CREON

Main information

  • Trade name:
  • CREON Capsule 25000 Milligram
  • Dosage:
  • 25000 Milligram
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CREON Capsule 25000 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0108/025/002
  • Authorization date:
  • 22-04-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Creon25000Capsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains300mgPancreatinequivalentto:

Lipase25,000Ph.Eur.units

Amylase18,000Ph.Eur.units

Protease1,000Ph.Eur.Units

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Gastro-resistantcapsule,hard.

Size0,hardgelatincapsuleswithopaqueorangecapsandcolourlesstransparentbodiesfilledwithgastro-resistant

browngranules.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofpancreaticexocrinedeficiency.

4.2Posologyandmethodofadministration

Adults(includingtheelderly)andchildren:

Initiallyonecapsulewithmeals.Doseincreases,ifrequired,shouldbeaddedslowly,withcarefulmonitoringof

responseandsymptomatology.

Thedailydoseofpancreaticenzymesformostpatientsshouldremainbelow2500unitsoflipaseperkilogrampermeal

(10,000unitsperkilogramperday),andthathigherdosesshouldbeusedwithcautionandonlyifquantitative

measuresdemonstratesubstantiallyimprovedabsorptionwithsuchtreatment.Thisparticularlyappliestoyoung

children.

ItisimportanttoensureadequatehydrationofpatientsatalltimeswhilstdosingCreon25000.

Thecapsulescanbeswallowedwhole,orforeaseofadministrationtheymaybeopenedandthegranulestakenwith

fluidorsoftfood.Ifthegranulesaremixedwithfood,itisimportantthattheyaretakenimmediately,otherwise

dissolutionoftheentericcoatingmayresult.Inordertoprotecttheentericcoating,itisimportantthatthegranulesare

notcrushedorchewed.

Colonicdamagehasbeenreportedinpatientswithcysticfibrosistakinghighdosesofpancreaticenzymesupplements

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4.3Contraindications

Patientswithknownhypersensitivitytoporcineproteins.

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

Rarely,casesofhyper-uricosuriaandhyper-uricaemiahavebeenreportedwithveryhighdosesofpancreatin.

Meconiumileustypeobstructivesymptomsandcasesofcolonicstrictureresultinginbowelre-section,have

beenseenwithhighdosesofpancreaticenzymesupplements.Similarproblemshavenotoccurredtodatewith

thisproduct.However,unusualabdominalsymptomsorchangesinabdominalsymptomsshouldbereviewedto

excludethepossibilityofcolonicdamage.

ThefollowingunwantedeffectshavebeenreportedwithCreon:diarrhoea,constipation,stomachpains,feeling

sick,andskinreactions(rash,itching).

4.9Overdose

Mostcasesrespondtosupportivemeasuresincludingstoppingenzymetherapy,ensuringadequaterehydration

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Replacementtherapyinpancreaticenzymedeficiencystates.Theenzymeshavehydrolyticactivityonfat,

carbohydratesandproteins.

5.2Pharmacokineticproperties

Pharmacokineticdataarenotavailableastheenzymesactlocallyinthegastro-intestinaltract.Afterexertingtheir

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5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Granules:

Macrogol4000

HypromellosePhthalate

Cetylalcohol

Triethylcitrate

Dimeticone

Capsules:

Gelatin

RedandYellowIronOxides(E172)

Titaniumdioxide(E171)

Sodiumlaurylsulphate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

6.5Natureandcontentsofcontainer

HDPEcontainerwithpolypropyleneclosure,containing50or100capsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AbbottHealthcareProductsLtd

MansbridgeRoad

WestEnd

Southampton

SO183JD

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8MARKETINGAUTHORISATIONNUMBER

PA0108/025/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24April1997

Dateoflastrenewal: 21March2007

10DATEOFREVISIONOFTHETEXT

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