FAMULCO FILM-COATED

Main information

  • Trade name:
  • FAMULCO FILM-COATED
  • Dosage:
  • 40mg Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FAMULCO FILM-COATED
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0593/019/002
  • Authorization date:
  • 26-11-1999
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0593/019/002

CaseNo:2036382

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

StadaArzneimittelAG

Stadastrasse2-18,D-61118BadVilbel,Germany

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Famulco40mg,filmcoatedtablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom14/06/2007until15/11/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 15/06/2007 CRN 2036382 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FAMULCO®40mg,filmcoatedtablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Famotidine40mg

Forexcipients,see6.1

3PHARMACEUTICALFORM

Film-coatedtablets.

Round,biconvex,whitefilm-coatedtablets,engraved“40”ononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Duodenalulcer

Benigngastriculcer

Zollinger-Ellison-Syndrome

Treatmentofmildtomoderaterefluxoesophagitis

4.2Posologyandmethodofadministration

Dosinginstructions:

Duodenalulcersandbenigngastriculcers

40mgoffamotidineoncebeforegoingtosleep

Zollinger-Ellisonsyndrome

Providingtherehasnotbeenprevioustherapywithantisecretorymedications,Zollinger-Ellisonsyndrometherapy

shouldstartbyadministering20mgoffamotidine(film-coatedtabletswith20mgoffamotidineareavailableherefor)

every6hours.Dependingontheacidsecretionandthepatient'sclinicalresponse,adosagetitrationshouldbe

performedastreatmentcontinuesuntilthedesiredacidlevelshavebeenreached(e.g.<10mEq/hinthehourpreceding

thenextdoseoffamotidine).Ifthedesiredinhibitionofacidsecretioncannotbeattainedwithadailydosageof800

mg,alternativetreatmentshouldbeconsideredtoregulateacidsecretion,sincenolong-termexperiencewithdosages

ofmorethan800mgoffamotidine/dayhavebeenrecorded.

Treatmentshouldbecontinuedforaslongasclinicallynecessary.

PatientswhohavepreviouslyundergoneHreceptorantagonisttreatmentcanbeginfamotidinetreatmentatahigher

dosagethantheinitialdosagethatisusuallyrecommended.Thedosagedependsontheseverityofthediseaseandthe

dosageofpreviousmedications.

Mildtomoderaterefluxoesophagitis

Intreatingmildtomoderaterefluxoesophagitis,adailydosageoftwice40mgoffamotidine(correspondingtotwo

film-coatedtabletsofFamulco®40mg)isrecommended.

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clearanceislessthan30ml/min,thedailydosageoffamotidineshouldbereducedto50%.

Dialysispatientsshouldalsotakedosagesthatarereducedto50%.Famulco®40mgshouldbeadministeredattheend

ofdialysisorthereaftersincesomeoftheactiveingredientisremovedviadialysis.

Modeanddurationofadministration:

Famulco®40mgshouldbeswallowedwholewithsomeliquid.Itdoesnotneedtobetakenatmealtimes.

Duodenalulcersandbenigngastriculcers

Intreatingduodenalulcersandbenigngastriculcers,therapyshouldbeconductedfor4to8weeks.Thisperiod,

however,maybeshortenedifendoscopyrevealsthattheulcerhashealed.Ifanendoscopicexaminationdoesnotyield

suchfindings,thetreatmentshouldbecontinuedforanother4weeks.

Zollinger-Ellisonsyndrome

Treatmentshouldbecontinuedforaslongasclinicallynecessary.

Mildtomoderaterefluxoesophagitis

Generally,treatmentshouldbeconductedfor6weeks.If6weekstreatmentdoesnotresultinhealing,treatmentshould

becontinuedforanother6weeks.

4.3Contraindications

Famulco®40mgmaynotbeadministeredwherethereisknownhypersensitivitytotheactiveingredient,famotidine,

ortoanyoftheotheringredients.Ifsymptomsofhypersensitivitydevelop,Famulco®40mgshouldbediscontinued.

Thereisnotsufficientinformationaboutthesafetyandefficacyoffamotidineinchildren.Therefore,childrenshould

notbetreatedwithFamulco®40mg.

4.4Specialwarningsandprecautionsforuse

MalignancycannotnecessarilyberuledoutwhentreatmentwithFamulco®40mghasapositiveeffectonthe

symptoms.Appropriatediagnosticmeasuresshouldbeusedtodeterminethenon-malignancyofanulcerbefore

famotidinetreatmentisundertaken.

Famotidineisprimarilyeliminatedviathekidneysandpartiallybrokendownintheliver.Cautionmustthereforebe

exercisedinpatientswithimpairedrenalfunction.

Thedailydosageshouldbereducedforpatientswithimpairedrenalfunction(cfposology).

DonotadministerFamulco®40mgincasesofminorgastrointestinalcomplaints.

InpatientswithduodenalulcersandbenigngastriculcerstheH.pyloristatusshouldbedetermined.Whenever

possible,patientswithH.pylorishouldundergoeradicationtherapytoeliminatethebacteria.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noclinicallyimportantmetabolicinteractionswithotherdrugsorsubstanceshavebeenrecorded.

Duringconcomitantuseofsubstanceswhoseabsorptionisaffectedbygastricacidlevels,apossiblechangeinthe

absorptionofthesesubstancesshouldbeconsidered.Theabsorptionofketoconazoleoritraconazolecanbereduced;

ketoconazoleshouldbeadministeredtwohoursbeforeadministeringfamotidine.

Concomitantuseoffamotidineandantacidscanreducethefamotidineabsorptionandleadtolowerplasmalevelsof

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Concomitantuseofsucralfateinhibitstheabsorptionoffamotidine.Therefore,sucralfateshouldasarulenotbe

administeredwithintwohoursofthefamotidinedose.

Theadministrationofprobenecidcandelaytheeliminationoffamotidine.Concomitantuseofprobenecidand

Famulco®40mgshouldbeavoided.

4.6Pregnancyandlactation

Dataonalimitednumberofexposedpregnanciesindicatenoadverseeffectsoffamotidineonpregnancyoronthe

healthofthefetus/newbornchild.Todate,nootherrelevantepidemiologicaldataareavailable.Animalstudiesdonot

indicatedirectorindirectharmfuleffectswithrespecttopregnancy,embryonal/fetaldevelopment,parturitionor

postnataldevelopment(seesection5.3).

Famotidineshouldonlybeprescribedtopregnantwomenafteracarefulrisk/benefitassessmenthastakenplace.

Famotidineiseliminatedviabreastmilk.Sincethereisapossibilityoffamotidineaffectingtheinfant’sgastricacid

secretion,womenundergoingfamotidinetreatmentshouldrefrainfrombreastfeeding.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Bloodandthelymphaticsystemdisorders

Veryrare(<0.01%):Thrombocytopenia,leukopenia,agranulocytosisandpancytopenia.

Immunesystemdisorders

Rare(>0.01%,<0.1%):Hypersensitivityreactions(anaphylaxis,angioneuroticedema,bronchospasm).

Psychiatricdisorders

Veryrare(<0.01%):Reversiblepsychologicaldisturbances(e.g.hallucinations,disorientation,confusion,anxiety,

agitation,depression).

Nervoussystemdisorders

Common(>1%):Headache,dizziness.

Veryrare(<0.01%):Paresthesia,drowsiness,sleeplessness,epilepticseizures(grandmal).

Gastrointestinaldisorders

Common(>1%):Constipation,diarrhea.

Uncommon(>0.1%,<1%):Drymouth,nausea,vomiting,gastrointestinalcomplaints,flatulence,lossofappetite.

Hepato-biliarydisorders

Rare(>0.01%,<0.1%):Intrahepaticcholestasis(visiblesign:jaundice).

Skinandsubcutaneoustissuedisorders

Uncommon(>0.1%,<1%):Rash,pruritus.

Rare(>0.01%,<0.1%):Urticaria.

Veryrare(<0.01%):Hairloss,severeskinreactions(e.g.toxicepidermalnecrolysis).

Musculoskeletal,connectivetissueandbonedisorders

Rare(>0.01%,<0.1%):Arthralgia.

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Reproductivesystemandbreastdisorders

Veryrare(<0.01%):Impotence,reducedlibido.

Generaldisordersandadministrationsiteconditions

Uncommon(>0.1%,<1%):Fatigue.

Veryrare(<0.01%):Feelingsoftightnessinthechest.

Investigations

Rare(>0.01%,<0.1%):Increaseinlaboratoryvalues(transaminases,gammaGT,alkalinephosphatase,bilirubin).

4.9Overdose

Therearenoreportsofoverdosingwithfamotidine.

Ifthisshouldoccur,effortsshouldbemadetoinhibitabsorptionandrelievesymptoms.

Theusualmeasurestoremoveunabsorbedmaterialfromgastro-intestinaltractshouldbeemployedtogether

withclinicalmonitoringandsupportivetherapy.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode

A02BA03

Pharmacotherapeuticgroup

HistamineHreceptorantagonist

gastrointestinalmedication

FamotidineisacompetitivehistamineHreceptorantagonistwhichleadstotheinhibitionofgastricacidsecretion

mediatedbytheHreceptors.Inadditiontothegastricacidlevels,thepepsinlevelisalsoreduced.Toalesserextent

thereisalsoadecreaseinthevolumeofthebasalgastricjuiceandthegastricjuicesecretedonstimulation.

PharmacologicaleffectsontheCNS,immunological,cardiovascularorrespiratoryparametershavenotbeenobserved.

Thedrugtakeseffectwithinanhouroforaladministrationandreachesitspeakefficacywithin1-3hours.

Individualoraldosesof20mgand40mgeffectivelyinhibitedthebasalnight-timesecretionofgastricacid;mean

gastricacidsecretionwasinhibitedoveraperiodof10hoursby86%and94%,respectively.Thesamedoses,

administeredinthemorning,inhibitedthegastricacidsecretionstimulatedbyeatingfor3-5hoursp.a.byameanof

76%and84%,respectively.8-10hoursafteradministration,thelevelswereat25%and30%,respectively,althoughthe

effectofone20mgdosepersistedforonly6-8hoursinsomeofthevolunteers.Repeatedadministrationdidnotleadto

anaccumulationoftheactiveingredient.

Thebasalnight-timeintragastralpHvaluewasincreasedtoameanof5and6.4byeveningdosesof20mgand40mg

offamotidine,respectively.Whenfamotidinewasadministeredafterbreakfast,thepHvalueinboththe20mgandthe

40mggroupswasincreasedtoapproximately5after3and8hours.

Famotidinehadlittleornoeffectonthefastingandpostprandialserumgastrinlevels.Gastricemptyingandexocrine

pancreasfunctionwerenotaffectedbyfamotidine,norwerehepaticandportalbloodflow.Therewasalsonoeffecton

endocrinefunction.Hormonelevelsofprolactin,cortisone,thyroxin(T4)andtestosteroneremainedunchangedunder

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5.2Pharmacokineticproperties

Famotidinekineticsarelinear.

Famotidineisquicklyresorbedafteroraladministration.

Oralbioavailabilityisabout40%.

Peakplasmaconcentrationsareachieved1-3.5hoursafteradministration.Peakplasmaconcentrationsare

approximately0.04to0.06µg/mlafteradministrationof20mgoffamotidineand0.075to0.1µg/mlafter

administrationof40mgoffamotidine.Repeatedadministrationdoesnotleadtoanaccumulationoftheactive

ingredient.Famotidineabsorptionisnotinfluencedbyconcomitantfoodintake.

Famotidineisfoundinthecerebrospinalfluidonlytoalimitedextent.Thefluid/plasmaratio4hoursafter

administering40mgoffamotidinewasameanof0.1.

Famotidineisexcretedinmaternalmilk.6hoursafteroraladministrationamilk/plasmaconcentrationratioof1.78was

reached.Theeliminationhalf-lifeintheplasmais2.6to4hours.

Upto30-35%oftheactiveingredientismetabolisedintheliver;asulfoxidemetaboliteisformed.

24hoursafteroraladministration,25-30%oftheactiveingredientisexcretedviatheurineunchanged;after

intravenousadministration,65-70%isexcretedunchangedinurine.Renalclearanceis250-450ml/min,which

indicatestubularsecretion.Aslightamountcanbeeliminatedassulfoxide.

Renalinsufficiency:

Asrenalfunctiondeclines,renalandtotalclearanceoffamotidinedecreasewithouttherebeinganincreaseinnon-renal

elimination.Theeliminationhalf-lifeafterintravenousinjectionofasingledoseof20or10mgoffamotidineis

increasedto4.5-9hoursinmoderaterenalinsufficiency(creatinineclearance60-30ml/min),to10-12hoursinsevere

renalinsufficiency(creatinineclearance<30ml/min)andto18-27hoursinpatientswithterminalrenalinsufficiency

oranuria.Theamountofunchangedfamotidineexcretedwiththeurineisreducedto60%inpatientswithmoderate

renalinsufficiency.Incasesofsevererenalinsufficiencyitisonly25%.

Dependingonthedialysisprocedure(haemofiltration,5-hourhaemodialysisorcontinuoushaemofiltration),dialysis

patientshaveaneliminationhalf-lifeof7-14hoursafterintravenousadministrationof20mgoffamotidine;afteroral

administrationof20mgoffamotidine,itis22.5hours.

Liverfunctionimpairment:

Thepharmacokineticsoffamotidineareunchangedinpatientswithliverfunctionimpairment.

Kineticsamongelderlypatients:

Pharmacokineticstudiesonelderlypatientsshowednosignsofanyclinicallysignificantage-relatedchanges;however,

age-relatedimpairmentofrenalfunctionshouldbeconsideredwhendeterminingthedosage.

5.3Preclinicalsafetydata

Preclinicaldataregardingfamotidinerevealnospecialhazardforhumansbasedonconventionalstudiesofsafety

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore:Microcrystallinecellulose,maizestarch,pre-gelatinisedmaizestarch,povidone,talc,magnesiumstearate.

Tabletcoat:Hypromellose,talc,titaniumdioxide(E171),propyleneglycol.

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

4years.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

Thefilm-coatedtabletsarepackedinPVC/PVDC-aluminiumblisterpacks.

10,15,20,28,30,50,56,60,90,100,250,500,1000film-coatedtablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

STADAArzneimittelAG,

Stadastraße2–18,

D-61118BadVilbel,

Germany.

8MARKETINGAUTHORISATIONNUMBER

PA593/19/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26 th

November1999

Dateoflastrenewal:16 th

November2003

10DATEOFREVISIONOFTHETEXT

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