ABIDEC MULTIVITAMIN

Main information

  • Trade name:
  • ABIDEC MULTIVITAMIN
  • Pharmaceutical form:
  • Oral Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ABIDEC MULTIVITAMIN
    Ireland
  • Language:
  • English

Other information

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1562/050/001
  • Authorization date:
  • 22-07-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AbidecMultivitaminOralDropsSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

AbidecMultivitaminDropscontains1333IUretinol(asvitaminApalmitate),400IUergocalciferol,0.4mgthiamine

hydrochloride,0.8mgriboflavinsodiumphosphate,0.8mgpyridoxinehydrochloride,8mgnicotinamide,and40mg

ascorbicacidineach0.6mldose.

Excipients-containssucroseandarachisoil(refinedpeanutoil)

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Oraldrops,solution

ProductimportedfromtheUK:

Ayellowtoorangebrownoraldrops,solutionwhichdarkensuponstorage,withsomecloudiness.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AbidecMultivitaminDropsisindicatedforthepreventionofvitamindeficienciesandforthemaintenanceofnormal

growthandhealthduringtheearlyyearsofinfancyandchildhood;multivitaminsupplement.

4.2Posologyandmethodofadministration

Adultsandchildrenover12years:

Notappropriate.

Childrenaged1to12years:

Oral.

One0.6mldosetakendaily.

Maximumdailydose:0.6ml.

Childrenunder1year:

Oral.

One0.3mldosetakendaily.

Maximumdailydose:0.3ml.

TheElderly:

Notappropriate.

Hepatic/renaldysfunction:

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4.3Contraindications

AbidecMultivitaminDropsiscontra-indicatedinindividualswithknownhypersensitivitytotheproductoranyofits

componentsincludingpeanutoil.

VitaminApalmitatecontainsrefinedpeanutoil(Arachisoil)andshouldnotbetakenbypatientsknowntobeallergic

topeanut.Asthereisapossiblerelationshipbetweenallergytopeanutandallergytosoya,patientswithsoyaallergy

shouldalsoavoidAbidecMultivitaminDrops.

4.4Specialwarningsandprecautionsforuse

WhenprescribingAbidecMultivitaminDrops,aswithallmultivitaminpreparations,allowanceshouldbemadefor

vitaminsobtainedfromothersources.

WhilechildrenaretakingAbidecMultivitaminDropsnoothervitaminsupplementcontainingvitaminsAandD

shouldbetakenunlessundermedicalsupervision.

Thismultivitaminsupplementshouldnotbegiventobabieswhoarereceivingmorethan500mlsofformulamilkper

daytoavoidexceedingthesafeupperlimitofVitaminA.

ExcessivedosageofvitaminAandDmayleadtohypervitaminoses.Dueallowanceshouldalwaysbemadeforintake

ofthesevitaminsfromothersources.

Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltase

insufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Fertility,pregnancyandlactation

Notindicatedinthisagegroup.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

VitaminApalmitate

Adverseeffectsareextremelyrareatdailydosesoflessthan9mg.(16363.6IU).

Ergocalciferol(VitaminD

2 )

TheonlyknownadverseeffectsofvitaminDoccurwhenexcessivedosesaretaken.Adverseeffectsarenotanticipated

atthequantitypresentinAbidecMultivitaminDrops.

AscorbicAcid(C),Nicotinamide,Pyridoxine(B

6 ),Riboflavin(B

2 )&Thiamine(B

1 )

Thesewatersolublevitaminsaregenerallynontoxiccompoundswithawidemarginofsafety,theexcessamounts

beingrapidlyexcretedintheurine.AdverseeffectsarenotanticipatedatthequantitiespresentinAbidecMultivitamin

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4.9Overdose

Symptomsandsigns

AbidecMultivitaminDropscontainslevelsofvitaminswhichpresentlittleriskofoverdose.

VitaminApalmitate

AcuteadministrationofhighdosesofvitaminAcancauseheadache,nausea,vomitingandirritability.Ininfantsacute

toxicitycanleadtotransienthydrocephalus.Alltheseeffectsdisappearwithin24hoursoftakingretinol.

Ergocalciferol(VitaminD

2 )

ExcessivedosesofvitaminD,60000unitsperday,canresultinhypercalcaemiaandhypercalciuria.Adverseeffects

ofhypercalcaemiamayincludemuscleweakness,apathy,headache,anorexia,nauseaandvomiting,hypertensionand

cardiacarrhythmias.

Thiaminehydrochloride(VitaminB

1 )

Whentakenorally,thiamineisnon-toxic.Iflargedosesareingestedtheyarenotstoredbythebodybutexcreted

unchangedbythekidneys.

Riboflavin(VitaminB

2 )

Riboflavinhasbeenfoundtobepracticallynon-toxic.

Pyridoxinehydrochloride(VitaminB

6 )

Acutedoseslessthan500mgperdayappeartobesafe.Excessivedosesmaylowerserumfolateconcentrations.

Sensoryneuropathyhasbeendescribedwithchronicdosingof200mgdaily.

Nicotinamide

Asinglelargeoverdoseofnicotinamideisunlikelytohaveseriousilleffects,throughtransientabnormalitiesofliver

functionmightoccur.

Ascorbicacid(VitaminC)

Ascorbicacidisnotstoredtoagreatextentbythebody,anyexcessamountsareeliminatedintheurine.Ascorbicacid

isthoughtobecometoxicatchronicdosesinexcessof6g.

Treatment

Treatmentshouldbesupportiveandsymptomatic.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

VitaminApalmitate

VitaminAplaysanessentialroleinthefunctionoftheretina,thegrowthandfunctionofepithelialtissue,bone

growth,reproductionandembryonicdevelopment.

Ergocalciferol(VitaminD

2 )

VitaminDisaregulatorofbothcalciumandphosphatehomeostasis.

Thiaminehydrochloride(VitaminB

1 )

VitaminB

isessentialforpropercarbohydratemetabolismandplaysanessentialroleinthedecarboxylationofalpha

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Riboflavin(VitaminB

2 )

Riboflavinisessentialfortheutilisationofenergyfromfood.Itisacomponentofco-enzymeswhichplayanessential

roleinoxidative/reductivemetabolicreactions.Riboflavinisalsonecessaryforthefunctioningofpyridoxineand

nicotinicacid.

Pyridoxinehydrochloride(VitaminB

6 )

VitaminB

isaconstituentoftheco-enzymes,pyridoxalpyrophosphateandpyridoxaminephosphate,bothofwhich

playanimportantroleinproteinmetabolism.

Nicotinamide

Nicotinamideisanessentialcomponentofco-enzymesresponsibleforpropertissuerespiration.

Ascorbicacid(VitaminC)

Ascorbicacidisawatersolublevitaminandapowerfulantioxidant.Itisacofactorinnumerousbiologicalprocesses,

suchasthemetabolismoffolicacid,aminoacidoxidationandtheabsorptionandtransportofiron.Itisalsorequired

fortheformation,maintenanceandrepairofintercellularcementmaterial.Ascorbicacidisimportantinthedefence

againstinfection,thenormalfunctioningofT-lymphocytesandfortheeffectivephagocyticactivityofleucocytes.It

alsoprotectscellsagainstoxidationdamagetoessentialmolecules.

5.2Pharmacokineticproperties

Absorption

VitaminsA,B

,B

,B

,C,D

andnicotinamidearewellabsorbedfromthegastro-intestinaltract.

Distribution

ThevitaminspresentinAbidecMultivitaminDropsarewidelydistributedtoalltissuesinthebody.

Metabolismandelimination

VitaminApalmitate

VitaminApalmitateishydrolysedintheintestinallumentoretinolwhichisthenabsorbed.

Retinolcirculatesinthebloodboundtoretinolbindingproteinwhichprotectsitfromglomerularfiltration.The

complexcirculatestotargettissueswherethevitaminisreleased,permeatesthecellandbindsintracellularlytocellular

retinolbindingprotein.Oftheabsorbedretinol20-50%iseitherconjugatedoroxidisedtovariousproductsand

excretedoveramatterofdaysintheurineandfaeces,whiletheremainderisstored.Thisstoredretinolisgradually

metabolisedbytheliverandperipheraltissues.

Ergocalciferol(VitaminD

2 )

VitaminDcirculatesinthebloodassociatedwithvitaminDbindingprotein.Itisstoredinfatdeposits.Ergocalciferol

ishydroxylatedintheliverandgutto25-hydroxycholecalciferolwhichisthenfurthermetabolisedinthekidneytothe

activeform1,25-dihydroxycholecalciferolandotherhydroxylatedmetabolites.Ergocalciferolanditsmetabolitesare

excretedlargelyinbilewitheventualeliminationinthefaeces,withonlysmallamountsofsomeofthemetabolites

appearingintheurine.

Thiaminehydrochloride(VitaminB

1 )

Thiaminehasaplasmahalflifeof24hoursandisnotstoredtoanygreatextentinthebody.Excessingestedthiamine

isexcretedintheurineaseitherthefreevitaminorasthemetabolite,pyrimidine.

Riboflavin(VitaminB

2 )

Followingabsorptionriboflavinisconvertedintothecoenzymes:flavinmononucleotide(FMN)andflavinadenine

dinucleotide(FAD).Riboflavinisnotstoredinbodytissuetoanygreatextentandamountsinexcessofthebody’s

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Pyridoxinehydrochloride(VitaminB

6 )

Thehalflifeofpyridoxinerangesfrom15-20days.OnceabsorbedvitaminB

isconvertedtoitsactiveco-enzyme

frompyridoxal5-phosphate.Muscleisthemajorstoragesiteforpyridoxal5-phosphate.Itisdegradedintheliverto4-

pyridoxicacidwhichiseliminatedbythekidneys.

Nicotinamide

Nicotinamideisreadilytakenupintotissuesandutilisedforthesynthesisofthecoenzymeformsnicotinamideadenine

dinucleotide(NAD)andnicotinamideadeninedinucleotidephosphate(NADP).

Nicotinamideisdegradedintheliverandotherorganstoanumberofproductsthatareexcretedintheurine,themajor

metabolitesbeingN-methyl-2-pyridone-5-carboxamideandn-methylnicotinamide.

Ascorbicacid(VitaminC)

Ascorbicacidreachesamaximumplasmaconcentration4hoursfollowingoraladministrationafterwhichthereis

rapidurinaryexcretion.Followingoraladministration60%ofthedoseisexcretedin24hourseitherasascorbicacidor

itsmetabolitedihydroascorbicacid.

PharmacokineticsinRenalImpairment

TherehavebeennospecificstudiesofAbidecMultivitaminDropsinrenalimpairment.

PharmacokineticsintheElderly

Notappropriate.

5.3Preclinicalsafetydata

Mutagenicity

Thereisinsufficientinformationtodeterminethemutagenicpotentialoftheactiveingredients.However,verylarge

dosesofvitaminCareclaimedtobemutagenic.

Carcinogenicity

Thereisinsufficientinformationtodeterminethecarcinogenicpotentialoftheactiveingredients.

Teratogenicity

HighdosesofvitaminDareknowntobeteratogenicinexperimentalanimals,butdirectevidenceforthisislackingin

humans.TheteratogenicityofvitaminAinanimalsiswellknown,bothhighandlowlevelsofthevitaminresultin

defects.Butsignificanceofthisforhumansisindispute.SyntheticversionsofvitaminA(IsotretinoinandEtretinate)

havebeenshowntobepowerfulteratogens.Thereisinsufficientinformationtodeterminetheteratogenicpotentialof

theactiveingredients.

Fertility

Notappropriate.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumhydroxide

Sucrose

Refinedpeanutoil(acarrierforVitaminApalmitate)

Polysorbate60

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6.2Incompatibilities

Noneknown.

6.3Shelflife

Theshelflifeexpirydateforthisproductshallbethedateshownonthebottleandouterpackageoftheproductonthe

marketinthecountryoforigin.

Onceopenedusewithin4weeks.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

C.Keepthebottleintheoutercartontoprotectfromlight.

6.5Natureandcontentsofcontainer

AbidecMultivitaminDropsarepresentedinanamberTypeIIIglassbottle,withaROPPaluminiumcapcontaininga

PET/Aluminium/Polyethylene/ExpandedPolyethylenelaminatedwad.

One25mlbottleenclosedinaprintedcardboardcartonwithonepolyethylene/polystyrenesyringegraduatedat0.3ml

and0.6ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Washanddrysyringethoroughlyafteruse(notinasteamsteriliser).

Makesurenowaterisleftinside.

Resealthebottlewithoriginalcapaftereachuse.

Storesyringeinacleandryplace.Thesyringeisforusewiththisproductonly.

7PARALLELPRODUCTAUTHORISATIONHOLDER

LTTPharmaLimited

Unit18,OxleasowRoad

EastMoonsMoat

Redditch

WorcestershireB980RE

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1562/50/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:22 nd

July2011

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