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ChefaroIrelandLtd
ChefaroIreland,1stFloor,32VauxhallBridgeRoad,London,SW1V2SA,UK
Telephone:+44(0)2035989601
Email:omegaroi@professionalinformation.co.uk
WWW:www.omegapharma.ie
MedicalInformationDirectLine:+44(0)1748827299

SummaryofProductCharacteristicslastupdatedonmedicines.ie:14/01/2015

AbidecDrops

1.NAMEOFTHEMEDICINALPRODUCT
AbidecMultivitaminOralDropsSolution

2.QUALITATIVEANDQUANTITATIVECOMPOSITION
AbidecMultivitaminDropscontains1333IUretinol(asvitaminApalmitate),400IUergocalciferol,0.4mgthiamine
hydrochloride,0.8mgriboflavinsodiumphosphate,0.8mgpyridoxinehydrochloride,8mgnicotinamide,and40mg
ascorbicacidineach0.6mldose.

Excipientscontainssucrose45mgandArachisOil

Forafulllistofexcipients,seesection6.1.

3.PHARMACEUTICALFORM
Oraldrops,solution

Aclearyellow/brownsolutionwithacharacteristicodourandtaste.

4.CLINICALPARTICULARS

4.1Therapeuticindications
AbidecMultivitaminDropsisindicatedforthepreventionofvitamindeficienciesandforthemaintenanceofnormal
growthandhealthduringtheearlyyearsofinfancyandchildhoodmultivitaminsupplement.

4.2Posologyandmethodofadministration
Adultsandchildrenover12years:

Notappropriate.

Childrenaged1to12years:

Oral.

One0.6mldosetakendaily.

Maximumdailydose:0.6ml.

Childrenunder1year:

Oral.

One0.3mldosetakendaily.

Maximumdailydose:0.3ml.

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TheElderly:

Notappropriate.

Hepatic/renaldysfunction:

Normaldosageisappropriate.

4.3Contraindications
AbidecMultivitaminDropsiscontraindicatedinindividualswithknownhypersensitivitytotheproductoranyofits
componentsincludingpeanutoil.

VitaminApalmitatecontainsrefinedpeanutoil(Arachisoil)andshouldnotbetakenbypatientsknowntobeallergicto
peanut.Asthereisapossiblerelationshipbetweenallergytopeanutandallergytosoya,patientswithsoyaallergy
shouldalsoavoidAbidecMultivitaminDrops.

4.4Specialwarningsandprecautionsforuse
WhenprescribingAbidecMultivitaminDrops,aswithallmultivitaminpreparations,allowanceshouldbemadefor
vitaminsobtainedfromothersources.

WhilechildrenaretakingAbidecMultivitaminDropsnoothervitaminsupplementcontainingvitaminsAandDshouldbe
takenunlessundermedicalsupervision.

Thismultivitaminsupplementshouldnotbegiventobabieswhoarereceivingmorethan500mlsofformulamilkperday
toavoidexceedingthesafeupperlimitofVitaminA.

ExcessivedosageofvitaminAandDmayleadtohypervitaminoses.Dueallowanceshouldalwaysbemadeforintakeof
thesevitaminsfromothersources.

Patientswithrarehereditaryproblemsoffructoseintolerance,glucosegalactosemalabsorptionorsucraseisomaltase
insufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction
None.

4.6Fertility,pregnancyandlactation
Notindicatedinthisagegroup.

4.7Effectsonabilitytodriveandusemachines
Noneknown.

4.8Undesirableeffects
VitaminApalmitate

Adverseeffectsareextremelyrareatdailydosesoflessthan9mg.(16363.6IU).

Ergocalciferol(VitaminD2)

TheonlyknownadverseeffectsofvitaminDoccurwhenexcessivedosesaretaken.Adverseeffectsarenotanticipated
atthequantitypresentinAbidecMultivitaminDrops.

AscorbicAcid(C),Nicotinamide,Pyridoxine(B6),Riboflavin(B2)&Thiamine(B1)

Thesewatersolublevitaminsaregenerallynontoxiccompoundswithawidemarginofsafety,theexcessamountsbeing
rapidlyexcretedintheurine.AdverseeffectsarenotanticipatedatthequantitiespresentinAbidecMultivitaminDrops.

4.9Overdose
Symptomsandsigns

AbidecMultivitaminDropscontainslevelsofvitaminswhichpresentlittleriskofoverdose.

VitaminApalmitate

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AcuteadministrationofhighdosesofvitaminAcancauseheadache,nausea,vomitingandirritability.Ininfantsacute
toxicitycanleadtotransienthydrocephalus.Alltheseeffectsdisappearwithin24hoursoftakingretinol.

Ergocalciferol(VitaminD2)

ExcessivedosesofvitaminD,60000unitsperday,canresultinhypercalcaemiaandhypercalciuria.Adverseeffectsof
hypercalcaemiamayincludemuscleweakness,apathy,headache,anorexia,nauseaandvomiting,hypertensionand
cardiacarrhythmias.

Thiaminehydrochloride(VitaminB1)

Whentakenorally,thiamineisnontoxic.Iflargedosesareingestedtheyarenotstoredbythebodybutexcreted
unchangedbythekidneys.

Riboflavin(VitaminB2)

Riboflavinhasbeenfoundtobepracticallynontoxic.

Pyridoxinehydrochloride(VitaminB6)

Acutedoseslessthan500mgperdayappeartobesafe.Excessivedosesmaylowerserumfolateconcentrations.
Sensoryneuropathyhasbeendescribedwithchronicdosingof200mgdaily.

Nicotinamide

Asinglelargeoverdoseofnicotinamideisunlikelytohaveseriousilleffects,throughtransientabnormalitiesofliver
functionmightoccur.

Ascorbicacid(VitaminC)

Ascorbicacidisnotstoredtoagreatextentbythebody,anyexcessamountsareeliminatedintheurine.Ascorbicacidis
thoughtobecometoxicatchronicdosesinexcessof6g.

Treatment

Treatmentshouldbesupportiveandsymptomatic.

5.PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties
VitaminApalmitate

VitaminAplaysanessentialroleinthefunctionoftheretina,thegrowthandfunctionofepithelialtissue,bonegrowth,
reproductionandembryonicdevelopment.

Ergocalciferol(VitaminD2)

VitaminDisaregulatorofbothcalciumandphosphatehomeostasis.

Thiaminehydrochloride(VitaminB1)

VitaminB1isessentialforpropercarbohydratemetabolismandplaysanessentialroleinthedecarboxylationofalpha
ketoacids.

Riboflavin(VitaminB2)

Riboflavinisessentialfortheutilisationofenergyfromfood.Itisacomponentofcoenzymeswhichplayanessential
roleinoxidative/reductivemetabolicreactions.Riboflavinisalsonecessaryforthefunctioningofpyridoxineandnicotinic
acid.

Pyridoxinehydrochloride(VitaminB6)

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VitaminB6isaconstituentofthecoenzymes,pyridoxalpyrophosphateandpyridoxaminephosphate,bothofwhichplay
animportantroleinproteinmetabolism.

Nicotinamide

Nicotinamideisanessentialcomponentofcoenzymesresponsibleforpropertissuerespiration.

Ascorbicacid(VitaminC)

Ascorbicacidisawatersolublevitaminandapowerfulantioxidant.Itisacofactorinnumerousbiologicalprocesses,
suchasthemetabolismoffolicacid,aminoacidoxidationandtheabsorptionandtransportofiron.Itisalsorequiredfor
theformation,maintenanceandrepairofintercellularcementmaterial.Ascorbicacidisimportantinthedefenceagainst
infection,thenormalfunctioningofTlymphocytesandfortheeffectivephagocyticactivityofleucocytes.Italsoprotects
cellsagainstoxidationdamagetoessentialmolecules.

5.2Pharmacokineticproperties
Absorption

VitaminsA,B1,B2,B6,C,D2andnicotinamidearewellabsorbedfromthegastrointestinaltract.

Distribution

ThevitaminspresentinAbidecMultivitaminDropsarewidelydistributedtoalltissuesinthebody.

Metabolismandelimination

VitaminApalmitate

VitaminApalmitateishydrolysedintheintestinallumentoretinolwhichisthenabsorbed.

Retinolcirculatesinthebloodboundtoretinolbindingproteinwhichprotectsitfromglomerularfiltration.Thecomplex
circulatestotargettissueswherethevitaminisreleased,permeatesthecellandbindsintracellularlytocellularretinol
bindingprotein.Oftheabsorbedretinol2050%iseitherconjugatedoroxidisedtovariousproductsandexcretedover
amatterofdaysintheurineandfaeces,whiletheremainderisstored.Thisstoredretinolisgraduallymetabolisedby
theliverandperipheraltissues.

Ergocalciferol(VitaminD2)

VitaminDcirculatesinthebloodassociatedwithvitaminDbindingprotein.Itisstoredinfatdeposits.Ergocalciferolis
hydroxylatedintheliverandgutto25hydroxycholecalciferolwhichisthenfurthermetabolisedinthekidneytothe
activeform1,25dihydroxycholecalciferolandotherhydroxylatedmetabolites.Ergocalciferolanditsmetabolitesare
excretedlargelyinbilewitheventualeliminationinthefaeces,withonlysmallamountsofsomeofthemetabolites
appearingintheurine.

Thiaminehydrochloride(VitaminB1)

Thiaminehasaplasmahalflifeof24hoursandisnotstoredtoanygreatextentinthebody.Excessingestedthiamineis
excretedintheurineaseitherthefreevitaminorasthemetabolite,pyrimidine.

Riboflavin(VitaminB2)

Followingabsorptionriboflavinisconvertedintothecoenzymes:flavinmononucleotide(FMN)andflavinadenine
dinucleotide(FAD).Riboflavinisnotstoredinbodytissuetoanygreatextentandamountsinexcessofthebody's
requirementsareexcretedintheurinelargelyunchanged.

Pyridoxinehydrochloride(VitaminB6)

Thehalflifeofpyridoxinerangesfrom1520days.OnceabsorbedvitaminB6isconvertedtoitsactivecoenzymefrom
pyridoxal5phosphate.Muscleisthemajorstoragesiteforpyridoxal5phosphate.Itisdegradedintheliverto4
pyridoxicacidwhichiseliminatedbythekidneys.

Nicotinamide

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Nicotinamideisreadilytakenupintotissuesandutilisedforthesynthesisofthecoenzymeformsnicotinamideadenine
dinucleotide(NAD)andnicotinamideadeninedinucleotidephosphate(NADP).

Nicotinamideisdegradedintheliverandotherorganstoanumberofproductsthatareexcretedintheurine,themajor
metabolitesbeingNmethyl2pyridone5carboxamideandnmethylnicotinamide.

Ascorbicacid(VitaminC)

Ascorbicacidreachesamaximumplasmaconcentration4hoursfollowingoraladministrationafterwhichthereisrapid
urinaryexcretion.Followingoraladministration60%ofthedoseisexcretedin24hourseitherasascorbicacidorits
metabolitedihydroascorbicacid.

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.

6.PHARMACEUTICALPARTICULARS

6.1Listofexcipient(s)
Sodiumhydroxide

Sucrose

Refinedpeanutoil(acarrierforVitaminApalmitate)

Polysorbate60

Purifiedwater

6.2Incompatibilities
Noneknown.

6.3Shelflife
18months.

Onceopened:usewithin4weeks.

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6.4Specialprecautionsforstorage
Donotstoreabove25C.Keepthebottleintheoutercartontoprotectfromlight.

6.5Natureandcontentsofcontainer
AbidecMultivitaminDropsarepresentedinanamberTypeIIIglassbottle,withatamperevidentPolyropylenecapor
ROPPaluminiumcapcontainingaPET/Aluminium/Polyethylene/ExpandedPolyethylenelaminatedwad.

Oneortwo25mlbottlesenclosedinaprintedcardboardcartonwithonepolyethylene/polystyrenesyringegraduatedat
0.3mland0.6ml.

Notallpacksizesmaybemarketed

6.6Specialprecautionsfordisposalandotherhandling
Washanddrysyringethoroughlyafteruse(notinasteamsteriliser).

Makesurenowaterisleftinside.

Resealthebottlewithoriginalcapaftereachuse.

Storesyringeinacleandryplace.Thesyringeisforusewiththisproductonly.

7.MARKETINGAUTHORISATIONHOLDER
ChefaroIrelandLimited

FirstFloor,BlockA,

TheCrescentBuilding,

NorthwoodOfficePark,

Dublin9.

8.MARKETINGAUTHORISATIONNUMBER(S)
PA1186/1/1

9.DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION
Dateoffirstauthorisation:01September2000

Dateoflastrenewal:01September2010

10.DATEOFREVISIONOFTHETEXT
January2015

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