CREON 10000 CAPSULES

Main information

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

Documents

Localization

  • Available in:
  • CREON 10000 CAPSULES
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/125/001A
  • Authorization date:
  • 25-06-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Creon10000Capsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains150mgpancreatin,equivalentto:

Lipase10,000Ph.Eur.units

Amylase8,000Ph.Eur.units

Protease600Ph.Eur.units

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Gastro-resistantcapsule,hard.

ProductimportedfromGreeceandHungary:

Hardgelatincapsuleswithopaquebrowncapsandcolourless,transparentbodiesfilledwithgastro-resistantbrown

granules.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Pancreaticexocrineinsufficiency.

4.2Posologyandmethodofadministration

Adults(includingtheelderly)andchildren:

Initiallyonetotwocapsuleswithmeals.Doseincreases,ifrequired,shouldbeaddedslowly,withcarefulmonitoring

ofresponseandsymptomatology.Thedailydoseofpancreaticenzymesformostpatientsshouldremainbelow2500

unitsoflipaseperkilogrampermeal(10.000unitsperkilogramperday).Higherdosesshouldbeusedwithcaution

andonlyifquantitativemeasuresdemonstratesubstantiallyimprovedabsorptionwithsuchtreatment.Thisapplies

particularlytoyoungchildren.

ItisimportanttoensureadequatehydrationofpatientsatalltimeswhilstdosingCreon.

Thecapsulescanbeswallowedwhole,orforeaseofadministrationtheymaybeopenedandthegranulestakenwith

fluidorsoftfood.Ifthegranulesaremixedwithfood,itisimportantthattheyaretakenimmediately,otherwise

dissolutionoftheentericcoatingmayresult.Inordertoprotecttheentericcoating,itisimportantthatthegranulesare

notcrushedorchewed(see4.8UndesirableEffects).

Colonicdamagehasbeenreportedinpatientswithcysticfibrosistakinghighdosesofpancreaticenzymesupplements

Irish Medicines Board

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Date Printed 26/10/2011 CRN 2107150 page number: 1

4.3Contraindications

Useinpatientswithknownhypersensitivitytoporcineproteins.

4.4Specialwarningsandprecautionsforuse

Theproductisofporcineorigin

Oralmedicationsshouldnotbeadministeredduringtheearlystagesofacutepancreatitis.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Pregnancy:

Thereisinadequateevidenceofsafetyinuseduringpregnancy.

Animalstudiesareinsufficientwithrespecttoeffectsonpregnancyandembryonal/foetaldevelopment,parturition/and

postnataldevelopment.Thepotentialriskforhumansisunknown.Creonshouldnotbeusedduringpregnancyor

lactationunlessclearlynecessarybutisrequiredshouldbeusedindosesprovidingadequatenutritionstatus(see

warningsabouthighdosesections4.2and4.8).

Lactation:

Thereisinadequateevidenceofsafetyinuseduringlactation.However,asenzymesarenotabsorbed,itisunlikelythat

therewouldbeanyeffectonthenursinginfant.

4.7Effectsonabilitytodriveandusemachines

Noneexpected.

4.8Undesirableeffects

Rarely,casesofhyper -uricosuriaandhyper-uricaemiahavebeenreportedwithvery

highdosesofpancreatin.

Perianalirritationandrarelyinflammationmayoccurwithlargedoses.

Meconiumileustypeobstructivesymptomsandcasesofcolonicstrictureresultingin

bowelresection,havebeenseenwithhighdosesofpancreaticenzymesupplements.

Similarproblemshavenotoccurredtodatewiththisproduct.However,unusual

abdominalsymptomsorchangesinabdominalsymptomsshouldbereviewedto

excludethepossibilityofcolonicdamage.

ThefollowingunwantedeffectshavebeenreportedwithCreon:diarrhea,constipation,

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4.9Overdose

Symptoms:

Overdosage,althoughnotexperiencedtodate,couldprecipitatemeconiumileusorotherbowelobstructivesymptoms.

Treatment:

Mostcasesrespondtosupportivemeasuresincludingstoppingenzymetherapy,ensuringadequaterehydration.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Replacementtherapyinpancreaticenzymedeficiencystates.Theenzymeshavehydrolyticactivityonfat,

carbohydratesandproteins.

5.2Pharmacokineticproperties

Pharmacokineticdataarenotavailableastheenzymesactlocallyinthegastro -intestinaltract.Afterexertingtheir

action,theenzymesaredigestedthemselvesintheintestine.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol4000

Hypromellosephthalate

Dimethicone

Cetylalcohol

Triethylcitrate

Gelatin

Red,yellowandblackironoxides(E172)

Titaniumdioxide(E171)

Sodiumlaurylsulphate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

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6.5Natureandcontentsofcontainer

Plastictubsof50capsulescontainedinanover-labelledoutercardboardcarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA465/125/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25thJune2004

Dateoflastrenewal:24thJune2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 26/10/2011 CRN 2107150 page number: 4