CALCIUM-D-SANDOZ

Main information

  • Trade name:
  • CALCIUM-D-SANDOZ Tablets Effervescent 600mg+400I Base Milligrams
  • Dosage:
  • 600mg+400I Base Milligrams
  • Pharmaceutical form:
  • Tablets Effervescent
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALCIUM-D-SANDOZ Tablets Effervescent 600mg+400I Base Milligrams
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/038/001
  • Authorization date:
  • 28-04-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0030/038/001

CaseNo:2075491

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NovartisConsumerHealthUKLimited

WimblehurstRoad,Horsham,WestSussexRH125AB,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Calcium-D-Sandoz600mg+400IU,effervescenttablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom30/03/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 31/03/2010 CRN 2075491 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calcium-D-Sandoz600mg+400IU,effervescenttablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1effervescenttabletcontains

1500mgofcalciumcarbonate(equivalentto600mgor15mmolofcalcium)

400I.U.or10µgcholecalciferol(vitaminD

)ascholecalciferolconcentrate‘powderform’.

Excipient(s):52mgofsodium,1.52mgofsucrose,50mgoflemonflavouring(contains:sorbitol(E420)),0.30mgof

partiallyhydrogenatedsoybeanoil

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Effervescenttablet

White-roundtablet,smoothandnotvaulted.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CorrectionofcombinedvitaminD

andcalciumdeficiencies.

VitaminD

andcalciumsupplementationasanadjuncttospecifictreatmentforosteoporosisinpatientswhere

combinedcalciumandvitaminDdeficiencieshavebeendiagnosedorathighriskofsuchdeficiencies.

4.2Posologyandmethodofadministration

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

).For

pregnancyandlactation,seesection4.6‘PregnancyandLactation’.

Theeffervescenttabletsshouldbedissolvedinaglassofwater(approx.200ml)anddrunkimmediately.

Dosageinhepaticimpairment:Nodoseadjustmentisrequired.

Dosageinrenalimpairment:Calcium-D-Sandozshouldnotbeusedinpatientswithsevererenalimpairment.

Oraluse-Foradultsonly.

4.3Contraindications

Hypersensitivitytotheactivesubstances,soya,peanutortoanyoftheexcipients,

Hypercalcaemia,hypercalciuria,

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Diseaseand/orconditionsresultinginhypercalcaemiaand/orhypercalciuria(e.eg.primaryhyperparathyroidism,

myeloma,bonemetastases)

HypervitaminosisD

Renalfailure

4.4Specialwarningsandprecautionsforuse

Duringlong-termtreatment,serumcalciumlevelsshouldbefollowedandrenalfunctionshouldbemonitoredthrough

measurementsofserumcreatinine.Monitoringisespeciallyimportantinpatientsonconcomitanttreatmentwith

cardiacglycosidesorthiazidediuretics(seesection4.5)andinpatientswithahightendencytocalculusformation.In

caseofhypercalcaemiaorsignsofimpairedrenalfunctionthedoseshouldbereducedorthetreatmentdiscontinued.

Therapyshouldbereducedorpreliminaryinterrupted,ifurinarycalciumlevelexceeds7.5mmol/24h(300mg/24h).

VitaminDshouldbeusedwithcautioninpatientswithimpairmentofrenalfunctionandtheeffectoncalciumand

phosphatelevelsshouldbemonitored.Theriskofsofttissuecalcificationshouldbetakenintoaccount.Inpatientswith

severerenalinsufficiency,vitaminDintheformofcholecalciferolisnotmetabolisednormallyandotherformsof

vitaminDshouldbeused.

Calcium-D-Sandozshouldbeprescribedwithcautiontopatientssufferingfromsarcoidosis,duetotheriskofincreased

metabolismofvitaminDintoitsactiveform.Thesepatientsshouldbemonitoredwithregardtothecalciumcontentin

serumandurine.

Calcium-D-Sandozshouldbeusedcautiouslyinimmobilisedpatientswithosteoporosisduetoincreasedriskof

hypercalcaemia.

ThecontentofvitaminD(400IU)inCalcium-D-Sandozshouldbeconsideredwhenprescribingothermedicinal

productscontainingvitaminD.AdditionaldosesofcalciumorvitaminDshouldbetakenunderclosemedical

supervision.Insuchcasesitisnecessarytomonitorserumcalciumlevelsandurinarycalciumexcretionfrequently.

CalciumandVitaminDintakefromothersources(food,dietarysupplements)shouldbeestimated,beforeprescribing

theproduct.

Calcium-D-Sandozisnotintendedforuseinchildrenandadolescents.

Calcium-D-Sandozcontains2.26mmol(correspondingto52mg)ofsodiumpertablet.

Theproductcontainssorbitol,thereforepatientswithrarehereditaryproblemsoffructoseintoleranceshouldnottake

thismedicine.

Theproductcontainssucrose,thereforepatientswithrarehereditaryproblemsoffructoseintolerance,glucose-

galactosemalabsorptionorsucrase-isomaltaseinsufficiencyshouldnottakethismedicine.

Informationfordiabetics:

1effervescenttabletcontains0.01BreadUnitsandisthereforesuitablefordiabetics.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ConcomitantuseofphenytoinorotherbarbituratesmayreducetheeffectofvitaminD3sincethemetabolism

increases.

Thiazidediureticsreducetheurinaryexcretionofcalcium.Duetoincreasedriskofhypercalcaemia,serumcalcium

shouldberegularlymonitoredduringconcomitantuseofthiazidediuretics.

Systemiccorticosteroidsreducecalciumabsorption.Duringconcomitantuse,itmaybenecessarytoincreasethedose

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Simultaneoustreatmentwithionexchangeresinssuchascholestyramineorlaxativessuchasparaffinoilmayreduce

thegastrointestinalabsorptionofvitaminD.Thereforeatimeintervalaslongaspossiblebetweentheintakesshouldbe

recommended.

Calciumcarbonatemayinterferewiththeabsorptionofconcomitantlyadministeredtetracyclinepreparations.Forthis

reason,tetracyclinepreparationsshouldbeadministeredatleasttwohoursbeforeorfourtosixhoursafteroralintake

ofcalcium.

HypercalcaemiamayincreasethetoxicityofcardiacglycosidesduringtreatmentwithcalciumandvitaminD.Patients

shouldbemonitoredwithregardtoelectrocardiogram(ECG)andserumcalciumlevels.

Ifabisphosphonateorsodiumfluorideisusedconcomitantly,thispreparationshouldbeadministeredatleastthree

hoursbeforetheintakeofCalcium-D-Sandozsincegastrointestinalabsorptionofbisphosphonatemaybereduced.

Oxalicacid(foundinspinachandrhubarb)andphyticacid(foundinwholecereals)mayinhibitcalciumabsorption

throughformationofinsolublecompoundswithcalciumions.Thepatientshouldnottakecalciumproductswithintwo

hoursofeatingfoodshighinoxalicacidandphyticacid.

4.6Pregnancyandlactation

Duringpregnancyandlactation,combinedvitaminDandcalciumdeficienciescanbecorrected.Thedailyintake

shouldnotexceed1,500mgofcalciumand600I.U.ofvitaminD

.Therefore,thedailydosemustnotexceed1tablet.

OverdosesofvitaminDhavebeenshowntohaveteratogeniceffectsinanimalexperiments.

Inpregnantwomen,overdosageofvitaminD

shouldbeavoided,sinceprolongedhypercalcaemiahasbeensometimes

associatedwithretardationofphysicalandmentaldevelopment,supravalvularaorticstenosisandretinopathyinthe

child.

Thereare,however,severalcasereportsofadministrationofveryhighvitaminDdosesinhypoparathyroidisminthe

motherwherenormalchildrenwereborn.

Calciumpassesslightlyintobreast-milk,withouthavinganegativeeffectonchildren.

VitaminDanditsmetabolitesalsopassintobreast-milk.ThisshouldbeconsideredwhengivingadditionalvitaminD

tothechild.

Inpregnantandlactatingwomen,thecalciumpreparationshouldbetakenatadistanceoftwohoursfromamealdueto

apossibledecreaseofironabsorption.

4.7Effectsonabilitytodriveandusemachines

Anunfavourableeffectofthepreparationontheabilitytodriveoroperatemachinesisveryunlikely.

4.8Undesirableeffects

Immunesystemdisorders

VeryRare(<1/10,000):Hypersensitivityreactionssuchasangioedemaorlaryngealoedema.

Metabolismandnutritiondisorders

Uncommon(>1/1,000,<1/100):hypercalcaemia,hypercalciuria.

Unknown:milk-alkalisyndrome

Gastrointestinaldisorders

Rare(>1/10,000,<1/1,000):nausea,diarrhea,abdominalpain,constipation,flatulence,abdominaldistension.

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Skinandsubcutaneoustissuedisorders

Rare(>1/10,000,<1/1,000):rash,pruritus,urticaria.

4.9Overdose

Overdosageleadstohypervitaminosisandhypercalcaemiawiththefollowingsymptoms:

Anorexia,nausea,vomiting,thirst,polydipsia,polyuria,dehydration,constipation,abdominalpain,muscleweakness,

fatigue,mentaldisturbances,bonepain,nephrocalcinosisandinseverecasescardiacarrythmias.Extreme

hypercalcemiamayresultincomaanddeath.Chronicoverdosagewithresultinghypercalcaemiacancauseirreversible

renaldamageandsofttissuecalcification.

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

normalparathyroidfunction,forcalciuminexcessof2,000mgperday.

Treatment

Inthecaseofanintoxication,treatmentshouldbestoppedimmediatelyandthefluiddeficiencyshouldbebalanced.

Treatmentwiththiazidediuretics,lithium,VitaminAandcardiacglycosidesmustalsobediscontinued.

Emptyingofthestomachinpatientswithimpairedconsciousness.

Rehydrationand,accordingtoseverity,isolatedorcombinedtreatmentwithloopdiuretics,bisphosphonates,calcitonin

andcorticosteroids.Serumelectrolytes,renalfunctionanddiuresismustbemonitored.InseverecasesECGandCVP

shouldbefollowed.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup: Mineralsupplements

ATCcode:Calcium,combinationswithotherdrugs(A12AX)

Calcium-D-SandozisafixedcombinationofcalciumandvitaminD.ThehighcalciumandvitaminDconcentrationin

eachdoseunitenablessufficientabsorptionofcalciumwithalimitednumberofdoses.VitaminDisinvolvedin

calcium-phosphorusmetabolism.Itallowstheactiveabsorptionofcalciumandphosphorusfromtheintestineandtheir

uptakebybone.SupplementationwithcalciumandvitaminD

correctslatentvitaminDdeficiencyandsecondary

hyperparathyroidism.TheoptimalamountofVitaminDintheelderlyis500–1000IU/day.Thecommonlyaccepted

requirementofcalciumintheelderlyis1500mg/day.

Inadouble-blindplacebocontrolledstudyof18months,including3270womenaged84 ±

6andlivinginnursing

homes,supplementedwithcholecalciferol(800IU/day)+Calcium(1.2g/day),asignificantdecreaseinPTHsecretion

hasbeenobserved.After18months,theresultsoftheintenttotreatanalysisshowed80hipfracturesinthecalcium

vitaminDgroupand110hipfracturesintheplacebo-group(p=0.004).Sointheconditionsofthisstudy,thetreatment

of1387womenprevented30hipfractures.

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

and178intheplacebogroup(n=1127)(p0.02).

5.2Pharmacokineticproperties

Calciumcarbonate:

Absorption:

Ondissolutionoftheeffervescenttablet,thecalciumcarbonateisconvertedinthepresenceofcitricacidtosoluble

calciumcitrate.Some30-40%oftheingesteddoseofcalciumisabsorbed,predominantlyintheproximalpartofthe

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Elimination:

Calciumisexcretedintheurine,faecesandinsweat.Urinaryexcretiondependsonglomerularfiltrationandtubular

resorption.

VitaminD

Absorption:

VitaminD

isabsorbedintheintestineandtransportedbyproteinbindinginthebloodtotheliver(whereitundergoes

thefirsthydroxylationto25-hydroxycholecalciferol)andtothekidneys(secondhydroxylationto1,25-

dihydroxycholecalciferol),theactualactivemetaboliteofvitaminD

Non-hydroxylatedvitaminD

isstoredinmuscleandadiposetissues.

Elimination:

Theplasmahalf-lifeisintheorderofseveraldays;vitaminD

iseliminatedinthefaecesandurine.

5.3Preclinicalsafetydata

NootherrelevantdataisavailablethathasnotbeenmentionedelsewhereintheSummaryofProductCharacteristics

(see4.6Pregnancyandlactation;4.9Overdose).

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Citricacidanhydrous,

Malicacid,

Sodiumhydrogencarbonate,

Sodiumcyclamate,

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

Sodiumcarbonate,

Maltodextrin,

Saccharinsodium,

Sucrose,

Gelatin,

Maizestarch,

Partiallyhydrogenatedsoyaoil,

-tocopherol.

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

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6.4Specialprecautionsforstorage

Donotstoreabove30°C.

Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

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

Eachunitof20tabletsisinanaluminiumorpolypropylenetubewithpolyethylenestopper.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLimited

TradingasNovartisConsumerHealth

WimblehurstRoad

HorshamRH125AB

WestSussex

England

8MARKETINGAUTHORISATIONNUMBER

PA0030/038/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:28 th

April2000

Dateoflastrenewal:14 th

January2009

10DATEOFREVISIONOFTHETEXT

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