ASILONE ANTACID

Main information

  • Trade name:
  • ASILONE ANTACID
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASILONE ANTACID
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0618/019/003
  • Authorization date:
  • 11-10-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AsiloneAntacidTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activateddimeticone270mg

Driedaluminiumhydroxide500mg

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Chewabletablet.

Around,white,flattabletwithbevellededge,with“AsiloneAntacid”embossedononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Antiflatulentandantacid;forthereliefofdyspepticsymptomsoffunctionalororganicorigin,includingflatulenceand

associatedabdominaldistension,heartburn,hiatushernia,andoesophagitis.

4.2Posologyandmethodofadministration

Fororaladministration.

AdultsincludingtheElderly

Oneortwotabletstobechewedorsuckedbeforemealsandatbedtimeorwhenrequired.Forheartburn,theyshould

besuckedonly.

Children

AsiloneAntacidTabletsarenotrecommendedforchildrenunder12yearsofage.

4.3Contraindications

Antacidpreparationsshouldnotbeadministeredinseveredebilitationorrenalimpairment.Donotuseduringthefirst

trimesterofpregnancy.

4.4Specialwarningsandprecautionsforuse

AsiloneAntacidTabletsarenotrecommendedinflatulentabdominaldistentionpossiblyrelatedtointestinal

obstruction.

Irish Medicines Board

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Date Printed 06/03/2010 CRN 2079002 page number: 1

Labelstates:

Ifsymptomspersistconsultyourdoctor.

Notsuitableforchildrenunder12yearsofage.

Keepallmedicinesoutofthereachofchildren.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Antacidsmayinterferewiththeabsorptionoftetracyclines,rifampicin,warfarinanddigoxinifgivenconcomitantly.

Antacidsshouldpreferablynotbetakenatthesametimeasotherdrugssincetheymayimpairabsorption.Antacids

mayalsodamageentericcoatingdesignedtopreventdissolutioninthestomach.

4.6Pregnancyandlactation

Antacidpreparationsarenotrecommendedduringthefirsttrimesterofpregnancy.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Aluminiumsaltsmaycauseconstipation.However,suchboweldisturbancesarerarewiththeformulationofAsilone.

4.9Overdose

NocasesofoverdosagehavebeenreportedwithAsilone.ThecomponentsofAsilonearenotexpectedtocause

specificlocalorsystemictoxicityeveninacuteoverdosageinhealthyindividuals.Nospecialtreatment,but

symptomaticmanagementonlyifindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

AluminiumHydroxideisanantacid,whichincreasesgastricpHandhencediminishestheactivityofPepsiningastric

secretion.Inaddition,AluminiumHydroxidehasadirectinhibitingeffectonPepsin.Siliconesareusefulanti-

foamingagentsandtheadditionof4-8%offinelydividedSiliconDioxideincreasestheanti-foamingactivityof

Dimeticones.

DimeticonesactivatedbySiliconeDioxideactbychangingthesurfacetensionofgasbubbles,therebycausingthemto

coalesce.ThesodiumcontentislowandAsiloneAntacidTabletsarethereforeparticularlysuitedwherethereisco-

existinghypertension,congestiveheartfailure,hepaticand/orrenalfailure.

5.2Pharmacokineticproperties

Activeingredients;AluminiumHydroxideandActivatedDimethiconearenotgenerallyabsorbed.

5.3Preclinicalsafetydata

Irish Medicines Board

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Date Printed 06/03/2010 CRN 2079002 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sucrose

Sorbitol

Purifiedtalc

Levomenthol

Peppermintoil

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Fiveyears.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

200or250micronPVC/20micronaluminiumfoilblistersincardboardcartonsinpacksof4,8,12,20,24,96or100

tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

SetonProductsLtd.,

TubitonHouse,

Oldham,

LancashireOL13HS,

8MARKETINGAUTHORISATIONNUMBER

PA0618/019/003

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Irish Medicines Board

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Date Printed 06/03/2010 CRN 2079002 page number: 3