CALVIDIN ᆴ 600 MG/ 400 I.U. CHEWABLE TABLETS

Main information

  • Trade name:
  • CALVIDIN ᆴ 600 MG/ 400 I.U. CHEWABLE TABLETS
  • Dosage:
  • 600/ 400IU Base Milligrams
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALVIDIN ᆴ 600 MG/400 I.U. CHEWABLE TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0868/004/001
  • Authorization date:
  • 10-11-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CALVIDIN ®

600mg/400I.U.chewabletablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachchewabletabletcontains:

Calciumcarbonate 1500mg

equivalenttoelementalcalcium 600mg

Cholecalciferolconcentrate(powderform) 4 mg

equivalenttovitaminD

10µg(400I.U.)

Excipient:

Sucrose1,54mg

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Chewabletablet

WhitebiplanetabletswithasnapgroveandthelettersC/D.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CorrectionofcombinedvitaminDandcalciumdeficienciesintheelderly.

SupplyofvitaminDandcalciumasanadjuncttospecifictreatmentsforosteoporosis,inpatientswherecombined

vitaminDandcalciumdeficiencieshavebeendiagnosedorthoseatahighriskofsuchdeficiency.

4.2Posologyandmethodofadministration

Adultsandelderly

Onechewabletablettwiceaday[e.g.onetabletinthemorningandonetabletintheevening(equivalentto1200mgof

calciumand800I.U.ofvitaminD

)].Dosereductionshouldbeconsideredasnecessaryfollowingthemonitoringof

calciumlevelsasindicatedinsection4.4and4.5.

Pregnantwomen

Onechewabletabletaday(seesection4.6).

Posologyincasesofhepaticinsufficiency

Thedosedoesnotrequireadjustment.

Posologyincasesofrenalinsufficiency

Dosageinrenalimpairment:CALVIDIN ®

chewabletabletsshouldnotbeusedinpatientswithsevererenal

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Thetabletsarechewedandthenswallowedwithalittleliquid.

Inexceptionalcases(e.g.patientsdisabled)thetabletscan,afterconsultingadoctor,besucked.

Foradultsonly.

4.3Contraindications

Hypersensitivitytotheactivesubstancesortoanyoftheexcipients(seesection6.1)

Renalfailure

Hypercalciuriaandhypercalcaemiaanddiseasesand/orconditions,whichleadtohypercalcaemiaand/or

hypercalciuria(e.g.myeloma,bonemetastases,primaryhyperparathyroidism).

Kidneystones(nephrolitiasis,nephrocalcinosis)

HypervitaminosisD.

4.4Specialwarningsandprecautionsforuse

Intheeventofprolongedtreatment,checkingcalcaemiaandrenalfunctionbyassayingserumcreatinineisjustified.

Thismonitoringisparticularlyimportantintheelderly,incasesofcombinedtreatmentwithcardiacglycosidesand

diuretics(seesection4.5)andinpatientswhoarefrequentlysubjecttotheformationofkidneystones.Inthepresence

ofhypercalcaemiaorsignsofproblemswithrenalfunctionthedosemustbereducedortreatmentinterrupted.Therapy

shouldbereducedorpreliminaryinterruptedifurinarycalciumlevelexceeds7.5mmol/24hours(300mg/24hours).

CALVIDIN ®

chewabletabletsmustbeprescribedwithcautiontopatientswhoareimmobilizedandsufferingfrom

osteoporosis,becauseoftheincreaseintheriskofhypercalcaemia.

TakeintoaccounttheintakeofvitaminD,calciumandalkalilikecarbonatefromallothersources(e.g.dietary

supplementsorfood)beforeprescribingCALVIDIN ®

chewabletablets.AstheseproductsalreadycontainvitaminD

andcalciumcarbonate,theadditionaladministrationofvitaminDorcalciumcarbonatemayleadtoaBurnett

Syndrome(hypercalcaemia,metabolicalkalosis,renalfailureandsofttissuecalcification)andmustthereforebecarried

outunderstrictmedicalsupervisionwithregularmonitoringofcalcaemiaandcalciuria.

CALVIDIN ®

chewabletabletsmustbeusedwithcautioninpatientssufferingfromsarcoidosisbecauseofapossible

increaseinvitaminD

metabolismtoitsactiveform.Inthesepatients,calcaemiaandcalciuriamustbemonitored.

CALVIDIN ®

chewabletabletsmustbeusedwithcautionandphosphate-calciumlevelsmonitoredinpatients

presentingwithadecreaseinrenalfunction.Theriskofsofttissuecalcificationmustbetakenintoaccount.Inpatients

withsevererenalinsufficiencyvitaminD

intheformofcholecalciferolisnotmetabolizedinthenormalwayand

otherformsofvitaminD

mustbeused(seesection4.3).

CALVIDIN ®

chewabletabletsisnotintendedforuseinchildrenoradolescents.

Thisproductcontainssucrose,thereforepatientswithrarehereditaryproblemsoffructoseintolerance,glucose-

galactosemalabsorptionorsucrase-isomaltaseinsufficiencyshouldnottakethismedicine.

Notefordiabetics:

TheproportionofdigestiblecarbohydrateinCALVIDIN ®

chewabletabletsis0.47gpertablet.Thedailydoseof2

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thiazidediureticsreducecalciumexcretionintheurine.Becauseoftheincreasedriskofhypercalcaemia,calcium

monitoringisrecommendedincaseswhenthiazidediureticsaregivensimultaneously.

Systemiccorticosteroidsreducecalciumabsorption.Inthecaseofconcomitantadministrationofcorticosteroids,it

mightbenecessarytoincreasethedoseofCALVIDIN ®

chewabletablets.

Orlistat,combinedion-exchangeresintreatmentsuchascholestyramineorlaxativessuchasparaffinoilcanreducethe

gastrointestinalabsorptionofvitaminD

.Anintervalofatleasttwohoursshouldbeobservedbetweeningestionof

ion-exchangeresins(e.g.cholestyramine)orlaxativesandCALVIDIN ®

chewabletabletsasotherwisetheabsorption

ofvitaminD

isreduced.

Calciumcarbonatecanaltertetracyclineabsorptionwhengivensimultaneously.Itisrecommendedthattaking

tetracyclinebestaggeredbyatleast2hoursbeforeor4to6hoursaftertakingcalciumbymouth.

Hypercalcaemiacanincreasethetoxicityofcardiacglycosidesinthecaseofsimultaneousadministrationwithcalcium

andvitaminD.Consequentlypatientsmustbemonitoredregularly(ECGcheckandcalcaemia).

Rifampicin,phenytoinorbarbituratesmayreducetheactivityofvitaminD

,sincetheyincreasetherateofits

metabolism.

Calciumsaltsmaydecreasetheabsorptionofiron,zincorstrontium.Consequently,theiron,zincorstrontium

preparationshouldbetakenatadistanceoftwohoursfromthecalciumpreparation.

Calciumsaltsmayreducetheabsorptionoftheestramustinorthyroidhormones.Itisrecommendedthattaking

CALVIDIN ®

chewabletabletsbespacedatleast2hoursfromthesemedicines.

Inthecaseofconcomitantbisphosphonate,sodiumfluorideorfluoroquinoloneadministration,itisrecommendedthat

takingCALVIDIN ®

chewabletabletsbespacedbyatleast3hours,astheirabsorptionduringdigestionmaybe

reduced.

Oxalicacid(foundinspinachandrhubarb)andphyticacid(foundinwholegraincereals)caninhibitcalcium

absorptionbyforminginsolublecompoundwithcalciumions.Patientsmustnottakecalciumcontaining-productsin

thetwohoursaftertheconsumptionoffoodsrichinoxalicacidandphyticacid.

4.6Fertility,pregnancyandlactation

Pregnancy

CALVIDIN ®

chewabletabletsmaybegivenduringpregnancyincasesofcalciumandvitaminD

deficiency.

Duringpregnancythedailydoseshouldnotexceed1500mgofcalciumand600I.U.ofvitaminD.Thereforethedaily

dosemustnotexceed1tablet.

AnimalstudieshaveshowntoxiceffectsonreproductionathighdosesofvitaminD.Inpregnantwomen,allcalciumor

vitaminDoverdosesmustbeavoided,asprolongedhypercalcaemiainpregnancymayleadtoretardationofphysical

andmentaldevelopment,supravalvularaorticstenosisandretinopathyinthechild.Therearenoindicationsthat

VitaminD

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Lactation

CALVIDIN ®

chewabletabletscanbeusedduringbreastfeeding.CalciumandVitaminD

passintomaternalmilk.

ThismustbetakenintoconsiderationwhenvitaminD

isgivenconcomitantlytothechild.

Inpregnantandlactatingwomen,thecalciumpreparationshouldbetakenatadistanceoftwohoursfromamealdueto

apossibledecreaseofironabsorption.

4.7Effectsonabilitytodriveandusemachines

Therearenodatarelatingtotheeffectofthismedicinalproductontheabilitytodrivevehicles.

Howeverthereislittlelikelihoodofaneffect.

4.8Undesirableeffects

Theevaluationofundesirableeffectsisgenerallybasedonthefollowingfrequencyconvention:

verycommon(1/10),common(1/100to<1/10);

uncommon(1/1,000to<1/100);rare(1/10,000to<1/1,000);

veryrare(<1/10,000),notknown(cannotbeestimatedfromtheavailabledata).

Immunesystemdisorders:

Notknown(cannotbeestimatedfromtheavailabledata):Hypersensitivityreactionssuchasangiooedemaorlaryngeal

oedema

Metabolismandnutritiondisorders

Uncommon(1/1,000to<1/100):Hypercalcaemiaandhypercalciuria

Gastrointestinaldisorders

Rare( 1/10,000to<1/1,000):Constipation,flatulence,bloating,abdominaldistension,nausea,abdominalpain,

diarrhoea

Notknown(cannotbeestimatedfromtheavailabledata):Vomiting

Skinandsubcutaneoustissuedisorders

Rare(1/10,000to<1/1,000):Pruritus,rashandurticaria

4.9Overdose

Anoverdosecanleadtohypervitaminosisandhypercalcaemia.Thesymptomsofhypercalcaemiacaninclude:

anorexia,thirst,nausea,vomiting,constipation,dehydratation,abdominalpain,muscleweakness,fatigue,mental

disturbances,polydipsia,polyuria,skeletalpain,renalcalcinosis,kidneystonesandinseverecasescardiacarrhythmia.

Extremehypercalcaemiamayleadtocomaanddeath.Continuoushighcalciumlevelsmayleadtoirreversibledamage

tothekidneysandsofttissuecalcification.

Treatmentofhypercalcaemia:AllcalciumandvitaminD

treatmentsmustbestopped.Treatmentwiththiazide

diuretics,lithium,vitaminAandcardiacglycosidesmustalsobestopped.Gastriclavageshouldbeperformedon

patientswithproblemsaffectingconsciousness.

Rehydrateand,dependingonseverity,isolatedorcombinedtreatmentwithloopdiuretics,bisphosphonates,calcitonin

andcorticosteroidsshouldbeconsidered.Serumelectrolytes,kidneyfunctionanddiuresismustbemonitored.Insevere

casesECGandcalcaemiashouldbemonitored.

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

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Mineralsupplements,Calciumincombinationwithotheragents

ATCcode:A12AX

VitaminDsupplementationcorrectsaninsufficientvitaminDintake.Itincreasestheintestinalabsorptionofcalcium.

TheoptimalvitaminDdoseinelderlysubjectsis500-1000I.U.perday.Calciumsupplementationbalancesadietary

calciumdeficiency.Theusualcalciumrequirementoftheelderlyis1500mg/day.VitaminDandcalcium

supplementationcorrectsecondarysenilehyperparathyroidism.

An18months,double-blind,placebo-controlledstudycarriedoutin3270womenlivingininstitutions,aged84±6

yearsandreceivingavitaminD

supplement(800I.U./day)andcalciumphosphate(correspondingto1200mg/dayof

elementalcalcium)showedasignificantdecreaseinPTHsecretion.After18months,followingan“intentionto

treat”(ITT)analysis80hipfractureswereobservedinthecalciumvitaminD

groupand110hipfracturesinthe

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

observedinthecalciumvitaminD

group(n=1176)versus178intheplacebogroup(n=1127)(p0.02).

5.2Pharmacokineticproperties

Calcium

Absorption:

Inthestomach,calciumcarbonatereleasescalciumionsdependinguponpH.TheamountofCalciumabsorbedbythe

gastrointestinaltractisintheorderof30%oftheingesteddose.

Distributionandmetabolism:

99%ofcalciumisstoredinthehardmatterofbonesandteeth.Theremainingonepercentisfoundinintraand

extracellularliquids.Approximately50%oftotalbloodcalciumisfoundinthephysiologicallyactiveionisedform,of

whichapproximately10%incomplexeswithcitrate,phosphateorotheranionswith40%remainingboundtoproteins,

mainlyalbumin.

Elimination:

Calciumiseliminatedintheurine,faecesandinthesweat.Kidneyexcretiondependsonglomerularfiltrationand

calciumreabsorptionbythetubules.

VitaminD

Absorption:

VitaminDiseasilyabsorbedbythesmallintestine.

Distributionandmetabolism:

Cholecalciferolanditsmetabolitescirculateintheblood,linkedtoaspecificalphaglobulin.Cholecalciferolis

metabolisedintheliverbyhydroxylationtoitsactiveform,25-hydroxycholecalciferol.Itisthenmetabolisedinthe

kidneysto1,25-dihydroxycholecalciferol.1,25-dihydroxycholecalciferolisthemetaboliteresponsiblefortheincrease

incalciumabsorption.ThevitaminD

thatisnotmetabolisedisstoredinadiposeandmuscletissue.

Elimination

VitaminD

isexcretedviathefaecesandurine.

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5.3Preclinicalsafetydata

Ateratogeniceffecthasbeenobservedinanimalstudiesatverymuchhigherdosesthanhumantherapeuticdoses.

Thereisnofurtherinformationofrelevancetothesafetyassessmentinadditiontowhatisstatedinotherpartsofthe

SPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Xylitol

Mannitol(E421)

Magnesiumstearate

Silicacolloidalanhydrous

Pregelatinisedmaizestarch

Butylatedhydroxytoluene(E321)

Triglyceridesmedium-chain

Sucrose

Gelatin

Modifiedmaizestarch

Sodiumaluminiumsilicate

Flavouringagents(Tuttifrutti77919-31Givaudan:allylhexanoate,amyl-/isoamylbutyrate,ethylacetate,ethylbutyrate,

ethylvanillin,geraniol,isoamylacetate,-ionon,maltodextrin,propylenglycol)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

30months.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

PVC/PVDC/Aluminiumblisters,eachcontaining10chewabletablets.

Cardboardboxcontaining20,30,50,60,100,300chewabletablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

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7MARKETINGAUTHORISATIONHOLDER

RottapharmLtd.

DamastownIndustrialPark

Mulhuddart

Dublin15

8MARKETINGAUTHORISATIONNUMBER

PA868/4/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10 th

November2000

Dateoflastrenewal: 4 th

August2009

10DATEOFREVISIONOFTHETEXT

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