ANDREWS ANTACID FRUIT FLAVOURS

Main information

  • Trade name:
  • ANDREWS ANTACID FRUIT FLAVOURS
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANDREWS ANTACID FRUIT FLAVOURS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0678/048/002
  • Authorization date:
  • 04-03-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AndrewsAntacidTabletsFruitFlavour

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontainscalciumcarbonate600mgandheavymagnesiumcarbonate125mg.

ForexcipientsseeSection6.1.

3PHARMACEUTICALFORM

ChewableTablet

Palelemoncoloured¾”diameterflatbeveledgedchewabletabletswithanodourandtasteoflemon/lime,embossed

doubleAonbothsides.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AndrewsAntacidTabletsarerecommendedforthereliefofstomachupsetsduetohyperacidityandheartburn.

4.2Posologyandmethodofadministration

AndrewsAntacidTabletsarefororaladministrationonly.

AdultsandElderly:One-twotabletstobesuckedorcheweduptoamaximumof12tabletsperday.Thedosemaybe

repeatedasrequired.Donottakemorethan16tabletsin24hours.

Children:Notsuitableforchildrenunder12yearsofage.

4.3Contraindications

Therearenoknowncontraindications.

4.4Specialwarningsandprecautionsforuse

Ifsymptomspersist,consultyourdoctor.Keepoutofthereachofchildren.

Donotexceedthestateddoseexceptonmedicaladvice.

Ifyouaretakingmedicationorsufferfromkidneydisease,consultyourdoctorbeforeusing.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Antacidsmayreducetheabsorptionofotherdrugs,includingtetracyclines.

4.6Pregnancyandlactation

Therearenoknowncontraindicationsrelatingtotheuseofcalciumcarbonateormagnesiumcarbonateduring

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doctorshouldbesought.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Nostatement.

4.9Overdose

Therehavebeennocasesofoverdosestated.Ifalargeamountistaken,itshouldbesufficienttoemptythestomachby

emesis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CalciumcarbonateandMagnesiumcarbonateareconvertedtotherespectivechloridesaltsbytheinteractionwith

gastrichydrochloricacid.Inthismannertheyacttoneutralisehyperacidityinthestomach.

5.2Pharmacokineticproperties

Calciumcarbonateisconvertedtocalciumchloridebygastricacid.Someofthecalciumisabsorbedfromtheintestine

butabout85%isreconvertedtoinsolublecalciumsaltssuchasthecarbonateandisexcretedinthefaeces.

Magnesiumcarbonatereactswithgastricacidtoformsolublemagnesiumchlorideandcarbondioxideinthestomach.

Somemagnesiumisslowlyabsorbedfromthegastro-intestinaltractandeliminatedintheurine,otherwiseexcretionis

viathefaeces.

5.3Preclinicalsafetydata

TherearenopertinentdatanotalreadydescribedelsewhereinthisSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Malicacid

MicrotalDCEsugar

Magnesiumstearate

Talc

Lemon/limeflavour

Saccharinsodium

Sodiumhydrogencarbonate

Quinolinelakeyellow(E104)

6.2Incompatibilities

None.

6.3ShelfLife

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6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Rollpack(aluminiumfoilbackedwithbleachedtissue)withouterpaperwrapfurtherpackedintoacardboardbox

containing6,10,12,20,24,30,48,50,60,90,96,100,120and150.

RollpackenclosedinPVC/Cardboarddisplayboxcontaining6tablets.

Rollpackof15tabletsenclosedinaHDPEplastictubewithfittedcapfurtherpackedintoacardboardboxwithan

additionalrollpackoftablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKlineConsumerHealthcareLimited

StonemasonsWay

Rathfarnham

Dublin16

8MARKETINGAUTHORISATIONNUMBER

PA678/48/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:04March1993

Dateoflastrenewal:04March2003

10DATEOFREVISIONOFTHETEXT

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Date Printed 03/10/2006 CRN 2028528 page number: 3