ALKA ANTACID

Main information

  • Trade name:
  • ALKA ANTACID
  • Dosage:
  • 500 Milligram
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ALKA ANTACID
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1410/033/001
  • Authorization date:
  • 24-10-2008
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1410/033/001

CaseNo:2056854

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TransferredfromPA0021/047/001.

BayerLimited

TheAtrium,BlackthornRoad,Dublin18,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AlkaAntacid500mgChewableTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom24/10/2008until25/05/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/10/2008 CRN 2056854 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AlkaAntacid500mgChewableTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontainshydrotalcite500mg.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Chewabletablets.

Whiteroundtabletswithpeppermint-likeodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Symptomaticreliefinthefollowingconditions:indigestion;hyperacidity;dyspepsia;gastricandduodenalulceration;

gastritis;heartburn,especiallywhenassociatedwithrefluxoesophagitisorhiatusherniaandheartburninpregnancy.

4.2Posologyandmethodofadministration

Adultsandtheelderly

Oneortwotabletsthreetofourtimesdailytobetakenonetotwohoursbeforeoraftermeals,beforebedtime,oras

symptomsoccur.

Thetabletsshouldbechewedorcrushedbeforeswallowing.

Themaximumdailydoseiseighttablets(4g).

RenalImpairment

Cautionshouldbeexercisedinpatientswithimpairedkidneyfunction(creatinineclearance<30ml/min).Serumlevels

ofmagnesiumandaluminiumshouldbemonitored.Theserumlevelofaluminiumshouldnotexceed40µg/landthe

levelofmagnesiumshouldremainwithinthenormallyacceptedlimits.Long-termandhigh-dosetherapyshouldbe

avoided.

Children6-12years

Halftheadultdose.

Irish Medicines Board

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4.3Contraindications

Knownhypersensitivitytotheactive,hydrotalcite,oranyoftheingredients.

Severerenalinsufficiency(creatinineclearance<30ml/min).

Hypophosphataemia.

4.4Specialwarningsandprecautionsforuse

Thefollowingspecialwarningsandprecautionsforusearerelatedtothemagnesiumandaluminiumcomponentsof

hydrotalcite:

Chronicuseofhydrotalcitebypatientswithmildtomoderaterenalinsufficiency(creatinineclearance

<30ml/min)maycauseencephalopathy(aluminium)orhypermagnesaemia(magnesium)inrarecases.

Chronicuseincombinationwithalowphosphatediet(e.g.malnutrition)maycausehypophosphatemia,witha

riskofosteomalacia.

Inlong-termuse,thealuminiumconcentrationsinthebloodmustbemonitoredregularlyandshouldnotexceed

40µg/ml.

Inpatientswithimpairedrenalfunctionslong-termandhighdosetherapyshouldbeavoided.

Severeandpersistingsymptomscanbeasignofpepticulcerdiseaseormalignancy.Ifsymptomsdonot

improveduringtreatmentwithAlkaAntacidwithin14daysthedoctorshouldbeconsultedandfurther

examinationsshouldbecarriedout.Iftarry,blackstoolorhaematemesisoccurthedoctorshouldbecontacted

immediately.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Hydrotalcitemayreduceabsorptionofotherdrugs,suchascardiacglycosides,antibiotics,corticosteroidsandiron

salts,fromthegastrointestinaltract.Consequentlyanintervalof1-2hoursshouldbeallowedbetweenthe

administrationofAlkaAntacidandothermedicines.

Simultaneousadministrationofhydrotalciteandacid-containingbeverages(fruitjuices,winesetc.)mayincreasethe

uptakeofaluminiumfromtheintestineandshouldbeavoided.

4.6Pregnancyandlactation

Noembryotoxicityorteratogeniceffectswereobservedinanimalstudieswithhydrotalcite.However,itshouldbe

avoidedduringthefirsttrimesterofpregnancy.

Aluminiumcompoundspassintothebreastmilk.However,hydrotalciteisnotsignificantlyabsorbedwithinthe

therapeuticdoserange.Therefore,itmaybeadministeredtolactatingwomen.

4.7Effectsonabilitytodriveandusemachines

Irish Medicines Board

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4.8Undesirableeffects

Inrarecaseshighdosescancausesoftstoolsandgastrointestinalcomplaints(e.g.vomitinganddiarrhoea).

Withchronicuseinhighdoses,aluminiumcontainingproductsmayinrarecasescause‘phosphatedeficiency

syndrome’.

4.9Overdose

Nocasesofoverdosewithhydrotalcitehavebeenreported.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATC-classification

Hydrotalcitehasacidbindingaswellasdose-andpH-dependentbile-acidandlysolecithineabsorbingproperties.

Animalstudieshaveindicatedthathydrotalcitehasacytoprotectiveeffect.

HydrotalcitebuffersintheoptimalrangeofpH3-5andtheintragastricpHisincreasedforabout2hours.

Intracerebralaluminiumdepositshavebeenfoundinpatientswithdialysisencephalopathyanddialysispatientscan

developaluminium-associatedosteomalacia.Aluminium-associatedmicrocytic,hypochromicanaemiahasalsobeen

observed.

5.2Pharmacokineticproperties

ThelatticelayerstructureofhydrotalciteisdissolvedpH-dependentlyandaluminiumandmagnesiumionsarereleased

intragastrically.Thesearethenprecipitatedascarbonatesandphosphatesinthesmallintestine.Inthepresenceof

food,theprecipitationprocessmayalsotakeplaceinthestomach.

Someofthealuminiumionswhicharecontainedinhydrotalciteareabsorbedandleadtoatemporaryincreaseinthe

serumaluminiumconcentrationaswellastoariseinrenalaluminiumexcretion.Theserumaluminiumlevelsremain

withinthenormalrange.

Magnesiumisalsoabsorbedtoasmallextent.However,theserummagnesiumconcentrationgenerallyremains

constantduetorenalelimination.

Renalinsufficiencyandlong-termadministrationofhighdosescanresultinhypermagnesaemiaandgradual

aluminiuminfiltrationespeciallyinthenerveandbonetissue.

5.3Preclinicalsafetydata

Animalstudieshaveshownthataluminiumtakenupbythenervetissuehasneurotoxiceffects.

Symptomsofmagnesiumintoxicationincludecentralnervousdisorders,muscleweakness,areflexia,fatigue,paresis,

comaandcardiacarrhythmia.

Reproductiontoxicology(aluminiumsalts)

Studiesinvariousanimalspecies(rabbit,mouse)haveshownthataluminiumpermeatestheplacentaandaccumulates

infoetaltissue,predominantlyinthebones.Afterexposureduringpregnancy,eliminationviathemother’smilk

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Afteroraladministrationtomice(57.5mgaluminium/kg/day)embryolethality,increasedincidenceofcleftpalatesand

vertebraldeformationwereobserved.Ratfoetusesshowedreducedossification(133mgaluminium/kg/day).Postnatal

effectsofexposuretoaluminiumincludeanincreasedrateofstillbirths,perinatalmortality,retardedgrowth,

behaviouralchanges,andbiochemicalchangesinthebrain(long-termeffect,lowesteffectivedose:10-20mg

aluminium/kg/day).

Inanimalstudiesaluminiuminfiltrationinthebonesubstanceisclearlyhigherinfoetusesthaninadultanimals.

Studiesinprematurehumanneonateshaveshownthataluminiumaccumulatesinthebonesafterintravenous

administration.Similarconditionscanbeassumedtoexistinfoetusesinutero.

Mutagenicandcarcinogenicpotential

Mutagenicitystudieshavenotindicatedanyrelevantmutagenicpotential.Nostudiesareavailableonthecarcinogenic

potential.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Mannitol(E421)

Maizestarch

Magnesiumstearate

Saccharinsodium

Bananaflavour

Peppermintflavour

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Fiveyears.

6.4Specialprecautionsforstorage

Therearenospecialstorageconditions.

6.5Natureandcontentsofcontainer

Blisterpacksconsistingoftwoseparatestripsoffivetabletseach,composedofPPbackedwithaluminiumfoil.

Availableinpacksof10,20,30and50tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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Date Printed 28/10/2008 CRN 2056854 page number: 5

7MARKETINGAUTHORISATIONHOLDER

BayerLtd

TheAtrium

BlackthornRoad

Dublin18

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA1410/33/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26 th

May2000

Dateoflastrenewal:26 th

May2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 28/10/2008 CRN 2056854 page number: 6