CACIT D3

Main information

  • Trade name:
  • CACIT D3
  • Dosage:
  • 1000 Milligram
  • Pharmaceutical form:
  • Granules Effervescent
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CACIT D3
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0170/018/002
  • Authorization date:
  • 25-09-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0170/018/002

CaseNo:2046809

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

Procter&GamblePharmaceuticals

RushamPark,WhitehallLane,Egham,SurreyTW209NW,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CacitD31000mg/880IU,EffervescentGranulesforOralSolution.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom04/07/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CacitD31000mg/880IU,EffervescentGranulesforOralSolution.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onesachetof8gcontains:

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Effervescentwhitegranulesfororalsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CorrectionofvitaminDandcalciumcombineddeficiencyinelderlypeople.

VitaminDandcalciumsupplementationasanadjuncttospecifictherapyforosteoporosistreatmentinpatientswith

established,orathighriskofvitaminDandcalciumcombineddeficiencies.

4.2Posologyandmethodofadministration

Posology

Onesachetperday.

Methodofadministration

Oral.

Pourthecontentsofthesachetintoaglass,addalargequantityofwater,thendrinkimmediately.

4.3Contraindications

Diseasesand/orconditionsresultinginhypercalcaemiaand/orhypercalciuria.

Nephrolithiasis.

HypervitaminosisD.

Calciumelement 1000mgor25mmol

equivalenttocalciumcarbonate 2500 mg

Colecalciferol(VitaminD

µg

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4.4Specialwarningsandprecautionsforuse

Duringlong-termtreatment,serumcalciumlevelsshouldbefollowedandrenalfunctionshouldbemonitoredthrough

measurementsofserumcreatinine.Monitoringisespeciallyimportantinelderlypatientsonconcomitanttreatmentwith

cardiacglycosidesordiuretics(seesection4.5)andinpatientswithahightendencytocalculusformation.Incaseof

hypercalcaemiaorsignsofimpairedrenalfunctionthedoseshouldbereducedorthetreatmentdiscontinued.

VitaminDshouldbeusedwithcautioninpatientswithimpairmentofrenalfunctionandtheeffectoncalciumand

phosphatelevelsshouldbemonitored.Theriskofsofttissuecalcificationshouldbetakenintoaccount.Inpatientswith

severerenalinsufficiency,vitaminDintheformofcholecalciferolisnotmetabolisednormallyandotherformsof

vitaminDshouldbeused(seeSection4.3,Contraindications)

CacitVitaminD3sachetsshouldbeprescribedwithcautiontopatientssufferingfromsarcoidosis,duetotheriskof

increasedmetabolismofvitaminDintoitsactiveform.Thesepatientsshouldbemonitoredwithregardtothecalcium

contentinserumandurine.

CacitVitaminD3sachetsshouldbeusedcautiouslyinimmobilisedpatientswithosteoporosisduetotheincreasedrisk

ofhypercalcaemia.

ThecontentofvitaminD(440IU)inCacitVitaminD3sachetsshouldbeconsideredwhenprescribingothermedicinal

productscontainingvitaminD.AdditionaldosesofcalciumorvitaminDshouldbetakenunderclosemedical

supervision.Insuchcasesitisnecessarytomonitorserumcalciumlevelsandurinarycalciumexcretionfrequently.

CacitVitaminD3sachetsarenotintendedforuseinchildren.

Specialwarnings

Thismedicinalproductcontainssucrose.Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-

galactosemalabsorptionorsucrose-isomaltaseinsufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitantuserequiringprecautions:

Digitalisandothercardiacglycosides:theoraladministrationofcalciumcombinedwithvitaminDincreasesthe

toxicityofdigitalis(riskofdysrythmia).Strictmedicalsupervision,andifnecessary,monitoringECGand

calcaemiaarenecessary.

Bisphosphonate,sodiumfluoride:itisadvisabletoallowaminimumperiodoftwohoursbeforetakingthe

calcium(riskofreductionofthegastrointestinalabsorptionofbisphosphonateandsodiumfluoride).

Thiazidediuretics:reduceurinaryeliminationofcalciumthereforesupervisionofcalcaemiaisrecommended.

Phenytoinorbarbiturates:candecreasetheeffectofvitaminDbecauseofmetabolicinactivation.

Glucocorticosteroid:candecreasetheeffectofvitaminD.

Tetracyclinesbyoralroute:itisadvisabletodelaytakingthecalciumbyatleastthreehours(calciumsalts

reducetheabsorptionoftetracyclines).

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4.6Pregnancyandlactation

DuetothehighdosageinVitaminD,thispresentationisnotindicatedduringpregnancyandlactation.

Inpregnancy,overdosesofcolecalciferolmustbeavoided.

OverdosesofvitaminDhaveshownteratogeniceffectsinpregnantanimals.

Inhumans,overdosesofcolecalciferolmustbeavoidedaspermanenthypercalcaemiacanleadtophysicalandmental

retardation,supravalvularaorticstenosisandretinopathyinthechild.

Therearehoweverseveralcasereportsofadministrationofveryhighdosesinhypoparathyroidisminthemother,

wherenormalchildrenwereborn.

VitaminDanditsmetabolitespassintothebreastmilk.

4.7Effectsonabilitytodriveandusemachines

Noremarkablefindings.Noeffectexpected.

4.8Undesirableeffects

Adversereactionsarelistedbelow,bysystemorganclassandfrequency.Frequenciesaredefinedas:uncommon

(>1/1,000,<1/100)orrare(>1/10,000,<1/1,000).

Metabolismandnutritiondisorders

Uncommon:Hypercalcaemiaandhypercalciuria.

Gastrointestinaldisorders

Rare:Constipation,flatulence,nausea,abdominalpainanddiarrhoea.

Skinandsubcutaneousdisorders

Rare:Pruritus,rashandurticaria.

4.9Overdose

Consequenceofoverdosearehypercalciuriaandhypercalcaemia.Symptomsincludes:nausea,vomiting,thirst,

polydipsia,polyuria,constipation.

Chronicoverdosescanleadtovascularandorgancalcificationsasaresultofhypercalcaemia.

Treatment

StopallintakeofcalciumandvitaminD,rehydration.

5PHARMACOLOGICALPROPERTIES

VitaminDCalciumSupplement(medicinalproductactiveoncalciumcheckup.A:digestivetractandmetabolism).

5.1Pharmacodynamicproperties

VitaminDcorrectsaninsufficientintakeofvitaminDandincreasesintestinalabsorptionofcalcium.

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Thecommonlyacceptedrequirementofcalciumintheelderlyis1500mg/day.

TheoptimalamountofvitaminDintheelderlyis500-1000IU/day.

VitaminDandcalciumcorrectsecondarysenilehyperparathyroidism.

Inadoubleblindplacebocontrolledstudyof18months,including3270womenaged84 ±

6yearswithalowintakeof

calciumandlivinginnursinghomes,hadtheirdietsupplementedwithcolecalciferol(800UI/day)+Calcium(1.2

g/day).AsignificantdecreaseinPTHsecretionhasbeenobserved.

After18months,resultsoftheintendtotreatanalysisshowed80hipfractures(5.7%)intheCalciumVitaminDgroup

and110hipfractures(7.9%)intheplacebogroup(p=0.004).Therefore,inthesestudyconditions,thetreatmentof

1387womenprevented30hipfractures.After36monthsoffollowup,137womenpresentedatleastonehipfracture

(11.6%)intheCalciumVitaminDgroup(n=1176)and178(15.8%)intheplacebogroup(n=1127)(p 0.02).

5.2Pharmacokineticproperties

DuringdissolutionthecalciumsaltcontainedinCacitVitaminD3istransformedintocalciumcitrate.

Calciumcitrateiswellabsorbed,approximately30%to40%oftheingesteddose.

Calciumiseliminatedintheurineandfaecesandsecretedinthesweat.

VitaminDisabsorbedintheintestineandtransportedbyproteinbindinginthebloodtotheliver(firsthydroxylation)

thentothekidney(secondhydroxylation).

Thenon-hydroxylatedvitaminDisstoredinreservecompartmentssuchasadiposeandmuscletissue.Itsplasmahalf-

lifeisseveraldays;itiseliminatedinthefaecesandtheurine.

5.3Preclinicalsafetydata

Noremarkablefindings.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Citricacidanhydrous

Malicacid

Gluconolactone

Maltodextrin

Sodiumcyclamate

Saccharinsodium

Lemonflavouring(containing:Sorbitol,Mannitol,D-gluconolactone,Dextrin,Gumarabic,Lemonoil)

Ricestarch

Potassiumcarbonate

-Tocopherol

Soya-beanoilhydrogenated

Gelatin

Sucrose

Cornstarch

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

8gsachets(paper/aluminium/polyethylene);boxesof20,30,46,50or100sachetsandsamplepackof10sachets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Procter&GamblePharmaceuticalsUKLimited

RushamPark

WhitehallLane

Egham

TW209NW

Surrey

8MARKETINGAUTHORISATIONNUMBER

PA0170/018/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25 th

September1996

Dateoflastrenewal:11 th

February2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 05/07/2008 CRN 2046809 page number: 6