Eltroxin

Primær information

  • Handelsnavn:
  • Eltroxin 100 mikrogram tabletter
  • Dosering:
  • 100 mikrogram
  • Lægemiddelform:
  • tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for sundhedspersonale:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for sundhedspersonale.

Lokation

  • Fås i:
  • Eltroxin 100 mikrogram tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 00204
  • Sidste ændring:
  • 16-07-2018

Indlægsseddel: sammensætning, indikationer, bivirkninger, dosering, interaktioner, bivirkninger, graviditet, amning

Indlægsseddel: Information til brugeren

Eltroxin

®

50 mikrogram og 100 mikrogram tabletter

Levothyroxinnatrium

Læs denne indlægsseddel grundigt, inden du begynder at tage medicinen.

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

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

Lægen har ordineret Eltroxin 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 apoteket, hvis en bivirkning bliver værre, eller hvis du får

bivirkninger, som ikke er nævnt her.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide, før du begynder at tage Eltroxin

Sådan skal du tage Eltroxin

Bivirkninger

Opbevaring

Yderligere oplysninger

1. Virkning og anvendelse

Tyroxin er et hormon, der dannes i skjoldbruskkirtlen (thyroidea), og som regulerer stofskiftet.

Eltroxin indeholder levothyroxin, der er et syntetisk fremstillet skjoldbruskkirtelhormon med

samme effekt som naturligt tyroxin.

Eltroxin anvendes ved nedsat funktion af skjoldbruskkirtlen (myksødem) og ved nogle tilfælde

af forstørret skjoldbruskkirtel (struma).

Lægen kan have givet dig Eltroxin for noget andet. Følg altid lægens anvisning.

2. Det skal du vide, før du begynder at tage Eltroxin

Tag ikke Eltroxin, hvis du

er overfølsom (allergisk) over for levothyroxinnatrium eller et af de øvrige

indholdsstoffer.

har nedsat funktion af binyrerne eller hypofysen og ikke er i behandling herfor.

har øget stofskifte og ikke er i behandling herfor.

har forhøjet blodtryk og ikke er i behandling herfor.

har akut blodprop i hjertet eller anden akut hjertesygdom.

Vær ekstra forsigtig med at tage Eltroxin

Tal med lægen inden du tager Eltroxin, hvis du

er over 50 år.

har en hjertesygdom eller har hjertekramper.

har diabetes.

er i overgangsalderen og har øget risiko for knogleskørhed.

har symptomerne træthed, kuldskærhed, tør og fortykket hud, hårtab, langsom puls

(symptomer på hypotyreose).

har nedsat stofskifte som led i en anden hormonsygdom.

Brug af anden medicin

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

Side 1

for nylig. Dette gælder også medicin, som ikke er købt på recept, medicin købt i udlandet,

naturlægemidler, stærke vitaminer og mineraler samt kosttilskud.

Eltroxin kan ændre virkningen af anden medicin, og anden medicin kan ændre virkningen af

Eltroxin. Tal med din læge, hvis du tager:

medicin mod for højt kolesterol (colestyramin, colestipol, clofibrat, simvastatin,

lovastatin),

medicin mod epilepsi (carbamazepin, phenytoin, barbiturater),

smertestillende medicin (acetylsalicylsyre),

medicin mod væskeophobning og for højt blodtryk (furosemid),

hormontilskud eller hvis du tager p-piller (østrogen) eller medicin med indhold af

testosteron,

medicin mod diabetes,

medicin mod depression (tricykliske antidepressiva, sertralin),

medicin mod mavesår (antacida, sucralfat),

kalktilskud,

jernholdig medicin og jerntilskud,

blodtrykssænkende medicin (betablokkere),

medicin til forebyggelse af blodpropper,

medicin mod hjertesvigt (amiodaron),

medicin mod forhøjet stofskifte (propylthiouracil),

binyrebarkhormoner (kortisol),

sojaholdige produkter,

medicin mod malaria (proguanil, chloroquin),

metadon,

medicin mod kræft (tamoxifen, 5-fluoruracil, imatinib),

medicin mod for højt kalium i blodet (kayexalat),

jodholdigt kontrastmiddel som anvendes i forbindelse med røntgenundersøgelse.

Brug af Eltroxin sammen med mad og drikke

Eltroxin skal tages på tom mave, da mad kan nedsætte virkningen af Eltroxin.

Graviditet og amning

Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.

Graviditet

Hvis du er gravid, må du kun tage Eltroxin efter aftale med lægen.

Amning

Du kan tage Eltroxin, selvom du ammer.

Små mængder af det aktive stof udskilles i modermælken, og du skal derfor fortælle, at du

tager Eltroxin, hvis barnet skal have taget blodprøver i ammeperioden.

Trafik- og arbejdssikkerhed

Eltroxin påvirker ikke arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.

3. Sådan skal du tage Eltroxin

Tag altid Eltroxin nøjagtigt efter lægens anvisning. Er du i tvivl, så spørg lægen eller på

apoteket.

Eltroxin bør tages på tom mave med et glas vand fx en halv time før morgenmad. Eltroxin må

ikke deles eller knuses.

Voksne: Den sædvanlige startdosis er 50-100 mikrogram daglig, som øges med 50

mikrogram i intervaller på 4 til 6 uger. Dette kan kræve doser på 100-200 mikrogram daglig.

Det er vigtigt, at din dosis øges langsomt for at undgå bivirkninger.

Side 2

Hvis du er over 50 år og har en hjertesygdom, kan lægen anbefale, at du tager 50 mikrogram

hver anden dag.

Børn: Særlig doseringsvejledning for børn. Følg lægens anvisning.

Hvis du har taget for meget Eltroxin

Kontakt lægen, skadestuen eller apoteket, hvis du har taget mere Eltroxin, end der står her,

eller mere end lægen har foreskrevet, og du føler dig utilpas. Tag pakningen med.

Du kan få hjertebanken, angst, rastløshed, irritabilitet, forvirring, svedtendens, forstyrrelse i

hjerterytmen, ophidselse, uro, ufrivillige bevægelser, store pupiller, meget hurtigt åndedræt,

feber, kramper og hovedpine.

Hvis du har glemt at tage Eltroxin

Hvis du har glemt en dosis, så tag den så snart du kommer i tanke om det. Hvis du snart skal

tage den næste dosis, så spring den glemte dosis over. Tag aldrig dobbelt dosis.

4. Bivirkninger

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

Hvis du får alvorlige bivirkninger, skal du straks kontakte læge eller skadestue. Ring

evt. 112.

Alvorlige bivirkninger

Sjældne bivirkninger (det sker hos mellem 1 og 10 ud af 10.000 patienter):

Forhøjet tryk i hjernen.

Bivirkninger, hvor hyppigheden ikke er kendt

- Krampeanfald.

- Hjertesvigt.

- Blodprop i hjertet.

Ikke alvorlige bivirkninger

Bivirkninger, hvor hyppigheden ikke er kendt

- Hurtig hjerterytme. Kan blive alvorligt. Hvis du får meget hurtig og uregelmæssig puls eller

bliver utilpas eller besvimer, skal du kontakte læge eller skadestue. Ring evt. 112.

- Forstyrrelser i hjerterytmen. Kan være eller blive alvorligt. Tal med lægen.

- Smerter i brystet. Kontakt læge eller skadestue.

- Pludselige smerter i ryggen og tendens til knoglebrud pga. knogleskørhed. Kontakt lægen.

- For højt blodtryk. Tal med lægen. For højt blodtryk skal behandles. Meget forhøjet blodtryk

er alvorligt.

- Åndenød. Kan være eller blive alvorligt. Tal med lægen.

- Muskelsvaghed. Kan være eller blive alvorligt. Tal med lægen.

- Symptomer på overdosering som følge af forøget hormonproduktion fra skjoldbruskkirtlen

(hvis dosis ved start af behandling øges for hurtigt). Tal med lægen.

- Irritabilitet.

- Ophidselse, rysten, hovedpine, rastløshed, søvnløshed.

- Hjertebanken.

- Rødme, hedeture, svedtendens, hårtab.

- Forøget appetit, mavesmerter, kvalme, diaré, opkastning.

- Overfølsomhedsreaktioner i form af hududslæt og kløe.

- Uregelmæssig menstruation, infertilitet.

- Træthed, varmeintolerant, feber.

- Meget voldsomt vægttab.

Bivirkningerne forsvinder ofte når dosis nedsættes

Side 3

Side 4

Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller hvis du

får bivirkninger, som ikke er nævnt her.

Bivirkninger, som ikke er nævnt her, bør indberettes til Lægemiddelstyrelsen, så viden om

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

til Lægemiddelstyrelsen. Du finder skema og vejledning på Lægemiddelstyrelsens netsted:

http://www.meldenbivirkning.dk.

5. Opbevaring

Opbevares utilgængeligt for børn.

Opbevar ikke Eltroxin ved temperaturer over 30

Opbevar Eltroxin i original beholder, tæt tillukket.

Brug ikke Eltroxin efter den udløbsdato, der står på pakningen. Udløbsdatoen er den sidste

dag i den nævnte måned.

Aflever altid medicinrester på apoteket. Af hensyn til miljøet må du ikke smide medicinrester i

afløbet, toilettet eller skraldespanden.

6. Yderligere oplysninger

Eltroxin 50 mikrogram og 100 mikrogram tabletter indeholder:

Aktivt stof: Levothyroxinnatrium.

Øvrige indholdsstoffer: Mikrokrystallinsk cellulose, pregelatineret stivelse, talcum, kolloid

vandfri silica og magnesiumstearat.

Udseende og pakningsstørrelse

Udseende

Eltroxin tabletter er runde, hvide og hvælvede på begge sider.

50 mikrogram tabletten er mærket ”GS 11E” på den ene side og ”50” på den anden.

100 mikrogram tabletten er mærket ”GS 21C” på den ene side og ”100” på den anden.

Pakningsstørrelse

Eltroxin fås som 100 stk. pakninger for begge styrker.

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen

GlaxoSmithKline Pharma A/S

Nykær 68

2605 Brøndby

Telefon: 36 35 91 00

E-mail: dk-info@gsk.

Fremstiller

Glaxo Wellcome, Bad Oldesloe, Tyskland

Denne indlægsseddel blev sidst revideret juli 2009

GSK logo

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SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

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FDA - U.S. Food and Drug Administration

31-8-2018

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FDA - U.S. Food and Drug Administration

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18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18

Europe -DG Health and Food Safety

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Active substance: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-beta-D-galactopyranosyl]-4-O-(a-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide) - Transfer of orphan designation - Commission Decision (2018)7836 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/13/T/01

Europe -DG Health and Food Safety

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

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

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

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

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety