CALCICHEW D3

Main information

  • Trade name:
  • CALCICHEW D3
  • Dosage:
  • 500mg/200I %v/v
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0535/001/001
  • Authorization date:
  • 16-08-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0535/001/001

CaseNo:2031455

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ShirePharmaceuticalsLimited

HampshireInternationalBusiness,Chineham,Basingstoke,HampshireRG248EP,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CALCICHEWD3ChewableTablets,calcium/colecalciferolequivalentto500mgcalcium/200IUcolecalciferol

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom27/07/2007until15/08/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 22/09/2007 CRN 2031455 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calcichew-D

ChewableTablets,calciumcarbonate/colecalciferolequivalentto500mgCalcium/200IUcolecalciferol.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

ChewableTablet.

Round,white,biconvex,orange-flavouredtablet.Mayhavesmallspecks.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Calcichew-D

ChewableTabletsmaybeusedasanadjuncttospecifictherapyforosteoporosisorasatherapeutic

supplementinestablishedosteomalacia.Itmayalsobeusedinpregnantpatientsathighriskofneedingsucha

therapeuticsupplementationormalnutritionwhendietaryintakeislessthanthatrequired.

4.2Posologyandmethodofadministration

Oral

Adjunctivetherapyinosteoporosis:

Onechewabletablet2-3timesperday

CalciumandvitaminDdeficiency:

Adults Onechewabletablet2-3timesperday

Children Onechewabletablet1-2timesperday

Thetabletmaybechewedorsucked.

Dosageinhepaticimpairment:

Nodoseadjustmentisrequired.

Dosageinrenalimpairment:

Calcichew-D

Pertablet:

CalciumCarbonate 1250 mg

(equivalentto500mgofelementalcalcium)

Colecalciferol 200 IU

(equivalentto5microgramsvitaminD

Containssorbitol,390mg;isomalt,62mg;aspartame,1mg;sucrose0.76mgandsoyabeanoil,

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4.3Contraindications

Diseasesand/orconditionsresultinginhypercalcaemiaand/orhypercalciuria

Nephrolithiasis

HypervitaminosisD

Hypersensitivitytosoyaorpeanut

Hypersensitivitytotheactivesubstancesortoanyoftheexcipients

4.4Specialwarningsandprecautionsforuse

Duringlong-termtreatment,serumcalciumlevelsshouldbefollowedandrenalfunctionshouldbemonitoredthrough

measurementofserumcreatinine.Monitoringisespeciallyimportantinelderlypatientsonconcomitanttreatmentwith

cardiacglycosidesordiuretics(seesection4.5)andinpatientswithahightendencytocalculusformation.Incaseof

hypercalcaemiaorsignsofimpairedrenalfunction,thedoseshouldbereducedorthetreatmentdiscontinued.

VitaminDshouldbeusedwithcautioninpatientswithimpairmentofrenalfunctionandtheeffectoncalciumand

phosphatelevelsshouldbemonitored.Theriskofsofttissuecalcificationshouldbetakenintoaccount.Inpatients

withsevererenalinsufficiency,vitaminDintheformofcolecalciferolisnotmetabolisednormallyandotherformsof

vitaminDshouldbeused(seesection4.3Contraindications).

Calcichew-D

ChewableTabletsshouldbeprescribedwithcautiontopatientssufferingfromsarcoidosisbecauseofthe

riskofincreasedmetabolismofvitaminDtoitsactiveform..Thesepatientsshouldbemonitoredwithregardtothe

calciumcontentinserumandurine.

Calcichew-D

ChewableTabletsshouldbeusedwithcautioninimmobilisedpatientswithosteoporosisduetothe

increasedriskofhypercalcaemia.

Thedoseofcolecalciferol(200IU)inCalcichew-D

ChewableTabletsshouldbeconsideredwhenprescribingother

drugscontainingvitaminD.AdditionaldosesofcalciumorvitaminDshouldbetakenunderclosemedical

supervision.Insuchcasesitisnecessarytomonitorserumcalciumlevelsandurinarycalciumexcretionfrequently.

Calcichew-D

ChewableTabletscontainaspartame(asourceofphenylalanine)whichmaybeharmfulforpeoplewith

phenylketonuria.

Calcichew-D

ChewableTabletscontainsorbitol(E420),isomalt(E953)andsucrose.Patientswithrarehereditary

problemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltaseinsufficiencyshouldnottake

thismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thiazidediureticsreducetheurinaryexcretionofcalcium.Duetoincreasedriskofhypercalcaemia,serumcalcium

shouldberegularlymonitoredduringconcomitantuseofthiazidediuretics.

Systemiccorticosteroidsreducecalciumabsorption.Duringconcomitantuse,itmaybenecessarytoincreasethedose

ofCalcichew-D

ChewableTablets.

Simultaneoustreatmentwithionexchangeresinssuchascholestyramineorlaxativessuchasparaffinoilmayreduce

thegastrointestinalabsorptionofvitaminD.

Calciumcarbonatemayinterferewiththeabsorptionofconcomitantlyadministeredtetracyclinepreparations.Forthis

reason,tetracyclinepreparationsshouldbeadministeredatleasttwohoursbefore,orfourtosixhoursafter,oralintake

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HypercalcaemiamayincreasethetoxicityofcardiacglycosidesduringtreatmentwithcalciumandvitaminD.Patients

shouldbemonitoredwithregardtoelectrocardiogram(ECG)andserumcalciumlevels.

Ifabisphosphonateorsodiumfluorideisusedconcomitantly,thispreparationshouldbeadministeredatleastthree

hoursbeforetheintakeofCalcichew-D

ChewableTabletssincegastrointestinalabsorptionmaybereduced.

Oxalicacid(foundinspinachandrhubarb)andphyticacid(foundinwholecereals)mayinhibitcalciumabsorption

throughformationofinsolublecalciumsalts.Thepatientshouldnottakecalciumproductswithintwohoursofeating

foodshighinoxalicacidandphyticacid.

4.6Pregnancyandlactation

Pregnancy

Duringpregnancythedailyintakeshouldnotexceed1500mgcalciumand600IUcolecalciferol(15µgvitaminD).

StudiesinanimalshaveshownreproductivetoxicitywithhighdosesofvitaminD.Inpregnantwomen,overdosesof

calciumandvitaminDshouldbeavoidedaspermanenthypercalcaemiahasbeenrelatedtoadverseeffectsonthe

developingfoetus.TherearenoindicationsthatvitaminDattherapeuticdosesisteratogenicinhumans.Calcichew-

ChewableTabletscanbeusedduringpregnancy,incaseofacalciumandvitaminDdeficiency.

Lactation

Calcichew-D

ChewableTabletscanbeusedduringbreast-feeding.CalciumandvitaminD

passintobreastmilk.

ThisshouldbeconsideredwhengivingadditionalvitaminDtothechild.

4.7Effectsonabilitytodriveandusemachines

Therearenodataabouttheeffectofthisproductondrivingcapacity.Aneffectis,however,unlikely.

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

Overdosecanleadtohypercalcaemia.Symptomsofhypercalcaemiamayincludeanorexia,thirst,nausea,vomiting,

constipation,abdominalpain,muscleweakness,fatigue,mentaldisturbances,polydipsia,polyuria,bonepain,

nephrocalcinosis,nephrolithiasisandinseverecases,cardiacarrhythmias.Extremehypercalcaemiamayresultincoma

anddeath.Persistentlyhighcalciumlevelsmayleadtoirreversiblerenaldamageandsofttissuecalcification.

Treatmentofhypercalcaemia:Thetreatmentwithcalciummustbediscontinued.Treatmentwiththiazidediuretics,

lithium,vitaminA,vitaminDandcardiacglycosidesmustalsobediscontinued.Treatment:rehydration,and

accordingtoseverityofhypercalcaemia,isolatedorcombinedtreatmentwithloopdiuretics,bisphosphonates,

calcitoninandcorticosteroidsshouldbeconsidered.Serumelectrolytes,renalfunctionanddiuresismustbe

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:mineralsupplements

ATCcode:A12AX

VitaminDincreasestheintestinalabsorptionofcalcium.

AdministrationofcalciumandvitaminD

counteractstheincreaseofparathyroidhormone(PTH)whichiscausedby

calciumdeficiencyandwhichcausesincreasedboneresorption.

AclinicalstudyofinstitutionalisedpatientssufferingfromvitaminDdeficiencyindicatedthatadailyintakeoftwo

tabletsofcalcium500mg/vitaminD400iuforsixmonthsnormalisedthevalueofthe25-hydroxylatedmetaboliteof

vitaminD

andreducedsecondaryhyperparathyroidismandserumalkalinephosphatase.

5.2Pharmacokineticproperties

Calcium

Absorption:Theamountofcalciumabsorbedthroughthegastrointestinaltractisapproximately30%oftheswallowed

dose.

Distributionandmetabolism:99%ofthecalciuminthebodyisconcentratedinthehardstructureofbonesandteeth.

Theremaining1%ispresentintheintra-andextracelluarfluids.About50%ofthetotalblood-calciumcontentisin

thephysiologicallyactiveionisedformwithapproximately10%beingcomplexedtocitrate,phosphateorotheranions,

theremaining40%beingboundtoproteins,principallyalbumin.

Elimination:Calciumiseliminatedthroughfaeces,urineandsweat.Renalexcretiondependsonglomerularfiltration

andcalciumtubularreabsorption.

VitaminD

Absorption:VitaminDiseasilyabsorbedinthesmallintestine.

Distributionandmetabolism:Colecalciferolanditsmetabolitescirculateinthebloodboundtoaspecificglobulin.

Colecalciferolisconvertedintheliverbyhydroxylationtotheactiveform25-hydroxycholecalciferol.Itisthenfurther

convertedinthekidneysto1,25-hydroxycholecalciferol;1,25-hydroxycholecalciferolisthemetaboliteresponsiblefor

increasingcalciumabsorption.VitaminD,whichisnotmetabolised,isstoredinadiposeandmuscletissue.

Elimination:VitaminDisexcretedinfaecesandurine.

5.3Preclinicalsafetydata

Atdosesfarhigherthanthehumantherapeuticrangeteratogenicityhasbeenobservedinanimalstudies.Thereisno

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sorbitol(E420)

Povidone

Isomalt(E953)

Flavour(orange)

Magnesiumstearate

Aspartame(E951)

Mono,di-fattyacidglycerides

Sucrose

Gelatin

Soya-beanoil,hydrogenated

Tocopherol

MaizeStarch

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

WhiteHDPEcontainerswithaprimarytamperproofsealandsecondaryresealableclosurecontaining60and100

tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ShirePharmaceuticalsLimited

HampshireInternationalBusinessPark

Chineham

Basingstoke

HampshireRG248EP

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 16 th

August1993

Dateoflastrenewal: 16 th

August2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 22/09/2007 CRN 2031455 page number: 7