COLOFAC 135 MG TABLETS

Main information

  • Trade name:
  • COLOFAC 135 MG TABLETS
  • Dosage:
  • 135 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COLOFAC 135 MG TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0108/014/001
  • Authorization date:
  • 07-02-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Colofac135mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

MebeverineHydrochloride135mg.

Excipients:alsoincludesLactosemonohydrate97.0mgpertabletandSucrose79.0mgpertablet.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

CoatedTablet.

White,circular,sugarcoatedtablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Foruseinthemanagementofirritablebowelsyndrome,(particularlygastrointestinalspasm).

4.2Posologyandmethodofadministration

Adultsandchildrenover10years:

Onetabletthreetimesadaypreferably20minutesbeforemeals.

Afteraperiodofseveralweekswhenthedesiredeffecthasbeenobtained,thedosagemaybegraduallyreduced.

ChildrenandInfants:

Notrecommended.

4.3Contraindications

Useinpatientswithaknownhypersensitivitytomebeverine.

4.4Specialwarningsandprecautionsforuse

Priortotreatingpatientswithmebeverine,careshouldbetakentoexcludeorganicdiseaseofthebowel,particularly

malignancy.

Patientswithrarehereditaryproblemsofgalactoseorfructoseintolerance,theLapplactasedeficiency,glucose-

galactosemalabsorptionorsucrase-isomaltaseinsufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

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Date Printed 22/02/2011 CRN 2096067 page number: 1

4.6Fertility,pregnancyandlactation

Althoughstudiesinanimalshavenotshownanyteratogeniceffectwhichcanbedefinitelyattributedtomebeverine,the

safetyofColofacinhumanpregnancyhasnotbeenestablished.Onbasicprinciplestherefore,itsuseisnot

recommended.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Veryrarelyhypersensitivityreactionsmayoccur,inparticular,urticaria,angioedema,faceoedemaand

exanthema/rash.

4.9Overdose

Ontheoreticalgrounds,itmaybepredictedthatCNSexcitabilitywilloccurincasesofoverdosage.Nospecific

antidoteisknown;gastriclavageandsymptomatictreatmentisrecommended.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Mebeverineisanantispasmodicwithadirectactiononthesmoothmuscleofthegastrointestinaltract,relievingspasm

withoutaffectingnormalgutmotility.

5.2Pharmacokineticproperties

Mebeverineisrapidlyandcompletelyabsorbedafteroraladministrationintheformoftabletsorsuspension.

Mebeverineisnotexcretedassuch,butmetabolisedcompletely.Thefirststepinthemetabolismishydrolysis,leading

toveratricacidandmebeverinealcohol.Bothveratricacidandmebeverinealcoholareexcretedintotheurine,thelatter

partlyasthecorrespondingcarboxylicacidandpartlyasthedemethylatedcarboxylicacid.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Starch(potatoormaize)

Povidone

Talc

Magnesiumstearate

Sucrose

Gelatin

Acacia

Irish Medicines Board

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Date Printed 22/02/2011 CRN 2096067 page number: 2

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

AL/PVCblistersinboxescontaining4tablets(physician’ssample)or100tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AbbottHealthcareProductsLimited

MansbridgeRoad

WestEnd

Southampton

SO183JD

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA108/14/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:07February1983

Dateoflastrenewal:07February2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 22/02/2011 CRN 2096067 page number: 3