FAMULCO FILM-COATED

Main information

  • Trade name:
  • FAMULCO FILM-COATED
  • Dosage:
  • 20mg 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:
  • PA0593/019/001
  • 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)

PA0593/019/001

CaseNo:2036382

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

StadaArzneimittelAG

Stadastrasse2-18,D-61118BadVilbel,Germany

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Famulco20mg,filmcoatedtablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

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

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

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

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Famulco ®

20mg,filmcoatedtablet

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Famotidine20mg

Forexcipients,see6.1

3PHARMACEUTICALFORM

Film-coatedtablet

Round,biconvex,whitefilm-coatedtablets,engraved“20”ononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Preventionofrecurrentduodenalulcers

Duodenalulcer

Benigngastriculcer

Zollinger-Ellison-Syndrome

Symptomatictreatmentofmildrefluxoesophagitis

4.2Posologyandmethodofadministration

Dosinginstructions:

Duodenalulcersandbenigngastriculcers

40mgoffamotidineoncebeforegoingtosleep

Prophylactictreatmentforrecurrentduodenalulcers

20mgoffamotidineintheevening

Zollinger-Ellisonsyndrome

Providingtherehasnotbeenprevioustherapywithantisecretorymedications,Zollinger-Ellisonsyndrometherapy

shouldstartbyadministering20mgoffamotidine(correspondingtoonefilm-coatedtabletofFamulco®20mg)every

6hours.Dependingontheacidsecretionandthepatient'sclinicalresponse,adosagetitrationshouldbeperformedas

treatmentcontinuesuntilthedesiredacidlevelshavebeenreached(e.g.<10mEq/hinthehourprecedingthenext

doseoffamotidine).Ifthedesiredinhibitionofacidsecretioncannotbeattainedwithadailydosageof800mg,

alternativetreatmentshouldbeconsideredtoregulateacidsecretion,sincenolong-termexperiencewithdosagesof

morethan800mgoffamotidine/dayhavebeenrecorded.

Treatmentshouldbecontinuedforaslongasclinicallynecessary.

PatientswhohavepreviouslyundergoneHreceptorantagonisttreatmentcanbeginfamotidinetreatmentatahigher

dosagethantheinitialdosagethatisusuallyrecommended.Thedosagedependsontheseverityofthediseaseandthe

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/06/2007 CRN 2036382 page number: 2

Symptomatictreatingofmildrefluxoesophagitis

Adailydosageoftwice20mgoffamotidine(correspondingtotwofilm-coatedtabletsofFamulco®20mg)is

recommended.

Famotidineisprimarilyeliminatedviathekidneys.Forpatientswithimpairedrenalfunctioninwhomcreatinine

clearanceislessthan30ml/min,thedailydosageoffamotidineshouldbereducedto50%.

Dialysispatientsshouldalsotakedosagesthatarereducedto50%.Famulco®20mgshouldbeadministeredattheend

ofdialysisorthereaftersincesomeoftheactiveingredientisremovedviadialysis.

Modeanddurationofadministration:

Famulco®20mgshouldbeswallowedwholewithsomeliquid.Itdoesnotneedtobetakenatmealtimes.

Prophylactictreatmentofrecurrentduodenalulcers

Withregardstothemaintenancetherapyforpreventingtherecurrenceofduodenalulceration,therecommended

maintenancedoseof20mghasbeencontinuedeffectivelyinclinicalstudiesof12monthsduration.

Duodenalulcersandbenigngastriculcers

Intreatingduodenalulcersandbenigngastriculcers,therapyshouldbeconductedfor4to8weeks.Thisperiod,

however,maybeshortenedifendoscopyrevealsthattheulcerhashealed.Ifanendoscopicexaminationdoesnotyield

suchfindings,thetreatmentshouldbecontinuedforanother4weeks.

Zollinger-Ellisonsyndrome

Treatmentshouldbecontinuedforaslongasclinicallynecessary.

Symptomatictreatingofmildrefluxoesophagitis

Generally,treatmentshouldbeconductedfor6weeks,ifnecessaryfor12weeks.

4.3Contraindications

Famulco®20mgmaynotbeadministeredwherethereisknownhypersensitivitytotheactiveingredient,famotidine,

ortoanyoftheotheringredients.Ifsymptomsofhypersensitivitydevelop,Famulco®20mgshouldbediscontinued.

Thereisnotsufficientinformationaboutthesafetyandefficacyoffamotidineinchildren.Therefore,childrenshould

notbetreatedwithFamulco®20mg.

4.4Specialwarningsandprecautionsforuse

MalignancycannotnecessarilyberuledoutwhentreatmentwithFamulco®20mghasapositiveeffectonthe

symptoms.Appropriatediagnosticmeasuresshouldbeusedtodeterminethenon-malignancyofanulcerbefore

famotidinetreatmentisundertaken.

Famotidineisprimarilyeliminatedviathekidneysandpartiallybrokendownintheliver.Cautionmustthereforebe

exercisedinpatientswithimpairedrenalfunction.

Thedailydosageshouldbereducedforpatientswithimpairedrenalfunction(cfposology).

DonotadministerFamulco®20mgincasesofminorgastrointestinalcomplaints.

InpatientswithduodenalulcersandbenigngastriculcerstheH.pyloristatusshouldbedetermined.Whenever

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/06/2007 CRN 2036382 page number: 3

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noclinicallyimportantmetabolicinteractionswithotherdrugsorsubstanceshavebeenrecorded.

Duringconcomitantuseofsubstanceswhoseabsorptionisaffectedbygastricacidlevels,apossiblechangeinthe

absorptionofthesesubstancesshouldbeconsidered.Theabsorptionofketoconazoleoritraconazolecanbereduced,

ketoconazoleshouldbeadministeredtwohoursbeforeadministeringfamotidine.

Concomitantuseoffamotidineandantacidscanreducethefamotidineabsorptionandleadtolowerplasmalevelsof

famotidine.Therefore,famotidineshouldbeadministered1-2hoursbeforetakinganantacid.

Concomitantuseofsucralfateinhibitstheabsorptionoffamotidine.Therefore,sucralfateshouldasarulenotbe

administeredwithintwohoursofthefamotidinedose.

Theadministrationofprobenecidcandelaytheeliminationoffamotidine.Concomitantuseofprobenecidand

Famulco®20mgshouldbeavoided.

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

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/06/2007 CRN 2036382 page number: 4

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.

Veryrare(<0.01%):Musclecramps.

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-intestinaltractshouldbeemployedtogetherwith

clinicalmonitoringandsupportivetherapy.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:A02BA03

Pharmacotherapeuticgroup:HistamineH2receptorantagonist/gastrointestinalmedication

FamotidineisacompetitivehistamineH2receptorantagonistwhichleadstotheinhibitionofgastricacidsecretion

mediatedbytheH2receptors.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

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/06/2007 CRN 2036382 page number: 5

endocrinefunction.Hormonelevelsofprolactin,cortisone,thyroxin(T4)andtestosteroneremainedunchangedunder

famotidinetreatment.

5.2Pharmacokineticproperties

Famotidinekineticsarelinear.

Famotidineisquicklyresorbedafteroraladministration.

Oralbioavailabilityisabout40%.

Peakplasmaconcentrationsareachieved1-3.5hoursafteradministration.Peakplasmaconcentrationsare

approximately0.04-0.06µg/mlafteradministrationof20mgoffamotidineand0.075to0.1µg/mlafteradministration

of40mgoffamotidine.Repeatedadministrationdoesnotleadtoanaccumulationoftheactiveingredient.Famotidine

absorptionisnotinfluencedbyconcomitantfoodintake.

Famotidineisfoundinthecerebrospinalfluidonlytoalimitedextent.Thefluid/plasmaratio4hoursafter

administering40mgoffamotidinewasameanof0.1.

Famotidineisexcretedinmaternalmilk.6hoursafteroraladministration,amilk/plasmaconcentrationratioof1.78

wasreached.Theeliminationhalf-lifeintheplasmais2.6-4hours.

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

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/06/2007 CRN 2036382 page number: 6

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,

61118BadVilbel,

Germany.

8MARKETINGAUTHORISATIONNUMBER

PA593/19/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26 th

November1999

Dateoflastrenewal:16 th

November2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 15/06/2007 CRN 2036382 page number: 7