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:
  • Markedsført
  • Autorisationsnummer:
  • 15224
  • Sidste ændring:
  • 17-07-2018

Indlægsseddel

kreon

er et registreret varemærke, som tilhører

Solvay Pharmaceuticals GmbH

Læs denne indlægsseddel grundigt. Den

indeholder vigtige informationer

• De kan få kreon

uden recept. For at opnå den

bedste behandling skal De være omhyggelig med

at følge anvisningerne for kreon

• Gem indlægssedlen. De kan få brug for at læse

den igen.

• Spørg lægen eller på apoteket, hvis der er mere

De vil vide.

• Tal med lægen eller apoteket, hvis en bivirkning

bliver værre, eller De får bivirkninger, som ikke er

nævnt her.

Oversigt over indlægssedlen:

1. Virkning og anvendelse

2. Det skal De vide, før De begynder at bruge

kreon

3. Sådan skal De bruge kreon

4. Bivirkninger

5. Opbevaring

6. Yderligere oplysninger

1. VIRKNING OG ANVENDELSE

kreon

indeholder pancreaseenzymer.

Pancreaseenzymer er fordøjelsesenzymer, som

virker fremmende på fordøjelsen. kreon

anvendes

ved tilstande, hvor kroppens egen produktion af

enzymer til fordøjelse af føden er utilstrækkelig.

Lægen kan have foreskrevet anden anvendelse.

Følg altid lægens anvisning.

2. DET SKAL DE VIDE, FØR DE BEGYNDER

AT BRUGE KREON

®

Brug ikke kreon

®

, hvis:

• De er overfølsom overfor pancreaseenzymer eller

et af de øvrige indholdsstoffer i kreon

• De er overfølsom overfor svineprotein

• De lider af akut betændelse i bugspytkirtlen

(pancreatit)

• De har akut forværrelse af kroniske lidelser i

bugspytkirtlen

Vær ekstra forsigtig med at bruge kreon

®

, hvis:

• De lider af cystisk fi brose

• De har mavetarmproblemer som kan skyldes

andet end nedsat bugspytkirtelfunktion fx

betændelse i tarmen eller forsnævring af tarmen

Brug af anden medicin

Fortæl det altid til lægen eller apoteket, hvis De

bruger anden medicin eller har brugt det for nylig.

Det gælder også medicin, som ikke er købt på

recept.

Der er ingen kendt påvirkning af kreon

eller anden

medicin ved samtidig brug.

Brug af kreon

®

sammen med mad og drikke

De skal tage kreon

i forbindelse med et måltid.

Graviditet og amning

Spørg Deres læge eller apoteket til råds, før De

bruger nogen form for medicin.

Graviditet:

De må kun tage kreon

efter aftale med lægen.

Amning:

De kan amme, selvom De bruger kreon

Trafi k- og arbejdssikkerhed

kreon

påvirker ikke evnen til at betjene maskiner

eller færdes sikkert i trafi kken.

3. SÅDAN SKAL DE BRUGE KREON

®

Voksne: Den sædvanlige dosis er 1-2 enterokapsler

3 gange dagligt i forbindelse med et måltid.

Børn: De må kun anvende kreon

til børn (under 15

år) efter lægens anvisning.

De skal synke enterokapslerne hele. De kan evt.

åbne dem og opslæmme indholdet i vand. De må

ikke tygge eller knuse kapslerne.

Brug altid kreon

nøjagtigt efter lægens anvisning.

Er De i tvivl så spørg lægen eller apoteket.

Der er forskel på, hvad den enkelte har brug for.

0823065904

06/2009

Indlægsseddel: Information til brugeren

kreon

®

hårde enterokapsler

amylase/lipase/protease

Hvis De har taget for mange kreon

®

hårde

enterokapsler

Kontakt lægen, skadestuen eller apoteket, hvis

De har taget mere af kreon

, end der står i denne

information, eller mere end lægen har foreskrevet.

Høj dosering hos børn med cystisk fi brose kan føre

til alvorlige bivirkninger.

Symptomer på overdosering er urinsyreforgiftning

og øget urinsyremængde i blodet.

Hvis De har glemt at tage kreon

®

De må ikke tage en dobbeltdosis som erstatning for

den glemte dosis, men skal fortsætte med Deres

sædvanlige dosering.

Hvis De holder op med at bruge kreon

®

Spørg lægen eller apoteket hvis der er noget, De er i

tvivl om eller føler Dem usikker på.

Ændring eller stop med behandlingen bør kun ske i

samråd med lægen.

4. BIVIRKNINGER

kreon

kan som al anden medicin give bivirkninger,

men ikke alle får bivirkninger.

Alvorlige bivirkninger

Meget sjældne bivirkninger (det sker

hos færre end 1 ud af 10.000 patienter):

Bindevævsforandringer i tarmen hos patienter med

cystisk fi brose.

Ukendt hyppighed: Blodig afføring, tillukning af

mave/tarmkanal.

Kontakt læge eller sygehus, ring evt. 112.

Ikke alvorlige bivirkninger

Almindelige bivirkninger (det sker hos 1-10 ud af

100 patienter): Mavesmerter.

Ikke almindelige bivirkninger (det sker hos 1-10

ud af 1000 patienter): Forstoppelse, diarre, kvalme,

opkastning, unormal afføring, allergiske reaktioner.

Ukendt hyppighed: Vægttab, luft i maven, irritation

omkring endetarmen.

Tal med lægen eller apoteket, hvis en bivirkning

bliver værre, eller De får bivirkninger, som ikke er

nævnt her.

Fortæl læge eller apotek, hvis De får bivirkninger,

der bliver ved eller er generende. Nogle bivirkninger

kræver behandling.

Patienter eller pårørende kan også indberette

bivirkninger direkte til Lægemiddelstyrelsen. De

fi nder skema og vejledning på Lægemiddelstyrel-

sens netsted: www.meldenbivirkning.dk

5. OPBEVARING

kreon

opbevares utilgængeligt for børn.

Brug ikke kreon

, efter den udløbsdato, der står på

pakningen. Udløbsdatoen er den sidste dag i den

nævnte måned.

Spørg på apoteket hvordan De skal afl evere

medicinrester. Af hensyn til miljøet må De ikke smide

medicinrester i afl øbet, toilettet eller skraldespanden.

6. YDERLIGERE OPLYSNINGER

kreon

®

hårde enterokapsler indeholder:

• Aktive stoffer: Amylase 8000 Ph. Eur. enheder,

lipase 10000 Ph. Eur. enheder, protease 600 Ph.

Eur. enheder.

• Øvrige indholdsstoffer: Macrogol 4000, hypromel-

losephtalat, cetylalkohol, triethylcitrat, dimeticon,

gelatine.

Gelatine kapslen er farvet med titandioxid (E 171)

samt rød, gul og sort jernoxid (E 172).

kreon

®

s udseende og pakningsstørrelse:

kreon

hårde enterokapsler er brune og

gennemsigtige kapsler, med beigefarvet granulat

indeni.

kreon

fi ndes i pakningsstørrelsen 100 stk.

Indehaver af markedsføringstilladelsen i

Danmark:

Paranova Danmark A/S

Industriparken 23-25, 2750 Ballerup

Ompakket og frigivet:

Paranova Pack A/S

Industriparken 23-25, 2750 Ballerup

Denne indlægsseddel blev senest revideret

november 2007

06/2009

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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

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