Naltrexone "POA Pharma"

Primær information

  • Handelsnavn:
  • Naltrexone "POA Pharma" 50 mg filmovertrukne tabletter
  • Dosering:
  • 50 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Naltrexone "POA Pharma" 50 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 49645
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Naltrexone ”POA Pharma” 50 mg filmovertrukne tabletter

Naltrexonhydrochlorid

Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder

vigtige oplysninger.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.

Lægen har ordineret Naltrexone ”POA Pharma” til dig personligt. Lad derfor være med at give det til

andre. Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.

Tal med lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller hvis du får bivirkninger,

som ikke er nævnt her.

Den senest reviderede indlægsseddel kan findes på www.indlaegsseddel.dk

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide, før du begynder at tage Naltrexone ”POA Pharma”

Sådan skal du tage Naltrexone ”POA Pharma”

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Naltrexone ”POA Pharma” bruges som supplerende behandling mod alkoholafhængighed i forbindelse med

et omfattende behandlingsprogram, der understøtter afholdenhed.

Naltrexone ”POA Pharma” nedsætter alkoholindtagelsen i udstrakt grad, da trangen til alkohol nedsættes.

Flere patienter er i stand til at opretholde afholdenhed og undgå tilbagefald.

Naltrexone ”POA Pharma” medfører ikke afhængighed.

Lægen kan have givet dig Naltrexone ”POA Pharma” for noget andet. Følg altid lægens anvisning.

2.

Det skal du vide, før

du begynder at tage Naltrexone ”POA Pharma”

Tag ikke Naltrexone ”POA Pharma”

hvis du er allergisk overfor naltrexonhydrochlorid eller et af de øvrige indholdsstoffer i dette

lægemiddel (angivet i pkt. 6)

hvis du tager eller har taget opioidholdig medicin (f. eks. morphin, der anvendes til behandling af

alvorlige smerter efter operationer eller ved kræftsygdomme)

hvis du er opioidafhængig (uden at have fuldført afvænning)

hvis du har alvorlige leverproblemer eller akut leverbetændelse (hepatitis)

hvis du har alvorlige nyreproblemer

Advarsler og forsigtighedsregler

Din behandling bør påbegyndes af en læge med erfaring i alkoholafvænning.

Du skal informere alle de læger, der behandler dig, om at du tager Naltrexone ”POA Pharma” (se

”Samtidig behandling med Naltrexon ”POA Pharma ” og opioider” samt ”Brug af anden medicin

sammen med Naltrexone ”POA Pharma” nedenfor).

Informer din læge, hvis du har lever- eller nyresygdomme.

Der skal udføres en leverfunktionstest før og under behandling.

Informer din læge, hvis du bliver gravid.

Informer din læge om, at du tager Naltrexone ”POA Pharma”, hvis du skal have taget en blodprøve,

da tabletterne kan påvirke resultatet af leverfunktionsprøver.

Samtidig behandling med Naltrexone ”POA Pharma” og opioder:

Under behandling med Naltrexone ”POA Pharma” må smertetilstande ikke behandles med opioider.

Efter behandling med Naltrexone ”POA Pharma” kan du være mere følsom over for medicin, der

indeholder opioider.

Samtidig behandling med Naltrexone ”POA Pharma” hos patienter, der også er afhængige af opioider:

Tag ikke opioider efter brug af Naltrexone ”POA Pharma”.

Selvom Naltrexone ”POA Pharma” hæmmer virkningen af opioider, kan der være opioider i din

krop, når virkningen af Naltrexone ”POA Pharma” allerede er aftaget. Utilsigtet overdosering kan

have alvorlige eller fatale konsekvenser (kredsløbssvigt, nedsat åndedræt).

Naltrexone ”POA Pharma” kan forårsage livstruende abstinenssymptomer hos opioidafhængige

patienter.

Brug af anden medicin sammen med Naltrexone ”POA Pharma”

Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig. Dette

gælder også medicin, som ikke er købt på recept.

Medicin, der indeholder opioider, skal undgås under behandling med Naltrexone ”POA Pharma”, da

virkningen kan nedsættes. Informer din læge, hvis du tager medicin mod hoste, diarré eller smerter. Lægen

vil ordinere medicin, der ikke indeholder opioider.

Hvis du får brug for smertestillende medicin, der indeholder opioider, i akutte tilfælde, skal dosis evt. være

højere end normalt. I dette tilfælde kræves

ubetinget

overvågning af en læge med erfaring, da nedsat

vejrtrækning og andre symptomer kan være mere udpræget og vare længere.

Graviditet og amning

Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du

spørge din læge eller apoteket til råds, før du tager dette lægemiddel.

Lægen skal afgøre, om Naltrexone ”POA Pharma” må tages under graviditet og amning, idet risiko for mor

og barn overvejes.

Trafik- og arbejdssikkerhed

Naltrexone ”POA Pharma” kan give bivirkninger (f. eks. nedsatte fysiske evner), der i større eller mindre

grad kan påvirke arbejdssikkerheden og evnen til at færdes sikkert i trafikken.

Naltrexone ”POA Pharma” indeholder lactose

Denne medicin indeholder lactose. Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at

du ikke tåler visse sukkerarter.

3.

Sådan skal du tage Naltrexone ”POA Pharma”

Brug til voksne

Tag altid Naltrexone ”POA Pharma” nøjagtigt efter lægens eller apotekspersonalets anvisning. Er du i tvivl,

så spørg lægen eller på apoteket.

Den anbefalede dosis er 1 tablet dagligt medmindre lægen har ordineret andet.

Brug til børn og teenagere

Naltrexone ”POA Pharma” bør ikke anvendes til børn og teenagere under 18 år.

Brug til ældre

Der er ikke tilstrækkelig erfaring med hensyn til sikkerhed og virkning af Naltrexone ”POA Pharma” til

ældre patienter.

Brug til patienter med lever- eller nyresygdomme

Informer din læge, hvis du har lever- eller nyresygdomme. Lægen skal beslutte om dosis af Naltrexone

”POA Pharma” skal justeres eller om behandlingen skal afbrydes.

Behandlingsvarighed

Varigheden af behandling med Naltrexone ”POA Pharma” besluttes af din læge. Sædvanligvis skal

Naltrexone ”POA Pharma” tages i mindst 3 måneder, men i visse tilfælde kan det være nødvendigt med

behandling i længere tid.

Indgivelsesmåde

Naltrexone ”POA Pharma” filmovertrukne tabletter skal tages med en smule væske.

Hvis du har taget for mange Naltrexone ”POA Pharma”

Kontakt lægen, skadestuen eller apoteket, hvis du har taget flere Naltrexone ”POA Pharma” end lægen har

foreskrevet.

Der kendes ikke andre bivirkninger end de, der er nævnt nedenfor.

Hvis du har glemt at tage Naltrexone ”POA Pharma”

Tag aldrig en dobbelt dosis, hvis du har glemt at tage en dosis Naltrexone ”POA Pharma”.

Hvis du holder op med at tage Naltrexone ”POA Pharma”

Du må ikke stoppe behandlingen uden at rådføre dig med din læge.

Spørg lægen eller på apoteket, hvis der er noget, du er i tvivl om.

4.

Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Følgende bivirkninger kan forekomme:

Meget almindelig (forekommer hos flere end l ud af 10 behandlede):

Hovedpine, søvnforstyrrelser, rastløshed, nervøsitet, mavesmerter, mavekramper, kvalme, opkastningstrang,

led- og muskelsmerter, mathed.

Almindelig (forekommer hos mellem 1 og 10 ud af 100 behandlede):

Angst, øget energi, modløshed, irritabilitet, humørsvingninger, tørst, svimmelhed, kulderystelser,

øget svedproduktion, ørhed, øget tåreflod, brystsmerter, diarré, forstoppelse, udslæt, besvær med at lade

vandet, forsinket sædafgang, nedsat potens, appetitløshed.

Sjælden (forekommer hos mellem 1 og 10 ud af 10.000 behandlede):

Depression, selvmordstanker, selvmordsforsøg, taleforstyrrelser, leverproblemer.

Meget sjælden (forekommer hos færre end 1 ud af 10.000 behandlede):

Nedsat antal blodplader og dermed øget risiko for blødninger, uro, opstemthed, hallucinationer, rysten,

udslæt.

Tal med lægen eller apoteket, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne

indlægsseddel.

Bivirkninger, som ikke er nævnt her, bør indberettes til Sundhedsstyrelsen, så viden om bivirkninger kan

blive bedre. Du eller dine pårørende kan selv indberette bivirkninger direkte til Sundhedsstyrelsen. Du finder

skema og vejledning på Sundhedsstyrelsens netsted: www.meldenbivirkning.dk.

5.

Opbevaring

Opbevar dette lægemiddel utilgængeligt for børn.

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

Tag ikke Naltrexone ”POA Pharma” efter den udløbsdato, der står på pakningen og blisteret efter Exp.

Udløbsdatoen er den sidste dag i den nævnte måned.

Hvis du bemærker, at tabletterne er beskadigede f.eks. ridsede eller itu, skal du spørge lægen til råds, før du

tager dem.

Spørg på apoteket, hvordan du skal bortskaffe medicinrester. Af hensyn til miljøet må du ikke smide

medicinrester i afløbet, toilettet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Naltrexone ”POA Pharma” indeholder:

Aktivt stof: naltrexonhydrochlorid.

Hver tablet indeholder 50 mg naltrexonhydrochlorid.

Øvrige indholdsstoffer

:

Tabletkerne:

Lactosemonohydrat, mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon, magnesiumstearat.

Filmovertræk:

Hypromellose (E464), macrogol 400, polysorbat 80 (E433), rød jernoxid (E172), gul jernoxid (E172),

titandioxid (E171).

Udseende og pakningsstørrelser

Gule, ovale, hvælvede, filmovertrukne tabletter med en delekærv på den ene side og glat overflade på den

anden side.

Tabletten kan deles i to lige store doser.

Naltrexone ”POA Pharma” findes i pakninger med 7, 14, 28, 30, 50 og 56 filmovertrukne tabletter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen:

POA Pharma Scandinavia AB

Box 24026

Ebbe Lieberathsgatan 21

40022 Göteborg

Sverige

Fremstiller:

Accord Healthcare Limited, UK

Sage House, 319 Pinner Road,

Harrow, Middelsex, HA1 4HF

Storbritannien

Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:

Finland

Naltrexone POA Pharma 50

mg tabletti, kalvopäällysteinen

Danmark

Naltrexone ”POA Pharma”

Norge

Naltrexone POA Pharma 50

mg tablett, filmdrasjert

Sverige

Naltrexone POA Pharma 50

mg filmdragerade tabletter

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Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

6-8-2018

Kyntheum (Leo Pharma A/S)

Kyntheum (Leo Pharma A/S)

Kyntheum (Active substance: brodalumab) - Centralised - Yearly update - Commission Decision (2018)5383 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Active substance: nivolumab) - Centralised - 2-Monthly update - Commission Decision (2018)5204 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3985/II/41

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Active substance: fidaxomicin) - Centralised - Yearly update - Commission Decision (2018)4889 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (Active substance: dinutuximab beta) - Centralised - Yearly update - Commission Decision (2018)4886 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

19-7-2018

Aplidin (Pharma Mar S.A.)

Aplidin (Pharma Mar S.A.)

Aplidin (Active substance: plitidepsin) - Refusal of authorisation - Commission Decision (2018)4831 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4354

Europe -DG Health and Food Safety

13-7-2018

Briviact (UCB Pharma S.A.)

Briviact (UCB Pharma S.A.)

Briviact (Active substance: brivaracetam) - Centralised - 2-Monthly update - Commission Decision (2018)4715 of Fri, 13 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3898/II/10/G

Europe -DG Health and Food Safety

10-7-2018

Ninlaro (Takeda Pharma A/S)

Ninlaro (Takeda Pharma A/S)

Ninlaro (Active substance: ixazomib) - Centralised - Yearly update - Commission Decision (2018)4463 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

Mysimba (Orexigen Therapeutics Ireland Limited)

Mysimba (Orexigen Therapeutics Ireland Limited)

Mysimba (Active substance: naltrexone / bupropion) - PSUSA - Modification - Commission Decision (2018) 4347 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3687/PSUSA/10366/201709

Europe -DG Health and Food Safety

4-7-2018

Prialt (RIEMSER Pharma GmbH)

Prialt (RIEMSER Pharma GmbH)

Prialt (Active substance: ziconotide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4334 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/551/T/56

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Orphan designation - Commission Decision (2018)4181 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/012/18

Europe -DG Health and Food Safety

27-6-2018

Yondelis (Pharma Mar S.A.)

Yondelis (Pharma Mar S.A.)

Yondelis (Active substance: Trabectedin) - PSUSA - Modification - Commission Decision (2018)4096 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/3001/201709

Europe -DG Health and Food Safety

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

11-6-2018

Cimzia (UCB Pharma S.A.)

Cimzia (UCB Pharma S.A.)

Cimzia (Active substance: certolizumab pegol ) - Centralised - 2-Monthly update - Commission Decision (2018)3768 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1037/II/65

Europe -DG Health and Food Safety

6-6-2018

Cepedex (CP-Pharma Handelsgesellschaft mbH)

Cepedex (CP-Pharma Handelsgesellschaft mbH)

Cepedex (Active substance: dexmedetomidine) - Centralised - Yearly update - Commission Decision (2018)3684 of Wed, 06 Jun 2018

Europe -DG Health and Food Safety

4-6-2018

Yervoy (Bristol-Myers Squibb Pharma EEIG)

Yervoy (Bristol-Myers Squibb Pharma EEIG)

Yervoy (Active substance: ipilimumab) - Centralised - 2-Monthly update - Commission Decision (2018)3618 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2213/II/55

Europe -DG Health and Food Safety

4-6-2018

Sprycel (Bristol-Myers Squibb Pharma EEIG)

Sprycel (Bristol-Myers Squibb Pharma EEIG)

Sprycel (Active substance: Dasatinib) - Centralised - Yearly update - Commission Decision (2018)3619 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety