GAVISCON SACHETS ORAL POWDER FRESH TROPICAL FLAVOUR

Main information

  • Trade name:
  • GAVISCON SACHETS ORAL POWDER FRESH TROPICAL FLAVOUR
  • Pharmaceutical form:
  • Oral Powder
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GAVISCON SACHETS ORAL POWDER FRESH TROPICAL FLAVOUR
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/015/009
  • Authorization date:
  • 13-07-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

GavisconSachetsOralPowderFreshTropicalFlavour

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsachetcontainssodiumalginate500mg,sodiumhydrogencarbonate267mgandcalciumcarbonate160mg.

Excipient:AspartameE951.

Forafulllistofexcipients,seeSection6.1.

3PHARMACEUTICALFORM

Oralpowderinsachet.

Creamcolouredpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofsymptomsofgastro-oesophagealrefluxsuchasacidregurgitation,heartburnandindigestion(relatedto

reflux),forexample,followingmeals,orduringpregnancy,orinpatientswithsymptomsrelatedtorefluxoesophagitis.

4.2Posologyandmethodofadministration

Oraladministration.

Adultsandchildren12yearsandover:Onetotwosingledosecontainersaftermealsandatbedtime.Theproductis

takenorallywithoutwater.

Elderly:Nodosemodificationsnecessaryforthisagegroup.

HepaticImpairment:Nomodificationsnecessary.

RenalInsufficiency:Cautionifhighlyrestrictedsaltdietisnecessary.

Nodataavailableforchildrenunder12.

4.3Contraindications

Thismedicinalproductiscontraindicatedinpatientswithknownorsuspectedhypersensitivitytotheactivesubstances

ortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Thesodiumcontentofasingledosecontaineris123mg(5.3mmol).Thisshouldbetakenintoaccountwhenahighly

restrictedsaltdietisrecommended,e.g.insomecasesofcongestivecardiacfailureandrenalimpairment.

Eachsingledosecontainercontains160mg(1.6mmol)ofcalciumcarbonate.Careneedstobetakenintreating

patientswithhypercalcaemia,nephrocalcinosisandrecurrentcalciumcontainingrenalcalculi.

Irish Medicines Board

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Thereisapossibilityofreducedefficacyinpatientswithverylowlevelsofgastricacid.

Ifsymptomsdonotimproveaftersevendays,theclinicalsituationshouldbereviewed.

Treatmentofchildrenyoungerthan12yearsofageisnotgenerallyrecommended,exceptonmedicaladvice.

Consultyourdoctorifyouareover40yearsandhaveneversufferedwithheartburnandacidindigestionbefore.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Duetothepresenceofcalciumcarbonatewhichactsasanantacid,atime-intervalof2hoursshouldbeconsidered

betweenGavisconintakeandtheadministrationofothermedicinalproducts,especiallyH2antihistaminics

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

(atenolol,metoprolol,propanolol),glucocorticoid,chloroquine,anddiphosphonates.

4.6Fertility,pregnancyandlactation

Opencontrolledstudiesin281pregnantwomendidnotdemonstrateanysignificantadverseeffectsofGaviscononthe

courseofpregnancyoronthehealthofthefoetus/new-bornchild.Basedonthisandpreviousexperiencethemedicinal

productmaybeusedduringpregnancyandlactation.Nevertheless,takingintoaccountthepresenceofcalcium

carbonate,itisrecommendedtolimitthetreatmentdurationasmuchaspossible.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

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

oranaphylactoidreactions.

4.9Overdose

Intheeventofoverdosesymptomatictreatmentshouldbegiven.Thepatientmaynoticeabdominaldistension.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otherdrugsforpepticulcerandgastro-oesophagealrefluxdisease(GORD)ATCcode:

A02BX.

Oningestionthemedicinalproductreactsrapidlywithgastricacidtoformaraftofalginicacidgelhavinganear

neutralpHandwhichfloatsonthestomachcontentseffectivelyimpedinggastro-oesophagealreflux.Inseverecases

theraftitselfmayberefluxedintotheoesophagus,inpreferencetothestomachcontents,andexertademulcenteffect.

5.2Pharmacokineticproperties

Themechanismofactionofthemedicinalproductisphysicalanddoesnotdependonabsorptionintothesystemic

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5.3Preclinicalsafetydata

Nopre-clinicalfindingsofanyrelevancetotheprescriberhavebeenreported.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Mintflavour

Passionfruitflavour

Macrogol20,000

Macrogol400

Aspartame(E951)

Citricacidanhydrousgranular

Acesulfamepotassium(E950)

Xylitol

Silicondioxide

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Eighteenmonths.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Packsizesof4,6,12,16,20,24or32unitdosesachets.Thesachetsarecomposedofprinted

polyester/polyethylene/aluminiumfoil/polyethylene.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLimited

Pharmapark

Chapelizod

Dublin20

Ireland

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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Date Printed 04/04/2012 CRN 2105350 page number: 3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13 th

July2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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