CALCICHEW-D3 FORTE 500 MG/ 400 IU FILM-COATED TA

Main information

  • Trade name:
  • CALCICHEW-D3 FORTE 500 MG/ 400 IU FILM-COATED TA
  • Dosage:
  • 500/10
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALCICHEW-D3 FORTE 500 MG/ 400 IU FILM-COATED TA
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0535/001/005
  • Authorization date:
  • 11-12-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calcichew-D

Forte500mg/400IUFilm-coatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains:

Calciumcarbonateequivalentto500mgcalcium

Cholecalciferolconcentrate(powderform)equivalentto400IU(10microgram)cholecalciferol(vitaminD

Excipient(s):

Sorbitol(E420),154mg

Sucrose,1.6mg

Soya-beanoil,hydrogenated,0.33mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet

Oval,white/offwhite,film-coatedtablets.Mayhavehardlyvisiblegreyspots.

4CLINICALPARTICULARS

4.1TherapeuticIndications

PreventionandtreatmentofvitaminDandcalciumdeficiencyintheelderly.

VitaminDandcalciumsupplementasanadjuncttospecificosteoporosistreatmentofpatientswhoareatriskof

vitaminDandcalciumdeficiency.

4.2Posologyandmethodofadministration

Adultsandelderly

Onefilm-coatedtablettwicedaily.Thetabletmaybeswallowedorchewed.

Dosageinhepaticimpairment

Nodoseadjustmentisrequired

Dosageinrenalimpairment

Calcichew-D

Forte500mg/400IUFilm-coatedTabletsshouldnotbeusedinpatientswithsevererenalimpairment.

Calcichew-D

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4.3Contraindications

Diseasesand/orconditionsresultinginhypercalcaemiaand/orhypercalcuria

Severerenalimpairment

Nephrolithiasis

HypervitaminosisD

Hypersensitivitytosoyaorpeanut

Hypersensitivitytotheactivesubstancesortoanyoftheexcipients

4.4Specialwarningsandprecautionsforuse

Duringlong-termtreatment,serumcalciumlevelsshouldbefollowedandrenalfunctionshouldbemonitoredthrough

measurementsofserumcreatinine.Monitoringisespeciallyimportantinelderlypatientsonconcomitanttreatmentwith

cardiacglycosidesordiuretics(seesection4.5)andinpatientswithahightendencytocalculusformation.Incaseof

hypercalcaemiaorsignsofimpairedrenalfunctionthedoseshouldbereducedorthetreatmentdiscontinued.

VitaminDshouldbeusedwithcautioninpatientswithimpairmentofrenalfunctionandtheeffectoncalciumand

phosphatelevelsshouldbemonitored.Theriskofsofttissuecalcificationshouldbetakenintoaccount.Inpatientswith

severerenalinsufficiency,vitaminDintheformofcholecalciferolisnotmetabolisednormallyandotherformsof

vitaminDshouldbeused(seesection4.3,contraindications).

Calcichew-D

Forte500mg/400IUFilm-coatedTabletsshouldbeprescribedwithcautiontopatientssufferingfrom

sarcoidosis,duetotheriskofincreasedmetabolismofvitaminDintoitsactiveform.Thesepatientsshouldbe

monitoredwithregardtothecalciumcontentinserumandurine.

Calcichew-D

Forte500mg/400IUFilm-coatedTabletsshouldbeusedcautiouslyinimmobilisedpatientswith

osteoporosisduetoincreasedriskofhypercalcaemia.

ThecontentofvitaminD(400IU)inCalcichew-D

Forte500mg/400IUFilm-coatedTabletsshouldbeconsidered

whenprescribingothermedicinalproductscontainingvitaminD.AdditionaldosesofcalciumorvitaminDshouldbe

takenunderclosemedicalsupervision.Insuchcasesitisnecessarytomonitorserumcalciumlevelsandurinary

calciumexcretionfrequently.

Co-administrationwithtetracyclinesorquinolonesisusuallynotrecommended,ormustbedonewithprecaution(see

section4.5).

Calcichew-D

Forte500mg/400IUFilm-coatedTabletscontainssorbitol(E420)andsucrose.Patientswithrare

hereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltaseinsufficiency

shouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thiazidediureticsreducetheurinaryexcretionofcalcium.Duetoincreasedriskofhypercalcaemia,serumcalcium

shouldberegularlymonitoredduringconcomitantuseofthiazidediuretics.

Calciumcarbonatemayinterferewiththeabsorptionofconcomitantlyadministeredtetracyclinepreparations.Forthis

reason,tetracyclinepreparationsshouldbeadministeredatleasttwohoursbeforeorfourtosixhoursafteroralintake

ofcalcium.

HypercalcaemiamayincreasethetoxicityofcardiacglycosidesduringtreatmentwithcalciumandvitaminD.Patients

shouldbemonitoredwithregardtoelectrocardiogram(ECG)andserumcalciumlevels.

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Calcichew-D

Forte500mg/400IUFilm-coatedTabletssincegastrointestinalabsorptionmaybereduced.

Theefficacyoflevothyroxinecanbereducedbytheconcurrentuseofcalcium,duetodecreasedlevothyroxine

absorption.Administrationofcalciumandlevothyroxineshouldbeseparatedbyatleastfourhours.

Theabsorptionofquinoloneantibioticsmaybeimpairedifadministeredconcomitantlywithcalcium.Quinolone

antibioticsshouldbetakentwohoursbeforeorsixhoursafterintakeofcalcium.

4.6Fertility,pregnancyandlactation

Pregnancy

Duringpregnancythedailyintakeshouldnotexceed1500mgcalciumand600IUvitaminD.Studiesinanimalshave

shownreproductivetoxicityofhighdosesofvitaminD.Inpregnantwomen,overdosesofcalciumandvitaminD

shouldbeavoidedaspermanenthypercalcaemiahasbeenrelatedtoadverseeffectsonthedevelopingfoetus.Thereare

noindicationsthatvitaminDattherapeuticdosesisteratogenicinhumans.Calcichew-D

Forte500mg/400IUFilm-

coatedTabletscanbeusedduringpregnancy,incaseofacalciumandvitaminDdeficiency.

Breast-feeding

Calcichew-D

Forte500mg/400IUFilm-coatedTabletscanbeusedduringbreast-feeding.CalciumandvitaminD

passintobreastmilk.ThisshouldbeconsideredwhengivingadditionalvitaminDtothechild.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.Aneffectishowever,unlikely.

4.8Undesirableeffects

Adversereactionsarelistedbelow,bysystemorganclassandfrequency.Frequenciesaredefinedas:uncommon

(1/1,000to<1/100),rare(1/10,000to<1/1,000),orveryrare(<1/10,000).

Metabolismandnutritiondisorders

Uncommon:Hypercalcaemiaandhypercalciuria.

Veryrare:Dyspepsia

Gastrointestinaldisorders

Rare:Constipation,flatulence,nausea,abdominalpain,anddiarrhoea.

Skinandsubcutaneoustissuedisorders

Veryrare:Pruritus,rashandurticaria.

4.9Overdose

Overdosecanleadtohypervitaminosisandhypercalcaemia.Symptomsofhypercalcaemiamayincludeanorexia,thirst,

nausea,vomiting,constipation,abdominalpain,muscleweakness,fatigue,mentaldisturbances,polidipsia,polyuria,

bonepain,nephrocalcinosis,renalcalculiandinseverecases,cardiacarrhythmias.Extremehypercalcaemiamayresult

incomaanddeath.Persistentlyhighcalciumlevelsmayleadtoirreversiblerenaldamageandsofttissuecalcification.

Treatmentofhypercalcaemia:ThetreatmentwithcalciumandvitaminDmustbediscontinued.Treatmentwith

thiazidediuretics,lithium,vitaminA,vitaminDandcardiacglycosidesmustalsobediscontinued.Emptyingofthe

stomachinpatientswithimpairedconsciousness.Rehydration,and,accordingtoseverity,isolatedorcombined

treatmentwithloopdiuretics,bisphosphonates,calcitoninandcorticosteroids.Serumelectrolytes,renalfunctionand

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Calcium,combinationwithotherdrugs

ATCcode:A12AX

VitaminDincreasestheintestinalabsorptionofcalcium.

AdministrationofcalciumandvitaminD

counteractstheincreaseofparathyroidhormone(PTH)whichiscausedby

calciumdeficiencyandwhichcausesincreasedboneresorption.

AclinicalstudyofinstitutionalisedpatientssufferingfromvitaminDdeficiencyindicatedthatadailyintakeoftwo

calciumandvitaminD

500mg/400IUchewabletabletsforsixmonthsnormalisedthevalueofthe25-hydroxylated

metaboliteofvitaminD

andreducedsecondaryhyperparathyroidismandalkalinephosphatases.

An18monthdouble-blind,placebocontrolledstudyincluding3270institutionalisedwomenaged84+/-6yearswho

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

elementalcalcium),showedasignificantdecreaseofPTHsecretion.After18months,an"intent-totreat"analysis

showed80hipfracturesinthecalcium-vitaminDgroupand110hipfracturesintheplacebogroup(p=0,004).A

follow-upstudyafter36monthsshowed137womenwithatleastonehipfractureinthecalcium-vitaminDgroup

(n=1176)and178intheplacebogroup(n=1127)(p<0,02).

5.2Pharmacokineticproperties

Calcium

Absorption:Generally,theamountofcalciumabsorbedthroughthegastrointestinaltractisapproximately30%ofthe

swalloweddose.

Distributionandmetabolism:99%ofthecalciuminthebodyisconcentratedinthehardstructureofbonesandteeth.

Theremaining1%ispresentintheintra-andextracellularfluids.About50%ofthetotalblood-calciumcontentisin

thephysiologicallyactiveionisedformwithapproximately10%beingcomplexedtocitrate,phosphateorotheranions,

theremaining40%beingboundtoproteins,principallyalbumin.

Elimination:Calciumiseliminatedthroughfaeces,urineandsweat.Renalexcretiondependsonglomerularfiltration

andcalciumtubularreabsorption.

VitaminD

Absorption:VitaminDiseasilyabsorbedinthesmallintestine.

Distributionandmetabolism:Cholecalciferolanditsmetabolitescirculateinthebloodboundtoaspecificglobulin.

Cholecalciferolisconvertedintheliverbyhydroxylationto25-hydroxycholecalciferol.Itisthenfurtherconvertedin

thekidneystotheactiveform1,25dihydroxycholecalciferol.1,25dihydroxycholecalciferolisthemetabolite

responsibleforincreasingcalciumabsorption.VitaminDwhichisnotmetabolisedisstoredinadiposeandmuscle

tissues.

Elimination:VitaminDisexcretedinfaecesandurine.

5.3Preclinicalsafetydata

Atdosesfarhigherthanthehumantherapeuticrangeteratogenicityhasbeenobservedinanimalstudies.Thereis

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore:

Sorbitol(E420)

Mannitol

Acesulfamepotassium

Flavouring(lemon)

Croscarmellosesodium

Cellulose,microcrystalline

Magnesiumstearate

Maltodextrin

Tocopherol-richextract

All-rac-alpha-tocopherol

Soya-beanoil,hydrogenated

Gelatin

Sucrose

Maizestarch

Film-coating:

Talc

Hypromellose

Propyleneglycol

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Keepthecontainertightlyclosedinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Thefilm-coatedtabletsarepackedin:

HDPEcontainerswithHDPEscrewcaps:20,30,50,60,90,100,120,180and250tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

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7MARKETINGAUTHORISATIONHOLDER

ShirePharmaceuticalsLimited

HampshireInternationalBusinessPark

Chineham

Basingstoke

RG248EP

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA535/1/5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11December2009

10DATEOFREVISIONOFTHETEXT

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