FEFOL SPANSULE

Main information

  • Trade name:
  • FEFOL SPANSULE
  • Dosage:
  • 150/ 0.5 Milligram
  • Pharmaceutical form:
  • Capsules Modified Release
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FEFOL SPANSULE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0997/006/001
  • Authorization date:
  • 01-04-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0997/006/001

CaseNo:2074513

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

IntrapharmLaboratoriesLimited

60BoughtonLane,Maidstone,KentME159QS,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

FEFOLSPANSULE,150/0.5Milligram

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom14/12/2009until31/03/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/12/2009 CRN 2074513 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FefolSpansule150mg/0.5mgModifiedReleaseCapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmodifiedreleasecapsulecontains150mgdriedferroussulphate(equivalentto47mgelementaliron)and0.5mg

folicacid.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Modifiedreleasehardcapsules

Modifiedreleasecapsulecontainingred,yellowandwhitepelletsinsizeno.1hardgelatinshellswithclearbodiesand

transparentgreencaps.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fefolisahaematinicwithaddedfolicacidusedfortheprophylaxisofironandfolicaciddeficiency,afterthefirst13

weeksofpregnancy.

4.2Posologyandmethodofadministration

Dosage:

Adultsonly:

1capsuleadayduringpregnancy.Somepregnantpatientsmayneedahigherdoseofironbecauseofdietaryorother

factors.

Childrenandelderly:

Notrecommended.

Medicaladviceshouldbesoughtifsymptomsdonotimproveafter4weeksofuseofthisproductasthesesymptoms

mayreflectanunderlyingdiseaseprocess.

MethodofAdministration:

Oral.

4.3Contraindications

Donotuseinpatientswithaknownhypersensitivitytoanyoftheactiveingredients.

Useinpatientswithanaemiasofundiagnosedaetiology.

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4.4Specialwarningsandprecautionsforuse

Thelabelwillstate

“Importantwarning:ContainsIron.Keepoutofreachandsightofchildren,asoverdosemaybefatal”

Thiswillappearonthefrontofthepackwithinarectangleinwhichthereisnootherinformation.

Cautionisadvisedinindividualswithafamilyhistoryofhaemochromatosisorironoverloadsyndromes.Itshouldbe

notedthattheseconditionsmaybeunderdiagnosed.

Failuretorespondtotreatmentmayindicateothercausesofanaemiaandshouldbefurtherinvestigated.

Thefolicacidcontentisunlikelytomaskperniciousanaemiashouldthisconditionbepresent;pregnancyduring

perniciousanaemiaisveryrare.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Ironreducestheabsorptionofpenicillaminebyasmuchastwothirds,thoughthepotentialforinteractioncanbe

reducedbyseparatingadministrationofeachproductbyseveralhours.Ironcompoundsimpairthebioavailabilityof

quinolones,levodopa,carbidopa,methyldopa,thyroxine,bisphosphonatesandpossiblysulphasalazine.

Absorptionofbothironandtetracyclinearereducediftakenconcomitantly,andlikewisetheabsorptionof

concomitantlytakenironandzinc.

Aluminiumhydroxide,calciumormagnesiumcontainingcompounds,includingmineralsupplements,and(bi)

carbonates,oxalates,phosphates,silicatesandalginate-richpreparationsinteractstronglywithmedicinalironbythe

formationofinsolublecomplexes.Cholestyramineandironmaybindinthegutandthereforeseparatingthedosingof

thesetwocompoundswouldbeadvisable.

Concurrentadministrationofantacidsmayreduceabsorptionofiron.

Someinhibitionofironabsorptionorbioavailabilitymayoccurifitistakenwithtrientine,tea,eggs,milkorcoffee.

Responsetoirontherapymaybedelayedinpatientsreceivingchloramphenicol.Neomycinmayaltertheabsorptionof

iron.

Citrate,digestionproductsofmeat,fructose,ascorbicacidandalcoholmayenhancethebioavailabilityofiron.

Folicacidsupplementationmayreduceserumanticonvulsantlevels.Magnesiumtrisilicateandsulphasalazinemay

reducetheabsorptionoffolicacidfromthegut.Co-trimoxazole,sulphonamides,andaminopterinmayinterferewith

themetabolismoffolicacid.

Fluorouraciltoxicitymayoccurinpatientstakingconcurrentfolicacid;thisisconsistentwiththetherapeuticuseof

folinicacidtoincreasethepotencyoffluorouracil.

Themanufacturersoftheantimetaboliteraltitrexed,claimfolicacidcouldtheoreticallyinterferewiththeactionof

raltitrexed.

4.6Pregnancyandlactation

Fefolshouldnotbeusedduringthefirsttrimesterofpregnancy.Prophylaxisofironandfolatedeficiencyduringthe

remainderofpregnancyisjustified.

4.7Effectsonabilitytodriveandusemachines

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4.8Undesirableeffects

Darkstoolsareusualduringirontherapy,andnauseaandothersymptomsofgastrointestinalirritation,suchas

anorexia,vomiting,discomfort,constipation,anddiarrhoeaaresometimesencountered.FefolSpansuleCapsulesare

designedtoreducethepossibilityofgastrointestinalirritation.Therehavebeenrarereportsofallergicreactions.

4.9Overdose

Ironoverdosageisdangerous,particularlyinchildrenandrequiresimmediateattention.Treatmentisnecessaryifmore

than30mgelementalironperkilogrambodyweighthasbeeningested.Inthefirstphase,30minutesto6hoursafter

ingestion,symptomsmayincludeabdominalpain,vomiting,diarrhoeaandhaematemesis,withinmoreseverecases,

coma,convulsionsandshock.Symptomsthenabate,witheitherrecovery,orwithin12hoursafteringestion,

deterioration.Symptomscanthenincludeseverelethargyorcoma,gastrointestinalhaemorrhage,severeshock,

metabolicacidosis,convulsions,jaundice,coagulationdisorders,hypoglycaemia,renalfailureandpulmonaryoedema.

Thesemaylastupto48hoursafteringestion.Inthelastphase,2to4weeksafteringestion,effectssuchas

encephalopathy,hepaticnecrosisandpyloricstenosismayoccur.Thesustained-release“Spansule”Capsule

presentationofferroussulphatemaydelayexcessiveabsorptionofironandallowmoretimeforinitiationof

appropriatecountermeasures.Gastriclavageshouldbecarriedoutintheearlystages,orifthisisnotpossible,vomiting

shouldbeinduced.Giveoraldesferrioxamine(2gforachildand5gforanadult)anddemulcents.

Ifserumironlevelsat4hoursormorepost-ingestionareover5mg/linachild,or8mg/linanadult,orifthepatientis

inshockorcoma,intramuscularorintravenousdesferrioxamineshouldbeusedaccordingtoinstructionsforthis

product.Symptomaticandsupportivemeasuresshouldbegivenasrequired.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theproductisanoralironandfolicacidpreparationfortheprophylaxisofironandfolicaciddeficiencyduring

pregnancy.

5.2Pharmacokineticproperties

Theproductisformulatedtoavoidironreleaseinthestomachwheregastricirritationmaybecaused.Thefolicacidis

availableimmediately.

5.3Preclinicalsafetydata

Nofurtherinformation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MaizeStarch

Talc

HeavyKaolin

Sucrose

Gelatin

TitaniumDioxide(E171)

RedIronOxide(E172)

Povidone

Irish Medicines Board

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WhiteBeeswax

Calciumsulphatedihydrate

QuinolineYellow(E104)

PatentBlueV(E131)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

PVC/Aluminiumfoilblisterpackcontaining15or30capsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

IntrapharmLaboratoriesLtd.

60BoughtonLane

Maidstone

Kent

ME159QS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA997/6/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1980

Dateoflastrenewal:01April2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 24/12/2009 CRN 2074513 page number: 5