BISODOL HEARTBURN

Main information

  • Trade name:
  • BISODOL HEARTBURN
  • Dosage:
  • 400/200/100 Milligram
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BISODOL HEARTBURN
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0100/048/001
  • Authorization date:
  • 23-04-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0100/048/001

CaseNo:2072941

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ForestLaboratoriesUKLtd

RiverbridgeHouse,AnchorBoulevard,CrosswaysBusinessPark,Dartford,KentDA26SL,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BisodolHeartburnChewableTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom19/01/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 24/01/2010 CRN 2072941 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BisodolHeartburnChewableTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Excipients:Eachtabletcontains0.8gsucroseand27mgsodium.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Chewabletablet

Round,white,smooth,bevel-edgededgetablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofheartburn,includingheartburnofpregnancy,refluxoesophagitis,hiatushernia,regurgitationandall

casesofepigastricdistressassociatedwithgastricreflux.

4.2Posologyandmethodofadministration

Fororaladministration.

Adults,theelderlyandchildrenover12years:suckorchewoneortwotabletsaftermealsandatbedtimes.

Children:6–12years:suckorchewonetabletaftermealsandatbedtime.

Childrenunder6years:notrecommended.

4.3Contraindications

Noneknown.

4.4Specialwarningsandprecautionsforuse

Patientswithrenalimpairmentshouldnotusethisproductexceptontheadviceofadoctor.

Ifsymptomspersist,consultyourdoctor.

Magaldrate 400 mgpertablet

AlginicAcid 200 mgpertablet

Irish Medicines Board

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

AswithotherantacidsBisodolHeartburntabletsmayformcomplexeswithcertaindrugse.g.tetracyclinesandiron

tabletsresultingindecreasedabsorption.BisodolHeartburntabletsshouldnotbeadministeredwithin2hoursoftaking

suchdrugs.

4.6Pregnancyandlactation

TherearenocontraindicationstotheuseofBisodolHeartburnTabletsinpregnancyorlactation;however,itis

advisabletoavoidtheuseofthispreparationduringthefirsttrimesterofpregnancy.

4.7Effectsonabilitytodriveandusemachines

Noknowneffects.

4.8Undesirableeffects

Abdominaldistensionandflatulencemayoccur.

4.9Overdose

Abdominaldistensionanddiarrhoeamayoccur.

Hypermagnesaemia–intravenousadministrationofcalciumsalts.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Magaldrateactslocallyinthegastrointestinaltract.Ithasnoappreciablesystemicactivity.

AlginicAcidformsahighlyviscoussolutionthatfloatsonthesurfaceofthegastriccontentstoactasamechanical

barriertoreflux,ortoserveastheprimaryagentbeingrefluxed.

Sodiumbicarbonateisthoughttoreactwithalginicacidasthetabletischewed,leadingtotheformulationofsodium

alginateandcarbondioxide.

5.2Pharmacokineticproperties

Magaldratereactswithacidinstages.Thehydroxymagnesiumisrelativelyrapidlyconvertedtomagnesiumionandthe

aluminatetohydratedaluminiumhydroxide;thealuminiumhydroxidethenreactsmoreslowlytogiveasustained

antacideffect.

Anywherefrom15%to30%ofthemagnesiumionisabsorbed,however,inthenormalperson,magnesiumionis

rapidlyexcretedbythekidney.

Thereactionofmagnesiumhydroxidewithhydrochloricacidproducesmagnesiumchloride.Mostofthemagnesium

chlorideisconvertedtomagnesiumcarbonateintheintestineandthusexcreted.

Irish Medicines Board

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Afterthealuminiumchlorideenterstheintestinesomeofthechlorideisreabsorbed,andinsolublealuminium

hydroxideandaluminiumphosphateareformed.

Wheningested,almostallofthealginicacidremainsundigestedandisexcretedeitherunchangedorasanalginate.

SodiumBicarbonatereactswithhydrochloricacidtoformsodiumchloride,andthistogetherwithanyunreacted

bicarbonateisabsorbedandexcretedintheurine.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CompressibleSugar(Sucrose,maltodextrin)

MicrocrystallineCellulose

MaizeStarch

MagnesiumStearate

VanillaFlavour

CherryFlavour

CreamFlavour

6.2Incompatibilities

Noneknown.

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Blisterpacksof250micronuPVC\20micronaluminiumfoilwith6gsmheatsealcoating.Packedincardcartonsof10

and20tabletpacks.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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7MARKETINGAUTHORISATIONHOLDER

ForestLaboratoriesUKLimited

RiverbridgeHouse

AnchorBoulevard

CrosswaysBusinessPark

Dartford

Kent

DA26SL

8MARKETINGAUTHORISATIONNUMBER

PA100/48/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23April1997

Dateoflastrenewal:23April2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 24/01/2010 CRN 2072941 page number: 5