AMISULPRIDE MYLAN 400 Milligram Film Coated Tablet

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
AMISULPRIDE
Available from:
McDermott Laboratories Ltd t/a Gerard Laboratories
INN (International Name):
AMISULPRIDE
Dosage:
400 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization number:
PA0577/125/004
Authorization date:
0000-00-00

Package leaflet:information for the user

Amisulpride Mylan400mgfilm-coatedTablets

Amisulpride

Read allofthisleafletcarefully beforeyou starttaking thismedicinebecauseitcontains important

information for you.

- Keep this leaflet. You mayneed to read itagain.

- Ifyou have anyfurtherquestions, askyourdoctororpharmacist.

- This medicine has been prescribed foryouonly. Do notpass iton to others. Itmayharmthem, even if

theirsigns ofillnessare the same as yours.

- Ifyou getanysideeffects, talkto yourdoctororpharmacist. This includesanypossibleside effects

notlisted in this leaflet.See section 4.

What is in this leaflet:

1. WhatAmisulpride Mylan is and whatitis used for

2. Whatyou need to knowbefore you take Amisulpride Mylan

3. Howto take Amisulpride Mylan

4. Possible side effects

5. Howto store Amisulpride Mylan

6. Contents ofthe packand otherinformation

1. What Amisulpride Mylan isandwhat itis used for

Amisulpride Mylancontains amedicine called amisulpride.This belongs to a group ofmedicinescalled

‘antipsychotics’.Itis used in the treatmentofacute and chronic schizophrenic disorders. This condition

causes symptoms such as becomingwithdrawn, sensing, seeingorhearingthings which do notexist,

mistakenbeliefs orunfounded suspicions. Sometimespeople with these symptoms mayalso feeltense,

anxious ordepressed.

Amisulpride Mylan also acts on mood disorderin the sense ofdepression.

2. What you need to knowbeforeyou take Amisulpride Mylan

Do not takeAmisulpride Mylan

- Ifyouare allergic to amisulpride oranyofthe otheringredients ofthis medicine (listed in section 6)

- ifyou noticesigns ofan allergic reaction including:a rash, swallowingorbreathingproblems, swelling

ofyourlips, face, throatortongue

- ifyouhave aprolactin dependenttumourorbreastcancer

- ifyouhave phaeochromocytoma (a tumouron the adrenalgland)

- Ifyouarepregnant, mightbecome pregnantorarebreast-feeding(see Pregnancyand brest-feeding

section)

- ifyou

Are takinglevodopa (used to treatParkinson's disease)

- ifthe patientis under18 years old

Do nottake this medicine ifanyofthe above applyto you. Ifyou are notsure, talkto yourdoctoror

pharmacistbefore takingAmisulpride Mylan.

Warnings and precautions

Talktoyourdoctororpharmacistbefore takingAmisulpride Mylanifyou:

- are an elderlypatientaselderlypeople are more likelyto getlowblood pressure and feelsleepy. A

smallincreasein the numberofdeaths ofelderlypeople with dementia has been reported forpatients

takinganti-psychoticscompared to thosenotreceivinganti-psychotics

- orsomeoneelsein yourfamilyhasa historyofblood clots, as medicineslike these have been associated

with formation ofblood clots

-

- have kidneyproblems

- have Parkinson’s disease (takingthis medicine mayworsen yourcondition)

- have ahistoryoffits (epileptic seizures)

- have an abnormalheartrate orrhythm

- have aslowheartbeat(less than 55 beats perminute)

- have heartdisease orfamilyhistoryofheartproblems

- have diabetesmellitus oratriskofhavingit

- have been told byyourdoctorthatyou are atriskofhavingstroke

- have been told you have alowamountofpotassiumin yourblood

- have alownumberofwhite blood cells (this means you maygetinfections more easilythan usual)

- have frequentinfections such as fever, severe chills, sore throatormouth ulcers. These could be signs of

a blood problemcalled leucopenia

Ifyou are notsure ifanyofthe above applyto you, talkto yourdoctororpharmacistbefore taking

Amisulpride Mylan.

-

Contactyourdoctorimmediatelyifyou suddenlydevelop a high temperature (pleasereferto section 4).

Children andadolescents

Amisulpride Mylan should notbe given to children under18 years old.

Other medicinesandAmisulpride Mylan

Tellyourdoctororpharmacistifyou are taking,have recentlytakenormighttakeanyothermedicines.

In particular, do nottake this medicine and tellyourdoctorifyou are taking:

-Levodopa, amedicine to treatParkinson’s disease

-Drugs called dopamine agonists such as ropinirole and bromocriptine(medicinesused to treat

Parkinson’s disease)

Amisulpride Mylan can interactwith the followingmedicines:

-Anaesthetics

-Antihistamines(which cause drowsiness)

-Medicinesused to controlyourheartbeatsuch asquinidine, disopyramide, amiodarone and sotalol

-Otheranti-psychotic medicinesused formentalproblems

-Medicinesforsevere pain called opiatessuch asmorphineorpethidine

-Medicinesforhigh blood pressure and heartproblems such as diltiazem,verapamil, guanfacine and

digitalis

-Clonidine used formigraines, flushingorhigh blood pressure

-Mefloquine used to treatmalaria

-Medicineswhich help you sleep such asbarbituratesand benzodiazepines

-Pain-killers suchastramadoland indometacin

Ifyou are notsure ifanyofthe above applyto you, talkto yourdoctororpharmacistbefore taking

Amisulpride Mylan.

Please referto “Do not takeAmisulpride Mylan”in addition.

Amisulpride Mylanwith alcohol

Do notdrinkalcoholwhile you are takingAmisulpride Mylan, itmaymake you drowsy.

Pregnancy and breast-feeding

Ifyou are pregnantorbreast-feeding, thinkyou maybe pregnantorare planningto have ababy, askyour

doctororpharmacistforadvicebefore takingthis medicine.

Due to verylimited clinicaldata, Amisulpride Mylan should notbe taken duringpregnancyand breast-

feeding.

The followingsymptoms mayoccurin newborn babies, ofmothers thathave usedamisulpridein the last

trimester(lastthreemonths oftheirpregnancy):shaking, muscle stiffness and/orweakness, sleepiness,

agitation, breathingproblems, and difficultyin feeding. Ifyourbabydevelops anyofthese symptoms you

mayneed to contactyourdoctor.

Driving and using machines

Amisulpride Mylanmaymake you feelless alert, drowsyorsleepywhile takingthis medicine.Ifthis

happens donotdrive oroperate machineryuntilyou are sure thatyou are notaffected.

Amisulpride Mylancontains lactose

Amisulpride Mylancontains lactose. Ifyou have been told byyourdoctorthatyou have an intolerance to

some sugars, contactyourdoctorbefore takingthis medicine.

3. Howto take Amisulpride Mylan

Always takethis medicineexactlyasyourdoctororpharmacisthastold you.Checkwith yourdoctoror

pharmacistifyou are notsure.

Adults:

Doses are adjusted individuallyand can range from50 mgup to 800 mgdaily.Yourdoctormaystartyou on

a lowerdoseifnecessary. Ifnecessaryyourdoctorcan prescribe up to 1200 mgeach day.This willdepend

on the nature ofyourillness and you should followyourdoctor’s instructions carefully.

Ifyou are takingup to400mgAmisulpride Mylana day, you should take itin one dose.Take the dose atthe

same time each day.Ifyou are takingmore than400mgAmisulpride Mylana day, you should divide the

doseinto two and take halfin the morningand halfin the evening.

Elderly:

Yourdoctorwillneed to keep a closecheckon you asyou are more likelyto have lowblood pressure or

sleepiness dueto this medicine.

People with kidneyproblems:

Yourdoctormayneed to give you a lowerdose.

Usein children and adolescents (under18 years ofage):

Amisulpride Mylan should notbe given to children under18 years old.

Amisulpride Mylan tablets can beadministered independentlyfromthe meals.Take this medicine bymouth.

Tablets should be taken wholeorhalved with a sufficientamountofliquid.Do notchewyourtablets.

Ifyou take moreAmisulpride Mylanthanyou should

Contactyourdoctororthe hospitalimmediately.Take this medicnepackwith you. This is so the doctor

knows whatyou have taken. The followingeffects mayhappen:feelingrestless orshaky, rigid muscles,

feelingdrowsyorsleepywhich could lead to a lossofconsciousness.

Ifyou forgettotakeAmisulpride Mylan

Do nottake adouble dose to make up fora forgotten dose.Take yournextdoseatthe usualtime.

Ifyou stop takingAmisulpride Mylan

Do notstop takingAmisulpride Mylanwithoutconsultingyourdoctor. Stoppingtreatmentsuddenlymay

causewithdrawaleffects such as feelingsick, vomiting, sweating, sleeplessness, extreme restlessness,

muscle stiffness orabnormalmovements, oryouroriginalcondition maycome back.

Blood Tests

TakingAmisulpride Mylan mayaffectthe results ofsome blood tests. These include tests to measure the

hormone called ‘prolactin’and livertests. Ifyou are goingto have ablood test, itis importantto tellyour

doctorthatyou are takingAmisulpride Mylan.

Ifyou have anyfurtherquestions on the useofthismedicine, askyourdoctororpharmacist.

4. Possibleside effects

Like allmedicines,this medicinecan causeside effects, although noteverybodygets them.

Ifany ofthe following happen,stop taking Amisulpride Mylan andtellyour doctoror go to your

nearesthospitalemergency departmentimmediately:

Frequencynotknown (cannotbe estimated from theavailable data):

yourheartstarts beatingfasterthan usualwhich could resultin heartattackorlife-threateningheart

disorder.

you have high temperature, muscle stiffness, feelingfaintorlight-headed,confused, drowsyor

agitated,paleness, racingheart,fastbreathing,changesto blood pressure, sweating, urinary

incontinence (these are symptoms ofa veryrare syndrome called NeurolepticMalignantSyndrome).

you have blood clots in the veins speciallyin the legs (symptoms include swelling, pain and redness

in the leg), which maytravelthough blood vessels to the lungs causingchestpain and difficultyin

breathing.

you getmore infections than usual. This could be becauseofa blood disorder(agranulocytosis)ora

decreasein the numberofwhite blood cells (neutropenia, leucopenia).

Uncommon (may affectup to 1 in 100 people):

you have an allergic reaction. The signs mayinclude:an itchy, lumpyrash, swallowingorbreathing

problems, swellingofyourlips, face, throatortongue

you have afit(seizure)

Tellyour doctor assoon as possibleifyou have any ofthe following side effects:

VeryCommon (may affectmorethan 1 in 10 people):

trembling, muscle stiffness orspasm, slowmovement, producingmore saliva than usualorfeeling

restless.

Common (may affectup to 1 in 10 people):

movements that you cannot control, mainlyof thearms and legs, head, neck, jawor eyes.

(These symptoms can bereduced ifyourdoctorlowers yourdoseofamisulpride orprescribesan

additionalmedicine.)

Uncommon (may affectup to 1 in 100 people):

movements thatyou cannotcontrol, mainlyofthe face ortongue

Other side effects include:

Commonside effects( may affectup to 1 in 10 people ):

difficultysleeping(insomnia, drowsiness)orfeelinganxious oragitated

constipation, feelingorbeingsick, drymouth

weightgain

difficultyreachingorgasm, impotence*

unusualsecretion ofmilkfromthe breasts in womenand men, breastpain*

breastenlargementin men*

menstrualperiod stops*

lowblood pressure (causingdizziness)

feelingdizzy(which can bedue to lowblood pressure)

Uncommon side effects( may affectup to 1 in 100 people ):

high blood sugarlevels (hyperglycaemia)

elevated liverenzymes

slowingofthe heartbeat

*These side effects disappeargraduallyafteryou stop takingAmisulpride Mylan.

Ifyou getanyside effects, talkto yourdoctororpharmacist. This includesanypossible side effects not

listed in this leaflet.

Reporting ofside effects

Ifyou getanyside effects, talkto yourdoctororpharmacist. This includesanypossible side effects not

listed in this leaflet. You can also reportside effects directlyvia:

Ireland

Pharmacovigilance Section

Irish MedicinesBoard

Kevin O’MalleyHouse

EarlsfortCentre

EarlsfortTerrace

IRL-Dublin 2

Tel:+353 1 6764971

Fax:+353 1 6767836

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

Byreportingside effects you can help provide more information on the safetyofthis medicine.

5. Howto storeAmisulpride Mylan

Keepthis medicineoutofthesightandreachofchildren.

This medicine does notrequire anyspecialstorage conditions.

Do notuseAmisulpride Mylanafterthe expirydate which is stated on the blisterand carton afterEXP. The

expirydate refers to the lastdayofthatmonth.

Donotthrowawayanymedicinesvia wastewaterorhousehold waste. Askyourpharmacisthowtothrow

awaymedicinesyouno longeruse. These measureswillhelp to protectthe environment.

6. Contentsofthe pack and otherinformation

WhatAmisulpride Mylancontains

- The active substance is amisulpride.

EachAmisulpride Mylan 400 mgfilm-coated tabletcontains 400 mgamisulpride.

- The otheringredients are:

Core

Lactosemonohydrate,methylcellulose,sodiumstarchglycolate(typeA),cellulose,microcrystalline,

magnesiumstearate.

Filmcoating

Basic butylated methacrylate copolymer, titaniumdioxide, talc, magnesiumstearate, macrogol6000.

WhatAmisulpride Mylanlooks like andcontents ofthe pack

Amisulpride Mylan 400 mgare white to offwhite, 18 x 8 mmcapsule shaped, filmcoated tabletwith break

line on oneside inPVC/Aluminiumblisterpacks of30, 60 or100 film-coated tablets.

The tablets can bedivided into equaldoses.

Notallpacksizesmaybe marketed.

Marketing Authorisation Holder and Manufacturer

McDermottLaboratoriesLtd.t/a Gerard Laboratories, Baldoyle, Dublin 13, Ireland.

Thismedicinal productis authorised in the Member Statesofthe EEAunder the following names

Czech Republic Amisulprid Mylan 400 mg

Belgium AmisuMylan

Bulgaria Amisulgen400 film-coatedtablets

Ireland Amisulpride Mylan400mgfilm-coatedtablets

Greece Amisulpride/Genericsfilm-coatedtablets400mg

Hungary Amisulprid Mylan

Italy Amisulpride Mylan Generics400mgcompresse

Portugal Amissulprida Mylan

Slovakia Amisulprid Mylan400mg

Slovenia Amisulprid Mylan400mgfilmsko obloženetablete

Spain Amisulprida MylanPharmaceuticals

Thisleafletwas lastapproved in09/2013.

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AmisulprideMylan400mgfilm-coatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

AmisulprideMylancontains400mgamisulpridepertablet.

Excipientwithknowneffect:

200mglactosemonohydrate

Forthefulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet.

Whitetooffwhite,18x8mmcapsuleshaped,filmcoatedtabletwithbreaklineononeside.

Thetabletcanbedividedintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AmisulprideMylanisindicatedforthetreatmentofacuteandchronicschizophrenicdisorders:

Positivesymptomswithdelusions,hallucinations,thoughtdisorders,hostilityandsuspiciousbehavior.

Primarilynegativesymptoms(deficitsyndrome)withbluntedaffect,emotionalandsocialwithdrawal.

AmisulprideMylanalsocontrolssecondarynegativesymptomsinproductiveconditionsaswellasaffectivedisorders

suchasdepressivemoodorretardation.

4.2Posologyandmethodofadministration

Posology:

Foracutepsychoticepisodestherecommendedoraldoserangesfrom400to800mg/day.Inindividualcases,the

dailydosemaybeincreasedupto1200mg/day.Dosesabove1200mg/dayhavenotbeenextensivelyevaluatedfor

safetyandthereforeshouldnotbeused.Nospecifictitrationisrequiredwheninitiatingthetreatmentwith

AmisulprideMylan.Dosesshouldbeadjustedaccordingtoindividualresponse.Maintenancetreatmentshouldbe

establishedindividuallywiththeminimallyeffectivedose.

Forpatientswithmixedpositiveandnegativesymptoms,dosesshouldbeadjustedtoobtainoptimalcontrolof

positivesymptoms.

Forpatientscharacterizedbypredominantnegativesymptoms,oraldosesbetween50mg/dayand300mg/dayare

recommended.Dosesshouldbeadjustedindividually.

AmisulprideMylancanbeadministeredoncedailyorallyatadoseupto400mg.Higherdosesshouldbedividedin

twodoses.

Elderly

Thesafetyofamisulpridehasbeenexaminedinalimitednumberofelderlypatients.AmisulprideMylanshouldbe

usedwithparticularcautionbecauseofapossibleriskofhypotensionorsedation(seesection5.2).Reductionin

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Paediatricpopulation

Theefficacyandsafetyofamisulpridefrompubertytotheageof18yearshavenotbeenestablished:Thereare

limiteddataavailableontheuseofamisulprideinadolescentsinschizophrenia.Therefore,theuseofamisulpride

frompubertytotheageof18yearsisnotrecommended;inchildrenuptopubertyamisulprideiscontraindicated,as

itssafetyhasnotyetbeenestablished.(seesection4.3).

Patientswithrenalimpairment

AmisulprideMylaniseliminatedbytherenalroute.Inrenalinsufficiency,thedoseshouldbereducedtohalfin

patientswithcreatinineclearance(CRCL)between30-60mL/minandtoathirdinpatientswithCRCLbetween10-

30mL/min.Asthereisnoexperienceinpatientswithsevererenalimpairment(CRCL<10mL/min),particularcare

isrecommendedinthesepatients(seesection4.4andsection5.2).

Patientswithhepaticimpairment

Sinceamisulprideisweaklymetabolized,adosagereductionshouldnotbenecessary.

Methodofadministration:

AmisulprideMylantabletscanbeadministeredindependentlyfromthemeals.Tabletsshouldbetakenwholeor

halvedwithasufficientamountofliquid.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipientslistedinsection6.1.

Concomitantprolactin-dependenttumors(eg.pituitaryglandprolactinomasorbreastcancer)

Phaeochromocytoma.

Childrenuptopuberty.

Lactation.

Incombinationwithlevodopa(seesection4.5).

4.4Specialwarningsandprecautionsforuse

Aswithotherneuroleptics,NeurolepticMalignantSyndrome,apotentiallyfatalcomplication,characterizedby

hyperthermia,increasedmusclerigidity,autonomicinstability,alteredconsciousnessandelevatedCPK,mayoccur.In

theeventofhyperthermia,particularlywithhighdailydoses,allantipsychoticmedicinesincludingAmisulpride

Mylanshouldbediscontinued.

AmisulprideMylaniseliminatedbytherenalroute.Incasesofrenalinsufficiency,thedoseshouldbedecreasedand

intermittenttreatmentshouldbeconsidered(seesection4.2Posologyandmethodofadministration).

AmisulprideMylancanlowertheseizurethreshold.Thereforepatientswithahistoryofseizuresshouldbeclosely

monitoredduringamisulpridetherapy.Inelderlypatients,amisulpridetherapy,likeotherneuroleptics,shouldbeused

withparticularcautionbecauseofapossibleriskofhypotensionorsedation.Reductionindosagemayalsobe

requiredincaseofrenalinsufficiency.

Aswithotherantidopaminergicagents,cautionshouldbealsoexercisedwhenprescribingAmisulprideMylanto

patientswithParkinson'sdiseasesinceitmaycauseworseningofthedisease.AmisulprideMylanshouldbeusedonly

ifneuroleptictreatmentcannotbeavoided.

ProlongationofQTinterval

Cautionshouldbeexercisedwhenamisulprideisprescribedinpatientswithknowncardiovasculardiseaseorfamily

historyofQTprolongation,andconcomitantusewithneurolepticsshouldbeavoided.

Stroke

Inrandomizedclinicaltrialsversusplaceboperformedinapopulationofelderlypatientswithdementiaandtreated

withcertainatypicalantipsychoticmedicines,a3-foldincreaseoftheriskofcerebrovasculareventshasbeen

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medicines,orotherpopulationsofpatientscannotbeexcluded.AmisulprideMylanshouldbeusedwithcautionin

patientswithstrokeriskfactors.

VenousThromboembolism

Casesofvenousthromboembolism(VTE)havebeenreportedwithantipsychoticdrugs.Sincepatientstreatedwith

antipsychoticsoftenpresentwithacquiredriskfactorsforVTE,allpossibleriskfactorsforVTEshouldbeidentified

beforeandduringtreatmentwithAmisulprideMylanandpreventivemeasuresundertaken.

Leukopenia,neutropeniaandagranulocytosishavebeenreportedwithantipsychotics,includingamisulpride.

Unexplainedinfectionsorfevermaybeevidenceofblooddyscrasia(seesection4.8),andrequiresimmediate

haematologicalinvestigation.

Elderlypeoplewithdementia

Elderlypatientswithdementia-relatedpsychosistreatedwithatypicalantipsychoticshadanincreasedriskofdeath

comparedtoplaceboinameta-analysisof17controlledtrialsofatypicalantipsychotics.Theobservedriskofdeath

was1.6to1.7timestheriskofdeathinplacebo-treatedpatients.Therateofdeathinpatienttreatedwithatypical

antipsychoticwasabout4.5%,comparedtoarateofabout2.6%intheplacebogroupduringatypical10-week

controlledtrial.Thereweredifferentcausesofdeathinclinicaltrialswithatypicalantipsychotics,butmostofthe

deathsappearedtobeeithercardiovascular(eg,heartfailure,suddendeath)orinfectious(eg,pneumonia)innature.

Observationalstudiessuggestthat,similartoatypicalantipsychoticdrugs,treatmentwithconventionalantipsychotic

drugsmayincreasemortality.

Theextenttowhichthefindingsofincreasedmortalityinobservationalstudiesmaybeattributedtotheantipsychotic

drugasopposedtosomecharacteristic(s)ofthepatientsisnotclear.

AmisulprideMylanisnotapprovedforthetreatmentofpatientswithdementia-relatedbehaviouraldisturbances.

Other

Hyperglycemiahasbeenreportedinpatientstreatedwithsomeatypicalantipsychoticagents,includingAmisulpride

Mylan,thereforepatientswithanestablisheddiagnosisofdiabetesmellitusorwithriskfactorsfordiabetes,whoare

startedonAmisulprideMylan,shouldgetappropriateglycaemicmonitoring.

Theconcomitantprescriptionofotherantipsychoticsshouldbeavoided.

Withdrawalsymptomsincludingnausea,vomitingandinsomniahavebeendescribedafterabruptcessationofhigh

dosesofantipsychoticdrugs.Recurrenceofpsychoticsymptomsmayalsooccur,andtheemergenceofinvoluntary

movementdisorders(suchasakathisia,dystoniaanddyskinesia)havebeenreportedwithamisulpride.Therefore,

gradualwithdrawalofAmisulprideMylanisadvisable.

Lactose

Patientswithrarehereditaryproblemsofgalactoseintolerance,Lapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Contraindicatedcombinations:

Levodopa:reciprocalantagonismofeffectsbetweenlevodopaandneuroleptics.Amisulpridemayopposetheeffectof

dopamineagonistse.g.bromocriptine,ropirinol.

Combinationswhicharenotrecommended:

AmisulprideMylanmayenhancetheeffectsofalcohol.

Combinationswhichmustbetakenintoaccount:

CNSdepressantsincludingnarcotics,anaesthetics,analgesics,sedativeH1-antihistamines,barbiturates,

benzodiazepinesandotheranxiolyticmedicines,clonidineandderivatives.

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CautionisadvisedwhenprescribingamisulpridewithmedicinesknowntoprolongtheQTinterval,e.g.,class

IAantiarrhythmics(e.g.,quinidine,disopyramide)andclassIIIantiarrhythmics(e.g.,amiodarone,sotalol),

someantihistaminics,someotherantipsychoticsandsomeantimalarials(e.g.,mefloquine)(seesection4.4).

4.6Fertility,pregnancyandlactation

Pregnancy

AmisulprideMylandidnotshowreproductivetoxicityinanimals.Lowerfertilityassociatedwithpharmacological

effectoftheproduct(bymeansofprolactin)wasfound.Noteratogeniceffectsofamisulpridewerenoted.

Thereisonlyverylimitedclinicaldataonadministrationofthemedicinalproductduringpregnancy.Thereforethe

safetyofamisulprideduringpregnancyinhumanshasnotbeenestablished.Useofthemedicinalproductduring

pregnancyisnotrecommendedunlessthebenefitoutweighsthepossiblerisk.

Neonatesexposedtoantipsychotics,includingamisulpride,duringthethirdtrimesterofpregnancyareatriskofadverse

reactionsincludingextrapyramidaland/orwithdrawalsymptomsthatmayvaryinseverityanddurationfollowing

delivery(seesection4.8).Therehavebeenreportsofagitation,hypertonia,hypotonia,tremor,somnolence,respiratory

distress,orfeedingdisorder.Consequently,newbornsshouldbemonitoredcarefully.

Breastfeeding

Itisnotknownifamisulprideisexcretedinbreastmilk.Breast-feedingisthereforecontraindicated.

4.7Effectsonabilitytodriveandusemachines

AmisulprideMylancancausesomnolenceandthereforealsoreducetheabilitytodrivevehiclesandoperatemachines,

evenwhenusedatrecommendeddoses(seesection4.8).

4.8Undesirableeffects

Adversereactionshavebeenrankedundertheheadingsoffrequencyusingthefollowingconvention:

Verycommon(1/10);common(1/100,<1/10);uncommon(1/1000,<1/100);rare(1/10000,<1/1000);veryrare

(<1/10000);frequencynotknown(cannotbedeterminedfromavailabledata).

Withineachfrequencygrouping,undesirableeffectsarepresentedinorderofdecreasingseriousness.

Clinicaldata

Thefollowingadverseeffectshavebeenobservedincontrolledclinicaltrials.Itshouldbenotedthatinsomeinstances

itcouldbedifficulttodifferentiateadverseeventsfromsymptomsoftheunderlyingdisease.

Investigations:

Common:Weightgain

Uncommon:Elevationsofhepaticenzymes,mainlytransaminases

Cardiacdisorders:

Common:Hypotension

Uncommon:Bradycardia

Nervoussystemdisorders:

Verycommon:Extrapyramidalsymptomsmayoccur:Tremor,rigidity,hypokinesia,hypersalivation,akathisia,

dyskinesia.Thesesymptomsaregenerallymildatoptimaldosagesandpartiallyreversiblewithoutdiscontinuationof

amisulprideuponadministrationofantiparkinsonianmedication.Theincidenceofextrapyramidalsymptoms,whichis

doserelated,remainsverylowintreatmentofpatientswithpredominantlynegativesymptomswithdosesof50-300

mg/day.

Common:

-Acutedystonia(spasmtorticolis,oculogyriccrisis,trismus)mayappear.Thisisreversiblewithoutdiscontinuationof

amisulprideuponadministrationofantiparkinsonianmedication.

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Uncommon:

-Tardivedyskinesiacharacterizedbyrhythmic,involuntarymovementsprimarilyofthetongueand/orfacehasbeen

reported,usuallyafterlong-termadministration.Antiparkinsonianmedicationisineffectiveormayinduceaggravation

ofthesymptoms.

-Seizures

Gastrointestinaldisorders:

Common:Constipation,nausea,vomiting,drymouth

Endocrinedisorders:

Common:Amisulpridecausesanincreaseinplasmaprolactinlevels,whichisreversibleafterdrugdiscontinuation.

Thismayresultingalactorrhoea,amenorrhoeaormenstrualdisorder,gynaecomastia,breastpain,anderectile

dysfunction.

Metabolismandnutritiondisorders:

Uncommon:Hyperglycemia(seesection4.4)

Immunesystemdisorders:

Uncommon:Allergicreactions

Psychiatricdisorders:

Common:Insomnia,anxiety,agitation,orgasmicdysfunction

Postmarketingsurveillance:

Thefollowingundesirableeffectswerealsoreported(spontaneousreports):

BloodandLymphaticsystemdisorders:

Notknown:Leukopenia,neutropeniaandagranulocytosis(seesection4.4)

Cardiacdisorders:

Notknown:prolongationoftheQTintervalandventriculararrhythmiasuchastorsadesdepointes,ventricular

tachycardia,whichcouldleadtoventricularfibrillationorcardiacarrest,suddendeath(seesection4.4).

Vasculardisorders:

Notknown:Casesofvenousthromboembolism,includingcasesofpulmonaryembolism,sometimesfatalandcasesof

deepveinthrombosishavebeenreportedwithantipsychoticdrugs

Nervoussystemdisorders:

Notknown:Neurolepticmalignantsyndromesymptom(seesection4.4),whichisapotentiallyfatalcomplication.

Skinandsubcutaneoustissuedisorders:

Notknown:Angioedema,urticaria

Pregnancy,puerperiumandperinatalconditions

Notknown:Drugwithdrawalsyndromeneonatal(see4.6)

Reportingofsuspectedadversereactions

Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued

monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportany

suspectedadversereactionsviatheonlinereportingoption(preferredmethod)accessiblefromtheIMBhomepage

(www.imb.ie).AdownloadablereportformisalsoaccessiblefromtheIMBwebsite,whichmaybecompleted

manuallyandsubmittedtotheIMBvia‘freepost’(seedetailsbelow).Alternatively,thetraditionalpost-paid‘yellow

card’optionmayalsobeused.FREEPOSTPharmacovigilanceSection,IrishMedicinesBoard,KevinO’MalleyHouse,

EarlsfortCentre,EarlsfortTerrace,Dublin2Tel:+35316764971Fax:+35316762517Website: www.imb.ie e-mail:

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/11/2013 CRN 2114110 page number: 5

4.9Overdose

Experiencewithoverdoseislimited.Exaggerationofpharmacologicaleffectsofthedrughasbeenreportedwith

symptomssuchasdrowsinessandsedation,coma,hypotensionandextrapyramidalsymptoms.Fataloutcomeshave

beenreportedmainlyincombinationwithotherpsychotropicagents.

Incasesofacuteoverdose,thepossibilityofmultipledrugintakesshouldbeconsidered.

Sinceamisulprideisweaklydialysed,hemodialysisisofnousetoeliminatethedrug.

ThereisnospecificantidotetoAmisulprideMylan.Appropriatesupportivemeasuresshouldthereforebeinstituted

withclosesupervisionofvitalfunctionsincludingcontinuouscardiacmonitoringduetotheriskofprolongationofthe

QTinterval,untilcompleterecoveryofthepatient.

Ifsevereextrapyramidalsymptomsoccur,anticholinergicagentsshouldbeadministered.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:antipsychotics

ATCcode:N05AL05

AmisulpridebindsselectivelywithahighaffinitytohumandopaminergicD

receptorsubtypeswhereasitisdevoid

ofaffinityforD

,D

andD

receptorsubtypes.

Unlikeclassicalandatypicalneuroleptics,amisulpridehasnoaffinityforserotonin,alpha-adrenergic,H

-histamineand

cholinergicreceptors.Inaddition,amisulpridedoesnotbindtosigmareceptors.

Inanimalstudies,athighdoses,amisulprideblocksdopaminereceptorslocatedprimarilyoutsidestriatuminthe

mesolimbicsystem.Asopposedtoclassicalneuroleptics,itdoesnotcausecatalepsy.Duringrepeateduse,itdoesnot

develophypersensitivitytod

dopaminereceptors.Atlowdosesitpreferentiallyblockspre-synapticD

receptors,

producingdopaminereleaseresponsibleforitsdisinhibitoryeffects.

Thisatypicalpharmacologicalprofilecanexplainamisulpride’santipsychoticeffectathigherdosesthroughpost-

synapticdopaminereceptorblockadeanditseffectonnegativesymptomsatlowerdosescausedbytheinhibitionof

pre-synapticdopaminereceptors.Decreasedincidenceofundesirableextrapyramidalsymptomscanbecausedbythe

preferentialactivityinthelimbicsystem.

Inclinicalstudies,whichmonitoredpatientswithacuteexacerbationofschizophrenia,amisulpridesignificantly

reducedsecondarynegativesymptomsaswellasaffectivesymptomsandpsychomotorslow-down.

5.2Pharmacokineticproperties

Absorption

Inman,amisulprideshowstwoabsorptionpeaks:onewhichisattainedrapidly,onehourpost-doseandasecond

between3and4hoursafteradministration.Correspondingplasmaconcentrationsare39±3and54±4ng/mlaftera50

mgdose.

Distribution

Thevolumeofdistributionis5.8l/kg,plasmaproteinbindingislow(16%)andnodruginteractionsareknown.

Absolutebioavailabilityis48%.

Biotransformation

Amisulprideisweaklymetabolised:twoinactivemetabolites,accountingforapproximately4%ofthedose,havebeen

identified.Thereisnoaccumulationofamisulprideanditspharmacokineticsremainsunchangedafterthe

administrationofrepeateddoses.

Elimination

Irish Medicines Board

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Date Printed 11/11/2013 CRN 2114110 page number: 6

unchangedintheurine.50%ofanintravenousdoseisexcretedviatheurine,ofwhich90%iseliminatedinthefirst24

hours.Renalclearanceisintheorderof20l/hor330ml/min.Acarbohydraterichmeal(containing68%fluids)

significantlydecreasestheAUCs,TmaxandCmaxofamisulpridebutnochangeswereseenafterahighfatmeal.

However,thesignificanceofthesefindingsinroutineclinicaluseisnotknown.

Hepaticimpairment:sincethedrugisweaklymetabolized,thedosageneedsnottobereducedinpatientswithhepatic

insufficiency.

Renalimpairment:Theeliminationhalf-lifeisunchangedinpatientswithrenalinsufficiencywhilesystemicclearance

isreducedbyafactorof2.5to3.TheAUCofamisulprideinmildrenalfailureincreasedtwofoldandalmosttenfoldin

moderaterenalfailure(seesection4.2Posologyandmethodofadministration).Experienceishoweverlimitedand

thereisnodatawithdosesgreaterthan50mg.

Amisulprideisveryweaklydialysed.

Limitedpharmacokineticdatainelderlysubjects(>65years)showthata10-30%riseoccursinCmax,T1/2andAUC

afterasingleoraldoseof50mg.Nodataareavailableafterrepeatdosing.

5.3Preclinicalsafetydata

Anoverallreviewofthecompletedsafetystudiesindicatesthatamisulprideisdevoidofanygeneral,organ-specific,

teratogenic,mutagenicorcarcinogenicrisk.Changesobservedinratsanddogsatdosesbelowthemaximumtolerated

doseareeitherpharmacologicaleffectsoraredevoidofmajortoxicologicalsignificanceundertheseconditions.

Comparedwiththemaximumrecommendeddosagesinman,maximumtolerateddosesare2and7timesgreaterinthe

rat(200mg/kg/d)anddog(120mg/kg/d),whichcorrespondsto1.5–4.5higherAUCinratthaninhuman.

Amousecarcinogenicitystudy(120mg/kg/d)andreproductivestudies(160,300and500mg/kg/drespectivelyinrat,

rabbitandmouse)wereperformed.Theexposureoftheanimalstoamisulprideduringtheselatterstudieswasnot

evaluated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Core

Lactosemonohydrate

Methylcellulose

Sodiumstarchglycolate(typeA)

Cellulose,microcrystalline

Magnesiumstearate

Filmcoating

Basicbutylatedmethacrylatecopolymer

Titaniumdioxide

Talc

Magnesiumstearate

Macrogol6000

6.2Incompatibilities

Notapplicable

6.3Shelflife

Irish Medicines Board

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Date Printed 11/11/2013 CRN 2114110 page number: 7

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

PVC/Aluminiumblisterof30,60or100film-coatedtablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

Anyunusedmedicinalproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

McDermottLaboratoriesLtd/t/aGerardLaboratories

35/36BaldoyleIndustrialEstate

GrangeRoad

Dublin13

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA0577/125/004

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:28 th

August2009

Dateoflastrenewal:16 th

September2013

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 11/11/2013 CRN 2114110 page number: 8

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