GAVISCON PEPPERMINT TABLETS 500

Main information

  • Trade name:
  • GAVISCON PEPPERMINT TABLETS 500
  • Dosage:
  • 500 Milligram
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GAVISCON PEPPERMINT TABLETS 500
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/015/006
  • Authorization date:
  • 22-12-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0979/015/006

CaseNo:2048475

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ReckittBenckiserIrelandLtd

7Riverwalk,CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Gaviscon500mgPeppermintChewableTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom28/05/2008until21/12/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/05/2008 CRN 2048475 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gaviscon500mgPeppermintChewableTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontainssodiumalginate500mg,sodiumhydrogencarbonate267mgandcalciumcarbonate160mg.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Chewabletablet

Anoff-whitetocream,slightlymottledtablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofsymptomsofgastro-oesophagealrefluxsuchasacidregurgitation,heartburnandindigestion(relatedto

reflux),forexample,followingmeals,orduringpregnancy,orinpatientswithsymptomsrelatedtorefluxoesophagitis.

4.2Posologyandmethodofadministration

Fororaluse,afterbeingthoroughlychewed.

Adultsandchildren12yearsandover:Onetotwotabletsaftermealsandatbedtime.

Elderly:Nodosemodificationsnecessaryforthisagegroup.

4.3Contraindications

Thismedicinalproductiscontraindicatedinpatientswithknownorsuspectedhypersensitivitytotheactivesubstances

ortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Thesodiumcontentofatwo-tabletdoseis246mg(10.6mmol).Thisshouldbetakenintoaccountwhenahighly

restrictedsaltdietisrecommended,e.g.insomecasesofcongestivecardiacfailureandrenalimpairment.

Eachtwo-tabletdosecontains320mg(3.2mmol)ofcalciumcarbonate.Careneedstobetakenintreatingpatientswith

hypercalcaemia,nephrocalcinosisandrecurrentcalciumcontainingrenalcalculi.

Duetoitsaspartamecontentthismedicinalproductshouldnotbegiventopatientswithphenylketonuria.

Thereisapossibilityofreducedefficacyinpatientswithverylowlevelsofgastricacid.

Irish Medicines Board

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Treatmentofchildrenyoungerthan12yearsofageisnotgenerallyrecommended,exceptonmedicaladvice.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Duetothepresenceofcalciumcarbonatewhichactsasanantacid,atime-intervalof2hoursshouldbeconsidered

betweenGavisconintakeandtheadministrationofothermedicinalproducts,especially,H

-antihistaminics,

tetracyclines,digoxine,fluoroquinolone,ironsalt,ketoconazole,neuroleptics,thyroxine,penicilamine,beta-blockers

(atenolol,metoprolol,propanolol),glucocorticoid,chloroquineanddiphosphonates.

4.6Pregnancyandlactation

Opencontrolledstudiesin281pregnantwomendidnotdemonstrateanysignificantadverseeffectsofGaviscononthe

courseofpregnancyoronthehealthofthefoetus/new-bornchild.Basedonthisandpreviousexperiencethemedicinal

productmaybeusedduringpregnancyandlactation.Nevertheless,takingintoaccountthepresenceofcalcium

carbonate(seeSection5.3)itisrecommendedtolimitthetreatmentdurationasmuchaspossible.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

Veryrarely( ≤1/10,000)patientsmaydevelopallergicmanifestationssuchasurticariaorbronchospasm,anaphylactic

andanaphylactoidreactions.

4.9Overdose

Intheeventofoverdosesymptomatictreatmentshouldbegiven.Thepatientmaynoticeabdominaldistension.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otherdrugsforpepticulcerandgastro-oesophagealrefluxdisease(GORD)ATCcode:

A02BX.

Oningestionthemedicinalproductreactsrapidlywithgastricacidtoformaraftofalginicacidgelhavinganear

neutralpHandwhichfloatsonthestomachcontentseffectivelyimpedinggastro-oesophagealreflux.Inseverecases

theraftitselfmayberefluxedintotheoesophagus,inpreferencetothestomachcontents,andexertademulcenteffect.

5.2Pharmacokineticproperties

Themechanismofactionofthemedicinalproductisphysicalanddoesnotdependonabsorptionintothesystemic

circulation.

5.3Preclinicalsafetydata

Thereislimitedevidenceinsomereportsinanimalsofdelayincalcificationoffoetalskeleton/boneabnormalities

Irish Medicines Board

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Peppermintflavour

Macrogol20,000

Mannitol(E421)

Aspartame(E951)

Magnesiumstearate

Copovidone

Acesulfamepotassium(E950)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

6.5Natureandcontentsofcontainer

White,rigid,injection-moulded,polypropylenecylindricalcontainerwithsnap-beadneckfinishpackedintocartons.

Containercontaining20,40or60tablets.Packsizes:20,40,60and80chewabletablets.

Unprinted,glass-clear,thermoformablelaminateofuPVC/PE/PVdCwithaluminiumfoilliddingblisterspacked

intocartons.

Blistercontainingsixindividuallysealedtablets.Packsizes:12and24chewabletablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLimited

7Riverwalk

CitywestBusinessCampus

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:22December2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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