FOLIC ACID

Main information

  • Trade name:
  • FOLIC ACID
  • Dosage:
  • 5 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FOLIC ACID
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0073/057/001
  • Authorization date:
  • 01-04-1980
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FolicAcidTabletsBP5mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains5mgofFolicAcidPh.Eur.

3PHARMACEUTICALFORM

Tablet.

Yellow,circularcompressedtablets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofmegaloblasticanaemiaassociatedwithfolicaciddeficiency.

Toreducetheriskofrecurrenceofneuraltubedefect(NTD)inwomenwhohavealreadyhadababyaffectedbyNTD.

4.2Posologyandmethodofadministration

FolicAcidTabletsBParefororaladministration.

MegaloblasticAnaemiaassociatedwithfolicaciddeficiency.

Adults:

Initialdose:5to20mgdaily.

Maintenance:2.5to10mgdaily.

Children:

Agedupto1yearmaybegivenamaintenancedoseof250microgramsperkgbody-weightdaily;1to5years2.5mg

daily;6to12years5mgdaily.Aninitialdosageoftwicethemaintenancedosemaybegivenfor2days.

ToreduceriskofrecurrenceofNTD.WomenwhohavealreadyhadababyaffectedbyNTDandwhomaybecome

pregnantagainshouldtakeone5mgtabletdaily,commencingbeforeconceptionandcontinuinguntilthetwelfthweek

ofpregnancy.

4.3Contraindications

Useinpatientswithaknownhypersensitivitytofolicacid.

4.4Specialwarningsandprecautionsforuse

Inthetreatmentofperniciousanaemia,folicacidshouldneverbegivenaloneorinconjunctionwithinadequate

amountsofVitaminB

(cyanocobalaminorhydroxocobalamin).Beforetreatmentamegaloblasticanaemiawithfolic

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Folicacidtherapymayincreasephenytoinmetaboliaminfolatedeficientpatients,resultingindecreasedserum

phenytoinconcentrations.Anincreaseinseizurefrequencymayoccurinsomepatients.Largeandcontinuiousdosesof

folicacidlowertheplasmaconcentrationofVitaminB

4.6Pregnancyandlactation

Therehavebeennospecificstudiesinanimalreproduction.Studiesduringhumanpregnancyhavebeengenerally

relatedtodeficienciesoffolicacid.Thereisnoevidencetoindicatethatuseoffolicacidshouldbeavoidedduring

pregnancyandlactation.

4.7Effectsonabilitytodriveandusemachines

Nil.

4.8Undesirableeffects

Folicacidisgenerallywelltolerated.Gastrointestinaldisturbancesmayoccur.Hypersensitivityreactionssuchas

erythema,itching,generalmalaise,bronchospasmandfeverhavebeenreported.

4.9Overdose

Overdosagesofwater-solublevitaminsareunlikelytocausetoxicityastheyarereadilyexcretedinurine.No

emergencyprocedureorantidoteisapplicableandanysymptomsmaybeexpectedtoresolverapidlyfollowing

withdrawalofthepreparation.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

FolicacidisamemberoftheVitaminBgroup.Followingabsorption,folicacidisreducestotetrahydrofolicacid,

whichisaco-enzymeforvariousmetabolicprocessesincludingthebiosynthesisofpurinesandthymidylatesofnucleic

acids.

5.2Pharmacokineticproperties

Folicacidisabsorbedmainlyfromtheproximalportionofthesmallintestine.Itisreducedandmethylatedto

methyltetrahydrofolicacidwhichisrapidlytransportedtotissues.Theliveristhemainstoragesiteandthereis

enterohepaticcirculationoffolate.Administrationoflargedosesoffolicacidleadstoproportionatelymoreofthe

vitaminbeingexcretedinurine.

5.3Preclinicalsafetydata

NofurtherrelevantinformationotherthanthatwhichisincludedinothersectionsoftheSummaryofProduct

Characteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

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Povidone

Magnesiumstearate

Colloidalanhydroussilica

6.2Incompatibilities

Noneknown.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25 ˚C.

Storeintheoriginalcontainerinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Polypropylenesecuritainerswithtamperevidentpolypropylenecaps.

Packsizes: 100,500,1000.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Notapplicable.

7MARKETINGAUTHORISATIONHOLDER

AntigenPharmaceuticalsLtd.

Roscrea

Co.Tipperary

8MARKETINGAUTHORISATIONNUMBER

PA0073/057/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1980

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