FERSADAY

Main information

  • Trade name:
  • FERSADAY Tablets 100 Milligram
  • Dosage:
  • 100 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FERSADAY Tablets 100 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0701/004/001
  • Authorization date:
  • 16-10-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Fersaday100mgTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains322mgFerrousFumarateequivalentto100mgFerrousIron.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Filmcoatedtablet.

Brownbiconvex,film-coatedtabletsengraved‘Fersaday’aroundtheperipharyononefaceandplainonthereverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

FersadayTabletsareindicatedfortheProphylaxisandtreatmentofirondeficiencystates.

4.2Posologyandmethodofadministration

Fororaladministrationonly.

Adults:

Theusualadultdoseisonetabletdaily.Insevereorrefractoryirondeficiency,oneFersadayTabletmaybe

giventwiceadaily.Thefoilenclosingthetabletsisprintedwiththedaysoftheweekinsequence.

Children:

Thispresentationofferrousfumarateisnotintendedforthetreatmentofchildren.

4.3Contraindications

Hypersensitivitytoanyconstituentoftheproduct.

Useinpatientswithparoxysmalnocturnalhaemoglobinuria,haemosiderosis,haemochromatosis,activepeptic

ulcer,repeatedbloodtransfusions,regionalenteritis,andulcerativecolitis.

Useinthetreatmentofanaemiasotherthanthoseduetoirondeficiency.

4.4Specialwarningsandprecautionsforuse

Somepostgastrectomypatientsshowpoorabsorptionofiron.

Careisneededwhentreatingpatientswithirondeficiencyanaemiainpatientswithtreatedorcontrolledpeptic

Irish Medicines Board

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FersadayTabletsshouldbekeptoutofreachofchildren.

Durationoftreatmentofuncomplicatedirondeficiencyanaemiashouldnotusuallyexceed6months(or3

monthsafterreversaloftheanaemiahasbeenachieved).

Theproductshouldbeusedwithcautioninpatientswithhaemolyticanaemia.

SinceanaemiaduetocombinedironandvitaminB12orfolatedeficienciesmaybemicrocyticintype,patients

withmicroyticanaemiaresistanttotherapywithironaloneshouldbescreenedforvitaminB12orfolate

deficiency.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Ironreducestheabsorptionofpenicillamine.

AbsorptionofbothironandantibioticmaybereducedifFersadayisgivenwithtetracycline.

Concurrentadministrationofantacidsmayreduceabsorptionofiron.

Chloramphenicoldelaysplasmaironclearance,incorporationofironintoredbloodcellsandinterfereswith

erythropoiesis.

Someinhibitionofironabsorptionmayoccurifitistakenwithcholestyramine,tea,eggsormilk.

4.6Pregnancyandlactation

AdministrationofFersadaytabletsduringthefirsttrimesterofpregnancymaybeundesirable.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Gastro-intestinaldisordershavebeenreportedincludinggastro-intestinaldiscomfort,anorexia,nausea,vomiting,

constipationanddiarrhoea.Darkeningofthestoolsmayoccur.

4.9Overdose

Ingestionofanoverdoseofironorallyrequiresemergencytreatmentasfollows:

Inyoungchildren200-250mg/kgferrousfumarateisconsideredtobeextremelydangerous.

Symptomsandsignsofabdominalpain,vomitinganddiarrhoeaappearwithin60minutes.Cardiovascular

collapsewithcomamayfollow.Someimprovementmayoccurafterthisphaseinsomepatients,andmaybe

followedbyrecovery.Inotherpatients,afterabout16hours,deteriorationmayoccurinvolvingdiffusevascular

congestion,pulmonaryoedema,convulsions,anuria,hypothermia,severeshock,metabolicacidosis,coagulation

abnormalitiesorhypoglycaemia.

Vomitingshouldbeinducedimmediately,followedassoonaspossiblebyparenteralinjectionofdesferrioxamine

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Dissolve2gramsofdesferrioxaminemesylatein2or3mlofwaterforinjectionsandgiveintramuscularly.A

solutionof5gramsdesferrioxaminemesylatein50to100mloffluidmaybeleftinthestomach.If

desferrioxamineisnotavailable,leave300mlof1%to5%sodiumbicarbonateinthestomach.Fluid

replacementisessential.

Recoverymaybecomplicatedbylongtermsequelae,suchashepaticnecrosis,pyloricstenosis,oracutetoxic

encephalitiswhichmayleadtoCNSdamage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

FerrousFumarateisanironsalt.

Ironisanessentialconstituentofthebody,beingnecessaryforhaemoglobinformationandtheoxidativeprocessesof

livingtissues.

5.2Pharmacokineticproperties

Ironisirregularlyandincompletelyabsorbedfromthegastro-intestinaltract,themainsitesofabsorptionbeing

theduodenumandjejunum.Absorptionisusuallyincreasedinconditionsofirondeficiencyorwhengiveninthe

fastingstate.Absorptionofironmaybereducedincertaindiseasestates.

5.3Preclinicalsafetydata

FerrousFumarateisalong-establishedproductthepre-clinicalpropertiesofwhicharewellestablished.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MaizeStarch

Sodiumlaurilsulfate

Gelatin

Liquidparaffin

Acetylatedmonoglyceride

Hypromellose

OpasprayTanK-1-3618:

Hydroxypropylcellulose

Titaniumdioxide(E171)

Talc

Ironoxideyellow(E172)

Ironoxidered(E172)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

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6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Aluminiumfoilblisterstripscontaining14tabletspresentedinacardboardcarton.Eachcartoncontains2

calendarpackblisterstrips.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

GoldshieldGroupPlc.

NLATower

12-16AddiscombeRoad

Croydon

CR0OXT

England

Tradingas:

GoldshieldPharmaceuticals.

8MARKETINGAUTHORISATIONNUMBER

PA0701/004/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 05January1987

Dateoflastrenewal: 16October2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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