Kreon 10.000

Primær information

  • Handelsnavn:
  • Kreon 10.000 Lipase 10.000 EP-e enterokapsler, hårde
  • Dosering:
  • Lipase 10.000 EP-e
  • Lægemiddelform:
  • enterokapsler, hårde
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Kreon 10.000 Lipase 10.000 EP-e enterokapsler, hårde
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Ikke markedsført
  • Autorisationsnummer:
  • 46520
  • Sidste ændring:
  • 02-02-2018

Indlægsseddel

Oversigt over indlægssedlen:

1. Virkning og anvendelse.

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

3. Sådan skal du tage Kreon.

4. Bivirkninger.

5. Opbevaring.

6. Pakningsstørrelser og yderligere oplysninger.

1. Virkning og anvendelse

• Kreon indeholder fordøjelsesenzymer, som fremmer fordøjelsen.

• Kreon virker ved at fremme nedbrydning af fedtstoffer, kulhydrater

og proteiner.

• Du kan tage Kreon ved sygdomme i bugspytkirtlen.

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

anvisning.

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

Kreon

Tag ikke Kreon

• hvis du er overfølsom over for svineprotein, pankreatin, eller et af

de øvrige indholdsstoffer i Kreon (angivet i punkt 6).

Advarsler og forsigtighedsregler

Kontakt lægen, eller apotekspersonalet, før du tager Kreon

• hvis du har svær forstoppelse,

• hvis tarmen ikke fungerer, eller hvis der er betændelse i tarmen.

• hvis du har cystisk fibrose, og får forsnævringer i tynd- og tyktar-

men (fibroserende colonpati). Ved forandringer i mave-tarmsyste-

met såsom mavesmerter, forstoppelse, opkast og oppustethed bør

du kontakte lægen.

Brug af anden medicin sammen med Kreon

Fortæl det altid til lægen eller apoteket, hvis du bruger anden medi-

cin eller har brugt det for nylig. Dette gælder også medicin, som ikke

er købt på recept, medicin købt i udlandet, naturlægemidler, stærke

vitaminer og mineraler samt kosttilskud.

Brug af Kreon sammen med mad og drikke og alkohol

Det er bedst at tage Kreon under eller umiddelbart efter hvert

hovedmåltid.

Graviditet, amning og frugtbarhed

Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller

planlægger at blive gravid, skal du spørge din læge eller apoteksper-

sonalet til råds, før du tager dette lægemiddel.

Graviditet:

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

Amning:

• Du kan tage Kreon, selvom du ammer.

Trafik- og arbejdssikkerhed

Kreon påvirker ikke arbejdssikkerheden og evnen til at færdes sikkert

i trafikken.

3. Sådan skal du tage Kreon

• Kapslerne bør indtages sammen med rigelig mængde vand (1½ dl).

• Du bør desuden indtage rigelig væske (2-3 liter) hver dag i de perio-

der, hvor du bruger Kreon.

• Du kan synke kapslerne hele, eller hvis der er problemer med at

synke kapslene, kan du åbne dem forsigtigt og granulatet kan til-

sættes blød mad (pH < 5,5), der ikke skal tygges, eller granulatet

kan tages sammen med væske (pH < 5,5). Dette kan være æble-

sauce, yoghurt eller frugtjuice med pH mindre end 5,5, f.eks æble,-

appelsin- eller ananasjuice. Blandinger af granulat og mad eller

væske skal anvendes umiddelbart og må ikke opbevares.

Du må ikke tygge eller knuse granulatet, da det kan ødelægge det

beskyttende entero-overtræk, og det kan medføre nedsat effekt og

irritation i slimhinderne. Det er også vigtigt at sikre, der ikke bliver

noget af produktet tilbage i munden.

Den sædvanlige dosis er

Cystisk fibrose

Dosis afhænger af din vægt og bør tilpasses sygdommens svær-

hedsgrad. Doseringen bør ikke overstige 10.000 lipase enheder/kg

legemsvægt/dag eller 4.000 lipase enheder/gram fedt i kosten/dag.

Følg lægens anvisning.

Voksne og børn over 4 år:

Dosis bør starte med 500 lipase enheder/kg legemsvægt/måltid.

Børn under 4 år:

Bør ikke anvendes til børn under 4 år uden lægens anvisning.

Dosis afhænger af barnets vægt. Dosis bør starte med 1.000 lipase

enheder/kg legemsvægt/måltid. Følg lægens anvisning.

Dosering ved andre tilstande forbundet med nedsat bugspytkirtel

Dosis bør tilpasses individuelt, baseret på graden af fedt i afføringen

og mængden af fedt i måltidet. Den nødvendige dosis til et måltid

varierer fra ca. 25.000 til 80.000 lipase EP-enheder (f.eks. 1-3 kapsler

Kreon 25.000), og det halve til et mellemmåltid.

Tag altid Kreon nøjagtigt som beskrevet i denne indlægsseddel eller

efter lægens, eller apotekspersonaletss anvisning. Er du i tvivl, så

spørg lægen eller apotekspersonalet.

Hvis du har taget for mange Kreon

Kontakt lægen, skadestuen eller apoteket, hvis du har taget flere

Kreon, end der står i denne information, eller flere end lægen har

foreskrevet, og du føler dig utilpas. Tag pakningen med.

Store doser pancreasenzymer kan give øget urinsyreindhold i blod og

urin.

Hvis du har glemt at tage Kreon

Du må ikke tage en dobbeltdosis som erstatning for den glemte

dosis.

Hvis du holder op med at tage Kreon

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

føler dig usikker på.

4. Bivirkninger

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

bivirkninger.

Alvorlige bivirkninger

Hyppigheden er ikke kendt:

• Pludseligt hududslæt, åndedrætsbesvær og besvimelse (inden for

minutter til timer), pga. overfølsomhed (anafylaktisk reaktion). Kan

være livsfarligt. Ring 112.

Ikke alvorlige bivirkninger

Meget almindelige bivirkninger (forekommer hos flere end 1 ud af

Indlægsseddel: Information til brugeren

KREON

®

10.000 hårde enterokapsler

KREON

®

25.000 hårde enterokapsler

KREON

®

40.000 hårde enterokapsler

Pankreatin

Orifarm A/S, Energivej 15, 5260 Odense S

Tlf.: +45 6395 2700

Læs denne indlægsseddel grundigt inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger. Tag altid dette

lægemiddel nøjagtigt som beskrevet i denne indlægsseddel eller efter de anvisninger, lægen eller apotekspersonalet har givet dig. Gem

indlægssedlen, du kan få brug for at læge den igen. Spørg på apoteket, hvis der er mere, du vil vide. Kontakt lægen eller apotekspersonalet,

hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her. Se punkt 4.

Nyeste indlægsseddel kan findes på www.indlaegsseddel.dk

93694-002-02

10 patienter):

• Mavesmerter.

Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100

patienter):

• Kvalme, opkastning, forstoppelse og oppustet mave, diaré.

Ikke almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af

1.000 patienter):

• Udslæt.

Hyppigheden er ikke kendt:

• Kløe, nældefeber.

• Mavesmerter, forstoppelse, oppustethed og evt. opkast pga. fibro-

serende colonopati (sjælden sygdom, som ses hos patienter med

cystisk fibrose).

Indberetning af bivirkninger til Sundhedsstyrelsen

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske

eller apoteket. Dette gælder også mulige bivirkninger, som ikke er

medtaget i denne indlægsseddel. Du eller dine pårørende kan også

indberette bivirkninger direkte til Sundhedsstyrelsen via adressen

Sundhedsstyrelsen, Axel Heides Gade 1, DK-2300 København S, Web-

sted: www.meldenbivirkning.dk eller E-mail: sst@sst.dk.

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe

mere information om sikkerheden af dette lægemiddel.

5. Opbevaring

• Opbevar Kreon utilgængeligt for børn.

• Opbevar ikke Kreon 10.000 og Kreon 40.000 ved temperaturer over

30 °C.

Efter anbrud: Må ikke opbevares ved temperaturer over 25 °C.

• Opbevar ikke Kreon 25.000 ved temperaturer over 30°C, opbevares

i tæt lukket emballage for at beskytte mod fugt.

Efter anbrud: Må ikke opbevares ved temperaturer over 25 °C.

• Tag ikke Kreon efter den udløbsdato, der står på pakningen. Efter

åbning af beholderen er holdbarheden 3 måneder. Hvis pakningen

er mærket med EXP betyder det at udløbsdatoen er den sidste dag i

den anførte måned.

Spørg på apoteket, hvordan du skal bortskaffe medicinrester. Af hen-

syn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller

skraldespanden.

6. Pakningsstørrelser og

yderligere oplysninger

Kreon, 10.000, hårde enterokapsler indeholder:

Pankreatin svarende til amylase 8.000 EP-enheder, lipase 10.000 EP-

enheder og protease 600 EP-enheder.

Kreon, 25.000, hårde enterokapsler indeholder:

Pankreatin svarende til amylase 18.000 EP-enheder, lipase 25.000 EP-

enheder og protease 1.000 EP-enheder.

Kreon, 40.000, hårde enterokapsler indeholder:

Pankreatin svarende til amylase 25.000 EP-enheder, lipase 40.000 EP-

enheder og protease 1.600 EP-enheder.

Øvrige indholdsstoffer:

Macrogol, cetylalkohol, triethylcitrat, hypromellosephtalat, dimeti-

con, gelatine, jernoxid (E 172), titanoxid (E 171), natriumlaurylsulfat.

Pakningsstørrelser:

Kreon fås i:

Kreon 10.000 i pakninger med 100 og 100 (2x50) enterokapsler.

Kreon 25.000 i pakninger med 100 og 100 (2x50) enterokapsler.

Kreon 40.000 i pakninger med 100 og 100 (2x50) enterokapsler.

Alle styrker og pakningsstørrelser er ikke nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen

Orifarm A/S, Energivej 15, 5260 Odense S

Mail: info@orifarm.com

Fremstiller

Orifarm Supply s.r.o., Palouky 1366, 25301 Hostivice, CZ

I Danmark markedsføres Kreon også som Creon

For yderligere oplysninger om denne medicin og ved reklamationer

kan du henvende dig til Orifarm A/S.

Denne indlægsseddel blev sidst ændret 06/2015.

Orifarm A/S, Energivej 15, 5260 Odense S

Tlf.: +45 6395 2700

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Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5045 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/10/T/01

Europe -DG Health and Food Safety