CREON, 300 MILLIGRAM

Main information

  • Trade name:
  • CREON, 300 MILLIGRAM
  • Dosage:
  • 300 Milligram
  • Pharmaceutical form:
  • Capsules Gastro-Resistant
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CREON, 300 MILLIGRAM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1447/011/002
  • Authorization date:
  • 31-07-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Creon25000300mgGastro-ResistantCapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains300mgpancreatin,equivalentto:

Lipase25,000Ph.Eur.units

Amylase18,000Ph.Eur.units

Protease1,000Ph.Eur.Units

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Gastro-resistantcapsule,hard

ProductimportedfromtheUnitedKingdom:

Hardgelatincapsuleswithopaqueorangecapsandcolourlesstransparentbodiesfilledwithgastro-resistantbrown

granules.

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

Irish Medicines Board

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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

1.Rarely,casesofhyper-uricosuriaandhyper-uricaemiahavebeenreportedwithveryhighdosesofpancreatin.

2.Meconiumileustypeobstructivesymptomsandcasesofcolonicstrictureresultinginbowelre-section,havebeen

seenwithhighdosesofpancreaticenzymesupplements.Similarproblemshavenotoccurredtodatewiththis

product.However,unusualabdominalsymptomsorchangesinabdominalsymptomsshouldbereviewedtoexclude

thepossibilityofcolonicdamage.

3.ThefollowingunwantedeffectshavebeenreportedwithCreon:diarrhoea,constipation,stomachpains,feelingsick

andskinreactions(rash,itching).

4.9Overdose

Mostcasesrespondtosupportivemeasuresincludingstoppingenzymetherapy,ensuringadequaterehydration.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Replacementtherapyinpancreaticenzymedeficiencystates.Theenzymeshavehydrolyticactivityonfat,

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5.2Pharmacokineticproperties

Pharmacokineticdataarenotavailableastheenzymesactlocallyinthegastro-intestinaltract.Afterexertingtheir

action,theenzymesaredigestedthemselvesintheintestine.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Granules:

Macrogol4000

Hypromellosephthalate

Cetylalcohol

Triethylcitrate

Dimeticone

Capsules:

Gelatin

Redandyellowironoxides(E172)

Titaniumdioxide(E171)

Sodiumlaurilsulfate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

6.5Natureandcontentsofcontainer

Overlabelledplasticcontainerinacardboardoutercarton.Eachpackcontains100capsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7PARALLELPRODUCTAUTHORISATIONHOLDER

G&ALicensingLimited

Ballymurray

Co.Roscommon

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1447/11/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:31 st

July2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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