CALCICHEW-D3 FORTE

Main information

  • Trade name:
  • CALCICHEW-D3 FORTE
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1659/024/001
  • Authorization date:
  • 01-10-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calcichew-D

ForteChewableTablets,calciumcarbonate/colecalciferolequivalentto500mgCalcium/400IU

colecalciferol

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Pertablet:

Calciumcarbonate 1250mg

(equivalentto500mgofelementalcalcium)

Colecalciferol 400IU

(equivalentto10microgramsvitaminD

Containssorbitol,390mg;isomalt,49.90mg;aspartame,1mg;sucrose1.52mg;andsoyabeanoil,hydrogenated,

0.30mg.Forafulllistofexcipients,seeSection6.1.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Chewabletablet.

ProductimportedfromtheUK:

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:

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Dosageinrenalimpairment:

Calcichew-D

Fortechewabletabletsshouldnotbeusedinpatientswithsevererenalimpairment

4.3Contraindications

Diseasesand/orconditionsresultinginhypercalcaemiaand/orhypercalciuria

Severerenalimpairment

Nephrolithiasis

HypervitaminosisD

Hypersensitivitytosoyaorpeanut

Hypersensitivitytotheactivesubstancesortoanyoftheexcipients

4.4Specialwarningsandprecautionsforuse

Duringlong-termtreatment,serumcalciumlevelsshouldbefollowedandrenalfunctionshouldbemonitoredthrough

measurementsofserumcreatinine.Monitoringisespeciallyimportantinpatientsonconcomitanttreatmentwith

cardiacglycosidesordiuretics(seesection4.5,Interactionswithothermedicinalproductsandotherformsof

interaction)andinpatientswithahightendencytocalculusformation.Incaseofhypercalcaemiaorsignsofimpaired

renalfunctionthedoseshouldbereducedorthetreatmentdiscontinued.

VitaminDshouldbeusedwithcautioninpatientswithimpairmentofrenalfunctionandtheeffectoncalciumand

phosphatelevelsshouldbemonitored.Theriskofsofttissuecalcificationshouldbetakenintoaccount.Inpatientswith

severerenalinsufficiency,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.

Insuchcasesitisnecessarytomonitorserumcalciumlevelsandurinarycalciumexcretionfrequently.

Calcichew-DForteChewableTabletscontainaspartame(asourceofphenylalanine)whichmaybeharmfulforpeople

withphenylketonuria.

Calcichew-D

ForteChewableTabletscontainsorbitol(E420)andisomalt(E953).Patientswithrarehereditary

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thiazidediureticsreducetheurinaryexcretionofcalcium.Duetoincreasedriskofhypercalcaemia,serumcalcium

shouldberegularlymonitoredduringconcomitantuseofthiazidediuretics.

Systemiccorticosteroidsreducecalciumabsorption.Duringconcomitantuse,itmaybenecessarytoincreasethedose

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

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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

Rare:Constipation,flatulence,dyspepsia,nausea,abdominalpainanddiarrhoea.

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:ThetreatmentwithcalciumvitaminDmustbediscontinued.Treatmentwiththiazide

diuretics,lithium,vitaminA,andcardiacglycosidesmustalsobediscontinued.Treatmentisrehydration,and,

accordingtoseverityofhypercalcaemia,isolatedorcombinedtreatmentwithloopdiuretics,bisphosphonates,

calcitoninandcorticosteroidsshouldbeconsidered.Serumelectrolytes,renalfunctionanddiuresismustbemonitored.

Inseverecases,ECGandCVPshouldbefollowed.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Calcium,combinationwithotherdrugs.ATCcode:A12AX

VitaminDincreasestheintestinalabsorptionofcalcium.

AdministrationofcalciumandvitaminD

counteractstheincreaseofparathyroidhormone(PTH)whichiscausedby

calciumdeficiencyandwhichcausesincreasedboneresorption.

AclinicalstudyofinstitutionalisedpatientssufferingfromvitaminDdeficiencyindicatedthatadailyintakeoftwo

tabletsofCalcichew-D

Fortechewabletabletsforsixmonthsnormalisedthevalueofthe25-hydroxylatedmetabolite

ofvitaminD

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An18monthdouble-blind,placebocontrolledstudyincluding3270institutionalisedwomenaged84+/-6yearswho

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

elementalcalcium),showedasignificantdecreaseofPTHsecretion.After18months,an"intent-to-treat"analysis

showed80hipfracturesinthecalcium-vitaminDgroupand110hipfracturesintheplacebogroup(p=0.004).A

follow-upstudyafter36monthsshowed137womenwithatleastonehipfractureinthecalcium-vitaminDgroup

(n=1176)and178intheplacebogroup(n=1127)(p0.02).

5.2Pharmacokineticproperties

Calcium

Absorption:Theamountofcalciumabsorbedthroughthegastrointestinaltractisapproximately30%oftheswallowed

dose.

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.VitaminDwhichisnotmetabolisedisstoredinadiposeandmuscletissues.

Elimination:VitaminDisexcretedinfaecesandurine.

5.3Preclinicalsafetydata

Atdosesfarhigherthanthehumantherapeuticrangeteratogenicityhasbeenobservedinanimalstudies.Thereisno

furtherinformationofrelevancetothesafetyassessmentinadditiontowhatisstatedinotherpartsoftheSmPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sorbitol(E420)

Povidone

Isomalt(E953)

Flavouring(lemon)

Fattyacidmono-anddiglycerides

Aspartame(E951)

Magnesiumstearate

Sucrose

Gelatin

Soyabeanoil,hydrogenated

Tocopherol

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6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.Keepthecontainertightlyclosedtoprotectformmoisture.

6.5Natureandcontentsofcontainer

White,highdensitypolyethylenebottles.

Bottlescontaining100tabletswithtamperevidentseal.Inacarton.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialinstructions

7PARALLELPRODUCTAUTHORISATIONHOLDER

IPSHealthcareLimited

SterlingHouse

501MiddletonRoad

Chadderton,Oldham

LancashireOL99LY

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1659/24/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

October2010

10DATEOFREVISIONOFTHETEXT

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