GERELAX

Main information

  • Trade name:
  • GERELAX 3.35g/ 5ml MG/ 5ml
  • Dosage:
  • 3.35g/ 5ml MG/ 5ml
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GERELAX  3.35g/5ml MG/5ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0577/002/001
  • Authorization date:
  • 16-12-1991
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0577/002/001

CaseNo:2019767

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

McDermottLaboratoriesLtd

35-36BaldoyleIndustrialEstate,GrangeRoad,Dublin13,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

GERELAX3.35g/5mlOralSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom09/03/2006until16/12/2006.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 13/03/2006 CRN 2019767 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gerelax

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each 5mlofthesolution contains3.30g Lactulose

Forexcipients, see6.1

3PHARMACEUTICALFORM

Oralsolution

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortreatmentofconstipation and hepaticencephalopathy (hepaticcoma).

4.2Posologyandmethodofadminstration

Routeofadministration: Oral

Gerelax may betaken with waterorfruitjuice

Initialdosageforconstipation:

Initialdosageforhepaticencephalopathy:

Adoctormay wish to changetheseinitialdosesasideally two orthreesoftstoolsshould beproduced daily and an

acidicfaecalpH.

4.3Contraindications

Usein patientswho requireagalactose-freediet.

Usein patientswith evidenceofgastro-intestinalobstruction.

4.4Special warningsandprecautionsforuse

GERELAXshould beused with caution in patientswith lactoseintolerance.Becauseofthephysiologicalmodeof

Adults: 15ml(onesachet)twicedaily

Children 5 to 10years: 10ml(two 5mlspoonful)twicedaily

Children 2 to 5 years: One5mlspoonfultwicedaily

Adults(including theelderly): 30 to 50mlthreetimesdaily

Irish Medicines Board

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which may enablethepatientto reducetheeffectivedosegradually overaperiod oftime.

In theeventofdiarrhoeaadequatefluid intakeshould bemaintained during treatment, and thedosagereduced.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theproductshould notbetaken with entericcoated mesalazine(5-ASA)asthelowerstoolpHmay preventtherelease

ofmesalazine.

Theeffecton colonicbacteriaby certain broad spectrumantibioticagentsmay interferewith thedegradation of

lactuloseand preventacidification ofcoloniccontents.

4.6Pregnancyandlactation

Theproductmay beused during pregnancy when considered necessary by thephysician.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Sideeffectsoccurrarely.Casesofmild abdominaldiscomfort, crampsorflatulencehavebeen reportedfollowinguse

ofGERELAX,buttheseeffectsgenerally subsideaftertheinitialstageoftreatment.

4.9Overdose

No casesofintoxication dueto deliberateoraccidentaloverdosewith GERELAXhavebeen reported tothecompany.

No specificantidote.Symptomatictreatmentshould begiven.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Lactuloseisasemi-syntheticdisaccharidewhich isused in thetreatmentofconstipation and in hepatic

encephalopathy.Lactuloseisbroken down by colonicbacteriamainly into aceticand lacticacidswhich exertalocal

osmoticeffectin thecolon resulting in increased faecalbulk and stimulation ofperistalsis.Itmay takeup to 48 hours

beforean effectisobtained.When largerdosesaregiven forhepaticencephalopathy thepHin thecolon isreduced

significantly by thisacid production and theabsorption ofammoniumionsand othertoxicnitrogenouscompoundsis

decreased leading to afallin blood-ammoniaconcentration.

5.2Pharmacokineticproperties

Following oraladministration, anegligibleamountoflactuloseisabsorbed in thegastro-intestinaltract.Itpasses

essentially unchanged into thelargeintestinewhereitismetabolised by saccharolyticbacteria, forming simpleorganic

acidssuch aslacticand aceticacid.Urinaryexcretion hasbeen reported to be3%orless.

5.3Preclinical safetydata

Irish Medicines Board

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Purified water

6.2Incompatibilities

Noneknown

6.3ShelfLife

1 year

6.4Special precautionsforstorage

Do notstoreabove25°C.

Do notrefrigerate.

6.5Natureandcontentsofcontainer

HPDEbottlewith whiteHDPEorpolypropylenescrewcap, containing 100, 150, 200,300, 500, 1000 or5000 mlof

LactuloseSolution.

Amberglassbottleand whiteHDPEscrewcap with polyethylenepolyconeliner, containing 100, 150, 200, 300, 500 or

1000mlofLactuloseSolution.

15 mlLDPElined Aluminiumfoilsachetsin packsof14, 30, 50 or100.

6.6Instructionsforuseandhandling

None

7MARKETINGAUTHORISATIONHOLDER

McDermottLaboratoriesLimited trading asGerard Laboratories,

35-36 BaldoyleIndustrialEstate,

GrangeRoad,

Dublin 13

Ireland.

8MARKETINGAUTHORISATIONNUMBER

PA577/2/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisatioin: 16 th

December1991

Dateoflastrenewal: 16 th

December2001

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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