BISODOL ANTACID

Main information

  • Trade name:
  • BISODOL ANTACID
  • Pharmaceutical form:
  • Powder for Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0100/047/003
  • Authorization date:
  • 01-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0100/047/003

CaseNo:2071722

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ForestLaboratoriesUKLtd

RiverbridgeHouse,CrosswaysBusinessP,Kent,DA26SL,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BisodolAntacidPowderforOralSuspensionMagnesiumcarbonate,heavy18mgMagnesiumcarbonate,light345mgSodium

hydrogencarbonate532/5ml

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom25/09/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/09/2009 CRN 2071722 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BisodolAntacidPowderforOralSuspension

Magnesiumcarbonate,heavy18mg

Magnesiumcarbonate,light345mg

Sodiumhydrogencarbonate532mg/5ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5ml(0.9g)ofpowdercontains:

18mgMagnesiumcarbonate,heavy

345mgMagnesiumcarbonate,light

532mgSodiumhydrogencarbonate

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderfororalsuspension

Awhitepowderwithaslightodourandatasteofpeppermint,fordispersioninwater.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofsymptomsofindigestion,dyspepsia,heartburn,acidityandflatulence.

4.2Posologyandmethodofadministration

Adults:Onelevelteaspoon(5ml)stirredintoonethirdofatumblerofwateraftermealsorasrequired.

4.3Contraindications

Nonestated.

4.4Specialwarningsandprecautionsforuse

Personswithkidneydiseaseorreceivingmedicaltreatmentshouldconsulttheirdoctorbeforeusing.

Ifsymptomspersist,consultyourdoctor.

Donotexceedthestateddoseexceptonmedicaladvice.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Aswithotherantacids,BisodolAntacidPowdermayformcomplexeswithcertaindrugse.g.tetracyclines,digoxinand

vitaminsresultingindecreasedabsorption.BisodolAntacidPowdershouldnotbeadministeredwithintwohoursof

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/09/2009 CRN 2071722 page number: 2

4.6Pregnancyandlactation

AswithallmedicinesitisadvisabletoavoidBisodolAntacidPowderinthefirsttrimesterofpregnancy.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Magnesiumsaltscanhavealaxativeeffect.Thespecificmixtureofantacidsisintendedtoavoidthelowergastro-

intestinaleffectsseenwithasingleantacidpreparation.Nosideeffectsareassociatedwithsodiumhydrogen

carbonateexceptwhentakeninexcess.Reboundhypersensitivityoccurswithprolongeduse.

4.9Overdose

Nonestated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Sodiumhydrogencarbonateandmagnesiumcarbonateareantacids.Theyactbyneutralisingthehydrochloricacid

producedbythestomachandthusreducinggastricandduodenalirritation.

5.2Pharmacokineticproperties

MagnesiumCarbonate

Magnesiumcarbonatereactswithgastricacidtoformsolublemagnesiumchlorideandcarbondioxideinthestomach.

Somemagnesiumisabsorbedbutisusuallyexcretedintheurine.

SodiumHydrogenCarbonate

Administrationofsodiumhydrogencarbonatebymouthcausesneutralisationofgastricacidwiththeproductionof

carbondioxide.Bicarbonatenotinvolvedinthatreactionisabsorbedandintheabsenceofadeficitofbicarbonatein

theplasma,bicarbonateionsareexcretedintheurine,whichisrenderedalkalinewithanaccompanyingdiuresis.

5.3Preclinicalsafetydata

NoneStated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

PeppermintEssentialOil

6.2Incompatibilities

Aswithotherantacids,BisodolAntacidPowdermayformcomplexeswithcertaindrugse.g.tetracyclines,digoxinand

vitaminsresultingindecreasedabsorption.BisodolAntacidPowdershouldnotbeadministeredwithintwohoursof

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/09/2009 CRN 2071722 page number: 3

6.3ShelfLife

5years

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Whitepolypropylenesecuritainer(50gor100g)withbluepolyethylenecapswithtamperevidenttearoffretaining

strips.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ForestLaboratoriesUKLimited

RiverbridgeHouse

AnchorBoulevard

CrosswaysBusinessPark

Dartford

Kent

DA26SL

8MARKETINGAUTHORISATIONNUMBER

PA100/47/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

Dateoflastrenewal:01April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/09/2009 CRN 2071722 page number: 4