CIMETIDINE 800

Main information

  • Trade name:
  • CIMETIDINE 800
  • Dosage:
  • 800 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CIMETIDINE 800
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0593/007/003
  • Authorization date:
  • 25-06-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cimetidine800 mg StadaTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontainsCimetidine800mg

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Tablets.

White, oblong, biconvex tablet, scored on both sides, imprinted‘H3’.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofbenignulcerationofoesophagus,stomach,upperintestinaltract(includingpost-operative

stomalarea)and theZollinger-Ellison syndrome.

In themanagementofconditionsbenefiting fromreduced gastricacid secretion.

In thelong termmaintenancemanagementofbenign pepticulcerdiseaseunderregularsurveillance.

4.2Posologyandmethodofadminstration

Fororaladministration:

Adults:

Theusualdoseis400mgtwiceaday,withbreakfastandatbedtime.Alternativelypatientswithduodenalor

benigngastriculcerationmaybetreatedwithasingledoseof800mgatbedtime.Regimesof200mgthricedaily

with mealsand 400 mg nocteor, ifinadequate, 400 mg q.d.s. with mealsand atbedtimemay also beused.

Ifoesophagealreflux disease400 mg q.d.s. with mealsand atbedtimefor4 to 8 weeksisrecommended.

Inpatientswithveryhighgastricacidsecretion(e.g.Zollinger-Ellisonsyndrome)itmaybenecessarytoincrease

thedoseto 400 mg q.d.s. oroccasionally higher.

Treatmentshouldbegiveninitiallyforatleast4weeks(6 weeksin thecaseofbenignulcer).In patientswho may

benefitfromareductionofgastricsecretion,dosagemaybereducedtoamaintenanceof400mgatbedtime,orin

themorning and atbedtime.

Asimilarmaintenanceregimemay beused to preventrelapsein patientswith benign pepticulceration.

Intheprophylaxisofhaemorrhagefrom‘stress’ulcerationdosesuptoamaximumof2.4gdailymaybegivenin

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Intheprophylaxisofacidaspiration(Mendelson’sSyndrome)asingledoseof400mgmaybegiven90-120

minutesbeforeinductionofgeneralanaesthesiaor,inobstetricpractice,atthestartoflabour.Whilesucharisk

persistsadoseofupto400mgmayberepeated(parenterallyifappropriate)at4hourlyintervalsasrequired,up

to theusualmaximumof2.4 g/day.

Inpancreaticinsufficiency,forprotectionofpancreaticenzymesupplements,800-1600mgdaymaybegiven

according to responseinfourdivided doses, oneto oneand halfhoursbeforemeals.

Intheshortbowelsyndromee.g.followingsubstantialresectionforCrohn’sdisease,theusualdosagerangecan

beused according to individualresponse.

Thetotaldaily doseby any routeshould notusually exceed 2400 mg.

Dosageshouldbereducedinpatientswithimpairedrenalfunctionwhencreatinineclearanceisbelow50

ml/minute.

Cimetidineisremoved by haemodialysis, butnotto any significantextentby peritonealdialysis.

Elderly

Thenormaladultdosagemay beused unlessrenalfunctionismarkedly impaired.

Children

Experienceinchildrenislessthanthatinadults.Inchildrenmorethantwoyearsold,cimetidine25-30mg/kg

body weight/dayindivided dosesmaybeadministered by eithertheoralorparenteralroutes.Themaximumdaily

dosageshould notexceed 1600 mg/day splitin fourdivided doses.

Theuseofcimetidinein children lessthan 2 yearsold isnotfully evaluated.

4.3Contraindications

Hypersensitivity to cimetidineoranyotheringredientsofthepreparation.

4.4Special warningsandspecialprecautionsforuse

Beforeinitiationofcimetidinetherapyforanygastriculceration,malignancyshouldbeexcludedbyendoscopy,

andbiopsyifpossible.Treatmentwithcimetidinecanmasksymptomsandassisttransienthealingofgastric

cancer.Theconsequencesofapotentialdelayindiagnosisshouldbekeptinmindparticularlyinpatientsof

middleageoroverorwith neworrecently changed dyspepticsymptoms.

Patientsonprolongedcimetidinetherapyshouldbekeptunderregularsurveillancewithparticularattentiontothe

pathology ofthegastrointestinaltract.

Inpatientsondrugtreatmentorwithillnesseswhichcouldcausefallsinbloodcellcounts,thepossibilitythatH

receptorantagonismcouldpotentiatethiseffectshould bebornein mind.

Careshouldbetakenthatpatientswithahistoryofpepticulcer,particularlytheelderly,beingtreatedwithcimetidine

CreatinineClearance Daily dosage

30-50 ml/minute 200 mg q.d.s.

15-30 ml/minute 200 mg t.d.s

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Cimetidinecanprolongtheeliminationofdrugsmetabolisedbyoxidationintheliver.Pharmacologicalinteractions

withanumberofdrugse.g.diazepam,propranolol,havebeendemonstrated;onlythosewithoralanticoagulants,

phenytoinandtheophyllineappeartodatetobeofclinicalsignificance.Closemonitoringofpatientsoncimetidine

receivingoralanticoagulants,phenytoinortheophyllineisrecommended.Areductionintheirdosagemaybe

necessary.Conversely,upondiscontinuationofCimetidine,thedoseofdrugsimultaneouslyadministeredmayrequire

to beincreased.

4.6Pregnancyandlactation

Cimetidineshouldnotbeadministeredduringpregnancyorlactationinwomenbreast-feedinginfantsunless

consideredessentialbythephysician.Animalstudiesofreproductionhaveshownnodrug-relatedabnormality.

Significantlevelsofdrug reach breastmilk.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Gynaecomastiahasbeenreportedwithcimetidine,particularlyonprolongedand/orhighdoses.Diarrhoea,

dizziness,rash,tirednesshavealsooccurred.Evidenceofreversibleliverdamagehasbeenreportedandacute

pancreatitis,interstitialnephritiswithoccasionalincreasesinplasmacreatinine,thrombocytopenia,headache,

myalgia,arthralgia.Reversibleimpotencehasbeenreportedbutnocausalrelationshipestablishedatusual

therapeuticdoses.

Confusionalstates,moodandbehaviouralchanges,insomnia,mayoccurespeciallyintheelderlyorinveryill

patientsorthosewithrenalfailure.Thoseonhighdosageareparticularlyatrisk.Thesestatesareusually

reversible.

Very rarely, heartblock and anaphylaxishavebeen reported.

4.9Overdose

Acuteoverdosageofup20gramshasbeenreportedseveraltimeswithnosignificantilleffects.Inductionofvomiting

and/orgastriclavagemay beemployed togetherwith symptomaticandsupportivetherapy.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CimetidineisahistamineH

-receptorantagonistwhichrapidlyinhibitsbothbasalandstimulatedgastricsecretionof

acid and reducespepsin output.

5.2Pharmacokineticproperties

Cimetidineiswellabsorbedafteroraldosing.Peakplasmalevelsareobtainedapproximatelyonehourafteroral

dosing.Foodtakenconcomitantlydelaystherateandpossiblyalsotheextentofabsorption,peakplasmalevels

being reached aftertwo hours.

Bioavailability is60-70%dueto firstpassmetabolism.Plasmaprotein binding isweak, and in theregion of20%.

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increased in renalimpairment.Theeffectsonacid secretion areoflongerduration.

Cimetidinecrossestheplacentalbarrierand isexcreted into milk.

5.3Preclinical safetydata

Acutetoxicity studiesin animalshavenotshown any particularsensitivity.

Chronictoxicitystudies(oral)inratsanddogsforupto12monthsdemonstratedaweakantiandrogeniceffect

aftervery high doseswhich wasreversibleon discontinuation ofthedrug.

No tumorigenicormutagenicpotentialhasbeen observed.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose

Maizestarch

Povidone

Sodiumlaurilsulfate

Sodiumstarch glycollate

Magnesiumstearate

6.2Incompatibilities

Notapplicable

6.3ShelfLife

5 years

6.4Special precautionsforstorage

Thismedicinalproductdoesnotrequireany specialstorageconditions.

6.5Natureandcontentsofcontainer

AL/PVCblisterstrips.Packsof30 tablets.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

StadaArzneimittelAG

Stadastrasse2-18,

D-61118 Bad Vilbel

Germany

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 25 th

June1999

Dateoflastrenewal: 25 th

June2004

10DATEOFREVISIONOFTHETEXT

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