GERAMET

Main information

  • Trade name:
  • GERAMET Film Coated Tablet 400 Milligram
  • Dosage:
  • 400 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GERAMET Film Coated Tablet 400 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0577/005/002
  • Authorization date:
  • 27-11-1991
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0577/005/002

CaseNo:2032354

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

McDermottLaboratoriesLtdt/aGerardLaboratories

35/36BaldoyleIndustrialEstate,GrangeRoad,Dublin13,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Geramet400mgFilm-coatedTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom28/03/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 25/04/2008 CRN 2032354 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Geramet400mgFilm-coatedtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachtabletcontainsCimetidine400mg.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Filmcoatedtablets

Palegreenovalfilmcoatedbiconvextabletembossed“CN400”ononesideand“G”onthereverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofbenignulcerationofoesophagus,stomach,upperintestinaltract(includingpost-operativestomal

area)andtheZollinger-Ellisonsyndrome.

Inthemanagementofconditionsbenefitingfromreducedgastricacidsecretion.

Inthelongtermmaintenancemanagementofbenignpepticulcerdiseaseunderregularsurveillance.

4.2Posologyandmethodofadministration

Adults:

Theusualdoseis400mgtwiceadaywithbreakfastandatbedtime.Alternativelypatientswithduodenalorbenign

gastriculcerationmaybetreatedwithasingledoseof800mgatbedtime.Regimensof200mgthricedailywithmeals

and400mgnocte,or,ifinadequate,400mgq.d.s.withmealsandatbedtimemayalsobeused.

Inoesophagealreflux400mgq.d.s.withmealsandatbedtimefor4to8weeksisrecommended.

Inpatientswithveryhighgastricacidsecretion(e.g.Zollinger-Ellisonsyndrome)itmaybenecessarytoincreasethe

doseto400mgq.d.s.oroccasionallyhigher.

Treatmentshouldbegiveninitiallyforatleast4weeks(6weeksinthecaseofbenignulcer).Inpatientswhomay

benefitfromareductionofgastricsecretion,dosagemaybereducedtoamaintenanceregimenof400mgatbedtime,

orinthemorningandatbedtime.

Asimilarmaintenanceregimenmaybeusedtopreventrelapseinpatientswithbenignpepticulceration.Patientson

prolongedtreatment(particularlythosetreatedformorethanoneyear)shouldbekeptunderregularsurveillance.

Antacidsmaybeusedconcurrentlyifrequired.

Intheprophylaxisofhaemorrhagefrom‘stress’ulcerationdosesuptoamaximumof2.4gdailymaybegivenin

divideddoses.200-400mgdosescanbegivenevery4to6hoursbyoral,nasogastricorparenteralroutes(N.B.by

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Intheprophylaxisofacidaspiration(Mendelson’ssyndrome)asingledoseof400mgmaybegiven90-120minutes

beforeinductionofgeneralanaesthesiaor,inobstetricpractice,atthestartoflabour.Whilesuchariskpersistsadose

ofupto400mgmayberepeated(parenterallyifappropriate)at4hourlyintervalsasrequired,uptotheusual

maximumof2.4g/day.

Inpancreaticinsufficiency,forprotectionofpancreaticenzymesupplements,800-1600mg/daymaybegiven

accordingtoresponseinfourdivideddoses,onetooneandahalfhoursbeforemeals.

Thetotaldailydosebyanyrouteshouldnotusuallyexceed2400mg.

Elderly:

Inthenormaladultdosagemaybeusedunlessrenalfunctionismarkedlyimpaired.

Children:

Experienceinchildrenislessthanthatinadults.Inchildrenmorethan2yearsold,cimetidine25-30mg/kgbody

weight/dayindivideddosesmaybeadministeredbyeithertheoralorparenteralroutes.

Theuseofcimetidineinchildrenlessthan2yearsoldisnotfullyevaluated.

Patientswithimpairedrenalfunction:

Dosageshouldbereducedinpatientswithimpairedrenalfunctionwhencreatinineclearanceisbelow50ml/minute.

Patientsreceivingdialysistherapy:

Cimetidineisremovedbyhaemodialysis,butnottoanysignificantextentbyperitonealdialysis.

4.3Contraindications

Hypersensitivitytocimetidineoranyofitsexcipients.

4.4Specialwarningsandprecautionsforuse

Beforeinitiationofcimetidinetherapyforanygastriculcerationmalignancyshouldbeexcludedbyendoscopy,and

biopsyifpossible.Treatmentwithcimetidinecanmasksymptomsandassisttransienthealingofgastriccancer.The

consequencesofapotentialdelayindiagnosisshouldbekeptinmindparticularlyinpatientsofmiddleageoroveror

withneworrecentlychangeddyspepticsymptoms.

Thesafetyofprolongeduseisnotfullyestablishedandcareshouldbetakentokeeppatientsonprolongedtreatment

(particularlythosetreatedforgreaterthanoneyear)underregularsurveillance.

Inpatientsondrugtreatmentorwithillnesseswhichcouldcauseafallinbloodcellcounts,thepossibilitythat

Hreceptorantagonismcouldpotentiatethiseffectshouldbeborneinmind.

Careshouldbeexercisedinrenalandhepaticimpairment.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Cimetidinecanprolongtheeliminationofdrugsmetabolisedbyoxidationintheliver.Pharmacologicalinteractions

withanumberofdrugse.g.diazepam,propranolol,havebeendemonstrated;onlythosewithoralanti-coagulants,

CreatinineClearance DailyDosage

30-50ml/minute 200mgq.d.s.

15-30ml/minute 200mgt.d.s.

0-15ml/minute 200mgb.d.

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receivingoralanticoagulants,phenytoin,andtheophyllineisrecommended.Areductionintheirdosagemaybe

necessary.

4.6Pregnancyandlactation

Animalstudiesandclinicaldatahavenotrevealedanyhazardsfromtheuseofcimetidineduringpregnancyand

lactation.Studieshowever,establishedthatcimetidinecrossestheplacentalbarrierandisexcretedinbreastmilk.Its

administrationduringpregnancyandlactationshouldbeavoidedunlessconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Ifpatientsexperiencedizziness,theyshouldnotdrive.

4.8Undesirableeffects

Thefollowingfrequenciesareusedtoevaluateadverseevents.Common( ≥1/100and<1/10),Uncommon(≥1/1,000

and<1/100)andRare( ≥1/10,000and<1/1,000).Thefollowingadverseeventshavebeenreportedinconjuntionwith

Cimetidine400mg:

ThemostcommonadverseeventsreportedwereHeadache,dizzinessandmildgastrointestinalproblems.afulllistof

adverseeventsisavailableinthetablebelow.

Table1FrequencyofAdverseEvents

SystemOrganClass Common

(1/100and<1/10) Uncommon

(1/1,000and

<1/100) Rare

(1/10,000and

<1/1,000)

Reproductive

Systemandbreast

disorders Reversible

Gynaecomastia,

Reversible

impotence

Gastrointestinal

disorders Diarrhoea Acutepancreatitis

Nervoussystem

disorders Dizziness,fatigue,

Headache

Hepatobiliary

disorders Reversibleliver

damage

Renalandurinary

disorders Interstitialnephritis

Musculoskeletaland

connectivetissue

disorder Myaligia,

Antrhralgia

Psychiatricdisorders Confusion

(especiallyinthe

elderlyorinveryill

patients),Moodand

behavioural

changes,Insomnia.

Skinand

subcutaneoustissue

disorders Rash

Bloodandlymphatic

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4.9Overdose

Acuteoverdoseinvolvingdosesover20ghavebeenreportedseveraltimeswithnosignificantilleffects.Inductionof

vomitingand/orgastriclavagemaybeemployed,inadditiontosupportiveandsymptomatictherapy.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:H2-receptorantagonists,ATCcodeA02BA01.

CimetidineisahistamineHreceptorantagonistwhichrapidlyinhibitsbothbasalandstimulatedgastricsecretionof

acidandreducespepsinoutput.Itmayalsohaveamucosalprotectiveeffectindependentofitsanti-secretoryeffect.

5.2Pharmacokineticproperties

Cimetidineiswellabsorbedafteroraldosing.Itismetabolisedintheliverandisexcretedmainlythroughthekidney

withaT ofabout3-4hours.Theeffectsonacidsecretionareoflongerduration.

5.3Preclinicalsafetydata

Relevantdataarediscussedinthepregnancyandlactationsection.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

TabletCore

Sodiumstarchglycolate

PovidoneK29-32

Magnesiumstearate

Maizestarch

Microcrystallinecellulose

TabletCoating

OpadryOY-S-8826containing:

Hypromellose(E464)

Hyprolose

Titaniumdioxide(E171)

Povidone

Macrogol400

Ironoxideyellow(E172)

Indigocarminealuminiumlake(E132)

Ironoxideblack(E172)

TabletPolishing

Carnaubawax

6.2Incompatibilities

Irish Medicines Board

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6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

PolyethylenecontainerwithureawhitecapsandJayfillaullagefiller.

50&2500tablets

Blisterpackaging(PVdC/Aluminiumfoilblisters)

60tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

McDermottLaboratoriesLimited

Tradingas:

GerardLaboratories

35/36BaldoyleIndustrialEstate

GrangeRoad

Dublin13

8MARKETINGAUTHORISATIONNUMBER

PA577/5/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27 th

November1991

Dateoflastrenewal:27 th

November2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 25/04/2008 CRN 2032354 page number: 6