CREON FOR CHILDREN 5000 GASTRO-RESISTANT GRANULES

Main information

  • Trade name:
  • CREON FOR CHILDREN 5000 GASTRO-RESISTANT GRANULES
  • Dosage:
  • 60.36mg Milligram
  • Pharmaceutical form:
  • Granules Gastro-Resistant
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CREON FOR CHILDREN 5000 GASTRO-RESISTANT GRANULES
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0108/025/004
  • Authorization date:
  • 23-06-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0108/025/004

CaseNo:2076132

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

SolvayHealthcareLimited

MansbridgeRoad,WestEnd,SouthamptonSO183JD,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CreonforChildren5000Gastro-resistantGranules

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom09/02/2010until22/06/2011.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 09/02/2010 CRN 2076132 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CreonforChildren5000Gastro-resistantGranules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each100mgofgastro-resistantgranules(equivalenttoonemeasuringspoonful)contains60.12mgPancreatin,

containingthefollowingpancreaticenzymes:

Lipase5,000Ph.Eur.units

Amylase3,600Ph.Eur.units

Protease 200Ph.Eur.units

Forexcipients,see6.1

3PHARMACEUTICALFORM

Gastroresistantgranules

Round,lightbrowngastro-resistantgranules

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofpancreaticexocrineinsufficiency.

4.2Posologyandmethodofadministration

Initially100mg(5000lipaseunits)ofgastro-resistantgranules(onemeasure)shouldbetakenwitheachfeedormeal.

Doseincreases,ifrequired,shouldbeaddedslowly,withcarefulmonitoringofresponseandsymptomatology.The

requiredquantityofgastro-resistantgranulesshouldbedispensedusingthemeasuringspooncontainedinthepack

whichholds100mg.

Inyounginfants,CreonforChildren5000granulesshouldbemixedwithasmallamountofinfantformula,

expressedbreastmilkorfruitpureeandgivenfromaspoondirectlybeforethefeed.Inweanedinfants,granulesshould

betakenwithacidicliquidsorsoftfoods(e.g.mixedwithfruitjuicesorapplepuree),butwithoutchewing,directly

beforethemeal.

ItisimportanttoensureadequatehydrationofpatientsatalltimeswhilstdosingwithCreon.

Thedailydoseofpancreaticenzymesformostpatientsshouldremainbelow2500unitsoflipaseperkilogrampermeal

(10,000unitsperkilogramperday),andhigherdosesshouldbeusedwithcautionandonlyifquantitativemeasures

demonstratesubstantiallyimprovedabsorptionwithsuchtreatment.Thisappliesparticularlytoyoungchildren.

Ifthegranulesaremixedwithfood,itisimportantthattheyaretakenimmediately,otherwisedissolutionoftheenteric

coatingmayresult.Inordertoprotecttheentericcoating,itisimportantthatthegranulesarenotcrushedorchewed.

Colonicdamagehasbeenreportedinpatientswithcysticfibrosistakinghighdosesofpancreaticenzymesupplements

Irish Medicines Board

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4.3Contraindications

Patientswithknownhypersensitivitytoporcineproteinsortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Theproductisofporcineorigin.

Oralmedicationsshouldnotbeadministeredduringtheearlystagesofacutepancreatitis.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

TherearenoadequatedatafromtheuseofCreoninpregnantwomen.Animalstudiesareinsufficientwithrespectto

effectsonpregnancyandembryonal/foetaldevelopment,parturition/andpostnataldevelopment.Thepotentialriskfor

humansisunknown.Creonshouldnotbeusedduringpregnancyorlactationunlessclearlynecessarybutifrequired

shouldbeusedindosesprovidingadequatenutritionalstatus(seewarningsabouthighdosesections4.2&4.8.)

4.7Effectsonabilitytodriveandusemachines

Creonhasnoinfluenceontheabilitytodriveorusemachines.

4.8Undesirableeffects

Inpooleddatafromclinicaltrials,theoverallincidenceofadversedrugeventsreportedwithCreonwasthesameas

withplacebo.Theincidencetendedtoreflectthegeneralsymptomatologyoftheunderlyingdisease.

Verycommon(Frequency>10%):

Gastrointestinaldisorders:abdominalpain

Common(Frequency1-10%):

Gastrointestinaldisorders:diarrhoea,constipation,abnormalstool,nauseaandvomiting.

Skinandsubcutaneoustissue:allergicorhypersensitivityreactions.

Rarely(Frequency0.1-1%)

Casesofhyper-uricosuriaandhyper-uricaemiahavebeenreportedwithveryhighdosesofpancreatin.

Strictureoftheileo-caecumandlargebowelandcolitishasbeenreportedinchildrenwithcysticfibrosistakinghigh

dosesofpancreaticenzymesupplements.Todate,Creon10000and25000havenotbeenimplicatedinthe

developmentofcolonicdamage.ExperiencewithCreon40000andCreonforchildren5000inclinicaluseislimited.

Unusualabdominalsymptomsorchangesinabdominalsymptomsshouldbereviewedtoexcludethepossibilityof

colonicdamageespeciallyifthepatientistakinginexcessof10,000unitslipase/kg/day.

4.9Overdose

Mostcasesrespondtosupportivemeasuresincludingstoppingenzymetherapy,ensuringadequaterehydration.Rarely

Irish Medicines Board

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

TheATCcodeisA09AA(Enzymepreparations).

Replacementtherapyinpancreaticenzymedeficiencystates.Theenzymeshavehydrolyticactivityonfat,

carbohydratesandproteins.

5.2Pharmacokineticproperties

Pharmacokineticdataarenotavailableastheenzymesactlocallyinthegastro-intestinaltract.Afterexertingtheir

action,theenzymesaredigestedthemselvesintheintestine.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Hypromellosephthalate

Macrogol4000

Triethylcitrate

Cetylalcohol

Dimeticone

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

12weeksafterfirstopening

6.4Specialprecautionsforstorage

Donotstoreabove30 °

Keepthecontainertightlyclosedinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

GlasscontainerwithLDPEcap.

Containershold20gofgastro-resistantgranules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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7MARKETINGAUTHORISATIONHOLDER

SolvayHealthcareLtd

MansbridgeRoad

WestEnd

Southampton

SO183JD

8MARKETINGAUTHORISATIONNUMBER

PA108/25/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:23rdJune2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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