Kreon 25.000

Primær information

  • Handelsnavn:
  • Kreon 25.000 Lipase 25.000 EP-e enterokapsler, hårde
  • Dosering:
  • Lipase 25.000 EP-e
  • Lægemiddelform:
  • enterokapsler, hårde
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Kreon 25.000 Lipase 25.000 EP-e enterokapsler, hårde
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Ikke markedsført
  • Autorisationsnummer:
  • 37950
  • Sidste ændring:
  • 24-02-2018

Indlægsseddel

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

har givet dig.

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

– Spørg lægen eller apotekspersonalet, 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.

– Kontakt lægen, hvis du får det værre, eller hvis du ikke får

det bedre.

Se den nyeste indlægsseddel på www.indlægsseddel.dk.

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. Enzymerne er udvundet af svinebugspytkirtler.

Du kan tage Kreon ved sygdomme i bugspytkirtlen.

Kontakt lægen, hvis du får det værre, eller hvis du ikke får

det bedre.

2. DET SKAL DU VIDE, FØR DU BEGYNDER

AT TAGE KREON

Lægen kan have foreskrevet anden anvendelse eller dosering

end angivet i denne information. Følg altid lægens anvisning og

oplysningerne på doseringsetiketten.

Tag ikke Kreon:

• hvis du er allergisk over for pankreatin eller et af de øvrige

indholdsstoffer i Kreon (angivet i punkt 6).

Tag ikke Kreon, hvis ovenstående gælder for dig. Hvis du er

usikker, så tal med din læge eller apotekspersonalet, før du

tager medicinen.

Advarsler og forsigtighedsregler

Kontakt lægen eller apotekspersonalet, inden du tager

Kreon:

• hvis du har svær forstoppelse.

• hvis din tarm ikke fungerer, eller hvis der er betændelse i

tarmen.

• hvis du lider af cystisk fibrose. En sjælden tarmsygdom,

hvor der forekommer forsnævringer i tynd- og tyktarmen

(fibroserende colonopati), er set hos patienter med

cystisk fibrose, som har fået høje pankreatindoser. Ved

forandringer i mave-tarmsystemet såsom mavesmerter,

forstoppelse, opkast og oppustethed bør du kontakte

lægen.

Brug af anden medicin sammen med Kreon

Fortæl det altid til lægen eller apotekspersonalet, hvis du

bruger anden medicin eller har gjort det for nylig. Dette

gælder også medicin, som ikke er købt på recept, f.eks.

naturlægemidler og vitaminer og mineraler.

Brug af Kreon sammen med mad og drikke

Det er bedst at tage Kreon under eller umiddelbart efter

hvert måltid eller mellemmåltid. Kapslerne bør synkes hele

med tilstrækkelig væske.

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 apotekspersonalet til råds, før du tager dette

lægemiddel.

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

lægen.

Du kan tage Kreon, selvom du ammer.

Trafik- og arbejdssikkerhed

Kreon påvirker ikke arbejdssikkerheden eller evnen til at

færdes sikkert i trafikken.

3. SÅDAN SKAL DU TAGE KREON

Tag altid Kreon nøjagtigt som beskrevet i denne indlægs-

seddel eller efter lægens eller apotekspersonalets anvisning.

Er du i tvivl, så spørg lægen eller apotekspersonalet.

• Dosis angives i lipase enheder. Lipase er et af enzymerne

i pankreatin. De forskellige Kreon styrker indeholder

forskellige mængder lipase.

• Tag altid den mængde Kreon, som din læge har angivet.

• Lægen vil justere dosis, så den passer til dig. Den vil

afhænge af:

din sygdom

din vægt

din kost

hvor meget fedt din afføring indeholder.

Hvis du stadig har fedtet afføring eller andre mave- eller

tarmsymptomer, skal du tale med lægen. Din dosis skal

måske justeres.

Den sædvanlige dosis er

Cystisk fibrose:

• Den sædvanlige startdosis til børn under 4 år er

1.000 lipase enheder pr. kg legemsvægt pr. måltid.

• Den sædvanlige startdosis til børn over 4 år, unge og

voksne er 500 lipase enheder pr. kg legemsvægt pr.

måltid.

Andre bugspytkirtelsygdomme:

• Den sædvanlige dosis pr. måltid er mellem 25.000 og

80.000 lipase enheder.

• Den sædvanlige dosis pr. mellemmåltid er det halve af

dosis pr. måltid.

06/2017

Indlægsseddel: Information til brugeren

Kreon

10.000 og 25.000 hårde enterokapsler

pankreatin

056913P006

Kreon

svarer til lægemidlet Creon

Kreon

og Creon

er registrerede varemærker, som tilhører BGP Products Operations GmbH.

Hvornår skal du tage Kreon

Tag altid Kreon sammen med eller umiddelbart efter et

måltid eller et mellemmåltid. Det vil sikre, at enzymerne

blandes effektivt med maden, se de kan fordøje den, mens

den passerer gennem tarmen.

Hvordan skal du tage Kreon

• Synk kapslerne hele.

• Knus eller tyg ikke kapslerne.

• Hvis du har svært ved at synke kapslerne hele, kan de

åbnes forsigtigt, og indholdet kan tilsættes en mindre

mængde blød, syrlig mad eller drikke, f.eks. yoghurt,

appelsin-, æble- eller ananasjuice.

• Indtag blandingen af Kreon og mad eller væske STRAKS,

den må IKKE opbevares, og den må IKKE tygges. Det er

vigtigt, at du sikrer dig, at der ikke bliver noget af

produktet tilbage i munden. Skyl eventuelt efter med sur

væske.

• Drik rigeligt med væske hver dag.

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 mere end

lægen har foreskrevet (og du føler dig utilpas). Tag pakningen

med.

Patienter med cystisk fibrose bør straks søge læge. Det

gælder især for børn.

Hvis du har glemt at tage Kreon

Tag aldrig dobbelt dosis, hvis du har glemt at tage en dosis.

Fortsæt blot med den sædvanlige dosis.

Hvis du holder op med at tage Kreon

Du må kun holde pause eller stoppe behandlingen efter aftale

med lægen. Spørg lægen eller apotekspersonalet, hvis der er

noget, du er i tvivl om eller føler dig usikker på.

4. BIVIRKNINGER

Dette lægemiddel kan som al anden medicin give

bivirkninger, men ikke alle får bivirkninger.

Alvorlige bivirkninger

Bivirkninger, hvor hyppigheden ikke er kendt:

Stop behandling med Kreon og kontakt straks læge eller

skadestue, hvis du oplever nogle af følgende alvorlige

bivirkninger:

• Pludselige overfølsomhedsreaktioner (inden for minutter

til timer), f.eks. hududslæt, åndedrætsbesvær, blodtryks-

fald og besvimelse (anafylaksi). Det kan være livsfarligt.

Ring 112.

• Ved cystisk fibrose: tarmsygdom, hvor der forekommer

forsnævringer i tynd- og tyktarmen (fibroserende

colonopati). Viser sig ved usædvanlige eller ændrede

mavesymptomer.

Ikke alvorlige bivirkninger

Meget almindelige bivirkninger (det sker hos flere end

1 ud af 10 patienter):

• Mavesmerter.

Almindelige bivirkninger (det sker hos mellem 1 og 10 ud

af 100 patienter):

Kvalme, opkastning, forstoppelse og oppustet mave, diarré.

Ikke almindelige bivirkninger (det sker hos mellem 1 og

10 ud af 1.000 patienter):

• Udslæt.

Bivirkninger, hvor hyppigheden ikke er kendt:

• Kløe, nældefeber.

Indberetning af bivirkninger

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

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 Kreon utilgængeligt for børn.

• Opbevar ikke Kreon ved temperaturer over 25 °C.

• Opbevares i original emballage for at beskytte mod fugt.

• Holdbarhed efter åbning af kapselbeholder: 6 måneder.

• Brug ikke Kreon efter den udløbsdato, der står på

pakningen (efter EXP). Udløbsdatoen er den sidste dag i

den nævnte måned.

• 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

Kreon 10.000 hårde enterokapsler indeholder:

• Aktivt stof: Pankreatin 150 mg svarende til amylase

8000 EP-e, lipase 10.000 EP-e og protease 600 EP-e.

• Øvrige indholdsstoffer: Macrogol 4000, hypromellose-

phtalat, cetylalkohol, triethylcitrat, dimeticon 1000,

gelatine, titandioxid (E171), jernoxid (E172) og natrium-

laurylsulfat.

Kreon 25.000 hårde enterokapsler indeholder:

• Aktivt stof: Pankreatin 300 mg svarende til amylase

18.000 EP-e, lipase 25.000 EP-e og protease 1000 EP-e.

• Øvrige indholdsstoffer: Macrogol 4000, hypromellose-

phtalat, cetylalkohol, triethylcitrat, dimeticon 1000,

gelatine, titandioxid (E171), jernoxid (E172) og natrium-

laurylsulfat.

Udseende og pakningsstørrelser:

Kreon 10.000 hårde enterokapsler er brune og gennem-

sigtige kapsler, med beigefarvet granulat indeni.

Kreon 25.000 hårde enterokapsler er røde og gennem sigtige

kapsler, med beigefarvet granulat indeni.

Kreon 10.000 findes i pakninger med 100 (2×50) og

100 enterokapsler.

Kreon 25.000 findes i pakninger med 100, 100 (2x50) og

100 (5x20) enterokapsler.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen:

Paranova Danmark A/S, Marielundvej 46D, 2730 Herlev

Frigivet af:

Paranova Pack B.V., Vijzelweg 32, 8243 PM Lelystad, Holland

Denne indlægsseddel blev sidst revideret april 2017.

06/2017

14-3-2018

March 12, 2018: Champaign, Illinois, Resident Sentenced to One Year in Prison for Producing and Selling Over 80,000 Homemade Tramadol Capsules to Customers without Verifying Prescriptions

March 12, 2018: Champaign, Illinois, Resident Sentenced to One Year in Prison for Producing and Selling Over 80,000 Homemade Tramadol Capsules to Customers without Verifying Prescriptions

March 12, 2018: Champaign, Illinois, Resident Sentenced to One Year in Prison for Producing and Selling Over 80,000 Homemade Tramadol Capsules to Customers without Verifying Prescriptions

FDA - U.S. Food and Drug Administration

6-3-2018

FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes

FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes

FDA has authorized 23andMe to market a consumer test that reports only 3 out of more than 1,000 known mutations in BRCA genes

FDA - U.S. Food and Drug Administration

9-2-2018

November 8, 2018: Queensbury Oncologist and Spouse to Pay $500,000 for Submitting False Claims to Medicare for the Administration of Unapproved Cancer Drugs

November 8, 2018: Queensbury Oncologist and Spouse to Pay $500,000 for Submitting False Claims to Medicare for the Administration of Unapproved Cancer Drugs

November 8, 2018: Queensbury Oncologist and Spouse to Pay $500,000 for Submitting False Claims to Medicare for the Administration of Unapproved Cancer Drugs

FDA - U.S. Food and Drug Administration

9-2-2018

Raws For Paws Recalls Turkey Pet Food Because of Possible Salmonella Health Risk

Raws For Paws Recalls Turkey Pet Food Because of Possible Salmonella Health Risk

Raws for Paws of Minneapolis, MN is recalling approximately 4,000 pounds of its 5 lb. and 1 lb. chubs of Ground Turkey Pet Food because they have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

FDA - U.S. Food and Drug Administration

1-2-2018

Kareway Products, Inc Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromises Sterility

Kareway Products, Inc Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromises Sterility

Compton, California, Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.

FDA - U.S. Food and Drug Administration

4-12-2017

November 28, 2017: Champaign, Illinois, Resident Guilty of Producing and Selling Over 80,000 Homemade Tramadol Capsules to Customers Without Verifying Prescriptions

November 28, 2017: Champaign, Illinois, Resident Guilty of Producing and Selling Over 80,000 Homemade Tramadol Capsules to Customers Without Verifying Prescriptions

November 28, 2017: Champaign, Illinois, Resident Guilty of Producing and Selling Over 80,000 Homemade Tramadol Capsules to Customers Without Verifying Prescriptions

FDA - U.S. Food and Drug Administration

15-11-2017

Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death

Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death

Preliminary safety trial results in over 6,000 patients with gout being evaluated.

FDA - U.S. Food and Drug Administration

27-9-2017

September 26, 2017: Houston, Texas Man Sentenced to 40 Months and a $95,000 Fine for Smuggling Korean Human Growth Hormone Drugs to Local Patients and Professional Wrestlers

September 26, 2017: Houston, Texas Man Sentenced to 40 Months and a $95,000 Fine for Smuggling Korean Human Growth Hormone Drugs to Local Patients and Professional Wrestlers

September 26, 2017: Houston, Texas Man Sentenced to 40 Months and a $95,000 Fine for Smuggling Korean Human Growth Hormone Drugs to Local Patients and Professional Wrestlers

FDA - U.S. Food and Drug Administration

25-9-2017

 Global operation against illegal medicines

Global operation against illegal medicines

A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites. Illegal sale of medicines is an increasing problem that may pose a global threat to public health. Sales often take place over the internet and across geographical borders. Consequently, the Danish Medicines Agency, the Danish Veterinary and Food Administration, the Danish Customs and Tax Administr...

Danish Medicines Agency

10-8-2017

 Bravecto® may cause convulsions in dogs on rare occasions

Bravecto® may cause convulsions in dogs on rare occasions

The European Medicines Agency has reviewed the adverse events of Bravecto®, a veterinary medicine used to treat flea and tick infestations in dogs. The conclusion is that the medicine may on very rare occasions cause convulsions in dogs – primarily in dogs with pre-existing epilepsy. The analysis was made by the manufacturer Intervet International B.V. at the request of the Committee for Medicinal Products for Veterinary Use (CVMP) under the European Medicines Agency (EMA). CVMP has reviewed the report ...

Danish Medicines Agency

21-7-2017

The Idaho Foodbank Recalls Coconut Beverage, Broccoli Cheddar Soup, Eggs, and Cheese Product Because Of Possible Health Risk

The Idaho Foodbank Recalls Coconut Beverage, Broccoli Cheddar Soup, Eggs, and Cheese Product Because Of Possible Health Risk

The Idaho Foodbank is recalling approximately 27,000 pounds of Coconut Beverage, Broccoli Cheddar Soup, Eggs, and Cheese Product. These products are being recalled because they were not continuously maintained or stored at the required temperature due to a malfunction in the cooler. This could result in contamination by spoilage organisms or pathogens, which could lead to life-threatening illness if consumed.

FDA - U.S. Food and Drug Administration

19-7-2017

Statement from FDA Commissioner Scott Gottlieb, M.D., on the Funding Awards to States for FDA Food Safety Modernization Act (FSMA) Produce Safety Implementation

Statement from FDA Commissioner Scott Gottlieb, M.D., on the Funding Awards to States for FDA Food Safety Modernization Act (FSMA) Produce Safety Implementation

More than 3,000 Americans are estimated to die each year from foodborne illnesses and many more are hospitalized and sickened. Yet most of these illnesses and deaths are preventable. While the U.S. has one of the safest food supplies in the world, Congress entrusted the FDA with new authorities and resources – as part of the FDA Food Safety Modernization Act (FSMA) – to update and strengthen the FDA’s risk-based approach to the oversight of food safety.

FDA - U.S. Food and Drug Administration

20-6-2017

U.S. Marshals seize adulterated food from a Minnesota warehouse

U.S. Marshals seize adulterated food from a Minnesota warehouse

The U.S. Food and Drug Administration announced that on June 15, the U.S. Marshals Service seized food products held at Professional Warehouse and Distribution, Inc., in St. Paul, Minnesota. The food products seized are worth approximately $73,000 and include, among other things, barley flour, spices, pasta, dried beans, tea and cookies.

FDA - U.S. Food and Drug Administration

13-6-2017

 Annual report 2016 - Clinical trials of medicines

Annual report 2016 - Clinical trials of medicines

Last year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013. ”We saw an increase in the number of planned trial subjects in 2016 of around 3,000 on Danish sites for trials authorised in 2016. Despite the fall in the number of clinical trial applications in 2016, we saw an increase of 16% in the number of planned trial subject...

Danish Medicines Agency

2-12-2014

Danish Pharmacovigilance Update, November 2014

Danish Pharmacovigilance Update, November 2014

Five years ago, we issued Danish Pharmacovigilance Update for the first time. We are delighted to celebrate the newsletter's fifth anniversary with more than 3,000 subscribers to the Danish and the English version, and we hope the interest in Danish Pharmacovigilance Update will continue to grow. You can sign up for the newsletter on our website under News. Among the articles in this issue, you can read about how we have developed the pharmacovigilance activities in the recent years.

Danish Medicines Agency

28-5-2014

More than 10,000 websites shut down in global operation

More than 10,000 websites shut down in global operation

The recent global Operation PANGEA VII resulted in the shutdown of more than 10,000 websites. The operation focused on combating online sale of counterfeit medicines and making consumers aware that they need to take care of themselves when buying medicines online. Globally, the operation led to 237 arrests, some 540,000 parcels were inspected and over 9.4 million units containing potentially life-threatening medicines were seized – worth an estimated value of more than USD 35 million. More than 10,000 we...

Danish Medicines Agency

31-7-2012

Danish Pharmacovigilance Update, 24 May 2012

Danish Pharmacovigilance Update, 24 May 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Drug Analysis Prints involving data from more than 14,000 Danish adverse reaction reports available at the Danish Health and Medicines Authority’s website.

Danish Medicines Agency

9-3-2018

Acetaminophen Overdosing Common, Especially in Cold/Flu Season

Acetaminophen Overdosing Common, Especially in Cold/Flu Season

Researchers who asked more than 14,000 adults about their recent use of acetaminophen found significant numbers are exceeding the maximum adult daily dose of 4 g (4000 mg).

US - RxList

6-3-2018

FDA authorizes, w/ special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes. Test only reports 3 out of more than 1,000 known BRCA mutations & negative result doesn’t rule out increased cancer risk  https://go

FDA authorizes, w/ special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes. Test only reports 3 out of more than 1,000 known BRCA mutations & negative result doesn’t rule out increased cancer risk https://go

FDA authorizes, w/ special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes. Test only reports 3 out of more than 1,000 known BRCA mutations & negative result doesn’t rule out increased cancer risk https://go.usa.gov/xnuGN 

FDA - U.S. Food and Drug Administration

15-12-2017

Flu Kills 646,000 People Worldwide Each Year: Study

Flu Kills 646,000 People Worldwide Each Year: Study

Title: Flu Kills 646,000 People Worldwide Each Year: StudyCategory: Health NewsCreated: 12/14/2017 12:00:00 AMLast Editorial Review: 12/14/2017 12:00:00 AM

US - MedicineNet

20-10-2017

News and press releases:  Unparalleled access to clinical data - one year on

News and press releases: Unparalleled access to clinical data - one year on

Over 3,000 clinical documents published, 3,600 registered users and positive stakeholder feedback

Europe - EMA - European Medicines Agency

20-6-2017

Guns Kill or Wound 7,000 U.S. Kids a Year: Report

Guns Kill or Wound 7,000 U.S. Kids a Year: Report

Title: Guns Kill or Wound 7,000 U.S. Kids a Year: ReportCategory: Health NewsCreated: 6/19/2017 12:00:00 AMLast Editorial Review: 6/19/2017 12:00:00 AM

US - MedicineNet

30-5-2017

Triple Therapy More Cost-Effective Than MTX + Biologic in RA

Triple Therapy More Cost-Effective Than MTX + Biologic in RA

Patients with active rheumatoid arthritis (RA) did as well when switched from methotrexate (MTX) monotherapy to triple-drug therapy (MTX, sulfasalazine, and hydroxychloroquine) as when the biologic drug etanercept was added to ongoing MTX. Triple therapy saved more than $500,000 per patient for each year of good-quality life gained, the researchers found.

US - RxList

21-4-2017

Police-Inflicted Injuries Send 50,000 to ER Annually in U.S.

Police-Inflicted Injuries Send 50,000 to ER Annually in U.S.

Title: Police-Inflicted Injuries Send 50,000 to ER Annually in U.S.Category: Health NewsCreated: 4/19/2017 12:00:00 AMLast Editorial Review: 4/20/2017 12:00:00 AM

US - MedicineNet