CALCICHEW 500MG CHEWABLE TABLETS

Main information

  • Trade name:
  • CALCICHEW 500MG CHEWABLE TABLETS
  • Dosage:
  • 500 Milligram
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALCICHEW 500MG CHEWABLE TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0535/001/002
  • Authorization date:
  • 20-12-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Calcichew500mgChewableTabletscalciumcarbonateequivalentto500mgCalcium

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Pertablet:Calciumcarbonate1250mgequivalentto500mgofelementalcalcium.

Alsocontains390mgSorbitol(E420),62mgIsomalt(E953)and1mgAspartame(E951)

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

ChewableTablet.

Round,white,uncoatedandconvextablet.Mayhavesmallspecks.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Tocorrectcalciumdeficiencystatesandmaintainappropriatebalanceinsuchdisordersasosteoporosis,osteomalacia,

rickets,tetany,malabsorptionstatesandinpregnancyandlactation.

Asaphosphatebindingagentinthemanagementofrenalfailureinpatientsonrenaldialysis.

4.2Posologyandmethodofadministration

Oral

Thetabletsshouldbetakenjustbefore,duringorjustaftereachmeal.

Thetabletsshouldbechewedorsucked.

Dosageinhepaticimpairment:

Nodoseadjustmentisrequired.

Dosageinrenalimpairment:

Inpatientswithsevererenalfailurehavingacreatinineclearanceoflessthan25ml/minute,dosageadjustmentsmaybe

Adultsandelderly:

Adjuncttoosteoporosistherapy: 2to3tabletsdaily.

Dietarydeficiency: 2to3tabletsdaily.

Osteomalacia: 2to6tabletsdaily.

Children:

Dietarydeficiency: 2to3tabletsdaily

PhosphateBinder:

Adults,childrenandelderly: Doseasrequiredbytheindividualpatientdepending

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4.3Contraindications

Severehypercalcaemiaandhypercalciuria,forexampleinhyperparathyroidism,vitaminDoverdosage,

decalcifyingtumourssuchasplasmacytomaandskeletalmetastases,insevererenalfailureuntreatedbyrenal

dialysisandinosteoporosisduetoimmobilisation.

Nephrolithiasis

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Calcichew500mgChewableTabletscontainaspartame(asourceofphenylalanine)andshouldbeavoidedbypatients

withphenylketonuria.

Calcichew500mgChewableTabletscontainsorbitol(E420)andisomalt(E953).Patientswithrarehereditary

problemsoffructoseintoleranceorsucrase-isomaltaseinsufficiencyshouldnottakethismedicine.

Inrenalinsufficiencythetabletsshouldbegivenonlyundercontrolledconditionsforhyperphosphataemia.Caution

shouldbeexercisedinpatientswithahistoryofrenalcalculi.

DuringhighdosetherapyandespeciallyduringconcomitanttreatmentwithvitaminDand/ormedicationsornutrients

(suchasmilk)containingcalcium,thereisariskofhypercalcaemiawithsubsequentkidneyfunctionimpairmentor

milkalkalisyndrome.Inthesepatients,serumcalciumlevelsshouldbefollowedandrenalfunctionshouldbe

monitored.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thiazidediureticsreducetheurinaryexcretionofcalcium.Duetoincreasedriskofhypercalcaemia,serumcalcium

shouldberegularlymonitoredduringconcomitantuseofthiazidediuretics.

Systemiccorticosteroidsreducecalciumabsorption.Duringconcomitantuse,itmaybenecessarytoincreasethedose

ofCalcichew500mgChewableTablets.

Calciumcarbonatemayinterferewiththeabsorptionofconcomitantlyadministeredtetracyclinepreparations.Forthis

reason,tetracyclinepreparationsshouldbeadministeredatleasttwohoursbefore,orfourtosixhoursafter,oralintake

ofcalcium.

Hypercalcaemiamayincreasethetoxicityofcardiacglycosidesduringtreatmentwithcalcium.Patientsshouldbe

monitoredwithregardtoelectrocardiogram(ECG)andserumcalciumlevels.

Ifabisphosphonateorsodiumfluorideisusedconcomitantly,thispreparationshouldbeadministeredatleastthree

hoursbeforetheintakeofCalcichew500mgChewableTabletssincegastrointestinalabsorptionmaybereduced.

Theefficacyoflevothyroxinecanbereducedbytheconcurrentuseofcalcium,duetodecreasedlevothyroxine

absorption.Administrationofcalciumandlevothyroxineshouldbeseparatedbyatleastfourhours.

Theabsorptionofquinoloneantibioticsmaybeimpairedifadministeredconcomitantlywithcalcium.Quinolone

antibioticsshouldbetakentwohoursbeforeorafterintakeofcalcium.

Oxalicacid(foundinspinachandrhubarb)andphyticacid(foundinwholecereals)mayinhibitcalciumabsorption

throughformationofinsolublecalciumsalts.Thepatientshouldnottakecalciumproductswithintwohoursofeating

foodshighinoxalicacidandphyticacid.

4.6Fertility,pregnancyandlactation

Theadequatedailyintake(includingfoodandsupplementation)fornormalpregnantandlactatingwomenis1000–

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calciumaresecretedinmilkduringlactation.Calcichew500mgChewableTabletscanbeusedduringpregnancyin

caseofacalciumdeficiency.

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

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

Skinandsubcutaneoustissuedisorders

Rare:Pruritus,rashandurticaria.

4.9Overdose

Overdosecanleadtohypercalcaemia.Symptomsofhypercalcaemiamayincludeanorexia,thirst,nausea,vomiting,

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

nephrocalcinosis,nephrolithiasisandinseverecases,cardiacarrhythmias.Extremehypercalcaemiamayresultincoma

anddeath.Persistentlyhighcalciumlevelsmayleadtoirreversiblerenaldamageandsofttissuecalcification.

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:Thetreatmentwithcalciummustbediscontinued.Treatmentwiththiazidediuretics,

lithium,vitaminA,vitaminDandcardiacglycosidesmustalsobediscontinued.Treatment:rehydration,and,

accordingtoseverityofhypercalcaemia,isolatedorcombinedtreatmentwithloopdiuretics,bisphosphonates,

calcitoninandcorticosteroidsshouldbeconsidered.Serumelectrolytes,renalfunctionanddiuresismustbe

monitored.Inseverecases,ECGandCVPshouldbefollowed

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Calcium

ATCcode:A12AA04

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5.2Pharmacokineticproperties

Absorption:Theamountofcalciumabsorbedthroughthegastrointestinaltractisapproximately30%oftheswallowed

dose.

Distributionandmetabolism:99%ofthecalciuminthebodyisconcentratedinthehardstructureofbonesandteeth.

Theremaining1%ispresentintheintra-andextracelluarfluids.About50%ofthetotalblood-calciumcontentisin

thephysiologicallyactiveionisedformwithapproximately10%beingcomplexedtocitrate,phosphateorotheranions,

theremaining40%beingboundtoproteins,principallyalbumin.

Elimination:Calciumiseliminatedthroughfaeces,urineandsweat.Renalexcretiondependsonglomerularfiltration

andcalciumtubularreabsorption.

5.3Preclinicalsafetydata

ThereisnoinformationofrelevancetothesafetyassessmentinadditiontowhatisstatedinotherpartsoftheSmPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sorbitol(E420)

Povidone

Isomalt(E953)

Flavouring(orange)

Magnesiumstearate

Aspartame(E951)

Mono,di-fattyacidglycerides

6.2Incompatibilities

Notapplicable

6.3ShelfLife

3years

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

Keepthecontainertightlyclosedtoprotectfrommoisture.

6.5Natureandcontentsofcontainer

HDPEcontainerwithscrewcapcontaining100tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

ShirePharmaceuticalsLimited

HampshireInternationalBusinessPark

Chineham

Basingstoke

HampshireRG248EP

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA535/1/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:20 th

December1993

Dateoflastrenewal:20 th

December2008

10DATEOFREVISIONOFTHETEXT

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