AGIOLAX PICO

Main information

  • Trade name:
  • AGIOLAX PICO
  • Dosage:
  • 5 Milligram
  • Pharmaceutical form:
  • Lozenges
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AGIOLAX PICO
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1288/004/001
  • Authorization date:
  • 30-11-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1288/004/001

CaseNo:2042926

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TransferredfromPA0375/005/001.

MadausGmbH

51101Cologne,Germany

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AgiolaxPico5mgLozenges

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom30/11/2007until03/02/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/12/2007 CRN 2042926 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AgiolaxPico5mgLozenges

2QUALITATIVEANDQUANTITATIVECOMPOSITION

1lozengecontains:

SodiumpicosulfatemonohydrateequivalenttoSodiumpicosulfate,anhydrous5mg.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Lozenges

Arectangularyellowlozengewithabreak-line.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Foruseincasesofconstipationandillnessesrequiringaneasydefaecation.

4.2Posologyandmethodofadministration

Adults,elderlypeople,childrenover12years:1-2lozengesonceperday.

Childrenover4years:afterconsultingaphysician½lozengeonceperday.

Thelozengesshouldpreferablybetakenintheevening.Theycanbesuckedorchewedorbeswallowedwholewith

someliquid.

Asarule,thelaxativeeffectsetson10-12hoursafteradministration.

Themaximumuseinthreedays.However,itmayberepeatedifnecessary.

4.3Contraindications

Agiolax Picomustnotbeusedinpatientswithexistingorimminentileus.Itshouldnotbeusedeitherincasesof

acuteinflammatorydiseasesofthegastrointestinaltractandchildrenundertheageof4years.Inchildrenofamore

advancedage,theproductshouldbeusedonlyaftercarefulassessmentofthebenefit-riskratio.AgiolaxPicois

contraindicatedinpregnantwomen.

4.4Specialwarningsandprecautionsforuse

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/12/2007 CRN 2042926 page number: 2

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theactiveingredientsodiumpicosulfatecanpotentiatethelossofpotassiumcausedbyotherdrugs(e.g.diuretics,

corticosteroids).Thesensitivitytocardiacglycosidescanbeenhancedduetoincreasedlossesofpotassium.

Concurrentlyadministeredantibioticsmayresultinalossofthelaxativeeffectofsodiumpicosulfate.

4.6Pregnancyandlactation

AgiolaxPicoiscontraindicatedinpregnantwomen.

Noexperienceinwomenisavailableregardingtheadministrationduringlactation.Sodiumpicosulfateandits

metabolitesdonotpassintobreastmilk.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Adversereactionsarerareinshort-termadministration.ProlongeduseofAgiolax Picomayresultinanaggravation

ofconstipation.Furthermore,inhigh-doseadministrationabuseormisuse,severediarrhoeawithincreasedsaltand

waterlossmayoccur,whichcanresultincardiacandmusculardysfunction.Thismayrequireintravenousfluid

replacement.

4.9Overdose

Overdosageproducesdiarrhoea.Ifrequired,compensatorymeasuresshouldbeconsidered.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Sodiumpicosulfate,theactiveingredientofAgiolax Pico,isalaxativeofthetriarylmethanegroup.Afterits

metabolizationinthecolon,itinhibitstheabsorptionoffluidandenhancesthesecretionofwaterandelectrolytes.Hard

stoolsarehencesoftened.Thestoolvolumeisincreasedandperistalticactivitystimulated.

5.2Pharmacokineticproperties

Intestinalabsorptionofsodiumpicosulfateislow.Afterbacterialcleavageofsulfateesterinthecolon,theresulting

diphenoliclaxativeispartiallyabsorbed(maximumplasmalevelsareapprox.27ng/mlafter14hours)andafter

conjugationexcretedinbile.Eliminationoccurstoasmallextentasglucuronideviatheurine.Mostofitisexcretedin

faecesintheformoffreediphenolandalsoaspicosulfate.Nochemicalknowledgeonplasma-proteinbindingis

available.

5.3Preclinicalsafetydata

Acutetoxicity

Acutetoxicityofsodiumpicosulfateinavarietyofanimalsrangesfrom5to15g/kg(alsoseepara4.9Signsand

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/12/2007 CRN 2042926 page number: 3

Chronictoxicity

Inchronictoxicitytestsinavarietyofanimalspecies,dailydosesofupto50mg./kg/bodyweightdidnotshowany

evidenceoftoxiceffects.

Mutagenicandtumorigenicpotential

Noexperienceinvestigationsonthemutagenicandtumorigenicpotentialhavebeenreported.

Reproductivetoxicology

Embryonaltoxicitytestscarriedoutinratsandrabbitshavenotshownanyevidenceofteratogenicpotentialindosesof

upto100mg/kg/day.Atthisdoseembryotoxiceffectsappearedinbothspecies.Dailydosesofmorethan10mg/kg,

administeredduringfetaldevelopmentandlactation,inhibitedtheincreaseinweightoftheoffspringandproduceda

highermortalityrateintheyounganimals.Thefertilityofmaleandfemaleratsremainedundisturbeduptoadoseof

100mg/kg/day.Noexperienceinwomenisavailableregardingtheadministrationduringpregnancyandlactation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

AcesulfamePotassium

Gelatin

Glycerol85%

Guargum

Lecithin

MaizeStarch

Aromatic(naturalplumflavour)

-containsEthanol

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Blisterpacks(PVC/aluminium).

Contents:10,20and40lozenges.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/12/2007 CRN 2042926 page number: 4

7MARKETINGAUTHORISATIONHOLDER

MadausGmbH

51101Cologne

Germany

8MARKETINGAUTHORISATIONNUMBER

PA1288/4/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:04February2000

Dateoflastrenewal:04February2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/12/2007 CRN 2042926 page number: 5