GAVISCON

Main information

  • Trade name:
  • GAVISCON Tablets Chewable 500/ 25/ 100 Milligram
  • Dosage:
  • 500/ 25/ 100 Milligram
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GAVISCON Tablets Chewable 500/25/100 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/011/002
  • Authorization date:
  • 01-04-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gaviscon Tablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontains500mg Alginicacid,170 mg sodiumbicarbonate, 100 mg AluminiumHydroxideGeland 25mg

MagnesiumTrisilicate.

Forexcipients, see6.1

3PHARMACEUTICALFORM

Chewabletablet.

Circular, flat, off-whiteto cream, bevel-edged tablets, 0.9 inchesin diameterwith an odourand flavourofpeppermint,

with‘Gaviscon’and sword motifimprinted on both faces.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Gastricreflux, reflux oesophagitis, heartburn, hiatushernia, heartburn(including heartburn ofpregnancy)and similar

gastricdistress.

4.2Posologyandmethodofadminstration

Oral.

Adultsand children over12 years:Oneortwotabletsaftermealsandatbedtime.

Children 6 to 12years:Onetabletaftermealsand atbedtime.

4.3Contraindications

Noneknown.

4.4Special warningsandspecialprecautionsforuse

Sodiumcontentofatabletis47 mg (2.04 mmol).Thisshould betaken into accountwhen ahighly restricted saltdietis

required asin somerenaland cardiovascularconditions.Productscontaining aluminiumhydroxideshould beused

with caution in patientswith renaldysfunction orhypophosphataemia.

Aluminiumhydroxidemay causeconstipation dueto itsastringentaction;thiseffectmaybebalanced by thecathartic

effectofthemagnesiumsalts.

Aluminiumhydroxidemay lead to aphosphatedepletion syndrome, particularly in patientson alowphosphatediet,

e.g. malnutrition.

Irish Medicines Board

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Date Issued 22/09/2005 CRN 2014934 page number: 1

patientswith renalfailure.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Aluminiumhydroxidemay formcomplexeswith certain drugsincluding thoseused during pregnancy, e.g.

tetracyclines, digoxin and vitamins, resulting indecreased absorption.Thisshould bebornein mind when concomitant

administration isconsidered.

4.6Pregnancyandlactation

Alginatehasno systemicactivity and consequently can betakenduring pregnancy and lactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Very rarely patientssensitiveto theingredientsmay develop allergicmanifestationssuch asurticariaorbronchospasm.

4.9Overdose

In theeventofoverdosagesymptomatictreatmentshould begiven.Thepatientmay noticeabdominaldistension.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

On ingestion Gaviscon Tabletsreactwith gastricacid to formaraftofalginicacid gelhaving anearneutralpHand

which floatson thestomach contentseffectively impeding gastro-oesophagealreflux.In severecasestheraftitself

may berefluxed into theoesophagus, in preferencetothestomach contents, and exertademulcenteffect.

5.2Pharmacokineticproperties

Themodeofaction ofGaviscon Tabletsisphysicaland doesnotdepend on absorption into thesystemiccirculation.

5.3Preclinical safetydata

No preclinicalfindingsofrelevanceto theprescriberhavebeen reported.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MannitolE421

Xylitol

PovidoneK30

MagnesiumStearate

CalciumCarbonate

Vanillin

Peppermintoil

Irish Medicines Board

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Date Issued 22/09/2005 CRN 2014934 page number: 2

6.2Incompatibilities

NotApplicable

6.3ShelfLife

Threeyears.

6.4Special precautionsforstorage

Do notstoreabove30°C.Storein theoriginalcontainer.

6.5Natureandcontentsofcontainer

Polypropylenecontainercontaining 20 tablets.Threetubesin acarton.

6.6Instructionsforuseandhandling

No specialrequirements

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIreland Limited,

Pharmapark,

Chapelizod,

Dublin 20.

8MARKETINGAUTHORISATIONNUMBER

PA979/11/2.

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 1 st

April1983

Dateoflastrenewal: 31 st

March2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 22/09/2005 CRN 2014934 page number: 3