten.
- Dersom du skal bruke en ny flaske med Otrason for første gang, eller dersom du har ikke brukt sprayen på noen dager, må du klargjøre sprayflasken. Press ned på pumpen flere ganger inntil du får ut en fin spray.
- Hold flasken som vist (Bilde 3). Før dysen inn i det ene neseboret og lukk det andre neseboret, bøy hodet litt framover og hold flasken loddrett som vist (Bilde 4). Sikt litt bort fra midten av nesen.
- Begynn å puste sakte inn gjennom nesen. Mens du puster inn, presser du fast ned på kragen med fingrene for å spraye en dose inn i nesen.
- Pust ut gjennom munnen. Gjenta trinn 4 for å spraye enda en dose inn i samme nesebor.
- Ta dysen ut av dette neseboret, og pust ut gjennom munnen (Bilde 5).
- Gjenta trinn 4 til 6 med det andre neseboret.
- Etter at du har brukt sprayen, rengjør du dysen med et rent tørkepapir eller håndkle og setter på hetten.
Bilde 3
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Bilde 4
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Bilde 5
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)
Rengjøring av sprayen:- Ta av hetten og dysen (Bilde 6).
- Legg dysen og hetten i varmt vann i noen minutter (Bilde 7), og skyll dem under rennende vann (Bilde 8).
- Rist av vannet, og la dem tørke på en lun plass - ikke for varmt!
- Sett dysen på igjen (Bilde 9).
- Om nødvendig presser du på pumpen flere ganger inntil du får ut en fin spray. Sett på hetten.
- Ikke prøv å stikke opp eller forstørre det lille sprayhullet med en nål eller andre spisse gjenstander, siden det vil ødelegge spraymekanismen.
Bilde 6, 7, 8, 9
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)
Det kan ta 3 eller 4 dager for å oppnå maksimal effekt med Otrason. For å forebygge nesesymptomer på allergi må du begynne med Otrason noen dager før du blir utsatt for «triggeren» som utløser din allergi.
Du skal ikke bruke Otrason i lenger tid enn den tidsperioden du blir utsatt for dine vanlige allergi- "triggere" (f.eks. pollen).
Dersom du tar for mye av Otrason
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 legemidlet ved et uhell. For andre spørsmål om legemidlet, kontakt lege eller apotek.
Dersom du har glemt å ta Otrason
Dersom du glemmer en dose, tar du bare neste dose slik det er planlagt. Du må ikke ta en dobbelt dose som erstatning for en glemt dose.
Spør lege eller apotek dersom du har noen spørsmål om bruken av dette legemidlet.
4. Mulige bivirkninger
Som alle legemidler kan dette legemidlet forårsake bivirkninger, men ikke alle får det.
Når nesespray med kortikosteroid blir brukt i høye doser over lengre tid, kan det oppstå bivirkninger som skyldes at legemidlet er tatt opp i kroppen.
Alvorlige bivirkningerOppsøk medisinsk hjelp umiddelbart hvis noen av disse svært sjeldne, men alvorlige bivirkningene oppstår:
Det er ikke kjent hvor ofte disse bivirkningene oppstår:- Tegn på allergisk reaksjon, som utslett, hevelse i munn eller ansikt eller pustevansker
- Du opplever synsforandringer som oppstod etter at du begynte med dette legemidlet. Det har vært sjeldne rapporter om øyeproblemer, som grå stær eller grønn stær (glaukom), hos personer som har brukt store mengder kortikosteroider over flere år.
- Det kan hende at du får små hull (perforasjoner) i veggen inne i nesen som skiller neseborene
- Øyeproblemer som smerter
- Tåkesyn
- Sår i nesen
Dersom du får noen av disse symptomene, skal du slutte å bruke legemidlet og oppsøke medisinsk hjelp umiddelbart.
Andre bivirkningerSvært vanlige bivirkninger (kan påvirke flere enn 1 av 10 personer):
- Neseblødninger av og til
Vanlige bivirkninger (kan påvirke inntil 1 av 10 personer):
- Nysing etter bruk av sprayen, men det gir seg raskt
- Ubehagelig smak eller lukt
- Tørrhet eller irritasjon i nese eller hals
- Hodepine
Svært sjeldne bivirkninger (kan påvirke inntil 1 av 10 000 personer):
- Neseproblemer som smerter og/eller vedvarende neseblod
Hvis du får noen av disse symptomene, må du slutte å bruke legemidlet og fortelle legen din.
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 Otrason
Oppbevares utilgjengelig for barn.
Bruk ikke dette legemidlet etter utløpsdatoen som er angitt på flasken etter "EXP". Utløpsdatoen henviser til den siste dagen i den måneden.
Oppbevares ved høyst 30ºC.
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.
6. Innholdet i pakningen og ytterligere informasjon
Sammensetning av Otrason
- Virkestoffet er flutikasonpropionat. Hver spray frigir 100 mg suspensjon, som inneholder 50 mikrogram flutikasonpropionat som avgitt dose.
- Andre innholdsstoffer er glukose (vannfri), mikrokrystallinsk cellulose, karmellosenatrium, fenyletylalkohol, benzalkoniumklorid, polysorbat 80 og renset vann.
Hvordan Otrason ser ut og innholdet i pakningen
Otrason er en hvit, ugjennomsiktig, vandig nesespray, suspensjon.
Den ravfargede glassflasken er utstyrt med pumpe, neseapplikator og hette. Otrason er tilgjengelig som en flaske med 60 doser med et totalt innhold på minst 7,0 g, og en flaske med 120 doser med et totalt innhold på minst 14,0 g.
Innehaver av markedsføringstillatelsen
Haleon Denmark ApS
Delta Park 37
2665 Vallensbæk Strand
Danmark
Telefon: 80058630
E-mail: mystory.nd@haleon.com
TilvirkerDelta Park 37
2665 Vallensbæk Strand
Danmark
Telefon: 80058630
E-mail: mystory.nd@haleon.com
Glaxo Welcome S.A.
Avda, Extremadura 3
Pol. Ind. Allendeduero
Aranda de Duero
Burgos, 09400
Spania
Avda, Extremadura 3
Pol. Ind. Allendeduero
Aranda de Duero
Burgos, 09400
Spania
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstrasse 4
80339 München
Germany
Barthstrasse 4
80339 München
Germany
Haleon Germany GmbH
Barthstrasse 4
80339 München
Germany
Barthstrasse 4
80339 München
Germany
Dette pakningsvedlegget ble sist oppdatert 08.11.2023
Detaljert informasjon om dette legemidlet er tilgjengelig på nettstedet til www.felleskatalogen.no