CALCIUM VITAMIN D3 HERMES

Main information

  • Trade name:
  • CALCIUM VITAMIN D3 HERMES
  • Dosage:
  • 1000/ 880
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALCIUM VITAMIN D3 HERMES
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0952/005/001
  • Authorization date:
  • 17-02-2012
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CalciumVitaminD

Hermes1000mg/880IUChewableTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachchewabletabletcontains:

2,500mgofcalciumcarbonate(equivalentto1,000mgofcalcium).

8.8mgofcolecalciferolconcentrate(powderform)(equivalentto22microgramsofcolecalciferol=880IUof

vitaminD

Excipients:

Eachchewabletabletcontains1.00mgofaspartame(E951),119.32mgofsorbitol(E420),370.00mgofisomalt

(E953)and1.694mgofsucrose.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Chewabletablet.

Round,whitetabletwithfaultlesssurfaceandabreakmark.

Thetabletcanbedividedintoequalhalves.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CalciumVitaminD

Hermes1000mg/880IUChewableTabletsisindicated:

forthepreventionandtreatmentofvitaminDandcalciumdeficiencyintheelderly

asvitaminDandcalciumsupplementasanadjuncttospecificosteoporosistreatmentofpatientswhoareat

riskofvitaminDandcalciumdeficiency

4.2Posologyandmethodofadministration

Posology

Adultsandelderly

1chewabletabletdaily(correspondingto1,000mgofcalciumand880IUofvitaminD

Dosageinhepaticimpairment

Nodoseadjustmentisrequired

Dosageinrenalimpairment

CalciumVitaminD

Hermes1000mg/880IUChewableTabletsshouldnotbeusedinpatientswithsevererenal

impairment(seesection4.3).

Dosageduringpregnancy

Duringpregnancythedailyintakeshouldnotexceed1,500mgofcalciumand600I.U.ofvitaminD

.Therefore,the

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Methodofadministration

Oraluse.

CalciumVitaminD

Hermes1000mg/880IUChewableTabletsshouldbetakenatanytime,withorwithoutfood.The

chewabletabletsshouldbechewedandswallowed.

CalciumVitaminD

Hermes1000mg/880IUChewableTabletsarenotintendedforuseinchildrenoradolescents(see

section4.3).

4.3Contraindications

Hypersensitivitytotheactivesubstancesortoanyoftheexcipients

- Hypercalciuriaandhypercalcaemiaanddiseasesand/orconditions,whichleadtohypercalcaemiaand/or

hypercalciuria(e.g.myeloma,bonemetastases,primaryhyperparathyroidism,prolongedimmobilisation

accompaniedbyhypercalciuriaand/orhypercalcaemia).

Nephrolithiasis

Nephrocalcinosis

HypervitaminosisD

Severerenalimpairment

DuetoitshighcontentofvitaminDtheuseinchildrenoradolescentsisnotindicated.

4.4Specialwarningsandprecautionsforuse

Duringlong-termtreatment,serumcalciumlevelsshouldbefollowedandrenalfunctionshouldbemonitoredthrough

measurementsofserumcreatinine.Monitoringisespeciallyimportantinpatientsonconcomitanttreatmentwith

cardiacglycosidesorthiazidediuretics(seesection4.5)andinpatientswithahightendencytocalculusformation.In

caseofhypercalcaemiaorsignsofimpairedrenalfunction,ifurinarycalciumexcretionexceeds300mg/24hours(7.5

mmoles/24hours)thedoseshouldbereducedorthetreatmentdiscontinued.

VitaminDshouldbeusedwithcautioninpatientswithimpairmentofrenalfunctionandtheeffectoncalciumand

phosphatelevelsshouldbemonitored.Theriskofsofttissuecalcificationshouldbetakenintoaccount.Inpatientswith

severerenalinsufficiency,vitaminDintheformofcholecalciferolisnotmetabolisednormallyandotherformsof

vitaminDshouldbeused(seesection4.3).

CalciumVitaminD

Hermes1000mg/880IUChewableTabletsshouldbeprescribedwithcautiontopatientssuffering

fromsarcoidosis,duetotheriskofincreasedmetabolismofvitaminDintoitsactiveform.Thesepatientsshouldbe

monitoredwithregardtothecalciumcontentinserumandurine.

CalciumVitaminD

Hermes1000mg/880IUChewableTabletsshouldbeusedcautiouslyinimmobilisedpatientswith

osteoporosisduetoincreasedriskofhypercalcaemia.

ThecontentofvitaminD(880IU)inCalciumVitaminD

Hermes1000mg/880IUChewableTabletsshouldbe

consideredwhenprescribingothermedicinalproductscontainingvitaminD.AdditionaldosesofcalciumorvitaminD

shouldbetakenunderclosemedicalsupervision.Insuchcasesitisnecessarytomonitorserumcalciumlevelsand

urinarycalciumexcretionfrequently.

Co-administrationwithtetracyclinesorquinolonesisusuallynotrecommended,ormustbedonewithprecaution(see

section4.5).

Thismedicinalproductcontainsaspartame(E951),asourceofphenylalaninewhichmaybeharmfulforpeoplewith

phenylketonuria.Italsocontainssorbitol(E420),isomalt(E953)andsucrose.Patientswithrarehereditaryproblemsof

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medicinalproduct.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thiazidediureticsreducetheurinaryexcretionofcalcium.Duetoincreasedriskofhypercalcaemia,serumcalcium

shouldberegularlymonitoredduringconcomitantuseofthiazidediuretics.

Systemiccorticosteroidsreducecalciumabsorption.MoreovertheeffectofvitaminDmaybedecreased.During

concomitantuse,itmaybenecessarytoincreasethedoseofCalciumVitaminD

Hermes1000mg/880IUChewable

Tablets.

ConcomitanttreatmentwithphenytoinorbarbituratescandecreasetheeffectofvitaminDbecauseofmetabolic

activation.

Simultaneoustreatmentwithionexchangeresinssuchascholestyramineorlaxativessuchasparaffinoilmayreduce

thegastrointestinalabsorptionofvitaminD.Thereforeatimeintervalaslongaspossiblebetweentheintakesis

recommended.

Oxalicacid(foundinspinachandrhubarb)andphyticacid(foundinwholecereals)mayinhibitcalciumabsorption

throughformationofinsolublecompoundswithcalciumions.Thepatientshouldnottakecalciumproductswithintwo

hoursofeatingfoodshighinoxalicacidandphyticacid.

Calciumcarbonatemayinterferewiththeabsorptionofconcomitantlyadministeredtetracyclinepreparations.Forthis

reason,tetracyclinepreparationsshouldbeadministeredatleasttwohoursbeforeorfourtosixhoursafteroralintake

ofcalcium.

HypercalcaemiamayincreasethetoxicityofcardiacglycosidesduringtreatmentwithcalciumandvitaminD.Patients

shouldbemonitoredwithregardtoelectrocardiogram(ECG)andserumcalciumlevels.

Ifabisphosphonateorsodiumfluorideisusedconcomitantly,thispreparationshouldbeadministeredatleastthree

hoursbeforetheintakeofCalciumVitaminD

Hermes1000mg/880IUChewableTabletssincegastrointestinal

absorptionmaybereduced.

Theefficacyoflevothyroxinecanbereducedbytheconcurrentuseofcalcium,duetodecreasedlevothyroxine

absorption.Administrationofcalciumandlevothyroxineshouldbeseparatedbyatleastfourhours.

Theabsorptionofquinoloneantibioticsmaybeimpairedifadministeredconcomitantlywithcalcium.Quinolone

antibioticsshouldbetakentwohoursbeforeorsixhoursafterintakeofcalcium.

4.6Fertility,pregnancyandlactation

Pregnancy

CalciumVitaminD

Hermes1000mg/880IUChewableTabletscanbeusedduringpregnancyincaseofacalciumand

VitaminDdeficiency.Duringpregnancythedailyintakeshouldnotexceed1,500mgofcalciumand600I.U.of

vitaminD

.Therefore,thedailydosemustnotexceedhalfatablet.

OverdosesofvitaminDhavebeenshowntohaveteratogeniceffectsinanimalexperiments.

Inpregnantwomen,overdosageofcalciumandvitaminDshouldbeavoided,sinceprolongedhypercalcaemiahasbeen

sometimesassociatedwithretardationofphysicalandmentaldevelopment,supravalvularaorticstenosisand

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Breastfeeding

CalciumVitaminD

Hermes1000mg/880IUChewableTabletscanbeusedduringbreast-feeding.Calciumand

vitaminD

passintothebreast-milk.ThisshouldbeconsideredwhengivingadditionalvitaminDtothechild.

Fertility

Nodataavailable.

4.7Effectsonabilitytodriveandusemachines

CalciumVitaminD

Hermes1000mg/880IUChewableTabletshasnoinfluenceontheabilitytodriveanduse

machines.

4.8Undesirableeffects

Theevaluationofadversereactionsisbasedonthefollowingdefinitionoffrequency:

Verycommon (1/10)

Common (1/100to<1/10)

Uncommon (1/1,000to<1/100)

Rare (1/10,000to<1/1,000)

Veryrare (<1/10,000)

Notknown (cannotbeestimatedfromtheavailabledata)

Immunesystemdisorders

Notknown(cannotbeestimatedfromtheavailabledata):Hypersensitivityreactionssuchasangioedemaorlaryngeal

oedema.

Metabolismandnutritiondisorders

Uncommon:Hypercalcaemia,hypercalciuria.

Gastrointestinaldisorders

Rare:Nausea,diarrhoea,abdominalpain,constipation,flatulence,abdominaldistension.

Skinandsubcutaneoustissuedisorders

Rare:Rash,pruritus,urticaria.

4.9Overdose

Overdosecanleadtohypervitaminosisandhypercalcaemia.Symptomsofhypercalcaemiamayincludeanorexia,thirst,

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

Combinationofcalciumwithotherdrugs,ATCcodeA12AX

Mechanismofaction

CalciumVitaminD

Hermes1000mg/880IUChewableTabletsisafixedcombinationofcalciumandvitaminD

.The

highcalciumandvitaminD

concentrationineachdoseunitenablessufficientabsorptionofcalciumwithalimited

numberofdoses.VitaminD

isinvolvedincalcium-phosphorusmetabolism.Itallowstheactiveabsorptionofcalcium

andphosphorusfromtheintestineandtheiruptakebybone.SupplementationwithcalciumandvitaminD

corrects

latentvitaminDdeficiencyandsecondaryhyperparathyroidism.

Pharmacodynamiceffects

Inadouble-blindplacebocontrolledstudyof18months,including3270womenaged84±6andlivinginnursing

homes,supplementedwithcholecalciferol(800IU/day)+calcium(1.2g/day),asignificantdecreaseinPTHsecretion

hasbeenobserved.After18months,theresultsoftheintenttotreatanalysisshowed80hipfracturesinthecalcium

vitaminDgroupand110hipfracturesintheplacebo-group(p=0.004).Sointheconditionsofthisstudy,thetreatment

of1387womenprevented30hipfractures.After36monthsoffollow-up,137womenpresentedatleastonehip

fractureinthecalcium-vitaminDgroup(n=1176)and178intheplacebogroup(n=1127)(p0.02).

5.2Pharmacokineticproperties

Calcium

Absorption

30-40%oftheingesteddoseofcalciumisabsorbed,predominantlyintheproximalpartofthesmallintestine.

Distributionandbiotransformation

99%ofthecalciuminthebodyisconcentratedinthemineralcomponentofbonesandteeth.Theremaining1%is

presentintheintra-andextracellularfluids.About50%ofthetotalblood-calciumcontentisinthephysiologically

activeionisedformwithapproximately5%beingcomplexedtocitrate,phosphateorotheranions.Theremaining45%

beingboundtoproteins,principallyalbumin.

Elimination

Calciumisexcretedintheurine,faecesandinsweat.Urinaryexcretiondependsonglomerularfiltrationandtubular

resorption.

VitaminD

3

Absorption

VitaminD

isabsorbedintheintestine.

Distributionandbiotransformation

VitaminD

istransportedbyproteinbindinginthebloodtotheliver(whereitundergoesthefirsthydroxylationto25-

hydroxycholecalciferol)andtothekidneys(secondhydroxylationto1,25-dihydroxycholecalciferol,theactive

metaboliteofvitaminD

Non-hydroxylatedvitaminD

isstoredinmuscleandadiposetissues.

Elimination

Theplasmahalf-lifeisintheorderofseveraldays;vitaminD

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5.3Preclinicalsafetydata

Atdosesfarhigherthanthehumantherapeuticrangeteratogenicityhasbeenobservedinanimalstudies.Noother

relevantdataisavailablethathasnotbeenmentionedelsewhereintheSmPC(seesection4.6and4.9).

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Isomalt(E953)

Xylitol

Sorbitol(E420)

Citricacid,anhydrous

Sodiumdihydrogencitrate

Magnesiumstearate

Carmellosesodium

FlavourOrange“CPB”(containingnaturalorangeoilconcentrate,natural/natureidenticalmandarineoil,natural/nature

identicalliquidflavourtropicalfruit,natural/natureidenticalorangeoil,natural/natureidenticalsolidflavourmultifruit,

mannitol(E421),maltodextrin,gluconolactone,sorbitol(E420))

FlavourOrange“CVT”(containingnaturalorangeoil,naturalmandarineoil,natureidenticalpowderflavourorange,

mannitol(E421),gluconolactone,sorbitol(E420),medium-chainedtriglyceride)

Aspartame(E951)

Acesulfampotassium

Sodiumascorbate

All-rac-alpha-tocopherol

Modified(maize)starch

Sucrose

Triglycerides,mediumchain

Silicondioxide,colloidal

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years

6.4Specialprecautionsforstorage

Fortabletcontainer:

Keepthetabletcontainertightlyclosedinordertoprotectfrommoisture.

Forstrips:Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

Thechewabletabletsareavailableinpolypropylenetabletcontainerswithpolyethylenestopperscontainingadesiccant

inthefollowingpackagesizes:

10,20,28,30,40,50,56,60,90,100(bundlingpackage5x20)chewabletablets

Thechewabletabletsareavailableinstripsoflaminatedaluminiumpaperfoilinthefollowingpackagesizes:

10,20,28,30,40,48,56,60,60(bundlingpackage2x30),90,90(bundlingpackage3x30),96,100(bundlingpackage

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Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

HermesArzneimittelGmbH

Georg-Kalb-Strasse5-8

82049Grohesselohe

Munich

Germany

8MARKETINGAUTHORISATIONNUMBER

PA0952/005/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:17thFebruary2012

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