FER-IN-SOL

Main information

  • Trade name:
  • FER-IN-SOL Oral Drops Solution 25 Mg/Ml
  • Dosage:
  • 25 Mg/Ml
  • Pharmaceutical form:
  • Oral Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FER-IN-SOL Oral Drops Solution 25 Mg/Ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1751/001/001
  • Authorization date:
  • 30-09-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FerInSol25mg/mloraldrops,solution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each1mlofliquidcontains125mgofFerrousSulphateequivalentto25mgofavailableiron.

AlsocontainsSucrose383.1mg/ml,SorbitolSolution(70%)309.1mg/mlandEthanol1.612mg/ml.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Oraldrops,solution.

Acolourlessorlightbluishgreentoyellowishbrownliquid.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthepreventionandtreatmentofirondeficiencyanaemia.

4.2Posologyandmethodofadministration

Neonates:

TheuseofFer-in-Solinneonates(infantslessthan4weeksofage)isnotrecommended.

InfantsandChildren:

Prevention:Theusualdoseis0.3to0.6mldaily.

Treatment:Theusualdoseofelementalironis3to6mg/kg(max.200mg)dailygivenin2to3divideddoses.Usethe

syringeprovidedalongwiththetablebelow.

Dosesshouldbegiveninwater,fruitorvegetablejuice.

AdultsandtheElderly:Fer-In-Solisnotrecommendedforuseinadults.

4.3Contraindications

Useinpatientswithknownhypersensitivitytoanyoftheingredients.Individualswithhaemochromatosisandiron

Weightof

Infant/Child Dosageof

Fer-in-Solperday Levelofelementaliron

Providedperday

3to4kg 2x0.3ml 15mgFe

4to6kg 3x0.3ml 23mgFe

7to9kg 2x0.6ml 30mgFe

9to15kg 3x0.6ml 45mgFe

Irish Medicines Board

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Date Printed 30/09/2011 CRN 2104689 page number: 1

4.4Specialwarningsandprecautionsforuse

Thisproductshouldonlybeusedforthetreatmentofirondeficiencyanaemiadiagnosedbylaboratorytesting,under

thesupervisionofamedicaldoctor.

Thisproductshouldbeusedwithcautioninpatientswithhaemochromatosisandhaemolyticanaemias.Cautionisalso

advisedinindividualswithafamilyhistoryofhaemochromatosisorironoverloadsyndromes.Itshouldbenotedthat

theseconditionsmaybeunderdiagnosed.Overdosemaybefatal,particularlyinchildren.

Prolongedorexcessiveuseinchildrenwithoutmedicalsupervisionmayleadtotoxicaccumulation.

Thispreparationmaycausetemporarydiscolorationoftheteethandcausethefaecestobecolouredblack.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theabsorptionofironsaltsisdecreasedinthepresenceofantacids,trientine,zincandtetracyclines.

Ironsaltsdiminishtheabsorptionoftetracyclines,ciprofloxacin,levofloxacin,norfloxacin,ofloxacin,bisphosphates,

zincsaltsandpenicillamine.Itmayalsoreducetheabsorptionofentacaponeandlevodopa.

Ferroussulphatealsoreducesthehypotensiveeffectofmethyldopa.

4.6Fertility,pregnancyandlactation

Fer-in-Solshouldnotbetakeninthefirst13weeksofpregnancy.Ifironcontainingproductsareconsideredessential

duringthefirst13weeksofpregnancytheyshouldonlybetakenundermedicalsupervision.Prophylaxisofiron

deficiencyduringtheremainderofpregnancyisjustified.Nocontraindicationsareknowntouseinlactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown

4.8Undesirableeffects

Sideeffectsincludingnausea,vomiting,diarrhoeaand/orconstipationmayoccur.

Hypersensitivityreactionshavebeenreported.Theserangefromrashes,sometimesseveretoanaphylaxis.

4.9Overdose

Relativelysmalloverdosesofironcanproducesymptomsoftoxicity(See'SpecialWarningsandSpecialPrecautions

forUse').Haemosiderosismayoccurasaresultofexcessiveoraltherapy.Intreatingacuteironpoisoning,speedis

essentialtoblockabsorptionofironfromthealimentarytract.Emesisorlavageshouldbeconsideredandserum-iron

concentrationsmaybeanaidtoestimatingtheseverityofpoisoning.Metabolicandcardiovasculardisordersshouldbe

treatedsymptomatically.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:B03AA07

Ironisanessentialconstituentofthebody,beingnecessaryforhaemoglobinformationandfortheoxidativeprocesses

Irish Medicines Board

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Date Printed 30/09/2011 CRN 2104689 page number: 2

5.2Pharmacokineticproperties

Ironisirregularlyandincompletelyabsorbedfromthegastro-intestinaltract,themainsitesofabsorptionbeingthe

duodenumandjejunum.Absorptionisaidedbytheacidsecretionofthestomachorbydietaryacidsandismore

readilyaffectedwhentheironisintheferrousstateorispartofthehaemcomplex(haem-iron).Absorptionisalso

increasedinconditionsofirondeficiencyorinthefastingstatebutisdecreasedifthebodystoresareoverloaded.

Onlyabout5to15%oftheironingestedinfoodisnormallyabsorbed.Apartfromhaemorrhage,ironislostfromthe

bodyinthefaeces,urine,fromskinandsweat,butthetotallossisverysmall.

5.3Preclinicalsafetydata

Nodataavailable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CitricAcidAnhydrous

Ethanol

LemonOil

PeppermintOil

SulphuricAcid

Sorbitol

Sucrose

PurifiedWater

6.2Incompatibilities

Notapplicable

6.3Shelflife

2years

6.4Specialprecautionsforstorage

Keepthebottletightlyclosed.

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

30mlTypeIIIPh.Eur.amberglassbottleclosedwithpolyethylenelinedplastic(HDPE)“Clic-loc”-typeclosurewith

tamperevidentsecurityseal.Onebottleispackedinacartontogetherwithacalibratedoralsyringe.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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Date Printed 30/09/2011 CRN 2104689 page number: 3

7MARKETINGAUTHORISATIONHOLDER

MEADJOHNSONNutrition

Middenkampweg2

6545CJNijmegen

TheNetherlands

8MARKETINGAUTHORISATIONNUMBER

PA1751/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

April1980

Dateoflastrenewal:1 st

April2010

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 30/09/2011 CRN 2104689 page number: 4