GAVISCON LEMON TABLETS 500

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/015/007
  • Authorization date:
  • 22-12-2004
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0979/015/007

CaseNo:2032524

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrants

ReckittBenckiserIrelandLtd

7Riverwalk,CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Gaviscon500mgLemonChewableTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjectto

thegeneralconditionsasmaybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom06/02/2007until21/12/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 13/04/2007 CRN 2032524 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gaviscon500mgLemonChewableTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontainssodiumalginate500mg,sodiumhydrogencarbonate267mgandcalcium

carbonate160mg.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Chewabletablet

Anoff-whitetocream,slightlymottledtablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofsymptomsofgastro-oesophagealrefluxsuchasacidregurgitation,heartburnandindigestion(relatedto

reflux),forexamplefollowingmeals,orduringpregnancy,orinpatientswithsymptomsrelatedtorefluxoesophagitis.

4.2Posologyandmethodofadministration

Fororaluse,afterbeingthoroughlychewed.

Adultsandchildren12yearsandover:Onetotwotabletsaftermealsandatbedtime.

Elderly:Nodosemodificationsnecessaryforthisagegroup.

4.3Contraindications

Thismedicinalproductiscontraindicatedinpatientswithknownorsuspectedhypersensitivitytotheactivesubstances

ortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Thesodiumcontentofatwo-tabletdoseis246mg(10.6mmol).Thisshouldbetakenintoaccount

whenahighlyrestrictedsaltdietisrecommended,e.g.insomecasesofcongestivecardiacfailureand

renalimpairment.

Eachtwo-tabletdosecontains320mg(3.2mmol)ofcalciumcarbonate.Careneedstobetakenin

Irish Medicines Board

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Duetoitsaspartamecontentthismedicinalproductshouldnotbegiventopatientswith

phenylketonuria.

Thereisapossibilityofreducedefficacyinpatientswithverylowlevelsofgastricacid.

Ifsymptomsdonotimproveaftersevendays,theclinicalsituationshouldbereviewed.

Treatmentofchildrenyoungerthan12yearsofageisnotgenerallyrecommended,exceptonmedical

advice.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Duetothepresenceofcalciumcarbonatewhichactsasanantacid,atime-intervalof2hoursshould

beconsideredbetweenGavisconintakeandtheadministrationofothermedicinalproducts,especially

-antihistaminicstetracyclines,digoxine,fluoroquinolone,ironsalt,ketoconazole,neuroleptics,

thyroxine,penicilamine,beta-blockers(atenolol,metoprolol,propanolol),glucocorticoid,chloroquine

anddiphosphonates.

4.6Pregnancyandlactation

Opencontrolledstudiesin281pregnantwomendidnotdemonstrateanysignificantadverseeffectsofGaviscononthe

courseofpregnancyoronthehealthofthefoetus/new-bornchild.Basedonthisandpreviousexperiencethemedicinal

productmaybeusedduringpregnancyandlactation.Nevertheless,takingintoaccountthepresenceofcalcium

carbonate(seeSection5.3)itisrecommendedtolimitthetreatmentdurationasmuchaspossible.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

Veryrarely(<1/10,000)patientssensitivetotheingredientsmaydevelopallergicmanifestationssuchasurticariaor

bronchospasm,anaphylacticoranaphylactoidreactions.

4.9Overdose

Intheeventofoverdosesymptomatictreatmentshouldbegiven.Thepatientmaynoticeabdominal

distension.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otherdrugsforpepticulcerandgastro-oesophagealrefluxdisease

(GORD)ATCcode:A02BX.

Irish Medicines Board

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havinganearneutralpHandwhichfloatsonthestomachcontentseffectivelyimpedinggastro-

oesophagealreflux.Inseverecasestheraftitselfmayberefluxedintotheoesophagus,inpreference

tothestomachcontents,andexertademulcenteffect.

5.2Pharmacokineticproperties

Themechanismofactionofthemedicinalproductisphysicalanddoesnotdependonabsorptioninto

thesystemiccirculation.

5.3Preclinicalsafetydata

Thereislimitedevidenceinsomereportsinanimalsofdelayincalcificationoffoetalskeleton/bone

Irish Medicines Board

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lemonflavourno.1

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-beadneckfinish

packedintocartons.

Containercontaining20,40,or60tablets.

Unprinted,glass-clear,thermoformablelaminateofuPVC/PE/PVdCwithaluminiumfoillidding

blisterspackedinto

cartons.

Blistercontainingsixindividuallysealedtablets.Packsizes:12and24chewabletablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerials

derivedfromsuchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLimited

7Riverwalk

Irish Medicines Board

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Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA979/15/7

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:22December2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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