Creon 10.000

Primær information

  • Handelsnavn:
  • Creon 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:
  • Creon 10.000 Lipase 10.000 EP-e enterokapsler, hårde
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 53727
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Oversigt over indlægssedlen:

1. Virkning og anvendelse.

2. Det skal du vide, før du begynder at tage Creon 10.000.

3. Sådan skal du tage Creon 10.000.

4. Bivirkninger.

5. Opbevaring.

6. Pakningsstørrelser og yderligere oplysninger.

1. Virkning og anvendelse

• Creon 10.000 indeholder fordøjelsesenzymer (amylase, lipase og

protease), som fremmer fordøjelsen. Enzymerne er udvundet af

svinebugspytkirtler.

• Creon 10.000 vil efter opløsning blive blandet med den bearbej-

dede mad fra mavesæk og tarm, hvor den virker ved at spalte fedt,

protein og kulhydrater til mindre dele, som kroppen kan optage.

• Du kan tage Creon 10.000 ved sygdomme i bugspytkirtlen.

Lægen kan have foreskrevet anden anvendelse eller dosering end

angivet i denne information. Følg altid lægens anvisning og oplysnin-

gerne på doseringsetiketten.

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

Creon 10.000

Tag ikke Creon 10.000

• hvis du er overfølsom over for pankreatin, eller et af de øvrige ind-

holdsstoffer i Creon 10.000 (angivet i punkt 6).

Advarsler og forsigtighedsregler

Kontakt lægen, eller apotekspersonalet, før du tager Creon 10.000

En sjælden tarmsygdom, hvor der forekommer forsnævringer i tynd-

og tyktarmen (fibroserende colonopati), er set hos patienter med

cystisk fibrose, som har fået høje pancreatindoser. Hvis du har cystisk

fibrose og tager mere end 10.000 lipase enheder pr. kg pr. dag og har

usædvanlige mavesymptomer eller ændrede mavesymptomer, skal du

kontakte din læge.

Brug af anden medicin sammen med Creon 10.000

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 Creon 10.000 sammen med mad og drikke og alkohol

Det er bedst at tage Creon 10.000 under eller umiddelbart efter hvert

hovedmåltid.

Graviditet, amning og fertilitet

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 Creon 10.000 efter aftale med

lægen.

Amning:

• Du kan tage Creon 10.000, selvom du ammer.

Trafik- og arbejdssikkerhed

Creon 10.000 påvirker ikke eller kun i ubetydelig grad arbejdssikker-

heden og evnen til at færdes sikkert i trafikken.

3. Sådan skal du tage Creon 10.000

Tag altid Creon 10.000 nøjagtigt som beskrevet i denne indlægssed-

del eller efter lægens, eller apotekspersonalets, anvisning. Er du i

tvivl, så spørg lægen eller apotekspersonalet.

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

Det er bedst at tage Creon 10.000 under eller umiddelbart efter hvert

hovedmåltid. Du bør desuden indtage rigelig væske (2-3 liter) hver

dag i de perioder, hvor du bruger Creon 10.000. Utilstrækkelig væske-

tilførsel kan forværre forstoppelse.

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

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

tes sur blød mad (pH < 5,5), der ikke skal tygges, eller granulatet kan

tages sammen med sur væske (pH < 5,5). Dette kan være æblesauce,

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

sin- 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:

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

enheder/kg legemsvægt/måltid. Følg lægens anvisning.

Bør ikke anvendes til børn under 4 år uden 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, og det halve til et

mellemmåltid.

Hvis du har taget for mange Creon 10.000

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

Creon 10.000, end der står i denne information, eller flere end lægen

har foreskrevet, og du føler dig utilpas.

Store doser pancreasenzymer kan give øget urinsyreindhold i blod og

urin.

Hvis du har glemt at tage Creon 10.000

Du må ikke tage en dobbeltdosis som erstatning for den glemte

dosis.

Hvis du holder op med at tage Creon 10.000

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

føler dig usikker på.

4. Bivirkninger

Creon 10.000 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.

• Voldsomme anfald af smerter i maven, opkastninger, stop for luft-

afgang og afføring pga. forsnævring i tarmen. Kontakt læge eller

skadestue.

Indlægsseddel: Information til brugeren

CREON

®

10.000 hårde enterokapsler

Pankreatin

Orifarm A/S, Energivej 15, 5260 Odense S

Tlf.: +45 6395 2700

Læs denne indlægsseddel grundigt, inden du begynder at tage/bruge 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 læse den igen. Spørg apotekspersonalet, hvis der er mere, du vil vide. Kontakt lægen eller apotek-

spersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her. Se punkt 4. Se den nyeste indlægsseddel på

www.indlaegsseddel.dk

1000096328-002-01

Ikke alvorlige bivirkninger

Meget almindelige bivirkninger (forekommer hos flere end 1 ud af

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.

• Overfølsomhed.

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge eller apote-

ket. Dette gælder også mulige bivirkninger, som ikke er medtaget i

denne indlægsseddel. Du eller dine pårørende kan også indberette

bivirkninger direkte til Lægemiddelstyrelsen via de oplysninger, der

fremgår herunder.

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk.

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe

mere information om sikkerheden af dette lægemiddel.

5. Opbevaring

• Opbevar Creon 10.000 utilgængeligt for børn.

• Tag ikke Creon 10.000 efter den udløbsdato, der står på pakningen.

Hvis pakningen er mærket med EXP betyder det at udløbsdatoen er

den sidste dag i den anførte måned.

• Efter åbning af beholderen er holdbarheden 6 måneder.

• Opbevar ikke Creon 10.000 ved temperaturer over 30 °C.

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 oplysnin-

ger

Creon 10.000, hårde enterokapsler indeholder:

Aktivt stof:

Pankreatin 150 mg svarende til amylase 8.000 EP-enheder, lipase

10.000 EP-enheder og protease 600 EP-enheder. Fremstillet af porcint

pancreasvæv (svinebugspytkirtler).

Øvrige indholdsstoffer:

Macrogol 4000, cetylalkohol, triethylcitrat, hypromellosephtalat,

dimeticon, gelatine, jernoxid (E 172), titandioxid (E 171), natrium-

laurylsulphat.

Udseende og pakningsstørrelser:

Creon 10.000 er brune/klare kapsler.

Creon 10.000 fås i:

Creon 10.000 i pakninger med 100 hårde enterokapsler.

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen

Orifarm A/S, Energivej 15, 5260 Odense S

Mail: info@orifarm.com

Fremstiller:

Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, CZ

For yderligere oplysninger om denne medicin og ved reklamationer

kan du henvende dig til Orifarm A/S.

Denne indlægsseddel blev sidst revideret 07/2016.

Orifarm A/S, Energivej 15, 5260 Odense S

Tlf.: +45 6395 2700

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Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

Recently Updated Records for the Week of July 25, 2018 Last Modified Date: Friday, August 10, 2018

FDA - U.S. Food and Drug Administration

2-10-2018

Zavesca (Janssen-Cilag International NV)

Zavesca (Janssen-Cilag International NV)

Zavesca (Active substance: Miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5472 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000435/T/0063

Europe -DG Health and Food Safety

2-10-2018

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Active substance: Parecoxib ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6471 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000381/T/0073

Europe -DG Health and Food Safety

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

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Lumark (IDB Holland B.V.)

Lumark (IDB Holland B.V.)

Lumark (Active substance: lutetium, isotope of mass 177) - PSUSA - Modification - Commission Decision (2018)6212 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010391/201712

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

27-8-2018

Somavert (Pfizer Europe MA EEIG)

Somavert (Pfizer Europe MA EEIG)

Somavert (Active substance: Pegvisomant ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5684 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000409/T/0087

Europe -DG Health and Food Safety

22-8-2018

Luveris (Merck Europe B.V.)

Luveris (Merck Europe B.V.)

Luveris (Active substance: Lutropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5631 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000292/T/0077

Europe -DG Health and Food Safety

22-8-2018

Xelevia (Merck Sharp and Dohme B.V.)

Xelevia (Merck Sharp and Dohme B.V.)

Xelevia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000762/T/0069

Europe -DG Health and Food Safety

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

22-8-2018

Pergoveris (Merck Europe B.V.)

Pergoveris (Merck Europe B.V.)

Pergoveris (Active substance: follitropin alfa / lutropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5629 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000714/T/0059

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

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