BELLCALCID CALCIUM CARBONATE 1500MG AND COLECALSIF

Main information

  • Trade name:
  • BELLCALCID CALCIUM CARBONATE 1500MG AND COLECALSIF
  • Dosage:
  • 1.5g/ 400 International Unit
  • Pharmaceutical form:
  • Tablets Effervescent
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BELLCALCID CALCIUM CARBONATE 1500MG AND COLECALSIF
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1185/003/001
  • Authorization date:
  • 22-12-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BellcalcidCalciumCarbonate1500mgandColecalciferol400I.U.EffervescentTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eacheffervescenttabletcontains:

1500mgofcalciumcarbonate(equivalentto600mgor15mmolofcalcium)and

400I.U.(10micrograms)colecalciferol(vitaminD

)ascolecalciferolconcentrate(powderform).

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Effervescenttablet

Awhite,roundeffervescenttablet,withtheodourandflavouroflemon.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CorrectionofcombinedvitaminD

andcalciumdeficiencies.

VitaminD

andcalciumsupplementationasanadjuncttospecifictreatmentforosteoporosisinpatients,where

combinedcalciumandvitaminDdeficiencieshavebeendiagnosedorathighriskofsuchdeficiencies.

4.2Posologyandmethodofadministration

Adultstake1-2effervescenttabletsdaily(equivalentto600-1200mgofcalciumand400-800I.U.ofvitaminD

).For

pregnancyandlactation,seeparagraph4.6‘PregnancyandLactation’.

Theeffervescenttabletsshouldbedissolvedinaglassofwater(approx.200ml)anddrunkimmediately.

Oraluse-Foradultsonly.

4.3Contraindications

Hypersensitivitytooneoftheconstituentsoftheeffervescenttablet

Hypercalcaemia.

Hypercalciuria.

Kidneystones.

Nephrocalcinosis.

Primaryhyperparathyroidism.

VitaminDoverdose.

Myeloma.

Bonemetastases.

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4.4Specialwarningsandprecautionsforuse

Duringlong-termuse,serumandurinarycalciumlevelsaswellaskidneyfunctionshouldbemonitoredthroughthe

measurementofserumcreatininelevels.Dosageshouldbereducedortreatmenttemporarilysuspendedifurinary

calciumexcretionexceeds7.5mmol/24hours(300mg/24hours).

Monitoringofkidneyfunctionisespeciallyimportantwhenthereisconcomitanttreatmentwithdigitalisglycosidesand

thiazidediuretics.Specialcareisrequiredonconcurrenttreatmentwithbisphosphonates,sodiumfluorideor

tetracycline(see4.5Interactions).

ThedosageofvitaminDperdosagefrom(400I.U.)shouldbetakenintoaccountonconcurrentadministrationofother

vitaminDpreparations.

SinceBellcalcidalreadycontainsvitaminD,additionalvitaminDorcalciumpreparationsshouldonlybetakenunder

strictmedicalsupervision.Insuchcases,itisessentialtocarryoutaweeklycheckonserumandurinarycalcium

levels.

InpatientssufferingfromsarcoidosisBellcalcidshouldbetakenundermedicalsupervisionbecauseoftheriskof

hypercalcaemiaduetoincreasedmetabolismofvitaminDtoitsactivemetabolite.Thesepatientsshouldhavethe

urinaryandplasmalevelsmonitored.

Bellcalcidshouldbeusedwithcautioninpatientswithrenaldysfunctionandchecksoncalciumandphosphate

homeostasisshouldbeundertaken.

Inpatientswithrenalinsufficiency,vitaminDintheformofcolecalciferolisnotmetabolisednormallyandotherforms

ofvitaminDshouldbeused.

Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltase

insufficiencyshouldnottakethismedicine.Hydrogenatedsoyaoilmaycontainpeanutproteinandistherefore

contraindicatedinpatientswhoareallergictopeanutorsoyaoil.

Informationfordiabetics

1effervescenttabletcontains0.01BreadUnitsandisthereforesuitablefordiabetics.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Duringtreatmentwithdigitalisglycosides,oralcalciumcombinedwithvitaminDmayincreasetoxicityofthedigitalis

glycosides(riskofcardiacarrhythmias).Closeclinicalsurveillance,ifnecessarycoupledwithECGandserumcalcium

monitoringisessential.

Whenusedincombinationwithbisphosphonatesorsodiumfluoride,itisrecommendedthatatleasttwohourselapse

beforethecalciumpreparationistaken,asotherwiseabsorptionofthebisphosphonateorsodiumfluorideisreduced.

Calciumsaltsmaydecreasetheabsorptionofiron.Consequently,theironpreparationshouldbetakenatadistanceof

twohoursfromthecalciumpreparation.

Thiazidediureticsleadtoadecreaseofcalciumexcretioninurine.Serumcalciumlevelsshouldthereforebemonitored

duringtreatmentwiththiazidediuretics.

Concomitantadministrationofrifampicin,phenytoinorbarbituratesmayacceleratethemetabolismandhencereduce

theeffectsofvitaminD

AnintervalofatleasttwohoursshouldbeobservedbetweeningestionofcholestyramineandBellcalcidasotherwise

theabsorptionofvitaminD

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SimultaneousadministrationofglucocorticoidsmayreducetheeffectsofvitaminD

Sincecalciumcanimpairtheabsorptionoforallyadministeredtetracycline,itisrecommendedtotakethepreparation

atleastthreehoursafterthetetracycline.

Interactionmayoccurwithsomefoods(forexample,foodcontainingoxalicacid,phosphatesorphytinicacidorhaving

ahighfibrecontent).

4.6Pregnancyandlactation

Duringpregnancyandlactation,combinedvitaminDandcalciumdeficienciescanbecorrected.Thedailyintake

shouldnotexceed1,500mgofcalciumand600I.U.ofvitaminD

.Therefore,thedailydosemustnotexceed1tablet.

OverdosesofvitaminDhavebeenshowntohaveteratogeniceffectsinanimalexperiments.

Inpregnantwomen,overdosagesofvitaminD

shouldbeavoided,sinceprolongedhypercalcaemiahasbeen

sometimesassociatedwithretardationofphysicalandmentaldevelopment,supravalvularaorticstenosisand

retinopathyinthechild.

Thereare,however,severalcasereportsofadministrationofveryhighvitaminDdosesinhypoparathyroidisminthe

mother,wherenormalchildrenwereborn.

Calciumpassesslightlyintobreast-milk,withouthavinganegativeeffectonchildren.VitaminDanditsmetabolites

alsopassintobreast-milk.ThisshouldbeconsideredwhengivingadditionalvitaminDtothechild.

Inpregnantandlactatingwomen,thecalciumpreparationshouldbetakenatadistanceoftwohoursfromamealdueto

apossibledecreaseofironabsorption.

4.7Effectsonabilitytodriveandusemachines

Anunfavourableeffectofthepreparationonabilitytodriveoroperatemachinesisveryunlikely.

4.8Undesirableeffects

Constipation,bloating,nausea,gastricpain,diarrhoea,hypercalciuria,hypercalcaemia.

4.9Overdose

Overdosageleadstohypercalciuriaandhypercalcaemiawiththefollowingsymptoms:

Nausea,vomiting,thirst,polydipsia,polyuria,dehydration,constipation.Chronicoverdosagewithresulting

hypercalcaemiacancausevascularandorganiccalcification.

ThethresholdforvitaminDintoxicationisbetween40,000and100,000I.U/dayfor1-2monthsinpersonswithnormal

parathyroidfunction,forcalciuminexcessof2,000mgperday.

Treatment

Inthecaseofanintoxication,treatmentshouldbestoppedimmediatelyandthefluiddeficiencyshouldbebalanced.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

BellcalcidisafixedcombinationofcalciumandvitaminD.ThehighcalciumandvitaminDconcentrationineach

doseunitenablessufficientabsorptionofcalciumwithalimitednumberofdoses.VitaminDisinvolvedincalcium-

phosphorusmetabolism.Itallowstheactiveabsorptionofcalciumandphosphorusfromtheintestineandtheiruptake

bybone.SupplementationwithcalciumandvitaminD

correctslatentvitaminDdeficiencyandsecondary

hyperparathyroidism. Pharmacotherapeuticgroup:Minerals (A12)

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Inadouble-blindplacebocontrolledstudyof18months,including3270womenaged84 ± 6andlivinginnursing

homes,supplementedwithcolecalciferol(800IU/day)+Calcium(1.2g/day),asignificantdecreaseinParathyroid

Hormone(PTH)secretionhasbeenobserved.After18months,theresultsoftheintenttotreatanalysisshowed80hip

fracturesinthecalciumvitaminDgroupand110hipfracturesintheplacebo-group(p=0.004).Sointheconditionsof

thisstudy,thetreatmentof1387womenprevented30hipfractures.

After36monthsoffollow-up,137womenpresentedatleastonehipfractureinthecalcium-vitaminDgroup(n=1176)

and178intheplacebogroup(n=1127)(p=0.02).

5.2Pharmacokineticproperties

Calciumcarbonate

Absorption:

Ondissolutionoftheeffervescenttablet,thecalciumcarbonateisconvertedinthepresenceofcitricacidtosoluble

calciumcitrate.Some30-40%oftheingesteddoseofcalciumisabsorbed,predominantlyintheproximalpartofthe

smallintestine.

Elimination:

Calciumisexcretedintheurine,faecesandinsweat.Urinaryexcretiondependsonglomerularfiltrationandtubular

resorption.

VitaminD

Absorption:

VitaminD

isabsorbedintheintestineandtransportedbyproteinbindinginthebloodtotheliver(whereitundergoes

thefirsthydroxylationto25-hydroxycolecalciferol)andtothekidneys(secondhydroxylationto1,25-di-

hydroxycolecalciferol),theactualactivemetaboliteofvitaminD

Non-hydroxylatedvitaminD

isstoredinmuscleandadiposetissues.

Elimination:

Theplasmahalf-lifeisintheorderofseveraldays;vitaminD

iseliminatedinthefaecesandurine.

5.3Preclinicalsafetydata

NootherrelevantdataisavailablethathasnotbeenmentionedelsewhereintheSummaryofProductCharacteristics

(see4.6PregnancyandLactation;4.9Overdose).

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Citricacidanhydrous(E330)

Malicacid(E296)

Sodiumhydrogencarbonate(E500)

Sodiumcyclamate

Lemonflavouring(contains:lemonoil,mannitol(E421),sorbitol(E420),dextrin,D-glucono-1,5-lactone(E575),

acacia(E414))

Sodiumcarbonateanhydrous(E500)

Maltodextrin

Saccharinsodium

Sucrose

Gelatin

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Partiallyhydrogenatedsoyaoil

All-rac--tocopherol(E307)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30 o

Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

Packsof20,40,(2x20),60(3x20),and100(5packsof20)effervescenttablets.Eachunitof20tabletsisina

aluminiumorpolypropylenetubewithpolyethylenestoppercontainingadesiccant.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

BellPharmaLimited

FirstFloor

69St.Patrick’sRoad

Dalkey

Co.Dublin

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1185/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:28April2000

Dateoflastrenewal:28April2005

10DATEOFREVISIONOFTHETEXT

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