CALTRATE

Main information

  • Trade name:
  • CALTRATE Film Coated Tablet 600/ 400
  • Dosage:
  • 600/ 400
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALTRATE Film Coated Tablet 600/400
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0172/038/001
  • Authorization date:
  • 24-04-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Caltrate600mg/400IU,Film-coatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

600mgofcalcium(ascalciumcarbonate)

10microgramsofcholecalciferol(equivalentto400I.U.vitaminD

Excipients:sucrose,partiallyhydrogenatedsoyabeanoil.

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet.

Capsule-shapedgrey/beigetablets.Onesideisscoredandengravedwith“D”ontheleftand“600”ontherightofthescore.The

othersideisengravedwith“Caltrate”.

Thescorelineisonlytofacilitatebreakingforeaseofswallowingandnottodivideintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CorrectionofcombinedvitaminDandcalciumdeficienciesintheelderly.

SupplyofvitaminDandcalciumasanadjuncttospecifictreatmentsforosteoporosis,inpatientswherecombinedvitaminDand

calciumdeficiencieshavebeendiagnosedorthoseathighriskofsuchdeficiency.

4.2Posologyandmethodofadministration

Adultsandelderly

Onetablettwiceaday(e.g.onetabletinthemorningandonetabletintheevening).Dosereductionshouldbeconsideredas

necessaryfollowingthemonitoringofcalciumlevelsasindicatedinsection4.4and4.5.

Pregnantwomen

Onetabletaday(seesection4.6).

Posologyincasesofhepaticinsufficiency

Thedosedoesnotrequireadjustment.

Thetabletshouldbeswallowedwithalargeglassofwater.

4.3Contraindications

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Theproductcontainspartiallyhydrogenatedsoyabeanoilandiscontraindicatedforpatientshypersensitivetopeanutor

soya.

Renalfailure.

Hypercalciuriaandhypercalcaemiaanddiseasesand/orconditions,whichleadtohypercalcaemiaand/orhypercalciuria(e.g.

myeloma,bonemetastases,primaryhyperparathyroidism).

Kidneystones(nephrolitiasis,nephrocalcinosis).

HypervitaminosisD.

4.4Specialwarningsandprecautionsforuse

Intheeventofprolongedtreatment,checkingcalcaemiaandrenalfunctionbyassayingserumcreatinineisjustified.This

monitoringisparticularlyimportantintheelderly,incasesofcombinedtreatmentwithcardiacglycosidesordiuretics(see

section4.5)andinpatientswhoarefrequentlysubjecttotheformationofkidneystones.Inthepresenceofhypercalcaemiaor

signsofproblemswithrenalfunction,thedosemustbereducedortreatmentinterrupted.

Caltratemustbeprescribedwithcautiontopatientswhoareimmobilizedandsufferingfromosteoporosis,becauseofthe

increaseintheriskofhypercalcaemia.

TakeintoaccounttheintakeofvitaminDandcalciumfromallothersourcesbeforeprescribingCaltrate.Asthisproductalready

containsvitaminD,theadditionaladministrationofvitaminDorcalciummustbecarriedoutunderstrictmedicalsupervision

withregularmonitoringofcalcaemiaandcalciuria.Itisadvisabletoreduceorinterrupttreatmenttemporarilyifurinecalcium

exceeds7.5mmol/24h(300mg/24h).

CaltratemustbeusedwithcautioninpatientssufferingfromsarcoidosisbecauseofapossibleincreaseinvitaminD

metabolism

toitsactiveform.Inthesepatients,calcaemiaandcalciuriamustbemonitored.

Caltratemustbeusedwithcautionandphosphate-calciumlevelsmonitoredinpatientspresentingwithadecreaseinrenal

function.Theriskofsofttissuecalcificationmustbetakenintoaccount.Inpatientswithsevererenalinsufficiency,vitaminD

theformofcholecalciferolisnotmetabolisedinthenormalwayandotherformsofvitaminD

mustbeused(seesection4.3).

Post-marketingcasesofasphyxiationduetotabletchokinghavebeenreported.Itisalwaysrecommendedtotaketabletswitha

largeglassofwater(200ml).Inordertofacilitateintakebypatients,especiallyelderlyorpatientswithknowndifficultiesin

swallowing,thebreakabletabletmaybedividedintotwopartsbeforetakingthemwithalargeglassofwater.

Thisproductcontainssucrose,thereforepatientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactose

malabsorptionorsucrase-isomaltaseinsufficiencyshouldnottakethismedicine.

Thisproductcontainspartiallyhydrogenatedsoyabeanoilwhichcancausehypersensitivityreactions(urticaria,anaphylactic

shock).Itisthereforecontraindicatedforpatientshypersensitivetopeanutorsoya(seesection4.3).

Caltrateisnotintendedforuseinchildrenandadolescents.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thiazidediureticsreducecalciumexcretionintheurine.Becauseoftheincreasedriskofhypercalcaemia,calciummonitoringis

recommendedincaseswhenthiazidediureticsaregivensimultaneously.

Systemiccorticosteroidsreducecalciumabsorption.Inthecaseofconcomitantadministrationofcorticosteroids,itmightbe

necessarytoincreasethedoseofCaltrate.

Orlistat,combinedion-exchangeresintreatmentsuchascholestyramineorlaxativessuchasparaffinoilcanreducethe

gastrointestinalabsorptionofvitaminD

Calciumcarbonatecanaltertetracyclineabsorptionwhengivensimultaneously.Itisrecommendedthattakingtetracyclinebe

staggeredbyatleast2hoursbeforeor4to6hoursaftertakingcalciumbymouth.

Hypercalcaemiacanincreasethetoxicityofcardiacglycosidesinthecaseofsimultaneousadministrationwithcalciumand

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PhenytoinorbarbituratesmayreducetheactivityofvitaminD

,sincetheyincreasetherateofitsmetabolism.

Calciumsaltsmaydecreasetheabsorptionofiron,zincorstrontium.Consequently,theiron,zincorstrontiumpreparationshould

betakenatadistanceoftwohoursfromthecalciumpreparation.

Calciumsaltsmayreducetheabsorptionoftheestramustinorthyroidhormones.ItisrecommendedthattakingCaltratebe

spacedatleast2hoursfromthesemedicines.

Inthecaseofconcomitantbisphosphonate,sodiumfluorideorfluoroquinoloneadministration,itisrecommendedthattaking

Caltratebespacedbyatleast3hours,astheirabsorptionduringdigestionmaybereduced.

Oxalicacid(foundinspinachandrhubarb)andphyticacid(foundinwholegraincereals)caninhibitcalciumabsorptionby

forminginsolublecompoundswithcalciumions.Patientsmustnottakecalciumcontaining-productsinthetwohoursafterthe

consumptionoffoodsrichinoxalicacidandphyticacid.

4.6Fertility,pregnancyandlactation

Pregnancy

CaltratemaybegivenduringpregnancyincasesofcalciumandvitaminD

deficiency.

Duringpregnancythedailydoseshouldnotexceed1500mgofcalciumand600IUofvitaminD.Animalstudieshaveshown

toxiceffectsonreproductionathighdosesofvitaminD.Inpregnantwomen,allcalciumorvitaminDoverdosesmustbeavoided

asprolongedhypercalcaemiainpregnancymayleadtoretardationofphysicalandmentaldevelopment,supravalvularaortic

stenosisandretinopathyinthechild.TherearenoindicationsthatVitaminD

attherapeuticdosesisteratogenicinman.

Lactation

Caltratecanbeusedduringbreastfeeding.CalciumandvitaminD

passintomaternalmilk.Thismustbetakenintoconsideration

whenvitaminD

isgivenconcomitantlytothechild.

4.7Effectsonabilitytodriveandusemachines

Therearenodatarelatingtotheeffectofthismedicinalproductontheabilitytodrivevehicles.Howeverthereislittlelikelihood

ofaneffect.

4.8Undesirableeffects

Adverseeffectsarelistedbelow,classifiedbysystem,organ,classandfrequency.Frequenciesaredefinedasfollows:

uncommon( ≥1/1,000to<1/100)orrare(≥1/10,000to<1/1,000).

Metabolismandnutritiondisorders

Uncommon:hypercalcaemiaandhypercalciuria.

Gastrointestinaldisorders

Rare:constipation,flatulence,nausea,abdominalpainanddiarrhoea.

Skinandsubcutaneoustissuedisorders

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4.9Overdose

Anoverdosecanleadtohypervitaminosisandhypercalcaemia.Thesymptomsofhypercalcaemiacaninclude:

anorexia,thirst,nausea,vomiting,constipation,abdominalpain,muscleweakness,fatigue,mentaldisturbances,

polydipsia,polyuria,skeletalpain,renalcalcinosis,kidneystones,andinseverecases,cardiacarrhythmia,Burnett’s

syndrome”.Extremehypercalcaemiamayleadtocomaanddeath.Continuoushighcalciumlevelsmayleadto

irreversibledamagetothekidneysandsofttissuecalcification.

Treatmentofhypercalcaemia:AllcalciumandvitaminD

treatmentsmustbestopped.Treatmentwiththiazide

diuretics,lithium,vitaminAandcardiacglycosidesmustalsobestopped.Gastriclavageshouldbeperformedon

patientswithproblemsaffectingconsciousness.Rehydrateand,dependingonseverity,isolatedorcombinedtreatment

withloopdiuretics,bisphosphonates,calcitoninandcorticosteroidsshouldbeconsidered.Serumelectrolytes,kidney

functionanddiuresismustbemonitored.Inseverecases,ECGandcalcaemiashouldbemonitored.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Calciumcarbonateandcholecalciferol,ATCCode:A12AX.

VitaminDsupplementationcorrectsaninsufficientvitaminDintake.Itincreasestheintestinalabsorptionofcalcium.

TheoptimalvitaminDdoseinelderlysubjectsis500-1000I.U.perday.Calciumsupplementationbalancesadietary

calciumdeficiency.Theusualcalciumrequirementoftheelderlyis1500mg/day.VitaminDandcalcium

supplementationcorrectsecondarysenilehyperparathyroidism.

An18-month,double-blind,placebo-controlledstudycarriedoutin3270womenlivingininstitutions,aged84±6

yearsandreceivingavitaminD

supplement(800IU/day)andcalciumphosphate(correspondingto1200mg/dayof

elementalcalcium),showedasignificantdecreaseinPTHsecretion.After18months,followingan“intentionto

treat”(ITT)analysis,80hipfractureswereobservedinthecalcium-vitaminD

groupand110hipfracturesinthe

placebogroup(p=0.004).Inafollow-upstudyafter36months,137womenwithatleastonefractureofthehipwere

observedinthecalcium-vitaminD3group(n=1176)versus178womenintheplacebogroup(n=1127)(p ≤0.02).

5.2Pharmacokineticproperties

Calcium

Absorption:inthestomach,calciumcarbonatereleasescalciumionsdependinguponpH.Theamountofcalciumabsorbedby

thegastrointestinaltractisintheorderof30%oftheingesteddose.

Distributionandmetabolism:99%ofcalciumisstoredinthehardmatterofbonesandteeth.Theremainingonepercentisfound

inintraandextracellularliquids.Approximately50%oftotalbloodcalciumisfoundinthephysiologicallyactiveionisedform,

ofwhichapproximately10%incomplexeswithcitrate,phosphateorotheranionswith40%remainingboundtoproteins,mainly

albumin.

Elimination:calciumiseliminatedinthefaeces,urineandinsweat.Kidneyexcretiondependsonglomerularfiltrationandon

calciumreabsorptionbythetubules.

VitaminD

Absorption:vitaminDiseasilyabsorbedbythesmallintestine.

Distributionandmetabolism:cholecalciferolanditsmetabolitescirculateintheblood,linkedtoaspecificalphaglobulin.

Cholecalciferolismetabolisedintheliverbyhydroxylationtoitsactiveform,25-hydroxycholecalciferol.Itisthenmetabolised

inthekidneysto1,25-dihydroxycholecalciferol.1,25-dihydroxycholecalciferolisthemetaboliteresponsiblefortheincreasein

calciumabsorption.ThevitaminD

thatisnotmetabolisedisstoredinadiposeandmuscletissue.

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5.3Preclinicalsafetydata

Calciumcarbonateandcholecalciferoldidnotshowmutagenicpotentialinvitro(Amestest).

Ateratogeniceffecthasbeenobservedinanimalstudiesatverymuchhigherdosesthanhumantherapeuticdoses.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

TabletCore:

Microcrystallinecellulose

Povidone

CrospovidonetypeA

Sodiumlaurilsulphate

Sodiumcroscarmellose

Magnesiumstearate

DL--tocopherol

Partiallyhydrogenatedsoyabeanoil

Sucrose

Bovinegelatin

Cornstarch

TabletCoat:

Lightliquidparaffin

Talc

OPADRYOY-S-27203:

methylhydroxypropylcellulose

titaniumdioxide(E171)

lightliquidparaffin

sodiumlaurilsulphate

redironoxide(E172)

blackironoxide(E172)

yellowironoxide(E172)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Storebelow25°C.Keepthebottletightlyclosedinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Opaquewhitehighdensitypolyethylenebottleswithapolypropylenecapandinductionsealedfoilliner.

Bottlescontain30,60,90or180tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

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7MARKETINGAUTHORISATIONHOLDER

PfizerConsumerHealthcareLtd

RamsgateRoad

Sandwich

KentCT139NJ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA172/38/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24 th

April2009

10DATEOFREVISIONOFTHETEXT

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