CREON

Main information

  • Trade name:
  • CREON Capsule 10000 Milligram
  • Dosage:
  • 10000 Milligram
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CREON Capsule 10000 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0108/025/001
  • Authorization date:
  • 21-03-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Creon10000Capsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

150mgpancreatin,equivalentto:

Lipase 10,000Ph.Eur.units

Amylase 8,000Ph.Eur.units

Protease 600Ph.Eur.units

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Gastro-resistantcapsules,hard.

Size2hardgelatincapsuleswithbrowncapsandcolourlessbodiesfilledwithgastro-resistantbrowngranules.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Pancreaticexocrinedeficiency.

4.2Posologyandmethodofadministration

Adults(includingtheelderly)andchildren:

Initiallyonetotwocapsuleswithmeals.Doseincreases,ifrequired,shouldbeaddedslowly,withcarefulmonitoring

ofresponseandsymptomatology.Thedailydoseofpancreaticenzymesformostpatientsshouldremainbelow2500

unitsoflipaseperkilogrampermeal(10,000unitsperkilogramperday),andthathigherdosesshouldbeusedwith

cautionandonlyifquantitativemeasuresdemonstratesubstantiallyimprovedabsorptionwithsuchtreatment.This

appliesparticularlytoyoungchildren.

ItisimportanttoensureadequatehydrationofpatientsatalltimeswhilstdosingCreon.

Thecapsulescanbeswallowedwhole,orforeaseofadministrationtheymaybeopenedandthegranulestakenwith

fluidorsoftfood.Ifthegranulesaremixedwithfood,itisimportantthattheyaretakenimmediately,otherwise

dissolutionoftheentericcoatingmayresult.Inordertoprotecttheentericcoating,itisimportantthatthegranulesare

notcrushedorchewed(see4.8UndesirableEffects).

Colonicdamagehasbeenreportedinpatientswithcysticfibrosistakinghighdosesofpancreaticenzymesupplements

(see4.8Undesirableeffects).

4.3Contraindications

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4.4Specialwarningsandprecautionsforuse

Theproductisofporcineorigin.

Oralmedicationsshouldnotbeadministeredduringtheearlystagesofacutepancreatitis.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

TherearenoadequatedatafromtheuseofCreoninpregnantwomen.Animalstudiesareinsufficientwithrespectto

effectsonpregnancyandembryonal/foetaldevelopment,parturition/andpostnataldevelopment.Thepotentialriskfor

humansisunknown.Creonshouldnotbeusedduringpregnancyorlactationunlessclearlynecessarybutifrequired

shouldbeusedindosesprovidingadequatenutritionalstatus(seewarningsabouthighdosesections4.2&4.8.)

4.7Effectsonabilitytodriveandusemachines

Noneexpected.

4.8Undesirableeffects

1.Rarely,casesofhyper-uricosuriaandhyper-uricaemiahavebeenreportedwithveryhighdosesofpancreatin.

2.Meconiumileustypeobstructivesymptomsandcasesofcolonicstrictureresultinginbowelre-section,havebeen

seenwithhighdosesofpancreaticenzymesupplements.Similarproblemshavenotoccurredtodatewiththisproduct.

However,unusualabdominalsymptomsorchangesinabdominalsymptomsshouldbereviewedtoexcludethe

possibilityofcolonicdamage.

3.ThefollowingunwantedeffectshavebeenreportedwithCreon:diarrhoea,constipation,stomachpains,feelingsick,

andskinreactions(rash,itching).

4.9Overdose

Symptoms: Overdosage,althoughnotexperiencedtodate,couldprecipitatemeconiumileusorotherbowel

obstructivesymptoms.

Treatment: Mostcasesrespondtosupportivemeasuresincludingstoppingenzymetherapy,ensuringadequate

rehydration.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Replacementtherapyinpancreaticenzymedeficiencystates.Theenzymeshavehydrolyticactivityonfat,

carbohydratesandproteins.

5.2Pharmacokineticproperties

Pharmacokineticdataarenotavailableastheenzymesactlocallyinthegastro-intestinaltract.Afterexertingtheir

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5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Granules:

Macrogol4000

Hypromellosephthalate

Dimeticone

Cetylalcohol

Triethylcitrate

Capsuleshell:

Gelatin,

Red,yellowandblackironoxides(E172)

Titaniumdioxide(E171)

Sodiumlaurylsulphate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

6.5Natureandcontentsofcontainer

HDPEcontainerwithpolypropylenecap.Containershold100,250or300capsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AbbottHealthcareProductsLtd

MansbridgeRoad

WestEnd

Southampton

SO183JD

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8MARKETINGAUTHORISATIONNUMBER

PA0108/025/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21March1997

Dateoflastrenewal: 21March2007

10DATEOFREVISIONOFTHETEXT

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