CEDINE

Main information

  • Trade name:
  • CEDINE Coated Tablets 400 Milligram
  • Dosage:
  • 400 Milligram
  • Pharmaceutical form:
  • Coated Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEDINE Coated Tablets 400 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0711/044/002
  • Authorization date:
  • 27-02-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0711/044/002

CaseNo:2035808

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

RowexLtd

Bantry,Co.Cork,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Cedine400mgFilm-CoatedTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom15/05/2007until26/02/2011.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 18/05/2007 CRN 2035808 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cedine400mgFilm-CoatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontainsCimetidine400.00mg.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-CoatedTablet

Palegreen,oblong,biconvex,film-coatedtabletswithascorenotchoneachsideandengraved“C400”ononeside.

Thescorenotchisonlytofacilitatebreakingforeaseofswallowingandnottodivideintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CEDINEisindicatedinthetreatmentofbenignulcerationoftheoesophagus,stomachupperintestinaltract(including

postoperativestomalarea)andinthemanagementofZollinger–EllisonSyndrome.

Inthemanagementofconditionsbenefitingfromreducedgastricacidsecretion.

Inthelong-termmaintenancemanagementofbenignpepticulcerdiseaseunderregularsurveillance.

Forthetreatmentofbenignulcerationassociatedwithlong–termuseofnon-steroidalanti-inflammatorydrugs.

4.2Posologyandmethodofadministration

RouteofAdministration:

Oral.

RecommendedDosageSchedule

Adults:

Thetotaldailydoseshouldnotnormallyexceed2.4g.Dosageshouldbereducedinpatientswithimpairedrenal

function(referSection4.4).

Forpatientswithduodenalorbenigngastriculceration,asingledailydoseof800mgatbedtimeisrecommended.

Otherwisetheusualdosageis400mgtwiceadaywithbreakfastandatbedtime.Othereffectiveregimensare200mg

threetimesadaywithmealsand400mgatbedtime[1.0g/day]andifinadequate,400mgfourtimesaday[1.6g/day]

alsowithmealsandatbedtime.

Treatmentshouldbegiveninitiallyforatleastfourweeks[sixweeksinbenigngastriculcer,eightweeksinulcer

associatedwithcontinuednon-steroidalanti-inflammatoryagents].

Treatmentmaybecontinuedforlongerperiodsinthosepatientswhomaybenefitfromreductionofgastricsecretion

andthedosagemaybereducedasappropriateto400mgatbedtimeor400mginthemorningandatbedtime.

Inpatientswithbenignpepticulcerdisease,relapsemaybepreventedbycontinuedtreatment,usuallywith400mgat

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Patientsonprolongedtreatment(particularlythosetreatedformorethanoneyear)shouldbekeptunderregular

surveillance.

Inoesophagealrefluxdisease,400mgfourtimesaday,withmealsandatbedtime,forfourtoeightweeksis

recommended.

Inpatientswithveryhighgastricacidsecretion[e.g.Zollinger-Ellisonsyndrome]itmaybenecessarytoincreasethe

doseto400mgfourtimesaday,orinoccasionalcasesfurther.

Antacidscanbemadeavailabletoallpatientsuntilsymptomsdisappear.

Intheprophylaxisofhaemorrhagefromstressulcerationinseriouslyillpatients,dosesof200-400mgcanbegiven

everyfourtosixhours.

Inpatientsthoughttobeatriskofacidaspirationsyndrome,anoraldoseof400mgcanbegiven90-120minutes

beforeinductionofgeneralanaesthesiaorinobstetricpractice,atthestartoflabour.Whilesuchariskpersists,adose

ofupto400mgmayberepeatedatfour-hourlyintervalsasrequireduptotheusualdailymaximumof2.4g.

Toreducedegradationofpancreaticenzymesupplements,800-1600mgadaymaybegivenaccordingtoresponsein

fourdivideddoses,onetooneandahalfhoursbeforemeals.

Elderly:

Thenormaladultdosagemaybeusedunlessrenalfunctionismarkedlyimpaired.(referSection4.4andSection4.8)

Children:

Experienceinchildrenislessthanthatinadults.Inchildrenmorethantwoyearsold,CEDINE25-30mg/kgbody

weightperdayindivideddoses.TheuseofCEDINEinchildrenlessthantwoyearsoldisnotfullyevaluated.

4.3Contraindications

CEDINEshouldnotbetakenbypatientswhoarehypersensitivetoCimetidineorotheringredientsoftheformulation.

4.4Specialwarningsandprecautionsforuse

Dosageshouldbereducedinpatientswithimpairedrenalfunctionaccordingtocreatinineclearance.Thefollowing

dosagesaresuggested:creatinineclearanceof0to15mlperminute,200mgtwiceaday;15to30mlperminute,200

mgthreetimesaday,30to50mlperminute,200mgfourtimesaday;over50mlperminute,normaldosage.

Cimetidineisremovedbyhaemodialysis,butnottoanysignificantextentbyperitonealdialysis.

BeforeinitiationofCEDINEtherapyforanygastriculceration,malignancyshouldbeexcludedbyendoscopyand

biopsyifpossible.TreatmentwithCEDINEcanmasksymptomsandallowtransienthealingofgastriccancer.The

consequencesofapotentialdelayindiagnosisshouldbekeptinmindparticularlyinpatientsofmiddleageorover

withneworrecentlychangeddyspepticsymptoms.

Careshouldbetakenthatpatientswithahistoryofpepticulcer,particularlytheelderly,beingtreatedwithCEDINE

andanon-steroidalanti-inflammatoryagentareobservedregularly.

Inpatientsondrugtreatmentorwithillnessesthatcouldcausefallsinbloodcellcount,thepossibilitythatH

-receptor

antagonismcouldpotentiatethiseffectshouldbeborneinmind.

Thesafetyofprolongeduseisnotfullyestablishedandcareshouldbetakentokeeppatientsonprolongedtreatment

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

CEDINEcanprolongtheeliminationofdrugsmetabolisedbyoxidationintheliver.Althoughpharmacological

interactionswithanumberofdrugs,e.g.diazepam,propranolol,havebeendemonstratedonlythosewithoral

anticoagulants,phenytoin,theophyllineandintravenouslidocaineappear,todate,tobeofclinicalsignificance.Close

monitoringofpatientsonCEDINEreceivingoralanticoagulants,phenytoinortheophyllineisrecommendedanda

reductioninthedosageofthesedrugsmaybenecessary.

4.6Pregnancyandlactation

AlthoughtestsinanimalsandclinicalevidencehavenotrevealedanyhazardsfromtheadministrationofCEDINE

duringpregnancyorlactation,bothanimalandhumanstudieshaveshownthatitdoescrosstheplacentalbarrierandis

excretedinmilk.Aswithmostdrugs,theuseofCEDINEshouldbeavoidedduringpregnancyandlactationunless

essential.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Morethan56millionpatientshavebeentreatedwithCimetidineworld-wideandadversereactionshavebeen

infrequent.Diarrhoea,dizzinessorrash,usuallymildandtransientandtirednesshavebeenreported.Gynaecomastia

hasbeenreportedbutisalmostalwaysreversibleondiscontinuingtreatment.Biochemicalorbiopsyevidenceof

reversibleliverdamagehasbeenreportedoccasionally.Reversibleconfusionalstatessometimesassociatedwithmood

andbehaviouralchangesorinsomnia,mayoccur,especiallyinelderlyorveryillpatients[e.g.thosewithrenalfailure]

onhighdosage.Thrombocytopeniaandleucopeniaincludingagranulocytosis(referSection4.4)reversibleon

withdrawaloftreatmenthavebeenreportedveryrarely.Therehavebeenveryrarereportsofinterstitialnephritis,acute

pancreatitis,(referSection4.4)headache,myalgia,arthralgia,sinusbradycardia,tachycardiaandheartblock,all

reversibleonwithdrawaloftreatment.IncommonwithotherH

-receptorantagoniststherehavebeenveryrarereports

ofanaphylaxis.Reversibleimpotencehasalsobeenveryrarelyreportedbutnocausalrelationshiphasbeenestablished

atusualtherapeuticdoses.Isolatedincreasesinplasmacreatininehavebeenofnoclinicalsignificance.

4.9Overdose

Acuteoverdosageofupto20gramshasbeenreportedseveraltimeswithnosignificantilleffects.Inductionof

vomitingand/orgastriclavagemaybeemployedtogetherwithsymptomaticandsupportivetherapy.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CimetidineisahistamineH

-receptorantagonistwhichrapidlyinhibitsbothbasalandstimulatedgastricsecretionof

acidandreducespepsinoutput.Cimetidinemayalsohaveamucosalprotectiveeffectindependentofitsanti-secretory

action.

5.2Pharmacokineticproperties

Cimetidineisreadilyabsorbedfromthegastro-intestinaltractandpeakplasmaconcentrationsareobtainedaboutan

hourafteradministrationonanemptystomach.Asecondpeakmaybeseenafterabout3hours.Fooddelaystherateof

absorptionwiththepeakplasmaconcentrationoccurringafterabouttwohours.

ThebioavailabilityofCimetidinefollowingoraladministrationisabout60to70%duetofirstpassmetabolism.The

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about20%toplasmaproteins.Cimetidineispartiallymetabolisedinthelivertothesulphoxideandto

hydroxymethylcimetidinebutmostisexcretedunchangedintheurine.Cimetidinecrossestheplacentalbarrierandis

excretedintobreastmilkwhereconcentrationsarereportedtobehigherthanthoseinplasma.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MaizeStarch

PovidoneK25

Glycerol85%

SodiumLaurilsulfate

MicrocrystallineCellulose

SodiumStarchGlycolate

MagnesiumStearate

Hypromellose

Macrogol6000

TitaniumDioxide[E171]

YellowIronOxide[E172]

BlackIronOxide[E172]

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

4years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

CEDINE400mgTabletsarepackedinblistersoftransparent,non-toxicpolypropylene,weldedonaninternallyfilm-

coatedaluminiumsemi-rigidsupportandareavailableinblisterpacksof60tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

RowexLimited

Bantry

Irish Medicines Board

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8MARKETINGAUTHORISATIONNUMBER

PA711/44/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27February1991

Dateoflastrenewal:27February2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 18/05/2007 CRN 2035808 page number: 6