CIMETIDINE

Main information

  • Trade name:
  • CIMETIDINE Coated Tablets 200 Milligram
  • Dosage:
  • 200 Milligram
  • Pharmaceutical form:
  • Coated Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CIMETIDINE Coated Tablets 200 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1046/009/001
  • Authorization date:
  • 14-03-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cimetidine200mgFilm-coatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabl etcontains200mgofcimetidine.

Forexcipients,seesection6.1 .

3PHARMACEUTICALFORM

Film-coatedtablet

Cimetidine200mgtabletsarefilmcoated,palegreen,biconvextabletsmarked‘S47’ononesideand‘Sterwin’onthereverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofbenignulcerationofoesophagus,stomach,upperintestinaltract(includingpost-operativestomalarea)andthe

Zollinger-EllisonSyndrome.

Inthemanagementofconditionsbenefitingfromreducedgastricacidsecretion.

Inthelongtermmaintenanceofbenignpepticulcerdiseaseunderregularsurveillance.

4.2Posologyandmethodofadministration

Thetotaldailydosebyanyrouteshouldnotnormallyexceed2.4g.Dosageshouldbereducedinpatientswithimpairedrenal

function(seesection4.4).

Adults

Forpatientswithduodenalorbenigngastriculcerationasingledailydoseof800mgatbedtimeisrecommended.Otherwisethe

usualdosageis400mgtwicea daywithbreakfastatbedtime. Regimensof200mgthricedailywithmealsand400mgnocte

(night) (1.0g/day)or,ifinadequate,400mgq.d.s. (fourtimesaday) (1.6g/day)withmealsandatbedtimemayalsobeused.

Inoesophagealreflux400mgq.d.s.withmealsandatbedtimefor4to8weeksisrecommended.

Inpatientswithveryhighgastricacidsecretion(e.g.,Zollinger-EllisonSyndrome)itmaybenecessarytoincreasethedoseto400

mgq.d.s.oroccasionallyhigher.

Treatmentshouldbegiveninitiallyforatleast4weeks(6weeksinthecaseofbenignulcer,8weeksinulcerassociatedwith

continuednon-steroidanti-flammatoryagents).Mostulcerswillhavehealedbythatstage,butthosewhichhavenotwillusually

dosoafterafurthercourseoftreatment.Treatmentmaybecontinuedforlongerperiodsinthosepatientswhomaybenefitfroma

reductionofgastricsecretionandthedosagemaybereducedasappropriateto400mgat bedtime or400mginthemorningandat

bedtime.

Inpatientswithbenignpepticulcerdisease,relapsemaybepreventedbycontinuedtreatment,usuallywith400mgatbedtime;

400mginthemorningandatbedtimehasalsobeenused.

Patientsonprolongedtreatment(particularlythosetreatedformorethanoneyear)shouldbekeptunderregularsurveillance.

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Intheprophylaxisofhaemorrhagefrom‘stress’ulcerationdosesuptoamaximumof2.4gdaily maybegivenindivided

doses. 200–400mgdosescanbegivenevery4to6hoursbyoral,nasogastricorparenteralroutes(NBbydirectintravenous

injectionadoseof200mgshouldnotbeexceeded–seeparenteraldosagerecommendations).

Intheprophylaxisofacidaspiration(Mendelson’sSyndrome)asingledoseof400mgmaybegiven90–120minutesbefore

inductionofgeneralanaesthesiaor,inobstetricpra ctice,atthestartoflabour. Whilesuchariskpersistsadoseofupto400mg

mayberepeated(parenterallyifappropriate)at4hourlyintervalsasrequired,uptotheusualmaximumof2.4g/day.

Intheshortbowelsyndrome,e.g.followingsubstantialresectionforCrohn’sdisease,theusualdosagerange(seeabove)canbe

usedaccordingtoindividualresponse.

Inpancreaticinsufficiency,forprotectionofpancreaticenzymesupplements,800–1600mgdailymaybegivenaccordingto

responseinfourdivideddoses,onetooneandahalfhoursbeforemeals.

Elderly

Thenormaladultdosagemaybeusedunlessrenalfunctionismarkedlyimpaired(seesection4.4).

Children

Experienceinchildr enislessthanthatinadults. Inchildrenmorethan2yearsold,cimetidine25–30mg/kgbodyweight/day

individeddosesmaybeadministeredbyeithertheoralorparenteralroutes.

Theuseofcimetidineinchildrenlessthan2yearsoldisnotfullyevaluated.

4.3Contraindications

Hypersensitivitytocimetidineoritsexcipients.

4.4Specialwarningsandprecautionsforuse

Dosageshouldbereducedinpatientswithimpairedrenalfunctionwhencreatinineclearanceisbelow50ml/minute.

Cimetidineisremovedbyhaemodialysis,butnottoanysignificantextentbyperitonealdialysis.

Clinicaltrialsofoversixyearscontinuoustreatmentandmorethan15yearswidespreadusehavenotrevealedunexpectedadverse

reactionsrelatedtolongtermtherapy.Thesafetyofprolongeduseisnot,however,fullyestablishedandcareshouldbetakento

keeppatientsonprolongedtreatment(particularlythosetreatedforgreaterthanoneyear)underregularsurveillance.

Beforeinitiationofcimetidinetherapyforanygastriculcerationmalignancyshouldbeexcludedbyendoscopy,andbiopsyif

possible.Treatmentwithcimetidinecanmasksymptomsandassisttransienthealingofgastriccancer.Theconsequencesofa

potentialdelayindiagnosisshouldbekeptinmindparticularlyinpatientsofmiddleageoroverorwithneworrecentlychanged

dyspepticsymptoms.

Careshouldbetakenthatpatientswithahistoryofpepticulcer,particularlytheelderly,beingtreatedwithcimetidineandanon-

steroidalanti-inflammatoryagentareobservedregularly.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactosemalabsorption

shouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Cimetidinecanprolongtheeliminationofdrugsmetabolisedbyoxidationintheliver.Pharmacologicalinteractionswitha

numberofdrugse.g.,diazepam,propranolol,havebeendemonstrated;onlythosewithoralanticoagulants,phenytoinand

theophyllineandintravenouslidocaineappeartodatet obeofclinicalsignificance. Closemonitoringofpatientsoncimetidine

CreatinineClearance

30-50ml/minute

15-30ml/minute

0-15ml/minute DailyDosage

200mgq.d.s(fourtimesaday)

200mgt.d.s(threetimesaday)

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Inpatientsondrugtreatmentorwithillnesswhichcouldcausefallsinbloodcellcounts,thepossibilitythatH

receptor

antagonismcouldpotentiatethiseffectshouldbeborneinmind.

4.6Pregnancyandlactation

Cimetidineshouldnotbeadministeredduringpregnancyorlactationinwomenbreast-feedinginfantsunlessconsideredessential

bythephysician.Animalstudiesofreproductionhaveshownnodrug-relatedabnormality.Significantlevelsofdrugreachbreast

milk.

4.7Effectsonabilitytodriveandusemachines

Ifdizziness,headacheortirednessoccurs,careshouldbetakenregardingdrivinganduseofmachinery.

4.8Undesirableeffects

Adversereactions: Morethan56millionpatientshavebeentreatedwithcimetidineworldwideandadverser eactionshave

beeninfrequent.

Uncommonlyreportedadverseevents:

Gastrointestinaldisorders:diarrhoea .

Nervoussystemdisorders:dizziness .

Skinand subcutaneoustissuedisorders: rash,usuallymildandtransient .

Generaldisordersandadministrationsiteconditions:tiredness .

Reproductivesystemandbreastdisorders:gynaecomastia,whichisalmostalwaysreversibleupondiscontinuingtreatment .

Rarelyreportedadverseevents:

Bloodandthelymphaticsystemdisorders:-thrombocytopenia;leucopenia;agranulocytosis,(seesection4.4)whicharereversible

onwithdrawaloftreatment .

Immunesystemdisorders: hypersensitivityvasculitis,whichisreversibleonwithdrawaloftreatment .

Psychiatricdisorders: reversibleconfusionalstates,usuallyinelder lyoralreadyveryillpatients e.g.thosewithrenalfailure;

depression .

Hepato-b iliarydisorders: biochemicalorbiopsyevidenceofreversibleliverdamage .

Veryrarelyreportedadverseevents:

Thefollowingadverseeventsareusuallyreversibleuponwithdrawaloftreatment:

Immunesystemdisorders: hypersensitivityreactionsincludinganaphylaxis .

Psychiatricdisorders: hallucinations .

Bloodand thelymphaticsystemdisorders: pancytopeniaandaplasticanaemia .

Nervoussystemdisorders: headache .

Cardiacdisorders: sinusbradycardia;tachycardia,heartblock .

Gastrointestinal disorders: acutepancreatitis .

Musculoskeletal,connectivetissueand bonedisorders: myalgia;arthralgia .

Renalandurinarydisorders: interstitialnephritis .

Generaldisordersandadministrationsitec onditions: fever .

Alopeciahasbeenreportedbutnocausalrela tionshiphasbeenestablished. Reversibleimpotencehasalsobeenveryrarely

reportedbutnocausalrelationshiphasbeenestablish edatusualtherapeuticdoses. Isolatedincreasesofplasmacreatininehave

beenofnoclinicalsignificance.

4.9Overdose

Acuteoverdosageofupto20gramshasbeenreportedseveraltimeswithnosignificantilleffects.Inductionofvomitingand/or

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticcategory:H

-Receptorantagonists,ATCCode:A02BA01 .

AnH

receptorantagonistwellabsorbedafteroraldosing,metabolisedintheliverandexcretedmainlythroughthekidneywitha

T½ofabout3-4hours.Theeffectsonacidsecretionareoflongerduration.

5.2Pharmacokineticproperties

Cimetidineisreadilyabsorbedfromthegastro-intestinaltractandpeakplasmaconcentrationsareobtainedaboutanhourafter

administrationonanemptystomachandabout2hoursa fteradministrationwithfood. Thebioavailabilityofcimetidine

followingoraladministrationisabout60-70%comparedtoanintravenousdos eduetofirstpassmetabolism. Theelimination

halflifefromplasmaisaround2hoursandcimetidineisweaklybound, about20%,toplasmaproteins. Cimetidineispartially

metabolisedinthelivertothesulphoxideandtohydroxymethylcimetidinebutmostisex cretedunchangedintheurine.

Cimetidinecrossestheplacentalbarrierandisexcretedinbreastmilkwhenconcentrationsarereportedto behigherthanthose

inplasma. Itdoesnotreadilycrosstheblood-brainbarrier.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinothersectionsofthe

SPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Maizestarch

Povidone

DalfcolGreen3203

-patentblueV(E131)

-quinolineyellow(E104)

Sodiumlaurilsulfate

Purifiedtalc

Magnesiumstearate

Croscarmellosesodium

Hypromellose

Macrogol400

MastercoteFA1507

-patentblueValuminiumlake(E131)

-quinolineyellowaluminiumlake(E104)

-titaniumdioxide(E171)

6.2Incompatibilities

Notapplicable .

6.3ShelfLife

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6.4Specialprecautionsforstorage

Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

PVCaluminiumfoilblisterscontainedincardboardcartonscontaining30,50,56,112and120tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

WinthropPharmaceuticalsUKLimited

OneOnslowStreet

Guildford

SurreyGU14YS

8MARKETINGAUTHORISATIONNUMBER

PA1046/9/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 14 March1995

Dateoflastrenewal: 14March2005

10DATEOFREVISIONOFTHETEXT

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