ASILONE

Main information

  • Trade name:
  • ASILONE Oral Suspension
  • Pharmaceutical form:
  • Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASILONE Oral Suspension
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0618/019/002
  • Authorization date:
  • 11-10-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AsiloneSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Lightmagnesiumoxide70mg/5ml

Driedaluminiumhydroxide420mg/5ml

Activateddimeticone135mg/5ml

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Oralsuspension.

Awhitemobilesuspensionwiththetasteandodourofpeppermintandaniseed.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Antiflatulentandantacid;forthereliefofdyspepticsymptomsoffunctionalororganicorigin,includingflatulenceand

associatedabdominaldistension,heartburn,hiatushernia,andoesophagitis.

4.2Posologyandmethodofadministration

Fororaladministration.

AdultsincludingtheElderly

Oneortwo5mlspoonfulsaftermealsandatbedtimeorwhenrequired,uptoamaximumoffourtimesdaily.

Children

Thesuspensionformulationisnotrecommendedforchildrenunder12yearsofage.

4.3Contraindications

Antacidpreparationsshouldnotbeadministeredinseveredebilitationorrenalimpairment.Donotuseduringthefirst

trimesterofpregnancy.

4.4Specialwarningsandprecautionsforuse

Asiloneisnotrecommendedinflatulentabdominaldistentionpossiblyrelatedtointestinalobstruction.

Ifsymptomspersistconsultyourdoctor.

Irish Medicines Board

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

Keepallmedicinesoutofreachofchildren.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Antacidsmayinterferewiththeabsorptionoftetracyclines,rifampicin,warfarinanddigoxinifgivenconcomitantly.

Antacidsshouldpreferablynotbetakenatthesametimeasotherdrugssincetheymayimpairabsorption.Antacids

mayalsodamageentericcoatingdesignedtopreventdissolutioninthestomach.

4.6Pregnancyandlactation

Antacidpreparationsarenotrecommendedduringthefirsttrimesterofpregnancy.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Aluminiumsaltsmaycauseconstipationandmagnesiumsaltsdiarrhoea.However,suchboweldisturbancesarerare

withtheformulationofAsilone.

4.9Overdose

NocasesofoverdosagehavebeenreportedwithAsilone.ThecomponentsofAsilonearenotexpectedtocause

specificlocalorsystemictoxicityeveninacuteoverdosageinhealthyindividuals.Nospecialtreatment,but

symptomaticmanagementonlyifindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

TheactiveingredientspossessAntacidandAntiflatulentpropertieswhicharelongestablished;theiractionsinawide

varietyofgastro-intestinaldisordersarewellrecognisedinstandardtexts.LightMagnesiumOxideandAluminium

HydroxideareantacidswhichincreasegastricpHandhencediminishtheactivityofPepsiningastricsecretion.In

addition,AluminiumHydroxidehasadirectinhibitingeffectonPepsin.

Siliconesareusefulanti-foamingagentsandtheadditionof4-8%offinelydividedSiliconDioxideincreasestheanti-

foamingactivityofDimeticones.DimeticonesactivatedbySiliconeDioxideactbychangingthesurfacetensionofgas

bubbles,therebycausingthemtocoalesce.

5.2Pharmacokineticproperties

NodataonpharmacokineticstudieswithAsiloneareavailable.Theactiveingredients,AluminiumHydroxideand

ActivatedDimeticonearenotnormallyabsorbed.SomeMagnesiummaybeabsorbedfromMagnesiumOxidein

AsiloneSuspension,butitisgenerallyrapidlyexcretedintheurine.

5.3Preclinicalsafetydata

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

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Potassiumsorbate

Saccharinsodium

Sorbitol

Flavexpeppermint/aniseedflavourL263

Flavexflavourmodiferno.12

Hydrogenperoxidesolution

Methylparahydroxybenzoate

Propylparahydroxybenzoate

Purifiedwater

6.2Incompatibilities

Nonestated.

6.3ShelfLife

Twoyears.

Usewithin28daysofopening.

6.4Specialprecautionsforstorage

Donotfreeze.

6.5Natureandcontentsofcontainer

Bottlesofhighdensitypolyethyleneinblue,withawhitepolypropylenecaporawhitepolyethylenetamperevident

capwithalowdensitypolyethyleneinnercorelinercontainingeither100ml,200ml,300mlor500ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

SetonProductsLtd.,

TubitonHouse,

Oldham,

LancashireOL13HS,

8MARKETINGAUTHORISATIONNUMBER

PA0618/019/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Irish Medicines Board

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