CALCICHEW-D3 FORTE CHEWABLE TABLETS, CALCIUM CARBO

Main information

  • Trade name:
  • CALCICHEW-D3 FORTE CHEWABLE TABLETS, CALCIUM CARBO
  • Dosage:
  • 500mg/400I %v/v
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALCICHEW-D3 FORTE CHEWABLE TABLETS, CALCIUM CARBO
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0535/001/003
  • Authorization date:
  • 10-10-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calcichew-D

ForteChewableTablets,calciumcarbonate/colecalciferolequivalentto500mgCalcium/400IU

colecalciferol

2QUALITATIVEANDQUANTITATIVECOMPOSITION

3PHARMACEUTICALFORM

Chewabletablet.

Round,white,uncoatedandconvextablet.Mayhavesmallspecks.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Calcichew-D

ForteChewableTabletsshouldonlybeusedasatherapeuticsupplementwhenthedietisdeficient.It

shouldnotbeusedasafoodsupplement.

TheprophylaxisandtreatmentofcombinedvitaminDandcalciumdeficiencyparticularlyinhouseboundand

institutionalisedelderlysubjects.

ThesupplementationofvitaminDandcalciumasanadjuncttospecifictherapyforosteoporosisorasatherapeutic

supplementinestablishedosteomalacia,pregnantpatientsathighriskofdeficiencyormalnutritionwhendietaryintake

islessthanthatrequired.

4.2Posologyandmethodofadministration

Oral.

Adultsandelderly:2chewabletabletsperday,preferablyonetabletmorningandevening.

Thetabletmaybechewedorsucked.

Dosageinhepaticimpairment:

Pertablet:

Calciumcarbonate 1250 mg

(equivalentto500mgofelementalcalcium)

Colecalciferol 400 IU

(equivalentto10microgramsvitaminD

Containssorbitol390mg;isomalt,49.90mg;

aspartame1mgandsucrose0.77mg.

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Dosageinrenalimpairment:

Calcichew-D

Fortechewabletabletsshouldnotbeusedinpatientswithsevererenalimpairment.

Calcichew-D

Fortechewabletabletsarenotintendedforuseinchildren.

4.3Contraindications

Diseasesand/orconditionsresultinginhypercalcaemiaand/orhypercalciuria

Severerenalimpairment

Nephrolithiasis

HypervitaminosisD

Hypersensitivitytotheactivesubstancesortoanyoftheexcipients

4.4Specialwarningsandprecautionsforuse

Duringlong-termtreatment,serumcalciumlevelsshouldbefollowedandrenalfunctionshouldbemonitoredthrough

measurementsofserumcreatinine.Monitoringisespeciallyimportantinpatientsonconcomitanttreatmentwith

cardiacglycosidesordiuretics(seesection4.5,Interactionswithothermedicinalproductsandotherformsof

interaction)andinpatientswithahightendencytocalculusformation.Incaseofhypercalcaemiaorsignsofimpaired

renalfunctionthedoseshouldbereducedorthetreatmentdiscontinued.

VitaminDshouldbeusedwithcautioninpatientswithimpairmentofrenalfunctionandtheeffectoncalciumand

phosphatelevelsshouldbemonitored.Theriskofsofttissuecalcificationshouldbetakenintoaccount.Inpatients

withsevererenalinsufficiency,vitaminDintheformofcolecalciferolisnotmetabolisednormallyandotherformsof

vitaminDshouldbeused(seesection4.3,Contraindications).

Calcichew-D

Fortechewabletabletsshouldbeprescribedwithcautiontopatientssufferingfromsarcoidosisdueto

theriskofincreasedmetabolismofvitaminDtoitsactiveform.Thesepatientsshouldbemonitoredwithregardtothe

calciumcontentinserumandurine.

Calcichew-D

ForteChewableTabletsshouldbeusedwithcautioninimmobilisedpatientswithosteoporosisdueto

theincreasedriskofhypercalcaemia.

Thecontentofcolecalciferol(400IU)inCalcichew-D

ForteChewableTabletsshouldbeconsideredwhenprescribing

othermedicinalproductscontainingvitaminDand/ormedicationsornutrients(suchasmilk)containingcalcium.

AdditionaldosesofcalciumorvitaminDincreasetheriskofhypercalcaemiawithsubsequentkidneyfunction

impairmentandmilk-alkalisyndrome;thereforetheyshouldbetakenunderclosemedicalsupervision.Insuchcasesit

isnecessarytomonitorserumcalciumlevelsandurinarycalciumexcretionfrequently.

Calcichew-D

ForteChewableTabletscontainaspartame(asourceofphenylalanine)whichmaybeharmfulforpeople

withphenylketonuria.

Calcichew-D

ForteChewableTabletscontainsorbitol(E420),isomalt(E953)andsucrose.Patientswithrare

hereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltaseinsufficiency

shouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thiazidediureticsreducetheurinaryexcretionofcalcium.Duetoincreasedriskofhypercalcaemia,serumcalcium

shouldberegularlymonitoredduringconcomitantuseofthiazidediuretics.

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ofCalcichew-D

ForteChewableTablets.

Simultaneoustreatmentwithionexchangeresinssuchascholestyramineorlaxativessuchasparaffinoilmayreduce

thegastrointestinalabsorptionofvitaminD.

Calciumcarbonatemayinterferewiththeabsorptionofconcomitantlyadministeredtetracyclinepreparations.Forthis

reason,tetracyclinepreparationsshouldbeadministeredatleasttwohoursbefore,orfourtosixhoursafter,oralintake

ofcalcium.

HypercalcaemiamayincreasethetoxicityofcardiacglycosidesduringtreatmentwithcalciumandvitaminD.Patients

shouldbemonitoredwithregardtoelectrocardiogram(ECG)andserumcalciumlevels.

Theefficacyoflevothyroxinecanbereducedbytheconcurrentuseofcalcium,duetodecreasedlevothyroxine

absorption.Administrationofcalciumandlevothyroxineshouldbeseparatedbyatleastfourhours.

Theabsorptionofquinoloneantibioticsmaybeimpairedifadministeredconcomitantlywithcalcium.Quinolone

antibioticsshouldbetakentwohoursbeforeorafterintakeofcalcium.

Ifabisphosphonateorsodiumfluorideisusedconcomitantly,thispreparationshouldbeadministeredatleastthree

hoursbeforetheintakeofCalcichew-D

ForteChewableTabletssincegastrointestinalabsorptionmaybereduced.

Oxalicacid(foundinspinachandrhubarb)andphyticacid(foundinwholecereals)mayinhibitcalciumabsorption

throughformationofinsolublecalciumsalts.Thepatientshouldnottakecalciumproductswithintwohoursofeating

foodshighinoxalicacidandphyticacid.

4.6Fertility,pregnancyandlactation

Pregnancy

Duringpregnancythedailyintakeshouldnotexceed1500mgcalciumand600IUcolecalciferol(15µgvitaminD).

StudiesinanimalshaveshownreproductivetoxicitywithhighdosesofvitaminD.Inpregnantwomen,overdosesof

calciumandvitaminDshouldbeavoidedaspermanenthypercalcaemiahasbeenrelatedtoadverseeffectsonthe

developingfoetus.TherearenoindicationsthatvitaminDattherapeuticdosesisteratogenicinhumans.Calcichew-

ForteChewableTabletscanbeusedduringpregnancy,incaseofacalciumandvitaminDdeficiency.

Lactation

Calcichew-D

ForteChewableTabletscanbeusedduringbreast-feeding.CalciumandvitaminD

passintobreast

milk.ThisshouldbeconsideredwhengivingadditionalvitaminDtothechild.

4.7Effectsonabilitytodriveandusemachines

Therearenodataabouttheeffectofthisproductondrivingcapacity.Aneffectis,however,unlikely.

4.8Undesirableeffects

Adversereactionsarelistedbelow,bysystemorganclassandfrequency.Frequenciesaredefinedas:uncommon

(>1/1,000, ≤1/100),rare(>1/10,000,≤1/1,000),orveryrare(≤1/10,000).

Metabolismandnutritiondisorders

Uncommon:Hypercalcaemiaandhypercalciuria.

Veryrare:Seenusuallyonlyinoverdose,see4.9:Milk-alkalisyndrome

Gastrointestinaldisorders

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Skinandsubcutaneoustissuedisorders

Rare:Pruritus,rashandurticaria.

4.9Overdose

OverdosecanleadtohypervitaminosisDandhypercalcaemia.Symptomsofhypercalcaemiamayincludeanorexia,

thirst,nausea,vomiting,constipation,abdominalpain,muscleweakness,fatigue,mentaldisturbances,polydipsia,

polyuria,bonepain,nephrocalcinosis,nephrolithiasisandinseverecases,cardiacarrhythmias.Extreme

hypercalcaemiamayresultincomaanddeath.Persistentlyhighcalciumlevelsmayleadtoirreversiblerenaldamage

andsofttissuecalcification.

Milk-alkalisyndrome(frequenturgetourinate;continuingheadache;continuinglossofappetite;nauseaorvomiting;

unusualtirednessorweakness;hypercalcaemia,alkalosisandrenalimpairment).Themilk-alkalisyndromeof

hypercalcaemia,alkalosisandrenalimpairmentstilloccurinpatientswhoingestlargeamountsofcalciumand

absorbablealkali;itisnotuncommonasacauseofhypercalcaemiarequiringhospitalisation.Thesyndromehasalso

beenreportedinapatienttakingrecommendeddosesofantacidscontainingcalciumcarbonateforchronicepigastric

discomfort,andinapregnantwomantakinghigh,butnotgrosslyexcessive,dosesofcalcium(about3gofelemental

calciumdaily).Metastaticcalcificationcandevelop.

Treatmentofhypercalcaemia:ThetreatmentwithcalciumandvitaminDmustbediscontinued.Treatmentwith

thiazidediuretics,lithium,vitaminAandcardiacglycosidesmustalsobediscontinued.Treatmentisrehydration,and,

accordingtoseverityofhypercalcaemia,isolatedorcombinedtreatmentwithloopdiuretics,bisphosphonates,

calcitoninandcorticosteroidsshouldbeconsidered.Serumelectrolytes,renalfunctionanddiuresismustbe

monitored.Inseverecases,ECGandCVPshouldbefollowed.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Calcium,combinationwithotherdrugs

ATCcode:A12AX

VitaminDincreasestheintestinalabsorptionofcalcium.

AdministrationofcalciumandvitaminD

counteractstheincreaseofparathyroidhormone(PTH)whichiscausedby

calciumdeficiencyandwhichcausesincreasedboneresorption.

AclinicalstudyofinstitutionalisedpatientssufferingfromvitaminDdeficiencyindicatedthatadailyintakeoftwo

tabletsofCalcichew-D

Fortechewabletabletsforsixmonthsnormalisedthevalueofthe25-hydroxylatedmetabolite

ofvitaminD

andreducedsecondaryhyperparathyroidismandserumalkalinephosphatase.

An18monthdoubleblind,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:Theamountofcalciumabsorbedthroughthegastrointestinaltractisapproximately30%oftheswallowed

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Distributionandmetabolism:99%ofthecalciuminthebodyisconcentratedinthehardstructureofbonesandteeth.

Theremaining1%ispresentintheintra-andextracellularfluids.About50%ofthetotalblood-calciumcontentisin

thephysiologicallyactiveionisedformwithapproximately10%beingcomplexedtocitrate,phosphateorotheranions,

theremaining40%beingboundtoproteins,principallyalbumin.

Elimination:Calciumiseliminatedthroughfaeces,urineandsweat.Renalexcretiondependsonglomerularfiltration

andcalciumtubularreabsorption.

VitaminD

Absorption:VitaminDiseasilyabsorbedinthesmallintestine.

Distributionandmetabolism:Colecalciferolanditsmetabolitescirculateinthebloodboundtoaspecificglobulin.

Colecalciferolisconvertedintheliverbyhydroxylationtotheactiveform25-hydroxycolecalciferol.Itisthenfurther

convertedinthekidneysto1,25-hydroxycolecalciferol;1,25-hydroxycolecalciferolisthemetaboliteresponsiblefor

increasingcalciumabsorption.VitaminDwhichisnotmetabolisedisstoredinadiposeandmuscletissue.

Elimination:VitaminDisexcretedinfaecesandurine.

5.3Preclinicalsafetydata

Atdosesfarhigherthanthehumantherapeuticrangeteratogenicityhasbeenobservedinanimalstudies.Thereisno

furtherinformationofrelevancetothesafetyassessmentinadditiontowhatisstatedinotherpartsoftheSmPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sorbitol(E420)

Povidone

Isomalt(E953)

Flavouring(lemon)

Fattyacidmono-anddiglycerides

Aspartame(E951)

Magnesiumstearate

Sucrose

Modifiedmaizestarch

Triglycerides,medium-chain

Sodiumascorbate

Silica,colloidalanhydrous

Tocopherol

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

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6.5Natureandcontentsofcontainer

White,highdensitypolyethylenebottles.

Bottlescontaining20,30,60,90,or100tabletswithtamperevidentseal.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ShirePharmaceuticalsLtd

HampshireInternationalBusinessPark

Chineham

Basingstoke

HampshireRG248EP

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA535/1/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:10 th

October1996

Dateoflastrenewal:10 th

October2001

10DATEOFREVISIONOFTHETEXT

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