CEDINE 200 MG FILM-COATED TABLETS

Main information

  • Trade name:
  • CEDINE 200 MG FILM-COATED TABLETS
  • Dosage:
  • 200 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEDINE 200 MG FILM-COATED TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0711/044/001
  • Authorization date:
  • 27-02-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cedine200mgfilm-coatedtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains200mgcimetidine.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet

Pale-green,round,biconvextabletswithascorenotchononesideand“C200”engravedonthesameside.

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

bedtime,400mginthemorningandatbedtimehasalsobeenused.Patientsonprolongedtreatment(particularlythose

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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

CEDINEshouldnotbetakenbypatientswhoarehypersensitivetoCimetidine,orotheringredientsoftheformulation.

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

(particularlythosetreatedforgreaterthanoneyear)underregularsurveillance.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

CEDINEcanprolongtheeliminationofdrugsmetabolisedbyoxidationintheliver.Althoughpharmacological

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anticoagulants,phenytoin,theophyllineandintravenouslidocaineappear,todate,tobeofclinicalsignificance.Close

monitoringofpatientsonCEDINEreceivingoralanticoagulants,phenytoinortheophyllineisrecommendedanda

reductioninthedosageofthesedrugsmaybenecessary.

4.6Pregnancyandlactation

AlthoughtestsinanimalsandclinicalevidencehavenotrevealedanyhazardsfromtheadministrationofCEDINE

duringpregnancyorlactation,bothanimalandhumanstudieshaveshownthatitdoescrosstheplacentalbarrierandis

excretedinmilk.Aswithmostdrugs,theuseofCEDINEshouldbeavoidedduringpregnancyandlactationunless

essential.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Diarrhoea,dizzinessorrash,usuallymildandtransientandtirednesshavebeenreported.Gynaecomastiahasbeen

reportedbutisalmostalwaysreversibleondiscontinuingtreatment.Biochemicalorbiopsyevidenceofreversibleliver

damagehasbeenreportedoccasionally.Reversibleconfusionalstatessometimesassociatedwithmoodandbehavioural

changesorinsomnia,mayoccur,especiallyinelderlyorveryillpatients[e.g.thosewithrenalfailure]onhighdosage.

Thrombocytopeniaandleucopeniaincludingagranulocytosis(referSection4.4)reversibleonwithdrawaloftreatment

havebeenreportedveryrarely.Therehavebeenveryrarereportsofinterstitialnephritis,acutepancreatitis,(refer

Section4.4),headache,myalgia,arthralgia,sinusbradycardia,tachycardiaandheartblock,allreversibleonwithdrawal

oftreatment.IncommonwithotherH

-receptorantagoniststherehavebeenveryrarereportsofanaphylaxis.

Reversibleimpotencehasalsobeenveryrarelyreportedbutnocausalrelationshiphasbeenestablishedatusual

therapeuticdoses.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

eliminationhalf-lifefromplasmaisaround2hoursandisincreasedinrenalimpairment.Cimetidineisweaklybound,

about20%toplasmaproteins.Cimetidineispartiallymetabolisedinthelivertothesulphoxideandto

hydroxymethylcimetidinebutmostisexcretedunchangedintheurine.Cimetidinecrossestheplacentalbarrierandis

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5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Maizestarch

Povidone25

Glycerol85%

Sodiumlaurilsulfate

Microcrystallinecellulose

Sodiumstarchglycolate(TypeA)

Magnesiumstearate

Hypromellose

Macrogol6000

Titaniumdioxide(E171)

Yellowironoxide(E172)

Blackironoxide(E172)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

4years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

CEDINE200mgtabletsarepackedinblistersoftransparent,non-toxicpolypropylene,weldedonaninternallyfilm-

coatedaluminiumsemi-rigidsupportandareavailableinblisterpacksof120tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

RowexLimited

Bantry

CountyCork

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27February1991

Dateoflastrenewal:27February2006

10DATEOFREVISIONOFTHETEXT

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