CORLAN

Main information

  • Trade name:
  • CORLAN Buccal Tablet 2.5 Milligram
  • Dosage:
  • 2.5 Milligram
  • Pharmaceutical form:
  • Buccal Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CORLAN Buccal Tablet 2.5 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0365/049/001
  • Authorization date:
  • 07-07-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0365/049/001

CaseNo:2082431

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

UCBPharmaLimited

208BathRoad,Slough,BerkshireSL13WE,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Corlan,2.5Milligram

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom10/05/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 10/05/2010 CRN 2082431 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Corlan2.5mgMuco-AdhesiveBuccalTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmuco-adhesivebuccaltabletcontains2.5mgHydrocortisoneasHydrocortisoneSodiumSuccinate.

Excipients:Eachtabletcontains67.742mglactose

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

MucoadhesiveBuccaltablet

Whitebiconvextabletengraved‘CorlanEvans’ononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthelocalmanagementofaphthousulcerationofthemouth.

4.2Posologyandmethodofadministration

Adultsandchildren:

Onepelletfourtimesdaily.Corlanpelletsshouldnotbesucked,butkeptinthemouthandallowedtodissolveslowly

incloseproximitytotheulcers.

Maintenancetherapy

Whenulcersre-occurquickly,afterwithdrawaloftreatment,maintenancetherapywithreduceddosageisdesirablefor

aperiod.Approximately2-3weeks.

4.3Contraindications

CorlanPelletsshouldnotbeusedinthepresenceofuntreatedoralinfectionsofbacterial,viral,tuberculousorfungal

origin.Hypersensitivitytoanycomponentoftheproduct.

4.4Specialwarningsandprecautionsforuse

Withdrawalmayresultinacutereboundexacerbationofdisease,acuteadrenocorticalinsufficiency,polyarteritis.

Patientscurrentlyoncorticosteroidtherapyorthosewhohavebeenonsuchtreatmentwithinthepreviousyearmay

requirespecialcontrolmeasuresifinvolvedinanaesthesia,surgicalproceduresandotherstress.

Irish Medicines Board

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Ifaphthousulcerationissevereorrecurring,seriousunderlyingdiseaseshouldbeexcluded.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentadministrationofbarbiturates,phenylbutazone,phenytoinmaydecreasecorticosteroidlevels,while,if

anticoagulantsaregivenwiththecorticosteroid,adjustmentofdosageoftheformerisusuallynecessary.

Theuseofcorticosteroidsinthepresenceofotherdisordersorofdrugswithspecificactions(e.g.hypoglycaemics),

impingingontheeffectsofcorticosteroidswillresultinimbalanceofcontrol.

4.6Pregnancyandlactation

Corticosteroidsshouldonlybeusedduringpregnancyifconsideredessentialbythephysician.Systemicadministration

toanimalscanproduceateratogeniceffect.Corticosteroidsareexcretedinbreastmilk.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Corticosteroidadministrationwillresultincertaineffects,theseverity,significanceandextentofwhichvarywiththe

dosageanddurationoftreatmentandtheparticularcorticosteroidused.

Theseincludedisturbanceinelectrolytebalance,mineralmetabolism,glucosemetabolismandgluconeogenesis,

nitrogendepletion,diminishedlymphoidtissueandimmuneresponse,inhibitionofpituitaryfunction,Cushingoid

Syndrome,increaseinbloodcoagulability,diminishedinflammatoryresponseandgrowthretardationinchildren.

Corticosteroidsmayworsenexistingdiabetes.Occasionally,topicalsteroidtherapymayresultinanexacerbationof

localinfection.

Hypersensitivityreactionshaveoccurredwithcorticosteroids,mainlywhenadministeredtopically.

Mosttopicallyappliedcorticosteroidsmay,undercertaincircumstances,beabsorbedinsufficientamountstoproduce

systemiceffects.

4.9Overdose

Treatmentisunlikelytobeneededincasesofacuteoverdosage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:A01AC03.

Nonestated.

5.2Pharmacokineticproperties

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5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactose

Acacia

MagnesiumStearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

1year.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Polypropylenechildresistantcontainercontaining20buccaltabletsinacarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

UCBPharmaLimited

208BathRoad

Slough

BerkshireSL13WE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA365/49/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:07July1993

Irish Medicines Board

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10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 10/05/2010 CRN 2082431 page number: 5