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:
  • PPA1500/081/001
  • Authorization date:
  • 06-05-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Creon10000Capsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

150mgpancreatin,equivalentto:

Lipase10,000Ph.Eur.units

Amylase8,000Ph.Eur.units

Protease600Ph.Eur.units

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Gastro-resistantcapsules,hard.

ProductimportedfromtheUKandHungary:

Hardgelatincapsuleswithbrowncapsandcolourlessbodiesfilledwithgastro-resistantbrowngranules.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Pancreaticexocrinedeficiency.

4.2Posologyandmethodofadministration

Adults(includingtheelderly)andchildren:

Initiallyonetotwocapsuleswithmeals.Doseincreases,ifrequired,shouldbeaddedslowly,withcarefulmonitoringof

responseandsymptomatology.Thedailydoseofpancreaticenzymesformostpatientsshouldremainbelow2500unitsof

lipaseperkilogrampermeal(10,000unitsperkilogramperday),andthathigherdosesshouldbeusedwithcautionand

onlyifquantitativemeasuresdemonstratesubstantiallyimprovedabsorptionwithsuchtreatment.Thisappliesparticularly

toyoungchildren.

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

Rarely,casesofhyper-uricosuriaandhyper-uricaemiahavebeenreportedwithveryhighdosesofpancreatin.

Meconiumileustypeobstructivesymptomsandcasesofcolonicstrictureresultinginbowelre-section,havebeen

seenwithhighdosesofpancreaticenzymesupplements.Similarproblemshavenotoccurredtodatewiththis

product.However,unusualabdominalsymptomsorchangesinabdominalsymptomsshouldbereviewedto

excludethepossibilityofcolonicdamage.

ThefollowingunwantedeffectshavebeenreportedwithCreon:diarrhoea,constipation,stomachpains,feeling

sick,andskinreactions(rash,itching).

4.9Overdose

Symptoms: Overdosage,althoughnotexperiencedtodate,couldprecipitatemeconiumileusorotherbowelobstructive

symptoms.

Treatment: Mostcasesrespondtosupportivemeasuresincludingstoppingenzymetherapy,ensuringadequate

rehydration.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Replacementtherapyinpancreaticenzymedeficiencystates.Theenzymeshavehydrolyticactivityonfat,carbohydrates

andproteins.

5.2Pharmacokineticproperties

Pharmacokineticdataarenotavailableastheenzymesactlocallyinthegastro-intestinaltract.Afterexertingtheiraction,

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5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Granules:

Macrogol4000

Hypromellosephthalate

Triethylcitrate

Cetylalcohol

Dimeticone

Capsuleshell:

Gelatin

Red,yellowandblackironoxides(E172)

Titaniumdioxide(E171)

Sodiumlaurylsulphate

6.2Incompatibilities

Notapplicable

6.3Shelflife

Theshelflifeexpirydateofthisproductisthedateshownonthecontainerandoutercartonoftheproductasmarketed

inthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove30ºC.

6.5Natureandcontentsofcontainer

Over-labelledcardboardcartoncontainingawhiteHDPEcontainerwithpolypropylenecap.

Packsizes:50capsulesor100capsules

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7PARALLELPRODUCTAUTHORISATIONHOLDER

ProfindWholesaleLtd

Unit625,KilshaneAvenue

NorthwestBusinessPark

Ballycoolin

Dublin15

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8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1500/81/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:6 th

May2011

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