CALCIUM SANDOZ

Main information

  • Trade name:
  • CALCIUM SANDOZ
  • Dosage:
  • 3.27/ 2.18 g/ 15ml Grams
  • Pharmaceutical form:
  • Syrup
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALCIUM SANDOZ
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/047/001
  • Authorization date:
  • 01-04-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0030/047/001

CaseNo:2043297

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NovartisConsumerHealthUKLtd

TradingasNovartisConsumerHealth,WimblehurstRoad,Horsham,WestSussexRH125AB,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CalciumSandozSyrup

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom01/04/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 18/11/2009 CRN 2043297 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CalciumSandozSyrup

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each15mlcontains3.27gcalciumglubionateand2.18gcalciumlactobionate.Three5mlspoonfulsprovide325mg

calcium(8.1mmol:16.2mEqCa++)

Each15mlalsocontains4.54gofSucrose.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Syrup

Colourlesstopalestraw-coloured,fruitflavouredsyrup

4CLINICALPARTICULARS

4.1TherapeuticIndications

High-doseoralcalciumintheformofCalciumSandozSyrupisindicatedinthetreatmentofneonataltetany,andasa

therapeuticsupplementinosteoporosis,post-gastrectomymalabsorption,osteomalacia,rickets,pregnancyand

lactation.

4.2Posologyandmethodofadministration

Useinchildren

Theusualtotaldailydoseis30-50ml.

Neonatalhypocalcaemia:Calcium-SandozSyrupmaybegivenatadoseof1mmolcalcium/kg/24hoursindivided

doses.

Serumcalciumlevelsshouldbemonitoredandthedosageadjustedif

necessary.Dosesmaybemixedwiththefirst(small)partofmilkfeeds.

Note:1mmolofcalciumisequivalentto1.85Calcium-SandozSyrup.

Useintheelderly

NoevidenceexiststhatdosageortoleranceofCalciumSandozSyrupisdirectlyaffectedbyadvancedage;however,

elderlypatientsshouldbesupervisedasfactorssometimesassociatedwithageing,suchaspoordietorimpairedrenal

Oral Dailydosage

Indication Syrup

Osteoporosis

Post-gastrectomymalabsorption 60–100ml

Osteomalaciaandrickets

Lactation 20–60ml

Irish Medicines Board

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4.3Contraindications

Severehypercalcaemiaandhypercalciuria(e.g.inhyperparathyroidism,vitaminDoverdosage,decalcifyingtumours

suchasplasmocytomaandskeletalmetastases,immobilisationosteoporosis;sarcoidosis),severerenalfailureandmilk-

alkalisyndrome.

DuetoitsgalactosecomponentCalcium-SandozSyrupshouldnotbegiventopatientswithgalactosaemia.

4.4Specialwarningsandprecautionsforuse

Usewithcautioninpatientswithimpairedrenalfunctionorwithnephrocalcinosis,orintheelderly.

Theuseofcalciumsaltsshouldbeaccompaniedbyacarefulsurveillancetoensuremaintenanceofcorrectcalcium

balance.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

HighvitaminDintakeshouldbeavoidedduringcalciumtherapy,unlessespeciallyindicated.

Theeffectsofdigoxinandothercardiacglycosidesmaybeaccentuated.

Tetracyclineabsorptionmaybereducedifgivenconcomitantlywithoralcalcium.

4.6Pregnancyandlactation

ThelikelihoodofhypercalcaemiaisincreasedinpregnantwomeninwhomcalciumandvitaminDareco-administered.

Epidemiologicalstudieswithcalciumhaveshownnoincreaseintheteratogenichazardtothefoetusisusedindoses

recommended.

Althoughsupplementalcalciummaybeexcretedinbreastmilk,theconcentrationisunlikelytobesufficienttoproduce

anyadverseeffectontheneonate.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Mildgastrointestinaldisturbanceshaveoccurredrarely(e.g.constipation,diarrhoea).Althoughhypercalcaemiawould

notbeexpectedinpatientsunlesstheirrenalfunctionwereimpaired,thefollowingsymptomscouldindicatethe

possibilityofhypercalcaemia:nausea,vomiting,anorexia,constipation,abdominalpain,bonepain,thirst,polyuria,

muscleweakness,drowsinessorconfusion.

4.9Overdose

TheamountofcalciumabsorbedfollowingoverdosagewithCalciumSandozSyrupwilldependontheindividual's

status.Deliberateoverdosageisunlikelywitheffervescentpreparationsandacuteoverdosagehasnotbeenreported.It

mightcausegastrointestinaldisturbancesbutwouldnotbeexpectedtocausehypercalcaemiaexceptinpatientstreated

withexcessivedosesofvitaminD.Treatmentshouldbeaimedatloweringserumcalciumlevels,e.g.administrationof

Irish Medicines Board

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Calciumisanessentialbodyelectrolyte.Itisinvolvedinthemaintenanceofnormaltissueandnervefunction,is

essentialfornormalcardiacfunctionandisessentialtobloodcoagulation.Thereisdynamicequilibriumbetweenthe

calciuminbloodandthatinskeleton.Homeostasisismainlyregulatedbyparathyroidhormone,bycalcitoninandby

vitaminD.

5.2Pharmacokineticproperties

5.3Preclinicalsafetydata

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzoicacid

Formicacid

Sucrose

Orange‘natural’flavour

Tamarisflavour

Purifiedwater.

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

C.Keepthecontainertightlyclosedtoprotectfrommoisture.

6.5Natureandcontentsofcontainer

500mland300mlamber,glassbottleswithapolypropyleneclosure(polyethylenewadfacewithPP,PVDCorPET

lining).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Calcium-SandozSyrupmaybedilutedwithSyrupBP;thedilutedsyrupshouldbeusedwithin14days.Calcium-

SandozSyrupcontains1.512gsucroseper5ml(4.536gsucroseper15mldose).Approximatecalorificvalueof

Irish Medicines Board

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7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLimited,

WimblehurstRoad,

Horsham,

WestSussexRH125AB,

UnitedKingdom.

Tradingas:NovartisConsumerHealth

8MARKETINGAUTHORISATIONNUMBER

PA30/47/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:1 st

April1983

Dateoflastrenewal:1 st

April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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