CALCICHEW-D3 FORTE DOUBLE STRENGTH 1000MG / 800 IU

Main information

  • Trade name:
  • CALCICHEW-D3 FORTE DOUBLE STRENGTH 1000MG / 800 IU
  • Dosage:
  • 1000/20
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALCICHEW-D3 FORTE DOUBLE STRENGTH 1000MG / 800 IU
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0535/001/004
  • Authorization date:
  • 11-12-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calcichew-D

ForteDoubleStrength1000mg/800IUChewableTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Onetabletcontains:

Calciumcarbonateequivalentto1000mgcalcium.

Cholecalciferolconcentrate(powderform)equivalentto800IU(20microgram)cholecalciferol(vitaminD

Excipient(s):

Isomalt(E953),99.9mg

Soya-beanoil,hydrogenated,0.66mg

Sucrose,3.3mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Chewabletablet

Round,white,uncoatedandconvextablets.Mayhavesmallspecks.

4CLINICALPARTICULARS

4.1TherapeuticIndications

PreventionandtreatmentofvitaminDandcalciumdeficiencyintheelderly.

VitaminDandcalciumsupplementasanadjuncttospecificosteoporosistreatmentofpatientswhoareatriskof

vitaminDandcalciumdeficiency.

4.2Posologyandmethodofadministration

Adultsandelderly

Onechewabletabletoncedaily.Thetabletmaybechewedorsucked.

Dosageinhepaticimpairment

Nodoseadjustmentisrequired

Dosageinrenalimpairment

Calcichew-D

ForteDoubleStrength1000mg/800IUChewableTabletsshouldnotbeusedinpatientswithsevere

renalimpairment.

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).

Calcichew-D

Citronshouldbeprescribedwithcautiontopatientssufferingfromsarcoidosis,duetotheriskof

increasedmetabolismofvitaminDintoitsactiveform.Thesepatientsshouldbemonitoredwithregardtothecalcium

contentinserumandurine.

Calcichew-D

Citronshouldbeusedcautiouslyinimmobilisedpatientswithosteoporosisduetoincreasedriskof

hypercalcaemia.

ThecontentofvitaminD(800IU)inCalcichew-D

Citronshouldbeconsideredwhenprescribingothermedicinal

productscontainingvitaminD.AdditionaldosesofcalciumorvitaminDshouldbetakenunderclosemedical

supervision.Insuchcasesitisnecessarytomonitorserumcalciumlevelsandurinarycalciumexcretionfrequently.

Co-administrationwithtetracyclinesorquinolonesisusuallynotrecommended,ormustbedonewithprecaution(see

section4.5).

Calcichew-D

Citroncontainsisomalt(E953)andsucrose.Patientswithrarehereditaryproblemsoffructose

intolerance,glucose-galactosemalabsorptionorsucrase-isomaltaseinsufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thiazidediureticsreducetheurinaryexcretionofcalcium.Duetoincreasedriskofhypercalcaemia,serumcalcium

shouldberegularlymonitoredduringconcomitantuseofthiazidediuretics.

Calciumcarbonatemayinterferewiththeabsorptionofconcomitantlyadministeredtetracyclinepreparations.Forthis

reason,tetracyclinepreparationsshouldbeadministeredatleasttwohoursbeforeorfourtosixhoursafteroralintake

ofcalcium.

HypercalcaemiamayincreasethetoxicityofcardiacglycosidesduringtreatmentwithcalciumandvitaminD.Patients

shouldbemonitoredwithregardtoelectrocardiogram(ECG)andserumcalciumlevels.

Ifabisphosphonateisusedconcomitantly,thispreparationshouldbeadministeredatleastonehourbeforetheintakeof

Calcichew-D

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Theefficacyoflevothyroxinecanbereducedbytheconcurrentuseofcalcium,duetodecreasedlevothyroxine

absorption.Administrationofcalciumandlevothyroxineshouldbeseparatedbyatleastfourhours.

Theabsorptionofquinoloneantibioticsmaybeimpairedifadministeredconcomitantlywithcalcium.Quinolone

antibioticsshouldbetakentwohoursbeforeorsixhoursafterintakeofcalcium.

4.6Fertility,pregnancyandlactation

Pregnancy

Duringpregnancythedailyintakeshouldnotexceed1500mgcalciumand600IUvitaminD,andCalcichew-D

Forte

DoubleStrength1000mg/800IUChewableTabletsisthereforenotsuitableduringpregnancy.Studiesinanimals

haveshownreproductivetoxicityofhighdosesofvitaminD.Inpregnantwomen,overdosesofcalciumandvitaminD

shouldbeavoidedaspermanenthypercalcaemiahasbeenrelatedtoadverseeffectsonthedevelopingfoetus.

Breast-feeding

Calcichew-D

ForteDoubleStrength1000mg/800IUChewableTabletscanbeusedduringbreast-feeding.Calcium

andvitaminD

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.

Gastrointestinaldisorders

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

Veryrare:Dyspepsia

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.

AclinicalstudyofinstitutionalisedpatientssufferingfromvitaminDdeficiencyindicatedthatadailyintakeof1000

mgcalciumand800IUvitaminDforsixmonthsnormalisedthevalueofthe25-hydroxylatedmetaboliteofvitaminD

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

furthernoinformationofrelevancetothesafetyassessmentinadditiontowhatisstatedinotherpartsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Xylitol(E967)

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Isomalt(E953)

Flavouring(lemon)

Magnesiumstearate

Sucralose(E955)

Mono-anddiglyceridesoffattyacids

All-rac-alpha-tocopherol

Soya-beanoil,hydrogenated

Sucrose

Gelatin

Maizestarch

6.2Incompatibilities

Notapplicable.

6.3Shelflife

HDPEcontainer:3years

Blister:2years

6.4Specialprecautionsforstorage

HDPEcontainer:Donotstoreabove30°C.Storeintheoriginalcontainerinordertoprotectfromlight.

Keepthecontainertightlyclosedinordertoprotectfrommoisture.

Blister:Donotstoreabove25°C.Storeintheoriginalpackageinordertoprotectfrommoisture.

Keepblisterintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Thechewabletabletsarepackedin:

HDPEcontainerswithHDPEscrewcaps:15,30,40,60and90tablets.

PVC/PE/PVdC/Aluminiumblisters:7,14,28,50x1(unitdose),56,84,112,140and168tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

ShirePharmaceuticalsLimited

HampshireInternationalBusinessPark

Chineham

Basingstoke

RG248EP

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11December2009

10DATEOFREVISIONOFTHETEXT

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