CACIT

Main information

  • Trade name:
  • CACIT Tablets Effervescent 500 Milligram
  • Dosage:
  • 500 Milligram
  • Pharmaceutical form:
  • Tablets Effervescent
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CACIT Tablets Effervescent 500 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0170/015/001
  • Authorization date:
  • 17-07-1990
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cacit500mgEffervescentTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains1.25gCalciumCarbonatewhichwhendissolvedinwaterprovides500mgofcalciumascalcium

citrate.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

EffervescentTablet

Round,flatwhiteeffervescenttabletswithpinkspecklesandadistinctiveorangeodourandflavour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofcalciumdeficiencystatesincludingosteomalacia,ricketsandmalabsorptionsyndromesaffecting

theuppergastrointestinaltract.

Anadjuncttoconventionaltherapyinthearrestorslowingdownofbonedemineralisationinosteoporosis.

Asatherapeuticsupplementduringtimeswhenintakemaybeinadequate,particularlythoseassociated

withtheincreaseddemandofchildhood,oldage,pregnancyandlactation.

4.2Posologyandmethodofadministration

Thetabletsmustbedissolvedinaglassofwaterandthesolutionshouldthenbedrunkimmediatelyaftercomplete

dissolutionofthetablets.

AdultsandtheElderly

Forcalciumdeficiencystatesandmalabsorption,thedosageshouldbetailoredtotheindividualpatient’sneeds.Adose

of1.0gto2.5gperdayisrecommended.

Forthetreatmentofosteoporosisadoseofupto1.5gperdayisnormallyrequired.Inpatientswithadequatedietary

calciumintake,500mgdailymaybesufficient.

Upto1.5gofcalciumperdayistherecommendeddosagefortherapeuticsupplementation.

Children

Forcalciumdeficiencystatesincludingmalabsorptionandrickets,thedosagerecommendationunderadultdosage

shouldbefollowed.

Irish Medicines Board

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Date Printed 04/11/2006 CRN 2029701 page number: 1

4.3Contraindications

Useinpatientswithcalci-lithiasis,hypercalcaemiaandhypercalciuriasuchasinhyperparathyroidism,

hypervitaminosisD,neoplasticdiseaseswithdecalcificationofboneandwithprolongedimmobilisation.

Useinthemilk-alkalisyndrome.Hypersensitivitytoanyoftheingredients.

4.4Specialwarningsandprecautionsforuse

Inmildhypercalciuria(exceeding7.5mmol/24hoursinadultsor0.12-0.15mmol/kg/24hoursinchildren)orrenal

failure,orwherethereisevidenceofstoneformationintheurinarytract;adequatechecksmustbekeptonurinary

calciumexcretion.Ifnecessarythedosageshouldbereducedorcalciumtherapydiscontinued.

Calciumsaltsshouldbeusedwithcautioninpatientswithimpairedrenalfunction,orwithsarcoidosis.

Theuseofcalciumsaltsshouldbeaccompaniedbyacarefulsurveillancetoensuremaintenanceofcorrectbalance.

Thisproductmayinducehypophosphataemia.

Thisproductcontainsasmallamountofsorbitol(E420),patientswithrarehereditaryproblemsoffructoseintolerance

shouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ConcomitantadministrationwithvitaminDcausesanincreaseincalciumabsorptionandplasmalevelsmaycontinue

toriseafterstoppingvitaminDtherapy.

Theeffectsofdigoxinandothercardiacglycosidesmaybeaccentuatedbycalciumandtoxicitymaybeproduced,

especiallyincombinationwithvitaminD.

Calciumsaltsreducetheabsorptionofsomedrugs,inparticulartetracyclines.Itisthereforerecommendedthat

administrationofCacittabletsbeseparatedfromtheseproductsbyatleast3hours.

Thiazidediureticsincreaserenalabsorptionofcalcium,sotheriskofhypercalcaemiashouldbeconsidered.

Bisphosphonate,sodiumfluoride:itisadvisabletoallowatwohourminimumperiodbeforetakingCacit(riskof

reductionofthegastrointestinalabsorptionofbisphosphonateandsodiumfluoride).

4.6Pregnancyandlactation

Calciumsupplementshavebeeninwideuseformanyyearswithoutapparentillconsequence.

4.7Effectsonabilitytodriveandusemachines

Cacitdoesnotinterferewiththeabilitytodriveorusemachines.

4.8Undesirableeffects

Gastrointestinaldisturbanceshavebeenreported(e.g.nausea,abdominalpain,constipation,diarrhoea,flatulenceand

eructation).ThecolouringagentE110cancauseallergic-typereactionsincludingasthma.Skinreactionssuchas

pruritus,rashandurticariahavebeenreported.Allergyismorecommoninthosepeoplewhoareallergictoaspirin.

4.9Overdose

Irish Medicines Board

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effervescentpreparationsandacuteoverdosagehasnotbeenreported.Itmightcausegastrointestinaldisturbancebut

wouldnotbeexpectedtocausehypercalcaemia,exceptinpatientstreatedwithexcessivedosesofvitaminD.

Treatmentshouldbeaimedatloweringserumcalciumlevels,e.g.administrationoforalphosphates.

Chronicoverdosecanleadtovascularandorgancalcificationsasaresultofhypercalaemia.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Calciumisanessentialelementoftissuesandplasma.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Citricacid(anhydrous)

Sodiumsaccharin

Sodiumcyclamate

Sunsetyellow(E110)

Flavour(ContainsSorbitol(E420)andMannitol(E421))

6.2Incompatibilities

Noneknown.

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

Storebelow30ºC.Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

Suppliedinboxesof76tablets(4polypropylenetubeswithpolyethylenestopperseachcontaining19tablets).

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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Date Printed 04/11/2006 CRN 2029701 page number: 3

7MARKETINGAUTHORISATIONHOLDER

Procter&GamblePharmaceuticalsUKLimited

RushamParkTechnicalCentre

WhitehallLane

Egham

Surrey,TW209NW

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA170/15/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:17July1990

Dateoflastrenewal:17July2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 04/11/2006 CRN 2029701 page number: 4