CREON

Main information

  • Trade name:
  • CREON Capsule 400 Milligram
  • Dosage:
  • 400 Milligram
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CREON Capsule 400 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0108/025/005
  • Authorization date:
  • 08-09-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Creon40000Capsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains400mgpancreatinequivalentto:

Lipase40000Ph.Eur.units

Amylase25000Ph.Eur.units

Protease1600Ph.Eur.units

Forexcipientsseesection6.1

3PHARMACEUTICALFORM

Capsule,hard

Brown/clearsize00hardgelatincapsulecontaininglightbrown,gastro-resistantgranules

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofpancreaticexocrineinsufficiency.

4.2Posologyandmethodofadministration

Adults(includingtheelderly)andchildren:

Creon40000shouldonlybeusedifthepatientrequiresequaltoormorethan40,000lipaseunitspermealorsnack.

Creon40000shouldonlybeusedinpatientsinwhomtheminimumeffectivedosehasalreadybeendeterminedusing

lowerstrengthpancreaticenzymeproducts.

Initiallyoneortwocapsuleswithmeals.Thecapsulesshouldbeswallowedwhole.Doseincreases,ifrequired,should

beaddedslowly,withcarefulmonitoringofresponseandsymptomatology.

ItisimportanttoensureadequatehydrationofpatientsatalltimeswhilstdosingCreon40000.

Colonicdamagehasbeenreportedinpatientswithcysticfibrosistakinginexcessof10,000unitsoflipase/kg/day(see

section4.8).

4.3Contraindications

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4.4Specialwarningsandprecautionsforuse

Theproductisofporcineorigin.

Oralmedicationsshouldnotbeadministeredduringtheearlystagesofacutepancreatitis.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Therearenoreportsofinteractionswithotherdrugsorotherformsofinteraction.

4.6Fertility,pregnancyandlactation

TherearenoadequatedatafromtheuseofCreoninpregnantwomen.Animalstudiesareinsufficientwithrespectto

effectsonpregnancyandembryonal/foetaldevelopment,parturition/andpostnataldevelopment.Thepotentialriskfor

humansisunknown.Creonshouldnotbeusedduringpregnancyorlactationunlessclearlynecessarybutifrequired

shouldbeusedindosesprovidingadequatenutritionalstatus(seewarningsabouthighdosesections4.2&4.8.)

4.7Effectsonabilitytodriveandusemachines

ThereisnoevidencethatCreon40000hasanyeffectontheabilitytodriveoroperatemachinesandthereforeno

adverseeffectswouldbeexpected.

4.8Undesirableeffects

1.Strictureoftheileocaecumandlargebowelandcolitishasbeenreportedinchildrenwithcysticfibrosistakinghigh

dosesofpancreaticenzymesupplements.Similarproblemshavenotoccurredtodatewiththisproduct.Unusual

abdominalsymptomsorchangesinabdominalsymptomsshouldbereviewedtoexcludethepossibilityofcolonic

damage-especiallyifthepatientistakinginexcessof10,000unitsoflipase/kg/day.

2.ThefollowingunwantedeffectshavebeenreportedwithCreon:

Gastrointestinaldisorders:Abdominalpain(common);constipation(uncommon);abnormalstool(uncommon);

diarrhoea(uncommon);andnausea/vomiting(uncommon).

Skinandsubcutaneoustissuedisorders:Allergicorhypersensitivityreactions(uncommon).

4.9Overdose

Extremelyhighdosesofpancreatinhavebeenreportedtobeassociatedwithhyperuricosuriaandhyperuricaemia.

Mostcasesofoverdoserespondtosupportivemeasuresincludingstoppingenzymetherapyandensuringadequate

rehydration.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticclass:digestiveagent,multienzyme,ATCcodeisA09AA02.

Replacementtherapyinpancreaticenzymedeficiencystates.Theenzymeshavehydrolyticactivityonfat,

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5.2Pharmacokineticproperties

Pharmacokineticdataarenotavailableastheenzymesactlocallyinthegastro-intestinaltract.Afterexertingtheir

action,theenzymesaredigestedthemselvesintheintestine.

5.3Preclinicalsafetydata

Preclinicaldatashownorelevantacute,subchronicorchronictoxicity.Studiesongenotoxicity,carcinogenicityor

toxicitytoreproductionhavenotbeenperformed.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

Keepthecontainertightlyclosed

6.5Natureandcontentsofcontainer

HDPEcontainerwithpolypropyleneclosure,containing50or100capsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Granules: Macrogol4000

Cetylalcohol

Triethylcitrate

Hypromellosephthalate

Dimeticone

Capsule: Gelatin

Ironoxide(E172)

Titaniumdioxide(E171)

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7MARKETINGAUTHORISATIONHOLDER

AbbottHealthcareProductsLtd

MansbridgeRoad

WestEnd

Southampton

SO183JD

8MARKETINGAUTHORISATIONNUMBER

PA108/25/5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:8thSeptember2006

10DATEOFREVISIONOFTHETEXT

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