EX-LAX SENNA PILLS

Main information

  • Trade name:
  • EX-LAX SENNA PILLS
  • Dosage:
  • 12mg Milligram
  • Pharmaceutical form:
  • Coated Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EX-LAX SENNA PILLS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/055/001
  • Authorization date:
  • 13-04-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0030/055/001

CaseNo:2067774

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NovartisConsumerHealthUKLtd

WimblehurstRoad,Horsham,WestSussexRH125AB,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Ex-LaxSennaPills12mgSugarCoatedTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom22/06/2009until21/04/2012.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/06/2009 CRN 2067774 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Ex-LaxSennaPills12mgSugarCoatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains20mgstandardisedsennadryextractequivalentto12mgsennosidescalculatedassennosidesA&

Forexcipientsseesection6.1

3PHARMACEUTICALFORM

Sugarcoatedtablets.

Circular,biconvex,brownishredsugarcoatedtabletswithapproximately6mmdiameter.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Reliefofoccasionalconstipation

4.2Posologyandmethodofadministration

Thefollowingdosesarenormallytakenatbedtime

Adultsandchildrenover12:1tablet

Aseconddosemaybetakenduringthedayifrequired.Donotexceedtwodosesinany24hours.

Notrecommendedforchildrenunder12 .

Thereisnoindicationthatthedosageshouldbemodifiedfortheelderly.

Route:

Oralrouteofadministration.

4.3Contraindications

Ex-LaxSennaPillsshouldnotbegiventopatientswithsymptomsofappendicitis,intestinalobstructionbleeding,

inflammatoryboweldisease,includingulcerativecolitisorabdominalpainofunknownorigin

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 24/06/2009 CRN 2067774 page number: 2

4.4Specialwarningsandprecautionsforuse

Prolongeduseisnotrecommended.Ex-LaxSennaPillsshouldnotbeusedformorethan7dayswithoutseeking

medicaladvice.

Label/leafletprecaution:

Ifalaxativeisneededeverydayorthereispersistentabdominalpain-consultyourdoctor.

Ifthereisnobowelmovementafter3daysconsultyourdoctor.

Ex-LaxSennaPillsshouldbeusedwithcautionshortlyafterbowelsurgery.

DuringuseofEx-LaxSennaPills,anadequateleveloffluidintakeshouldbemaintained.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

Ex-LaxSennashouldnotbeusedduringpregnancyandlactationunlessconsideredessentialbythephysician.

Anthroquinonesareexcretedinbreastmilkbutclinicalstudieshaveshownthatthebreastfedinfantsofmotherstaking

asennalaxativedidnotshowanysideeffectstothedrug.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Temporarymildgripingmayoccur.

4.9Overdose

Overdosagemayresultindiarrhoeawithexcessivelossofwaterandelectrolytes,particularlypotassium.Treatment

shouldincludeanincreaseinfluidintaketoreversethelossoffluidandelectrolytes.

Prolonged,excessiveuseoflaxativeswithoutinterruptionshouldbeavoidedbecauseoftheriskofelectrolyte

imbalancesandinextremecasesthepossibilityofirreversibleadverseeffectsonthebowel.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Sennaisananthraquinonelaxativewhichisusedtotreatconstipationandforbowelevacuationbeforeradiological

procedures.Theactiveanthraquinonesareliberatedintothecolonfromglycosidesbycolonicbacteriaandaneffect

Irish Medicines Board

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Date Printed 24/06/2009 CRN 2067774 page number: 3

5.2Pharmacokineticproperties

Thereissomeabsorptionoftheanthraquinonesfromsennapreparationsfollowinghydrolysisbycolonicbacteria.

Excretionoccursintheurineandfaecesandalsoinothersecretionsincludingmilk.

(Althoughanthraquinonederivativesmaybeexcretedinthemilkoflactatingmothers,followingnormaldosagethe

concentrationisusuallyinsufficienttoaffectthenursinginfant).

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sucrose

Lactosemonohydrate,

Maizestarch,

Talc,

Acacia,

Titaniumdioxide(E171),

Glucose,

Stearicacid,

Gelatin,

Colloidalanhydroussilica,

Redironoxide(E172),

Carnaubawax.

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

TransparentorbluecolouredblisterpackcomposedofPVC/PVdCblisterssealedwithaluminiumfoil.

Packsizes:6,9,10,12,18,20,24,30,36or48tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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Date Printed 24/06/2009 CRN 2067774 page number: 4

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLtd.,

Tradingas:NovartisConsumerHealth,

WimblehurstRoad,

Horsham,

WestSussex,

RH125AB,

UnitedKingdom.

8MARKETINGAUTHORISATIONNUMBER

PA30/55/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation13 th

April2007.

Irish Medicines Board

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Date Printed 24/06/2009 CRN 2067774 page number: 5