GAVISCON 250

Main information

  • Trade name:
  • GAVISCON 250
  • Pharmaceutical form:
  • Tablets Chewable
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GAVISCON 250
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/011/004
  • Authorization date:
  • 03-01-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gaviscon 250

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontains250 mg alginicacid (Ph. Eur.), 85 mg sodiumbicarbonate(Ph. Eur.)50 mg dried aluminium

hydroxide(Ph. Eur.)and 12.5 mg magnesiumtrisilicate(Ph. Eur.)

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Chewabletablet.

Circular, matt, offwhiteto creamchewabletablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Reliefofheartburn and indigestion.

4.2Posologyandmethodofadminstration

Fororaladministration, afterbeing thoroughly chewed.Thedosecan berinsed down with aquantity ofwater.

Adultsand children over12 years:Two tabletsasrequired.

Children under12 years:Notrecommended.

4.3Contraindications

Noneknown.

4.4Special warningsandspecialprecautionsforuse

Sodiumcontentofatabletis23.5 mg (1.02 mmol).Thismay beofimportancewhen ahighly restricted saltdietis

required asin somerenaland cardiovascularconditions.

Aluminiumhydroxidemay lead to aphosphatedepletion syndrome, particularly in patientson alowphosphatediet,

e.g. malnutrition.

Aluminiummay causeconstipation dueto itsastringentaction;thiseffectmay bebalanced by thecatharticeffectofthe

magnesiumsalts.

Magnesiumsaltsmay causecentralnervoussystemdepression in thepresenceofrenalinsufficiency and should notbe

Irish Medicines Board

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

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Aluminiumhydroxidemay formcomplexeswith certain drugsincluding 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

None.

4.8Undesirableeffects

Very rarely patientssensitiveto theingredientsmay develop allergicmanifestationssuch asurticariaorbronchospasm.

4.9Overdose

Asthemodeofaction ofGaviscon isalmostentirely physical, overdosagepresentsvirtually no hazard and no ill-

effectshavebeen reported.Theonly likely consequenceisabdominaldistension which isbesttreated conservatively.

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

Xylitol

PovidoneK30

Magnesiumstearate

Calciumcarbonate

Vanillin

Peppermintoil

Irish Medicines Board

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

6.2Incompatibilities

Noneknown.

6.3ShelfLife

2 years.

6.4Special precautionsforstorage

Do notstoreabove30°C. Storein adry place.

6.5Natureandcontentsofcontainer

ClearuPVCblisterscoated internally with PVdC, thermally sealed to ahard tempered aluminiumfoillid and

containing 8 tablets.Threefoilscontained in acardboard outercarton.

6.6Instructionsforuseandhandling

No specialinstructions.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIreland Limited,

Pharmapark,

Chapelizod,

Dublin 20.

8MARKETINGAUTHORISATIONNUMBER

PA979/11/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 3 rd

January 1996

Dateoflastrenewal: 3 rd

January 2001

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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