ALVERINE CITRATE 120 Milligram Capsules Hard

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
ALVERINE CITRATE
Available from:
Auden Mckenzie (Pharma Division) Ltd
ATC code:
A03AX08
INN (International Name):
ALVERINE CITRATE
Dosage:
120 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Other drugs for functional gastrointestinal disorders
Authorization status:
Authorised
Authorization number:
PA1352/010/002
Authorization date:
2010-01-29

ALVERINE CITRATE

60mg &120mg capsules

PATIENTINFORMATIONLEAFLET

READALLOFTHISLEAFLETCAREFULLYBECAUSEITCONTAINSIMPORTANT

INFORMATION FOR YOU

Thismedicineisavailablewithoutprescription.However,you stillneed to takeAlverine citrate

Capsulescarefullyto getthe bestresultsfromit.

Keep thisleaflet.You mayneed to readitagain.

Askyourpharmacistifyou need more information oradvice.

You mustcontacta doctorifyoursymptomsworsen ordo notimproveaftera fewdays.

Ifanyofthe side effectsgetsserious,orifyou noticeanysideeffectnotlistedinthisleaflet,please

tellyourdoctororpharmacist.

THELEAFLETCONTAINSINFORMATION ON:

1.WhatAlverinecitrateCapsulesare andwhattheyare used for.

2.Beforeyou takeAlverinecitrateCapsules

3.Howto takeAlverine citrateCapsules

4.Possible side effects

5.Howto storeAlverinecitrateCapsules

6.FurtherInformation

1.WHATALVERINECITRATECAPSULESAREANDWHATTHEYAREUSEDFOR

Alverine citratebelongstoa group ofmedicinescalled'antispasmodic'.Itworksbyrelaxing the

musclesin the intestine (gut)anduterus(womb).Thishelpsto stop the painyou feelwhen these

musclestense up.

Alverine citrateCapsulesare usedtohelppeople who haveIrritable BowelSyndrome(IBS).

These are some ofthe symptomsofIBS:

Tummypainslike cramp,which come andgo.

Diarrhoea.

Constipation.

Feeling fulland bloated.

Wanting to go tothetoileturgently

Sometimesthese symptomsareworse ifyouareworried orunderstress.

Alverine citrateCapsulesare alsousedfora conditionofthe largeintestine calledpainfuldiverticular

diseaseofthe colon.Itisalso used torelieve period pains.

Healthtipsforyou

Trytomake youreverydaylifea bithealthier:

Allowplentyoftime to dothings,and avoid stress.

Do notrush meals.

Trytoeata balanceddietwithhigh fibre foods.

Do noteatfoods,which seemtomakeyourIBSworse

2.BEFORE YOUTAKEALVERINE CITRATECAPSULES

Ifthisisthefirsttimeyouhavehad these symptoms,consultyourdoctorbefore using anytreatment.

Donot takeAlverine citrateCapsulesif you:

are allergic(hypersensitive)to Alverine citrateoranyotheringredientsinthe capsules.

havebeentold byyourdoctorthatyou have paralyticileus.

are ormaybepregnant

are breastfeeding

yourdoctorhastoldyouthatyouhave obstruction ofthe gutorthatyoursmallbowelisnot

working properly.

Consultyourdoctorifanyofthe aboveappliestoyou asthismaynotbe the righttreatmentforyou.

Take specialcarewithAlverine citrateCapsulesandconsult yourdoctorifyou:

have developed newsymptoms,orifyoursymptomsworsen,oriftheydonotimproveafter2

weeksoftreatment.

are aged40yearsorover

have passed blood fromthe bowel

are feeling sickorvomiting

have lostyourappetite orlostweight

are looking paleand feelingtired

are suffering fromsevere constipation

have a fever

have recentlytravelled abroad

have abnormalvaginalbleeding ordischarge

have difficultyorpain passing urine.

Takingothermedicine

Please tellyourdoctororpharmacistifyou are takingorhave recentlytaken anyothermedicines

including medicinesobtainedwithoutaprescription.

Pregnancyandbreast-feeding

The safetyofalverine citrate foruse duringpregnancyandbreast-feedinghasnotbeenestablished.

Hence,itshould betaken onlyifyourdoctoradvisestodo so.Pleaseaskyourdoctororpharmacist

foradvicebefore takinganymedicine.

Drivingandusingmachines

Ifyou feeldizzywhiletakingAlverine citrate Capsules,you shouldavoid drivingoroperating

machinery.

3.HOWTOTAKEALVERINECITRATECAPSULES

Followyourdoctor’sdirectionsaboutwhenandhowtotakeyourcapsulesandlookatthe labelonthe

carton.Yourpharmacistwillalso helpifyou arenotsure.

Alverine citrate60 mg Capsules:

1 or2 capsulesoneto three timesdaily.

Alverine citrate120mg Capsules:

1 capsule one to three timesdaily.

Swallowyourcapsuleswithoutchewing themwitha drink.

Childrenunder12yearsold shouldnottakeAlverine citrateCapsules

If youtakemoreAlverine citrateCapsulesthanyoushould

Itisimportantto stickto thedose on the labelofthemedicine.Ifyouorsomeoneelse swallows

severalofthese capsulesalltogether,contactyourdoctorornearesthospitalemergencydepartment

immediately.Alwaystake anycapsulesleftoverwithyou and also the box,asthiswillalloweasier

identificationofthe capsules.

If youforget totakeAlverine citrateCapsules

Ifyou forgetto take a dose,take itassoon asyouremember.Ifitisalmosttime foryournextdose do

nottake a doubledosetomake up fora forgottendose,justcarryon asbefore.

Ifyouhaveanyfurtherquestionson the useofthisproduct,askyourdoctororpharmacist.

4.POSSIBLESIDE EFFECTS

Like allmedicines,AlverinecitrateCapsulescanhaveside effectsalthoughnoteverybodygetsthem.

StoptakingAlverine citrateCapsulesandtellyourdoctorimmediatelyifyouexperience:

Yellowing ofthewhitesofthe eyesand skin.Thiscould beaninflammation oftheliverandmay

occurveryrarely.

Difficultiesin breathing,shortnessofbreath,wheezing,swelling ofyourface orotherpartsofyour

body,asseriousallergicreactionshave beenknown to occur.

Tellyourdoctorifyouexperience:

Arashorfeelunwell.

Thismaybe an allergicreaction toAlverine citrateCapsulesand mayoccuroccasionally.

Thefollowingsideeffectshavebeenreportedrarely:

feeling ofsickness,

dizziness,

headache,

allergy,

rash oritching.

Ifanyoftheside effectsgetsserious,orifyounotice anysideeffectsnotlistedinthisleaflet,please

tellyourdoctororpharmacist.

Reportingof sideeffects:

Ifyou getanysideeffects,talktoyourdoctor,pharmacistornurse.Thisincludesanypossible side

effectsnotlistedinthisleaflet.You can also reportsideeffectsdirectlyviaHPRAPharmacovigilance,

EarlsfortTerrace,IRL-Dublin 2;Tel:+3531 6764971;Fax:+3531 6762517.Website:www.hpra.ie;

E-mail:medsafety@hpra.ie.

Byreporting sideaffectsyou can help provide more information on the safetyofthismedicine.

5.HOWTO STOREALVERINECITRATECAPSULES

Keep outofthe reachandsightofchildren.

Do notuseAlverinecitrateCapsulesafterthe expirydate,which isstatedon theblisterand carton.

The expirydaterefersto the lastdayofthemonth.

Do notstore above25°C.Store in the originalpackaging.

Medicinesshould notbe disposed ofviawastewaterorhousehold waste.Askyourpharmacisthow

to dispose ofmedicinesnolongerrequired.These measureswillhelp toprotectthe environment.

6.FURTHER INFORMATION

WhatAlverine citrateCapsules contain

The name ofyourmedicineisAlverine citrate 60 mg Capsules&Alverine citrate120 mg Capsules.

The activesubstance inyourcapsule isAlverinecitrate.Each capsule contains60mg or120mg of

alverine citrate.ThisistheingredientthatmakesAlverine citrateCapsuleswork.Otheringredients

are maize starch,pregelatinized starch(Starch1500),magnesiumstearate,gelatin,blackiron oxide,

brilliantblue and titaniumdioxide.

WhatAlverinecitrateCapsuleslooklikeandcontentsof thepack

Alverine citrate60 mg Capsulesare grey/blue,hardgelatin capsulesprintedwith‘AV’on cap and‘60’

on body,containing awhiteto offwhitepowder.

Alverine citrate120mg Capsulesare grey/blue,hardgelatin capsulesprintedwith ‘AV’on capand

‘120’on body,containingawhite tooffwhite powder.

Alverine citrate60 mg andAlverine citrate120mg capsulesare supplied in blisterscontaining 3,10,

12,20,30,60,90 or100 capsules,in stripsof10capsulesasappropriate.Notallpacksizesmaybe

marketed.

MarketingAuthorisationHolderandManufacturer

MarketingAuthorisation Holderofthese capsulesisAudenMckenzie (Pharma Division)Ltd.,

WhiddonValley,Barnstaple,NorthDevon,EX328NS,UnitedKingdom.

Manufacturerofthese capsulesis

AudenMckenzie (Pharma Division)Ltd.,Mckenzie House,BuryStreet,Ruislip,Middlesex,HA47TL,

UK.

&

Tiofarma BV,Benjamin Franklinstraat7-9,3261LWOud-Beijerland,The Netherlands.

&

ActavisUKLimited,Whiddon Valley,Barnstaple,North Devon,EX32 8NS,United Kingdom.

ThisleafletwaspreparedinOctober2015.

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Alverinecitrate120mgCapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains120mgalverinecitrate

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Capsule,hard( Capsule ).

AGrey/Blue,size'1'hardgelatincapsulesprintedwith‘AV’oncapand‘120’onbody,containingwhitetooffwhite

powder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thereliefofsmoothmusclespasm,inconditionssuchasirritablebowelsyndrome,painfuldiverticulardiseaseofthe

colonandprimarydysmenorrhoea.

4.2Posologyandmethodofadministration

Recommendeddoseanddosageschedules:

Adults(includingtheelderly):1capsuleonetothreetimesdaily.

Childrenbelowtheageof12years:notrecommended.

4.3Contraindications

Paralyticileusorknownhypersensitivitytoanyoftheingredients.

Intestinalobstruction

Useduringpregnancyandlactation.

4.4Specialwarningsandprecautionsforuse

AdditionalwarningstobeincludedinthePatientInformationLeaflet:

Ifthisisthefirsttimeyouhavehadthesesymptoms,consultyourdoctorbeforeusinganytreatment.

IfanyofthefollowingapplydonotuseAlverineCitrateCapsules;itmaynotbetherighttreatmentforyou.Seeyour

doctorassoonaspossibleif:

-youareaged40yearsorover

-youhavepassedbloodfromthebowel

-youarefeelingsickorvomiting

Health Products Regulatory Authority

______________________________________________________________________________________________________________________

Date Printed 20/09/2016 CRN 2183112 page number: 1

-youarelookingpaleandfeelingtired

-youaresufferingfromsevereconstipation

-youhaveafever

-youhaverecentlytravelledabroad

-youareormaybepregnant

-youhaveabnormalvaginalbleedingordischarge

-youhavedifficultyorpainpassingurine.

Consultyourdoctorifyouhavedevelopednewsymptoms,orifyoursymptomsworsen,oriftheydonotimproveafter

2weekstreatment.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated

4.6Fertility,pregnancyandlactation

Althoughnoteratogeniceffectshavebeenreported,useduringpregnancyorlactationisnotrecommendedasevidence

ofsafetyinpreclinicalstudiesislimited.Useisthereforecontraindicatedduringpregnancyandlactation.

4.7Effectsonabilitytodriveandusemachines

Maycausedizziness.Donotdriveorusemachineryifaffected

4.8Undesirableeffects

Immunesystemdisorders:Allergicreaction,anaphylaxis,dyspnoeaand/orwheezing

Nervoussystemdisorders:Headache,dizziness

Gastrointestinaldisorders:Nausea

Hepato-biliarydisorders:Jaundiceduetohepatitis,typicallythisresolvesoncessationofAlverine

Skinandsubcutaneoustissuedisorders:Itching,rash

Reportingofsuspectedadversereactions:

ReportingofsuspectedadversereactionsReportingsuspectedadversereactionsafterauthorisationofthemedicinal

productisimportant.Itallowscontinuedmonitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcare

professionalsareaskedtoreportanysuspectedadversereactionsviaHPRAPharmacovigilance,EarlsfortTerrace,IRL

-Dublin2;Tel:+35316764971;Fax:+35316762517.Website: http://www.hpra.ie/ ;E-mail: medsafety@hpra.ie .

4.9Overdose

Canproducehypotensionandatropine-liketoxiceffects.Managementisasforatropinepoisoningwithsupportive

therapyforhypotension.

Fatalityhasoccurredfollowingoverdosewithveryhighdoses.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Alverinecitrateisaspasmolytic,whichhasaspecificactiononthesmoothmuscleofthealimentarytractanduterus,

withoutaffectingtheheart,bloodvesselsandtrachealmuscleattherapeuticdoses.

Health Products Regulatory Authority

______________________________________________________________________________________________________________________

Date Printed 20/09/2016 CRN 2183112 page number: 2

Afteroraladministration,alverineisrapidlyconvertedtoitsprimaryactivemetabolite,whichisthenfurtherconverted

totwosecondarymetabolites.Thereisahighrenalclearanceofallmetabolitesindicatingthattheyareeliminatedby

activerenalsecretion.Thepeakplasmalevelofthemostactivemetaboliteoccursbetween1and1½hoursafteroral

dosing.

5.3Preclinicalsafetydata

Preclinicalstudiesprovideevidencethatalverinecitratehasnosignificantsystemictoxicitypotentialattheproposed

dosage.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MaizeStarch

PregelatinisedStarch(Starch1500)

MagnesiumStearate

CapsuleshellCap

Gelatin

BlackIronOxide

TitaniumDioxide

CapsuleShellBody

Gelatin

BrilliantBlue

TitaniumDioxide

PrintingInkComposition

Shellac

DehydratedAlcohol

IsopropylAlcohol

ButylAlcohol

PropyleneGlycol

StrongAmmoniaSolution

BlackIronOxide(E172)

PotassiumHydroxide

6.2Incompatibilities

Notapplicable

6.3Shelflife

3years

Health Products Regulatory Authority

______________________________________________________________________________________________________________________

Date Printed 20/09/2016 CRN 2183112 page number: 3

Donotstoreabove25°C.Storeintheoriginalpackaging.

6.5Natureandcontentsofcontainer

TabletsarepackedinAl//PVC/PVdCblisterscontaining2,10,20,30,60or90capsules,instripsof10capsulesas

appropriate.Notallpacksizeswillbemarketed.

6.6Specialprecautionsfordisposal

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

AudenMckenzie(PharmaDivision)Ltd

WhiddonValley

Barnstaple

NorthDevon

EX328NS

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA1352/010/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:4December2009

10DATEOFREVISIONOFTHETEXT

Health Products Regulatory Authority

______________________________________________________________________________________________________________________

Date Printed 20/09/2016 CRN 2183112 page number: 4

Similar products

Search alerts related to this product

View documents history

Share this information