FYBOGEL LEMON

Main information

  • Trade name:
  • FYBOGEL LEMON
  • Dosage:
  • 3.5 Grams
  • Pharmaceutical form:
  • Granules Effervescent
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FYBOGEL LEMON
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0979/009/003
  • Authorization date:
  • 21-09-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0979/009/003

CaseNo:2032524

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrants

ReckittBenckiserIrelandLtd

7Riverwalk,CitywestBusinessCampus,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

FYBOGELLEMON3.5gEffervescentGranules

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjectto

thegeneralconditionsasmaybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom06/02/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/04/2007 CRN 2032524 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FybogelLemon3.5gEffervescentGranules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsachetcontains3.5gispaghulahusk.

Alsocontains16mgaspartame,persachet.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Effervescentgranules

Orangetobuff-colouredgranuleswithalemonodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

ClinicalIndication:forthetreatmentofpatientsrequiringahighfibreregimen.

4.2Posologyandmethodofadministration

FybogelLemonisintendedfororaladministrationinasuspensioninadrinkofwater.Thegranules

shouldbestirredintoaglassofwaterandtakenassoonaspossible,preferablyaftermeals.

Adultsandchildrenover12years:

Onesachetortwo5mlspoonfulseachmorningandevening,preferablyaftermeals.

Elderly:

Thereisnoindicationthatdosageneedstobemodifiedfortheelderly.

Children6to12years:

Halftoonelevel5mlspoonful,dependingonageandsize,morningandevening.

Childrenunder6years:

Tobetakenonlywhenprescribedbyadoctor,halftoonelevel5mlspoonful,dependingonageand

size,morningandevening.

4.3Contraindications

FybogelLemoniscontra-indicatedincasesofintestinalobstruction,faecalimpactionandcolonic

Irish Medicines Board

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4.4Specialwarningsandprecautionsforuse

DuetoitsaspartamecontentFybogelLemonshouldnotbegiventopatientswithphenylketonuria.

Ifsymptomspersistconsultadoctor.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

FybogelLemonmaybeusedduringpregnancyandlactationsincetheispaghulahuskisnotabsorbed

fromthegastrointestinaltract.

4.7Effectsonabilitytodriveandusemachines

Notapplicableinviewofitsphysicalmodeofaction.

4.8Undesirableeffects

Flatulenceandbloatingmaybeexperiencedduringthefirstfewdaysoftreatment,butdiminish

duringcontinuedtreatment.

4.9Overdose

Intheeventofoverdosageconservativemeasuresshouldbetaken.Thepatientmaynoticeabdominal

discomfortandflatulence,andattentionshouldbepaidtomaintaininganadequatefluidintake,

particularlyifthegranuleshavebeentakenwithoutwatercontrarytoadministrationinstructions.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ispaghulahuskiscapableofabsorbingupto40timesitsownweightinwaterinvitro,andpartofits

activitycanbeattributedtoitsactionasasimplebulkingagent.Inaddition,colonicbacteriaare

believedtousethehydratedmaterialasametabolicsubstrate.Thisresultsinanincreaseinthe

bacterialcellmassandconsequentsofteningofthefaeces.

5.2Pharmacokineticproperties

ThemodeofactionofFybogelLemonisphysicalanddoesnotdependonabsorptionintothe

systemiccirculation.

5.3Preclinicalsafetydata

Irish Medicines Board

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Citricacid

Lemonflavourno.1

Lemonflavourno.4

Aspartame(E951)

PotassiumHydrogenCarbonate

SodiumHydrogenCarbonate

RiboflavinSodiumPhosphate

Saccharinsodium

Polysorbate80

Silica,colloidalanhydrous

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove30 o

C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Sachetsofpaper/aluminiumfoil/polythene/surlynlaminateenclosedinacardboardoutercarton.

Cartoncontaining10and30sachets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerials

derivedfromsuchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ReckittBenckiserIrelandLimited

7Riverwalk

CitywestBusinessCampus

Dublin24

Ireland

Irish Medicines Board

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Date Printed 13/04/2007 CRN 2032524 page number: 4

PA979/9/3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21September2001

Dateoflastrenewal:21September2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 13/04/2007 CRN 2032524 page number: 5