CREON

Main information

  • Trade name:
  • CREON Capsules Gastro-Resistant 10000
  • Dosage:
  • 10000
  • Pharmaceutical form:
  • Capsules Gastro-Resistant
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CREON Capsules Gastro-Resistant 10000
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1562/008/001
  • Authorization date:
  • 18-09-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Creon10000Gastro-ResistantCapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains150mgPancreatinequivalentto:

Lipase10,000Ph.Eur.units

Amylase8,000Ph.Eur.units

Protease600Ph.Eur.Units

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Gastro-resistantcapsule,hard

ProductimportedfromtheUnitedKingdom:

Capsuleswithbrowncapsandcolourlessbodieswithgastroresistantbrowngranules(minimicrospheres).

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(seewarningsabouthighdosesections4.2and4.8.).

4.7Effectsonabilitytodriveandusemachines

Noneexpected.

4.8Undesirableeffects

1.Rarely,casesofhyper-uricosuriaandhyper-uricaemiahavebeenreportedwithveryhighdosesofpancreatin.

2.Meconiumileustypeobstructivesymptomsandcasesofcolonicstrictureresultinginbowelre-sectionhavebeen

seenwithhighdosesofpancreaticenzymesupplements.Similarproblemshavenotoccurredtodatewiththis

product.However,unusualabdominalsymptomsorchangesinabdominalsymptomsshouldbereviewedtoexclude

thepossibilityofcolonicdamage.

3.ThefollowingunwantedeffectshavebeenreportedwithCreon:diarrhoea,constipation,stomachpains,feelingsick

andskinreactions(rash,itching).

4.9Overdose

Symptoms:Overdosage,althoughnotexperiencedtodate,couldprecipitatemeconiumileusorotherbowelobstructive

symptoms.

Treatment:Mostcasesrespondtosupportivemeasuresincludingstoppingenzymetherapy,ensuringadequate

rehydration.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Replacementtherapyinpancreaticenzymedeficiencystates.Theenzymeshavehydrolyticactivityonfat,

carbohydratesandproteins.

5.2Pharmacokineticproperties

Pharmacokineticdataarenotavailableastheenzymesactlocallyinthegastro-intestinaltract.Afterexertingtheir

action,theenzymesaredigestedthemselvesintheintestine.

5.3Preclinicalsafetydata

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Granules

Macrogol4000

Hypromellosephthalate

Dimeticone

Triethylcitrate

Cetylalcohol

CapsuleShell

Gelatin

Ironoxides(E172)

Titaniumdioxide(E171)

Sodiumlaurilsulfate

6.2Incompatibilities

Notapplicable

6.3Shelflife

Theshelflifeexpirydateforthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove30°Candkeepintheoriginalcontainer.Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

HDPEcontainerwithpolypropylenecap.Containershold100capsules.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

LTTPharmaLimited

Unit18

OxleasowRoad

EastMoonsMoat

Redditch

Worcestershire

B980RE

8PARALLELPRODUCTAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:18 th

September2009

10DATEOFREVISIONOFTHETEXT

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