CIMETIDINE

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0476/004/001
  • Authorization date:
  • 07-06-1991
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CimetidineTablets200mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontainscimetidine200mg.

3PHARMACEUTICALFORM

Film-coatedtablets

4CLINICALPARTICULARS

4.1TherapeuticIndications

In thetreatmentofbenign ulceration ofoesophagus, stomach, upperintestinaltract(including post-operativestomal

area)and theZollinger-Ellison syndrome.

In themanagementofotherconditionsbenefiting fromreduced gastricacid secretion.

In thelong termmaintenancemanagementofbenign pepticulcerdiseaseunderregularsurveillance.

4.2Posologyandmethodofadminstration

Fororaladministration.

Adults:

Theusualdoseis400 mg twiceaday, with breakfastand atbedtime. Alternatively patientswith duodenalorbenign

gastriculceration may betreated with asingledoseof800mgatbedtime. Regimesof200 mg thricedaily with meals

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

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

In patientswith very high gastricacid secretion (e.g. Zollinger-Ellison syndrome)itmay benecessary to increasethe

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

Treatmentshould begiven initially foratleast4 weeks(6 weeksin thecaseofbenign ulcer). In patientswho may

benefitfromareduction ofgastricsecretion, dosagemay bereduced toamaintenanceof400 mgatbedtime, orin the

morning and atbedtime.

Asimilarmaintenanceregimemay beused to preventrelapsein patientswith benign pepticulceration. Patientson

prolonged treatment(particularly thosetreated foroneyear)should bekeptunderregularsurveillance.

Antacidsmay beused concurrentlyifrequired.

In theprophylaxisofhaemorrhagefrom‘stress’ulceration dosesup to amaximumof2.4 g daily may begiven in

divided doses. 200-400 mg dosescanbegiven every 4 to 6 hoursby oral, nasogastricorparenteralroutes(N.B. by

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In theprophylaxisofacid aspiration (Mendelson’sSyndrome)asingledoseof400 mg may begiven 90-120 minutes

beforeinduction ofgeneralanaesthesiaor, in obstetricpractice, atthestartoflabour. Whilesuch arisk persistsadose

ofup to 400 mg may berepeated (parenterally ifappropriate)at4 hourly intervalsasrequired, up to theusual

maximumof2.4 g/day.

In pancreaticinsufficiency, forprotection ofpancreaticenzymesupplements, 800-1600 mg/day may begiven

according to responseinfourdivided doses, oneto oneand halfhoursbeforemeals.

Thetotaldaily doseby any routeshould notusually exceed 2400 mg.

Dosageshould bereduced in patientswith impaired renalfunction whencreatinineclearanceisbelow50 ml/minute.

Cimetidineisremoved by haemodialysis, butnotto any significantextentby peritonealdialysis.

Elderly

Thenormaladultdosagemay beused unlessrenalfunctionismarkedly impaired.

Children

Experiencein children islessthan thatin adults. In children morethan2 yearsold, cimetidine25-30 mg/kg body

weight/day in divided dosesmay beadministered byeithertheoralorparenteralroutes.

Theuseofcimetidinein children lessthan 2 yearsold isnotfully evaluated.

4.3Contraindications

Hypersensitivity to cimetidineoranyotheringredientsofthepreparation.

4.4Special warningsandspecialprecautionsforuse

Confusionalstates, mood and behaviouralchanges, insomnia, may occurespecially in theelderly orin thevery ill

orthosewith renalfailure. Thoseon high dosageareparticularly atrisk. Thesestatesareusually reversible.

Beforeinitiation ofcimetidinetherapy forany gastriculceration malignancyshould beexcluded by endoscopy,

and biopsy ifpossible. Treatmentwith cimetidinecan mask symptomsand assisttransienthealing ofgastric

cancer. Theconsequencesofapotentialdelay in diagnosisshould bekeptin mind particularly in patientsof

middleageoroverorwith neworrecently changed dyspepticsymptoms.

Thesafety ofprolonged useisnotfully established and careshould betaken to keep patientson prolonged

treatment(particularly thosetreated togreaterthan oneyear)underregularsurveillance.

In patientson drug treatmentorwith illnesseswhich could causefallsin blood cellcounts, thepossibility that

Hreceptorantagonismcouldpotentiatethiseffectshould bebornein mind.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Cimetidinecan prolong theelimination ofdrugsmetabolised by oxidation in theliver. Pharmacologicalinteractions

CreatinineClearance Daily dosage

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

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

0-15 ml/minute 200 mg b.d.

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phenytoin and theophyllineappeartodateto beofclinicalsignificance. Closemonitoring ofpatientson cimetidine

receiving oralanticoagulants, phenytoin, theophyllineisrecommended. Areduction in theirdosagemay benecessary.

4.6Pregnancyandlactation

Cimetidineshould notbeadministered during pregnancyorlactation in womenbreast-feeding infantsunless

considered essentialby thephysician. Animalstudiesofreproduction haveshown no drug-related abnormality.

Significantlevelsofdrug reach breastmilk.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Gynaecomastiahasbeen reported with cimetidine. Diarrhoea, dizziness, rash, tirednesshavealso occurred. Evidenceof

reversibleliverdamagehasbeen reportedand acutepancreatitis, interstitialnephritiswith occasionalincreasesin

plasmacreatinine, thrombocytopenia, headache, myalgia, arthralgia. Reversibleimpotencehasbeen reported butno

causalrelationship established atusualtherapeuticdoses.

4.9Overdose

Acuteoverdosageofup to 20 gramshasbeen reported severaltimeswith no significantilleffects. Induction of

vomiting and/orgastriclavagemay beemployed togetherwith symptomaticand supportivetherapy.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CimetidineisahistamineH-receptorantagonist.

5.2Pharmacokineticproperties

Cimetidineiswellabsorbed afteroraldosing. Itismetabolised in theliverandexcreted mainly through thekidney with

aT½ofabout3-4 hours. Theeffectson acid secretionareoflongerduration.

5.3Preclinical safetydata

No dataispresented dueto thewidespread useformany yearsofproductscontaining cimetidine.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MagnesiumStearate

MaizeStarch

MicrocrystallineCellulose

Povidone

Talc

Hypromellose

Macrogol400

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

ThreeYears.

6.4Special precautionsforstorage

Do notstoreabove25°C.

6.5Natureandcontentsofcontainer

Thetabletsarepacked in amberglassbottleswith whiteclosuresofLD-polyethylene, polypropylenesecuritainerswith

tamperevidentpolyethylenecapsand blisterstripsofclearPVC250µmthick and A1 foilhard tempered, 20µm

thick.Pack sizesare30,50, 60, 100 and 120 tablets.

6.6Instructionsforuseandhandling

None.

7MARKETINGAUTHORISATIONHOLDER

Olinka(UK)Limited,

38/40 ChamberlayneRoad,

London, NW10 3JE,

United Kingdom.

8MARKETINGAUTHORISATIONNUMBER

PA476/4/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 7 th

June1991

Dateoflastrenewal: 7 th

June2001

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 11/11/2005 CRN 2016737 page number: 4