COLOFIBRE

Main information

  • Trade name:
  • COLOFIBRE Granules 65/ 2.2 %w/ %w/ w
  • Dosage:
  • 65/ 2.2 %w/ %w/ w
  • Pharmaceutical form:
  • Granules
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COLOFIBRE Granules 65/2.2 %w/ %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1288/003/001
  • 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)

PA1288/003/001

CaseNo:2042926

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TransferredfromPA0375/002/001.

MadausGmbH

51101Cologne,Germany

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ColofibreGranules

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom30/11/2007until05/12/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

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

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ColofibreGranules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Granules

Fine-grained,yellow-browngranuleswithanaromaticodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofpatientsrequiringahighfibredietregimenandasabulkformingagentintheregulationofbowel

function.

4.2Posologyandmethodofadministration

Fororaladministration.

ColofibreGranulesshouldbeplaceddryonthetongueandwithoutchewingorcrushingswallowedwithaglassof

waterorwarmdrink.ColofibreGranulescanbetakenmixedjustbeforeconsumptionwithyoghurt,ice-cream,

porridgeoranysemi-solidfood.Thelastdoseshouldnotbetakenimmediatelybeforeretiringtobed.Ensuring

adequatedailyfluidintakeof1-2litresisrecommended.

Adultsandchildrenover12years:

Onetotwostandard5mlspoonfulsaftersupperandifnecessarybeforebreakfast.Inobstinatecasestwo5mlspoonfuls

sixhourlyfor1to3days.

Elderly:

Theadultdosageisappropriate.

Children5-12years:

SeedsofPlantagoovata:65.0 %w/w

Irish Medicines Board

______________________________________________________________________________________________________________________

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

4.3Contraindications

4.4Specialwarningsandprecautionsforuse

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notapplicable.

4.6Pregnancyandlactation

Thisproductshouldnotbeusedinpregnancyunlessconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Abdominaldistensionandflatulencemayoccur.Aswithallpsylliumproducts,allergicreactionsmayoccurinrare

cases.

4.9Overdose

Thereisnoinformationaboutoverdosagewiththisproduct.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Plantagoovataseedsandhuskscontainlargeamountsofmucilagewhichtakesupmoistureintheintestinaltract

therebyincreasingthebulkofthefaecalcolumnandpromotingperistalsis.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

1.UseinpatientswithhypersensitivitytoPlantagoovata.

2.Useinpatientswithintestinalobstructionorfaecalimpactionorcolonicatony.

1.Useofthisproductmustbeaccompaniedbyanincreasedfluidintake,particularlyinpatientswithdecreased

intestinalmotility.Useinelderlyordebilitatedpatientsmayneedsupervision.

2.Ifsymptomspersist,consultyourdoctor.

3.Specialnotefordiabeticpatients:Each5mlspoonfulofColofibreGranulescontainsapproximately0.9gof

Irish Medicines Board

______________________________________________________________________________________________________________________

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

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CarawayOil

SageOil

PeppermintOil

Acacia

Talc

TitaniumDioxide

IronOxide(Red)

IronOxide(Yellow)

HardParaffin

LiquidParaffin

Sucrose

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Lacqueredaluminiumcanswithinnerlidandscrewcap.Packsize:250g

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

MadausGmbH

51101Cologne

Germany

8MARKETINGAUTHORISATIONNUMBER

PA1288/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:06December1983

Irish Medicines Board

______________________________________________________________________________________________________________________

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

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

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