FERROUS GLUCONATE

Main information

  • Trade name:
  • FERROUS GLUCONATE
  • Dosage:
  • 300 Milligram
  • Pharmaceutical form:
  • Coated Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FERROUS GLUCONATE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0126/058/001
  • Authorization date:
  • 11-05-1988
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FerrousGluconate300mgCoatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachtabletcontainsFerrousGluconate300mg.

300mgFerrousGluconatecontainsapproximately35mgofiron.

Eachtabletalsocontainstheexcipients:

Sucrose117.56mg

Ponceau4RRed(E124)3.63mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Coatedtablet(tablet)

Red,circular,biconvex,sugarcoatedtablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthepreventionandtreatmentofirondeficiencystates.

4.2Posologyandmethodofadministration

Adults:

Preventionofirondefienceyanaemia:-2tabletsdailybeforefood.

Treatmentofirondeficiencyanaemia:-4-6tabletsdailyindivideddosesbeforefood.

Routeofadministration

Oral

4.3Contraindications

Useinpatientsknowntohavehypersensitivitytotheactiveingredient.

4.4Specialwarningsandprecautionsforuse

Theabsorptionofironsaltsisdecreasedinthepresenceofantacids.

2.Thisproductshouldbeusedwithcautioninpatientswithhaemochromatosisandhaemolyticanaemias.

3.Thisproductshouldonlybeusedforthetreatmentofirondeficiencyanaemiadiagnosedbylaboratorytesting

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4.ThismedicinalproductcontainsSucrose.Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-

galactosemalabsorptionorsucrase-isomaltaseinsufficiencyshouldnottakethismedicine.

5.ThismedicinalproductcontainsPonceau4RRed(E124),whichmaycauseallergicreactions.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theabsorptionofironsaltsisdecreasedinthepresenceofantacids.

4.6Pregnancyandlactation

Iron-containingproducts,ifrequired,shouldbeusedduringpregnancyafterthefirstthirteenweeks.

4.7Effectsonabilitytodriveandusemachines

Noinformationsubmitted.

4.8Undesirableeffects

Becauseironsaltsareastringentgastrointestinalirritationmayoccur.Nauseaandepigastricpainmayoccurandare

doserelatedbuttherelationshipbetweendoseandalteredbowelhabit,givingrisetoconstipationordiarrhoea,isless

clear.

4.9Overdose

Ironpoisoningiscommonestinchildhoodandisusuallyaccidental.Thesymptomsarenausea,vomiting,abdominal

pain,diarrhoea,haematemesis;comaandhepatocellularnecrosisoccurlater.Mortalityisreducedwithintensiveand

specifictherapy.Theeffectiveantidoteisdesferrioxamine,whichchelatesiron.Thestomachshouldbeemptiedat

once,preferablybyinducingvomitingasthisisthequickest.Gastriclavageinhospitalshouldbefollowedassoonas

possibleusingdesferrioxaminemesylatesolution2gin1litreofwater.

Asolutionof10gofdesferrioxaminemesylatein50mlwatershouldbeleftinthestomach.Absorbedironcanalsobe

chelatedbyanintramuscularinjectionof2gofdesferrioxaminemesylatein10mlofwater.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Ironbivalent,oralpreparation

ATCcode:B03AA

Ironhasanimportantroleintheformationofredbloodcellsandisavitalcomponentoftheoxygen-carryingpigment,

haemoglobin.Itisinvolvedintheformationofmyoglobin,apigmentwhichstoresoxygeninmusclesforuseduring

exercise.Itisalsoanessentialcomponentofseveralenzymes,andisinvolvedintheuptakeofoxygenbythecellsand

theconversionofbloodsugartoenergy.

5.2Pharmacokineticproperties

Afteracidificationandpartialdigestionoffoodinthestomachitscontentofironispresentedtotheintestinalmucosa

aseitherinorganicorhemeiron.Thesefractionsaretakenupbytheabsorptivecellsoftheduodenumandtheupper

smallintestineandtheironiseithertransporteddirectlyintotheplasmaorisstoredasmucosalferritin.Normal

absorptionisabout1mgperdayintheadultmaleandabout1.4mgperdayintheadultfemale.Increaseduptakeand

deliveryofironintothecirculationoccurswhenthereisirondeficiency,whenironstoresaredepletedorwhen

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Twothirdsofthisironisexcretedfromthegastrointestinaltractasextravasatedredcells,ironinthebileandironin

exfoliatedmucosalcells.Theotherthirdisaccountedforbysmallamountsofironindesquamatedskinandinthe

urine.Physiologicallossesofironinthemalevaryoverarelativelynarrowrangedecreasingtoabout0.5mgintheiron

deficientindividualandincreasingtoasmuchas1.5mgorpossibly2mgperdaywhenexcessiveironisconsumed.

Additionallossesofironoccurinthefemaleduetomenstruation.Whilethisaveragesabout0.5mgperday,10%of

normalmenstruatingfemalesloseover2mgperday.

5.3Preclinicalsafetydata

Attherapeuticdoses,notoxiceffectsarerecognizedafteroraladministrationofironsaltstoexperimentalanimals.The

inmiceisreportedtobe230-1100mg.kg -1

iron.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Core

SodiumStarchGlycollate

StearicAcid

ColloidalAnhydrousSilica

PurifiedWater

SugarCoat

Opaseal*

(*ContainsPolyvinylacetatephthalate)

StearicAcid

Opaglos6000P*

(*ContainsYellowCarnaubaWax)

WhiteBeeswax

Shellac

Talc

CalciumCarbonate

Acacia

TitaniumDioxide(E171)

Sucrose

PonceauRed4R(E124)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Keepthecontainertightlyclosedinordertoprotectfrommoisture.

Storeintheoriginalcontainerinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

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Packsizes:50,100,250,500and1000tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

ClonmelHealthcareLimited,

WaterfordRoad,

Clonmel,

Co.Tipperary.

8MARKETINGAUTHORISATIONNUMBER

PA0126/058/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 11May1988

Dateoflastrenewal: 11May2008

10DATEOFREVISIONOFTHETEXT

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