BAYER MULTIVITAMIN & MINERAL FILM COATED TABLETS

Main information

  • Trade name:
  • BAYER MULTIVITAMIN & MINERAL FILM COATED TABLETS
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BAYER MULTIVITAMIN & MINERAL FILM COATED TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0021/061/002
  • Authorization date:
  • 02-12-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BayerMultivitamin&MineralFilmCoatedTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onefilm-coatedtabletcontains:

Ascorbicacid(vitaminC) 500mg

Thiaminenitrate 14.57mg

Correspondingto15mgthiaminehydrochloride

Riboflavin 15mg

Nicotinamide 50mg

Pantothenicacid 23mg

Informofcalciumpantothenate(25mg) 1)

Pyridoxinehydrochloride 10mg

Cyanocobalamin 0.01mg

Folicacid 0.4mg

Biotin0.15mg

Calciumcarbonate 244mg

Informofcalciumcarbonate 1)

Magnesiumcarbonate,heavy 122mg

Informofmagnesiumcarbonate,heavy 2)

Magnesium 115mg

Informofmagnesiumoxide,light 2)

Zinc 32mg

Informofzinccitratetrihydrate 3)

Totalcalciumcontent100mg

Totalmagnesiumcontent100mg

Totalzinccontent10mg

Excipients:

Lactose 90mg

aslactosemonohydrate

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/02/2009 CRN 2061611 page number: 1

3PHARMACEUTICALFORM

Filmcoatedtablet.

Oblong,biconvex,lightorangeorgreyishorange,odourlessoralmostodourlesstablet.Size:19mmx8.8mm.

4CLINICALPARTICULARS

4.1TherapeuticIndications

DeficiencyandincreasedrequirementofvitaminCandBvitamins.

DeficiencyandincreasedrequirementofZinc.

4.2Posologyandmethodofadministration

Adultsandadolescents:1film-coatedtabletdaily.

Therecommendeddailydoseofonetabletperdaymustnotbeexceeded.

Thismedicinalproductisnotrecommendedforchildrenbelow11years.

4.3Contraindications

KnownallergyorhypersensitivitytotheactivesubstancesortoanyoftheexcipientsinBayerMultivitamin&Mineral

FilmCoatedTablets.Hypercalcemia.Hypermagnesemia.Nephrolithiasis/urolithiasis.Hemochromatosis.

Ascorbicacidshouldnotbegiventopatientswithhyperoxaluria,reducedrenalfunctionordeficiencyofglucose-6-

phosphatedehydrogenase.

4.4Specialwarningsandprecautionsforuse

TheyellowdiscolourationoftheurineaftertakingBayerMultivitamin&MineralFilmCoatedTabletsisduetoits

contentofVitaminB2(riboflavin).

BayerMultivitamin&MineralFilmCoatedTabletsdonotcontainanyfat-solublevitamins.OneBayerMultivitamin

&MineralFilmCoatedTabletcontainsthemaximumdailydoseofvitaminB6(pyridoxine).Therecommendeddaily

doseofonetabletperdaymustnotbeexceeded.

Thelevelsofcalcium(12.5%oftheRDA)andmagnesium(33.3%oftheRDA)inBayerMultivitamin&Mineral

contributetotherecommendeddailyintake,buttheintakeofBayerMultivitamin&Mineralastheonlysourceof

calciumandmagnesiumcannotberegardedassufficientforthetreatmentofcalciumand/ormagnesiumdeficiencies,

orfortherapeuticfunctionsoftheseelementsapartfromtheirroleasco-factorsintheactivationandactionofB

vitamins.

BayerMultivitamin&MineralFilmCoatedTabletsshouldonlybeusedforthetreatmentofvitaminB12deficiencyif

thecauseisdietary.Themedicinalproductisnotintendedforuseinpatientswithatrophicgastritis,disorderofthe

ileumorpancreasandgastro-intestinalmalabsorptionofvitaminB12orintrinsicfactordeficiency.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakeBayerMultivitamin&MineralFilmCoatedTablets.

OneBayerMultivitamin&MineralFilmCoatedTabletcontains25mgofmannitol,94mgoflactosemonohydrateand

13.44mgofpolydextrose,correspondingto0.02diabeticexchangeandanenergyvalueof0.143kcal(EU).Thus,

BayerMultivitamin&MineralFilmCoatedTabletscanbeadministeredtodiabetespatients.

Patientsreceivinganyothermedicationorthoseundermedicalcareshouldconsultaphysicianbeforetakingthis

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/02/2009 CRN 2061611 page number: 2

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

VitaminC(ascorbicacid)mayinterferewithsometestsforglucoseintheurine.Therefore,theadministrationof

ascorbicacid(vitaminC)shouldbeinterruptedseveraldaysbeforesuchtestsareperformed.

Atdosesexceeding5mg,vitaminB6(pyridoxine)neutraliseslevodopaactivityinParkinsondiseasepatients.

However,nosuchantagonismisobservedwhenlevodopaisadministeredincombinationwithadecarboxylase

inhibitor(suchasbenserazideorcarbidopa).

ThevitaminB1antagoniststhiosemicarbazoneand5-fluorouracilneutralisetheeffectofvitaminB1.

AntacidsinhibittheresorptionofvitaminB1.

Neomycin,aminosalicylicacidandH2-blockerscanreducethegastrointestinalabsorptionofvitaminB12.

Acetylsalicylicacidreducestheabsorptionofascorbicacidbyaboutathird.

OralcontraceptivescanlowerserumlevelsofvitaminB12,folicacid,pyridoxineandascorbicacid.

Somepatientstreatedwithdeferoxamineand500mgVitaminCdailyhaveshownadeteriorationinleftventricular

function(oftentransitory).

4.6Pregnancyandlactation

NoindicationsexistthatthenutrientscontainedinBayerMultivitamin&Mineralhaveanyadverseeffectson

pregnancyoronthehealthofthefoetus/newbornchildattherecommendeddoseofonetabletperday.However,Bayer

Multivitamin&Mineralshouldbeadministeredinpregnancyonlywhenclinicallyindicated.

ThevitaminsandmineralsinBayerMultivitamin&MineralFilmCoatedTabletsareexcretedintobreastmilk,but

harmfuleffectsonthechildareunlikelyattherapeuticdoses.

4.7Effectsonabilitytodriveandusemachines

BayerMultivitamin&Mineralhasnoornegligibleinfluenceontheabilitytodriveandusemachines.

4.8Undesirableeffects

Themostcommonlyfoundadversereactionsaremildtransientmultivitamin/mineralgastrointestinaldisturbances,

occurringinupto5%ofpatients.

Allergicreactionsareveryrare( <

1/10,000).Urticaria,throatswellingandrashhavebeenreportedinisolatedcases.

Ascorbicacidmaycausehaemolyticanaemiaincertainindividualswithadeficiencyinglucose-6-phosphate-

dehydrogenase.

4.9Overdose

Casesofoverdoseshavenotbeenreported.Symptomsofoverdosemayincludegastrointestinaldisturbance,suchas

diarrhoeaandabdominaldiscomfort.Thedailyadministrationofover200mgofvitaminB6(pyridoxine)

(correspondingtomorethan20tabletsofBayerMultivitamin&Mineraldaily)overseveralmonthsmayleadto

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/02/2009 CRN 2061611 page number: 3

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:VitaminBcomplexwithvitaminCandminerals.

ATCcode:A11EBandA11EC.

ThevitamincontentoftheBayerMultivitamin&Mineralformulationisintendedforuseindeficienciesandincreased

requirementstates.Asaresult,thecontentoftheindividualvitaminsinBayerMultivitamin&Mineralwasformulated

abovetherecommendednutritionalRecommendedDietaryAllowances(RDAs)whicharenotintendedfortherapeutic

use.Onetabletcontains:ascorbicacid500mg(RDA=60mg),thiamine15mg(RDA=1.4mg),riboflavine15mg

(RDA=1.6mg),nicotinamide50mg(RDA=18mg),pyridoxine10mg(RDA=2mg),cyanocobalamin0.01mg

(RDA=0.001mg),folicacid0.4mg(RDA=0.2mg),pantothenicacid23mg(RDA=6mg)andbiotin0.15mg

(RDA=0.15mg).

Sincethewater-solublevitaminsarenotstoredbythebodytoanyappreciableextent,thesupplyofwater-soluble

vitaminsmightbeinsufficientintheelderly,duringpregnancyandlactation,inpersonsondiet,duringcertainchronic

diseases,duringextensivephysicalexerciseandduringlong-lastingstressandchronicalcoholabuse.Thedemandof

vitaminC(ascorbicacid)ishigherthannormalinsmokersandinwomenusingoralcontraception.

Bvitaminsareinvolvedinabroadspectrumofcellmetabolicreactions,suchassynthesisofneurotransmitters.

VitaminC(ascorbicacid)isabiologicalantioxidantandplaysanimportantroleintheinactivationoffreeradicals.Itis

alsorequiredfortheactivityofanumberofenzymesinvolvedinhydroxylationreactionsandinthemetabolismofe.g.

cholesterol,bileacidsanddrugs.VitaminC(ascorbicacid)enhancestheabsorptionofironintheintestine,influences

folicacidmetabolismandleukocytefunction.Itpromotestheformationofconnectivetissueandisessentialforthe

formulationandfunctionofteeth,bonesandcapillaries.

Calciumparticipatesinnumerousphysiologicalprocesses,enzymesystemsandinnervetransmission,andinteractsin

manyoftheseprocessesinacomplexwaywithmagnesiumandvitaminB6.

Magnesiumparticipatesinavarietyofreactionsincludingproteincatabolism,fattyacidmetabolism,sugaroxidation

andrespiratoryreactions.

Zincisanimportanttraceelementinthebodyandisinvolvedasacatalystinmorethan200enzymes.Itisanatural

constituentofmanyproteins,hormones,neuropeptidesandhormonereceptors.Amongstothers,zincisdirectly

involvedinthesynthesisofco-enzymesderivedfromvitaminB6(pyridoxine).

5.2Pharmacokineticproperties

Humanhealthandwell-beingisnaturallydependentonthecontinuousuptakeandmanagementofvitaminsandtrace

elements,andtheirabsorption,distribution,metabolismandeliminationaremaintainedbyspecificphysiological

mechanisms.AstheBayerMultivitamin&MineralFilmCoatedTabletsarecompletelydissolvedinthegastro-

intestinaltractagoodavailabilityofthesecompoundsisassured.

5.3Preclinicalsafetydata

AttherecommendeddoseofonetabletperdayBayerMultivitamin&MineralFilmCoatedTabletsaredevoidoftoxic

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/02/2009 CRN 2061611 page number: 4

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

TabletCore:

Lactosemonohydrate

Povidone(K90)

Sodiumcroscarmellose

Mannitol(E421)

Talc

Magnesiumstearate

Excipientsofcyanocobalamin0.1%WS:

Sodiumcitrate

Anhydrouscitricacid

Dextrin.

FilmCoat

Hypromellose

Fractionatedcoconutoil

Polydextrose

Titaniumdioxide(E171)

Red,yellowandblackironoxide(E172)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Packages:10,30,60and100.Blistersof10tablets(PVC/PE/PVDC/ALU).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/02/2009 CRN 2061611 page number: 5

7MARKETINGAUTHORISATIONHOLDER

Bayerplc

BayerHouse

StrawberryHill

Newbury

Berkshire

RG141JA

UnitedKingdom

Tradingas:Bayerplc,ConsumerCareDivision

8MARKETINGAUTHORISATIONNUMBER

PA0021/061/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 23November1998

Dateoflastrenewal: 23November2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/02/2009 CRN 2061611 page number: 6