GAVISCON LEMON FLAVOUR

Main information

  • Trade name:
  • GAVISCON LEMON FLAVOUR
  • Dosage:
  • 500/170/10 Milligram
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GAVISCON LEMON FLAVOUR
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/011/003
  • Authorization date:
  • 02-10-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gaviscon Tablets-Lemon Flavour

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontains500mg AlginicAcid, 170mg SodiumBicarbonate, 100mg AluminiumHydroxideGeland

25mg MagnesiumTrisilicate.

Forexcipients, see6.1

3PHARMACEUTICALFORM

Chewabletablet.

Circular, flat, off-whiteto cream, bevel-edged tabletswith asword logo on each faceand an odouroflemon.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Gastricreflux, reflux oesophagitis, heartburn, hiatushernia, flatulenceassociated with gastricreflux and heartburn of

pregnancy.Allcasesofepigastricand retrosternaldistresswheretheunderlying causeisgastricreflux.Treatmentof

regurgitation.

4.2Posologyandmethodofadminstration

Fororaladministration, afterbeing thoroughly chewed.

Adultsand children over12 years:Oneortwotabletsaftermealsandatbedtime.

Elderly:No dosemodification isrequired in thisagegroup.

Children 6 to 12years:Onetabletaftermealsand atbedtime.

Children 2 to 6 years:Should begiven only on medicaladvice.Dose-onetabletaftermealsand atbedtime.

Infants:Notrecommended.

4.3Contraindications

Noneknown.

4.4Special warningsandspecialprecautionsforuse

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

required asin somerenaland cardiovascularconditions.

Aluminiumhydroxidemay causeconstipation dueto itsastringentaction;thiseffectmaybebalanced by thecathartic

Irish Medicines Board

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Date Issued 22/09/2005 CRN 2014941 page number: 1

Aluminiumhydroxidemay lead to aphosphatedepletion syndrome, particularly in patientson alowphosphatediet,

e.g. malnutrition.

Magnesiumsaltsmay causecentralnervousdepression in thepresenceofrenalinsufficiency and should notbeused in

patientswith renalfailure.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Aluminiumhydroxidemay formcomplexeswith certain drugs, including thoseused in pregnancy, e.g. tetracyclines,

digoxin and vitamins, resulting in decreased 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 reactswith gastricacid to formaraftofalginicacid gelhaving anearneutralpHand which

floatson thestomach contentseffectively impeding gastro-oesophagealreflux.In severecasestheraftitselfmay be

refluxed into theoesophagus, in preferenceto thestomach contents, and exertademulcenteffect.

5.2Pharmacokineticproperties

Themodeofaction ofGaviscon isphysicaland doesnotdepend on absorption into thesystemiccirculation.

5.3Preclinical safetydata

No preclinicalfindingsofrelevanceto theprescriberhavebeen reported.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Mannitol(E421)

Xylitol

PovidoneK30

Magnesiumstearate

Irish Medicines Board

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Date Issued 22/09/2005 CRN 2014941 page number: 2

Lemon flavour

Sodiumsaccharin

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Two years.

6.4Special precautionsforstorage

Do notstoreabove30°C.Storein theoriginalcontainer.

6.5Natureandcontentsofcontainer

Polypropylenecontainerwith aplasticsnap on lid containing 20 tablets.Threecontainersin acarton.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIreland Limited,

Pharmapark,

Chapelizod,

Dublin 20.

8MARKETINGAUTHORISATIONNUMBER

PA979/11/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 2 nd

October1998

Dateoflastrenewal: 2 nd

October2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 22/09/2005 CRN 2014941 page number: 3