CREON 25000 CAPSULES

Main information

  • Trade name:
  • CREON 25000 CAPSULES
  • Dosage:
  • 300 Milligram
  • Pharmaceutical form:
  • Capsules Gastro-Resistant
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CREON 25000 CAPSULES
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/125/002A
  • Authorization date:
  • 25-06-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Creon25000Capsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains300mgpancreatinequivalentto:

Lipase 25,000Ph.Eur.units

Amylase 18,000Ph.Eur.units

Protease 1,000Ph.Eur.units

Forafulllistofexcipientsseesection6.1

3PHARMACEUTICALFORM

Gastro-resistantcapsule,hard.

ProductimportedfromGreeceandHungary:

Hardgelatincapsuleswithopaquebrick-redcapsandcolourless,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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4.3Contraindications

Useinpatientswithknownhypersensitivitytoporcineproteins.

4.4Specialwarningsandprecautionsforuse

Theproductisofporcineorigin

Oralmedicationsshouldnotbeadministeredduringtheearlystagesofacutepancreatitis.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Pregnancy:

Thereisinadequateevidenceofsafetyinuseduringpregnancy.

Lactation:

Thereisinadequateevidenceofsafetyinuseduringlactation.However,asenzymesarenotabsorbed,itisunlikelythat

therewouldbeanyeffectonthenursinginfant.

4.7Effectsonabilitytodriveandusemachines

Noneexpected.

4.8Undesirableeffects

1.Rarely,casesofhyper-uricosuriaandhyper-uricaemiahavebeenreportedwithveryhighdosesofpancreatin.

2.Perianalirritationandrarelyinflammationmayoccurwithlargedoses.

3.Meconiumileustypeobstructivesymptomsandcasesofcolonicstrictureresultinginbowelresection,havebeen

seenwithhighdosesofpancreaticenzymesupplements.Similarproblemshavenotoccurredtodatewiththis

product.However,unusualabdominalsymptomsorchangesinabdominalsymptomsshouldbereviewedto

excludethepossibilityofcolonicdamage.

4.ThefollowingunwantedeffectshavebeenreportedwithCreon:diarrhea,constipation,stomachpains,feelingsick,

andskinreactions(rash,itching).

4.9Overdose

Symptoms:

Overdosage,althoughnotexperiencedtodate,couldprecipitatemeconiumileiusorotherbowelobstructivesymptoms.

Treatment:

Irish Medicines Board

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Date Printed 14/04/2011 CRN 2091269 page number: 2

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Replacementtherapyinpancreaticenzymedeficiencystates.Theenzymeshavehydrolyticactivityonfat,

carbohydratesandproteins.

5.2Pharmacokineticproperties

Pharmacokineticdataarenotavailableastheenzymesactlocallyinthegastro-intestinaltract.Afterexertingtheir

action,theenzymesaredigestedthemselvesintheintestine.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol4000

Hypromellosephthalate

Cetylalcohol

Triethylcitrate

Dimethicone

Gelatin

Red,yellowandblackironoxides(E172)

Titaniumdioxide(E171)

Sodiumlaurylsulphate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

Plastictub:Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

Plastictubscontaining50capsulescontainedinanover-labelledoutercarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

Ireland

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA465/125/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25June2004

Dateoflastrenewal:24thJune2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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