GABAPENTIN TEVA

Main information

  • Trade name:
  • GABAPENTIN TEVA
  • Dosage:
  • 300 Milligram
  • Pharmaceutical form:
  • Capsules Hard
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GABAPENTIN TEVA
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0282/074/002
  • Authorization date:
  • 17-05-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

GabapentinTeva300mgCapsules.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Active

Eachcapsulecontainsgabapentin300mg

Excipients

Eachcapsulecontainssoyalecithin0.0015mg

EachcapsulecontainsYellowOrangeS(E110)0.537mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Capsule,hard.

Orange/Orange,size0,hardgelatincapsulecontainingwhitetooff-whitepowder.Thecapsuleshellsareprintedwith

’93’and‘39’.

4CLINICALPARTICULARS

4.1TherapeuticIndications

NeuropathicPain

Gabapentinisindicatedforthetreatmentofneuropathicpain.

Epilepsy

Monotherapyinadultsandchildrenover12yearsofage

Gabapentinisusedasanantiepilepticindicatedformonotherapyoradd-ontreatmentforadultsandchildrenover12

yearsofagewithpartialseizuresorpartialseizureswithsecondarygeneralisation,includingpatientswithnewly

diagnosedseizures.

Monotherapyinchildrenunder12yearsofageisnotrecommendeduntilfurtherinformationisavailablefrom

controlledtrialsinthisparticularagegroup.

Add-ontherapyinadultsandchildrenage3yearsandabove

Gabapentinisusedasanantiepilepticindicatedforadd-ontreatmentforpartialseizuresorpartialseizureswith

secondarygeneralisationinadultsandchildrenage3yearsandabove.

Forchildrenaged3yearsandabove,Gabapentinshouldbeinitiatedandsupervisedbyaneurologicalspecialist.

4.2Posologyandmethodofadministration

GabapentinTevaisgivenorallywithorwithoutfood.

Wheninthejudgmentoftheclinicianthereisaneedfordosereduction,discontinuation,orsubstitutionwithan

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NeuropathicPain

Adults(overtheageof18)

Thestartingdoseis900mgperdaygiveninthreedivideddoses,andtitratedifnecessary,basedonresponse,uptoa

maximumdoseof3600mgperday.TherapyshouldbeinitiatedbytitratingthedoseasdescribedinTable1.

Table1:DosingChart–InitialTitration

QD=onceaday b

BID=twotimesaday c

TID=threetimesaday

Elderly

Elderypatientsmayrequiredosageadjustmentbecauseofdecliningrenalfunctionwithage(seeTable2).

DosageAdjustmentforPatientswithCompromisedRenalFunction

Dosageadjustmentisrecommendedinpatientscompromisedrenalfunction,asdescribedinTable2.

Table2:Maintenancedosageofgabapentininadultswithreducedrenalfunction

Totaldailydoseshouldbeadministeredthreetimesdaily.

Tobeadministeredas300mgeveryotherday.

DosageadjustmentforPatientsonHaemodialysis

Forpatientsundergoinghaemodialysiswhohaveneverreceivedgabpentin,aloadingdoseof300to400mgis

recommendedthen200to300mgofgabapentinfollowingeach4hoursofhaemodialysis.

Epilepsy

AdultsandChildren(agedover12yearsofage)

TheeffectivedoseofGabapentinis900-3600mg/day.

TheusualstartingdoseofGabapentinasmonotherapyfornewlydiagnosedpatientsis900mg/day.

ItisnotnecessarytomonitorGabapentinplasmaconcentrationstooptimiseGabapentinTevatherapy.

Titrationtoaneffectivedosecanprogressrapidlyandcanbeachievedoverafewdaysbyadministering300mgoncea

dayonDay1,300mgtwiceadayonDay2and300mgthreetimesadayonDay3,asdescribedinTable1.Afterwards,

thedosecanbeincreasedusingincrementsof300mgperdaygiveninthreeequallydivideddosestoamaximumof

3600mgperday.

Themaximumtimebetweendosesinathreetimesdailyscheduleshouldnotexceed12hours.GabapentinTevamaybe

Dose Day1 Day2 Day3

900mg

300mgQd a

300mgBID b

300mgTID c

RenalFunction

CreatinineClearance(mL/min) TotalDailyDose(mg/dayRange a

≥80

900-3600mg

50-79 600-1800mg

30-49 300-900mg

15-29

-600mg

<15 150 b

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IfGabapentinTevaisdiscontinuedand/oralternateanticonvulsantmedicationisaddedtothetherapy,thisshouldbe

donegraduallyoveraminimumofoneweek.

Elderly

Elderlypatientsmayneeddosageadjustmentduetodeclineofrenalfunction.(seeTable2)

Children(3-12yearsofage)

ThestartingdoseofGabapentinis10to15mg/kg/daygivenindivideddoses(3timesaday).Titrationtoanaffective

dosecantakeplaceover3days.TheeffectivedoseofGabapentininpaediatricpatientsage5yearsandolderis25to

35mg/kg/dayinequallydivideddoses(3timesaday).Theeffectivedoseinpaediatricpatientsaged3tolessthan5

yearsis40mg/kg/daygiveninequallydivideddoses(3timesaday).Inlong-termclinicalstudy,dosagesupto

50mg/kg/dayhavebeenwelltolerated.Themaximumtimeintervalbetweendosesshouldnotexceed12hrs.

Therewasinsufficientevidenceavailablefromappropriatestudiesuponwhichtobasedosagerecommendationsfor

monotherapyuseinchildrenundertheageof12years.

PatientswithCompromisedRenalfunction

Itisrecommendedthatpatientswithcompromisedrenalfunctionhavetheirdosageadjusted(seeTable2).

PatientsonHaemodialysis

ForpatientsundergoinghaemodialysiswhohaveneverreceivedGabapentin,aloadingdoseof300mgto400mgis

recommended,then200to300mgGabapentinfollowingeach4hoursofhaemodialysis.

4.3Contraindications

GabapentinTevaiscontra-indicatedinpatientswhohaveshownhypersensitivitytoanyoftheconstituentsincluding

soyaoil.

4.4Specialwarningsandprecautionsforuse

Abruptwithdrawalofanticonvulsantagentsinepilepticpatientsmayprecipitatestatusepilepticusalthough,todate,

therehavebeennoreportedcasesofreboundseizureswithgabapentin.(seesection4.2,Posologyandmethodof

administration).Dosereduction,discontinuationorsubstitutionofalternativeanticonvulsantmedicationshouldbe

donegraduallyoveraminimumofoneweekatthediscretionoftheclinician.

Generally,gabapentinisnotconsideredeffectiveinthetreatmentofabsenceseizures.

Patientswhorequireconcomitanttreatmentwithmorphinemayexperienceincreasesingabapentinconcentrations.

PatientsshouldbecarefullyobservedforsignsofCNSdepression,suchassomnolence,andthedoseofgabapentinor

morphineshouldbereducedappropriately(Seesection4.5,Interactionwithothermedicinalproductsandotherforms

ofinteractions).

Patientswithepilepsycanbethesubjectofmoodandbehaviouraldisturbances.Althoughthesehavebeennotedin

patientsongabapentin,acausallinkhasnotbeenestablished.

Suicidalideationandbehaviourhavebeenreportedinpatientstreatedwithantiepilepticsagentsinseveralindications.

Ameta-analysisofrandomisedplacebocontrolledtrialsofanti-epilepticdrugshasalsoshownasmallincreasedriskof

suicidalideationsandbehaviour.Themechanismofthisriskisnotknownandtheavailabledatadonotexcludethe

possibilityofanincreasedriskforgabapentin.Thereforepatientsshouldbemonitoredforsignsofsuicidalideations

andbehavioursandappropriatetreatmentshouldbeconsidered.Patients(andcaregiversofpatients)shouldbeadvised

toseekmedicaladviceshouldsignsofsuicidalideationbehaviouremerge.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Morphine:Inastudyinvolvinghealthyvolunteers(N=12),whena60-mgcontrolled-releasemorphinecapsulewas

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gabapentinadministeredwithoutmorphine.Thiswasassociatedwithanincreasedpainthreshold(coldpressortest).

Theclinicalsignificanceofsuchchangeshasnotbeendefined.Morphinepharmacokineticparametervalueswerenot

affectedbyadministrationofgabapentin2hoursaftermorphine.Theobservedopioid-mediatedsideeffectsassociated

withmorphineplusgabapentindidnotdiffersignificantlyfrommorphineplusplacebo.Themagnitudeofinteractionat

otherdosesisnotknown.(seesection4.4,Specialwarningsandprecautionsforuse).

GabapentinTevamaybeusedincombinationwithotheranti-epilepticdrugswithoutconcernforalterationofthe

plasmaconcentrationsofGabapentinorserumconcentrationsofotheranti-epilepticdrugs.

Nointeractionwasobservedbetweengabapentinandphenytoin,valproicacid,carbamazepineorPhenobarbital.

Steady-statepharmacokineticsofgabapentinaresimilarforhealthysubjectsandpatientswithepilepsyreceiving

antiepilepticagents.

Administrationofgabapentinwithoralcontraceptivesincludingnorethisteroneand/orethinyloestradioldoesnot

influencethesteady-statepharmacokineticsofeithercomponent.

Co-administrationofantacidscontainingaluminiumandmagnesiumreducesthebioavailabilityofgabapentinupto

24%.Itisrecommendedthatgabapentinistakenabouttwohoursafteranyadministrationofantacid.

Renalexcretionofgabapentinisnotalteredbyprobenecid.Aslightdecreaseinrenalexcretionofgabapentin,thatis

observedwhenco-administrationwithcimetidine,isofnosignificantclinicalimportance.Fooddoesnotalterthe

pharmacokineticsofgabapentin.

FalsepositivereadingswerereportedwiththeAmesN-MultistixSGdipsticktestwhengabapentinorplacebowere

addedtootheranticonvulsantdrugs.Inthiscase,themorespecificsulphosalicylicacidprecipitationmethodis

recommendedtodetermineurinaryprotein.

4.6Fertility,pregnancyandlactation

Thesafeuseofgabapentininhumanpregnancyhasnotbeenestablished.Reproductionstudiesinmiceatdosesupto

42times,inratsatdosesupto28timesandinrabbitsatdosesupto21timesthehumandosehaveshownnocasesof

impairedfertilityorharmtothefoetus.However,asanimalreproductionstudiesarenotalwayspredictiveofhuman

response,administrationofgabapentinshouldonlyberecommendedinpregnancyifclearlyneeded.

Gabapentinisexcretedinhumanmilkbuttheeffectonthenursinginfantisunknown.Howeverasmanydrugsare

excretedinhumanmilk,therecanbepotentialforseriousadversereactionsfromgabapentininnursinginfants.A

decisionshouldthereforebemadetoeitherdiscontinuenursingortodiscontinuethedrug,takingintoaccountthe

importanceofgabapentintothemother.

4.7Effectsonabilitytodriveandusemachines

Likeallanticonvulsants,themodeofactionofgabapentinisonthecentralnervoussystem.Drowsiness,dizziness,or

otherrelatedsymptomsmayoccuruponadministrationofgabapentin.Theseincidents,althoughmildormoderate,may

bedangerousinpatientsdrivingoroperatingmachinery,particularlyuntilwhentheindividualpatientsexperiencewith

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4.8Undesirableeffects

NeuropathicPain

Table34liststreatment-emergentsignsandsymptomsthatoccurredinatleast1%ofpatientswithNeuropathicpainin

studiescomparinggabapentinwithplacebo.

Table34–SummaryofTreatmentEmergentSignsandSymptomsin ≥1%ofGabapentin-TreatedPatientsin

NeuropathicPainPlacebo-ControlledStudies

Epilepsy

COSTART

BodySystem/Adverse

Event Gabapentin

N=821

NofPts(%) Placebo

N=537

NofPts(%)

BodyasaWhole

AbdominalPain

AccidentalInjury

Asthenia

BackPain

FluSyndrome

Headache

Infection

Pain 23

(2.8)

(3.9)

(5.0)

(2.3)

(2.6)

(5.5)

(4.6)

(3.7) 17

(3.2)

(3.2)

(4.7)

(1.5)

(2.6)

(6.1)

(7.4)

(6.7)

DigestiveSystem

Constipation

Diarrhoea

DryMouth

Dyspepsia

Flatulence

Nausea

Vomiting 19

(2.3)

(5.6)

(3.3)

1.9)

(1.7)

(5.5)

(1.9) 9

(1.7)

(4.5)

(0.9)

(1.9)

(1.1)

(5.4)

(2.4)

Metabolicand

Nutritional

PeripheralOedema

WeightGain 44

(5.4)

(1.7) 14

(2.6)

(0.0)

NervousSystem

AbnormalGait

Amnesia

Ataxia

Confusion

Dizziness

Hypaesthesia

Somnolence

ThinkingAbnormal

Tremor

(1.1)

(1.8)

(2.3)

(1.8)

(21.1)

(1.3)

(16.1)

(1.5)

(1.1)

(0.0)

(0.6)

(0.0)

(0.9)

(6.5)

(0.6)

(5.0)

(0.0)

(1.1)

(0.4)

RespiratorySystem

Dyspnoea

Pharyngitis 9

(1.1)

(1.8) 3

(0.6)

(1.3)

SkinAppendages

Rash 14 (1.7) 4 (0.7)

SpecialSenses

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IncidenceinAdd-onControlledClinicalTrials

Table4liststreatment-emergentsignsandsymptomsthatoccurredinatleast1%ofpatientswithpartialseizures

during12-weekcontrolledstudiescomparinggabapentinwithplacebo.Inthesestudies,eithergabapentinorplacebo

wasaddedtothepatient'scurrentantiepilepticdrugtherapy.

Adverseevents,obtainedfrompooleddatafromfivemulticentrestudies,wereusuallyreportedasmildtomoderate

(66%ofpatients)withamediantimetoresolutionoftwoweeks.

Table4:SummaryofTreatmentEmergentSignsandSymptomsin 1%ofGabapentinTreatedPatientsin

Add-OnTherapyPlacebo-ControlledStudies

COSTART

Bodysystem/Adverse

Event Gabapentinª

N=543 Placeboª

N=378

Nofpts (%) NofPts (%)

BodyasWhole

AbdominalPain 10 1.8 9 2.4

BackPain 10 1.8 2 0.5

Fatigue 60 11.0 19 5.0

Fever 7 1.3 5 1.3

Headache 44 8.1 34 9.0

ViralInfection 7 1.3 8 2.1

Cardiovascular

Vasodilation 6 1.1 1 0.3

DigestiveSystem

Constipation 8 1.5 3 0.8

Dentalabnormalities 8 1.5 1 0.3

Diarrhoea 7 1.3 8 2.1

Dyspepsia 12 2.2 2 0.5

Increasedappetite 6 1.1 3 0.8

MouthorThroatDry 9 1.7 2 0.5

Nauseaand/orvomiting 33 6.1 27 7.1

Haematologic&

Lymphatic

Leucopoenia 6 1.1 2 0.5

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COSTART

Bodysystem/Adverse

Event Gabapentinª

N=543 Placeboª

N=378

Metabolicand

Nutritional

PeripheralOedema 9 1.7 2 0.5

WeightIncrease 16 2.9 6 1.6

Musculoskeletal

system

Fracture 6 1.1 3 0.8

Myalgia 11 2.0 7 1.9

Nervoussystem

Amnesia 12 2.2 0 0.0

Ataxia 68 12.5 21 5.6

Confusion 9 1.7 7 1.9

CoordinationAbnormal 6 1.1 1 0.3

Depression 10 1.8 7 1.8

Dizziness 93 17.1 26 6.9

Dysarthria 13 2.4 2 0.5

EmotionalLability 6 1.1 5 1.3

Insomnia 6 1.1 7 1.9

Nervousness 13 2.4 7 1.9

Nystagmus 45 8.3 15 4.0

Somnolence 105 19.3 33 8.7

Thinkabnormal 9 1.7 5 1.3

Tremor 37 6.8 12 3.2

Twitching 7 1.3 2 0.5

Respiratorysystem

Coughing 10 1.8 5 1.3

Pharyngitis 15 2.8 6 1.3

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OtherAdverseEventsObservedDuringAllAdd-onClinicalTrials

Thoseeventsthatoccurredinatleast1%ofthestudyparticipantswithepilepsywhoreceivedgabapentinasadd-on

therapyinanyclinicalstudyandthatarenotdescribedintheprevioussectionaresummarisedbelow.

BodyAsAWhole:asthenia,malaise,facialoedema

Cardiovascularsystem:hypertension

DigestiveSystem:flatulence,anorexia,gingivitis

HaemicandLymphaticSystems:purpuramostoftendescribedasbruisesresultingfromphysicaltrauma

MusculoskeletalSystem:arthralgia

NervousSystem:vertigo,hyperkinesia,increased,decreasedorabsentreflexes,paraesthesia,anxiety,hostility

RespiratorySystem:pneumonia

UrogenitalSystem:urinarytractinfection

SpecialSenses:abnormalvisionmostoftendescribedasavisualdisturbance

Thesideeffectreportedindosecontrolledmonotherapystudieswassimilartothatinadd-onstudies.

Post-marketingsurveillance

Aswiththeotherantiepilepticdrugs,therehavebeenrarereportsofpancreatitis,elevatedliverfunctiontests(LFT’s),

erythemamultiforme,acutekidneyfailure,allergicreactionincludingurticaria,alopecia,angioedema,bloodglucose

fluctuationsinpatientswithdiabetes,chestpain,hallucinations,movementdisorderssuchaschoreoathetosis,

dyskinesiaanddystonia,palpitations,thrombocytopenia,tinnitus,urinaryincontinence,StevensJohnsonSyndrome

andsuddenunexplaineddeathswhereacausalrelationshiptotreatmenthasnotbeenestablished

Adverseeventsfollowingtheabruptdiscontinuationofgabapentinhavealsobeenreported.Themostfrequently

COSTART

Bodysystem/Adverse

Event Gabapentinª

N=543 Placeboª

N=378

Skinandappendages

Abrasion 7 1.3 0 0.0

Acne 6 1.1 5 1.3

Pruritis 7 1.3 2 0.5

Rash 8 1.5 6 1.6

Specialsense

Amblyopia 23 4.2 4 1.1

Diplopia 32 5.9 7 1.9

Urogenitalsystem

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Children

Sideeffectsthatoccurredinchildrenaged3-12years,withanincidenceof2%orgreaterthanplaceboincontrolled

add-ontrials,were:somnolence,fatigue,weightincrease,hostility,emotionallability,dizziness,hyperkinesia,

nausea/vomiting,viralinfection,fever,bronchitis,respiratoryinfection.Someofthesesideeffectsmaybeattributedto

commonviralchildhoodillness.

4.9Overdose

Inlimitedexperiencewithoverdoses,thefollowinghavebeennoted:dizziness,doublevision,slurredspeech,

drowiness,lethargyandmilddiarrhoea.OverdosesofGabapentin,upto49gingestedatonetime,havebeenreported.

Allpatientsrecoveredfullywithsupportivecare.Therefore,acute,life-threateningtoxicityhasnotbeenobservedwith

Gabapentinoverdoseofupto49gperday.ReducedabsorptionofGabapentinathigherdosesmaylimitdrug

absorptionatthetimeofoverdosingand,hence,toxicityfromoverdose.

AlthoughGabapentincanberemovedbyhaemodialysisitisnotusuallyrequired.However,inpatientswithrenal

impairment,haemodialysismaybeindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Gabapentinisananticonvulsantstructurallyrelatedtotheneurotransmittergamma-aminobutyricacid(GABA)butits

mechanismofactionisdifferentfromthatofseveraldrugsthatinteractwithGABAsynapses.

Theidentificationandfunctionofthegabapentinbindingsiteremainstobeelucidatedandthesignificanceofits

variousactionstotheanticonvulsanteffectremainstobeestablished.

Analgesicactivityhasbeenshowninanimalmodelsofinflammatoryandneuropathicpain.

5.2Pharmacokineticproperties

FollowingsingleoraldosesofGabapentin,regardlessofdosesizeorformulation,themeanplasmagabapentin

concentrations(Cmax)occurredapproximately3hours(Tmax).Followingmultipledoseadministrationthemean

Tmaxvalueswereapproximately1hourshorterthanthevaluesfollowingsingle-doseadministration.

Atdosesof300-4800mg,meanCmaxandAUCvaluesincreasedwithincreasingdose,however,theincreasewasless

thandoseproportional.

FollowingrepeatedGabapentinadministration,steady-statewasachievedwithin1to2daysafterthestartofthe

multipledosingandwasmaintainedthroughoutthedosingregime.

Followingsingle-doseadministrationsof300and400mgofgabapentin,theplasmagabapentinconcentration-time

profilesweresimilarbetweengabapentinsolutionandcapsuleformulations.Absolutebioavailabilityofa300mgoral

doseofGabapentinwasapproximately60%.Followingmultiple-doseadministrationatdosesof300mgand400mg,

Gabapentinbioavailabilitywasunchanged.

ThepresenceoffooddidnotaffectthebioavailabitlyofGabapentin.

Gabapentinisnotmetabolisedinhumansanddoesnotinducehepaticmixedfunctionoxidaseenzymes.

GabapentineliminationfromplasmafollowingIVadministrationwasbestdescribedbylinearpharmacokinetics.

Eliminationhalf-life(T½)ofgabapentinrangedfrom5to7hours.Gabapentineliminationparameters,apparent

plasmaT½andrenalclearance(CL

)wereindependentofdoseandremainedunchangedfollowingrepeated

administration.Renalclearancewasthesoleeliminationpathwayforgabapentin.Sincegabapentinisnotmetabolised

inhumans,theamountofdrugrecoveredinurineisindicativeofgabapentinbioavailability.Followingasingle200mg

oraldoseof[C

]gabapentin,recoveryofradioactivitywasessentiallycompletewithapproximately80%and20%of

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Asrenalfunction(whichwasdeterminedbycreatinineclearance)decreaseswithincreasingage,gabapentinoral

clearance,renalclearanceandelimination-rateconstantdecreaseproportionally.

Gabapentinpharmacokineticswasdeterminedin24healthypaediatricsubjectsbetweentheagesof4and12years.In

general,pharmacokineticparameterswerecomparabletothoseinadults.

5.3Preclinicalsafetydata

Gabapentinwasgiveninthediettomiceat200,600and2000mg/kg/dayandtoratsat250,1000and2000mg/kg/day

fortwoyears.Astatisticallysignificantincreaseintheincidenceofpancreaticacinarcelltumourswasfoundonlyin

maleratsatthehighestdose.

Peakplasmadrugconcentrationsandareasundertheconcentrationtimecurveinratsat2000mg/kgis10timeshigher

thanthetherapeuticconcentrationsinhumansgiventherecommendedmaximumtherapeuticdoseof3600mg/day.

Thepancreaticacinarcelltumoursinmaleratswerelowgrademalignancies,didnotaffectsurvival,didnot

metastasiseorinvadesurroundingtissue,andweresimilartothoseseeninconcurrentcontrols.Therelevanceofthese

pancreaticacinarcelltumoursinmaleratstocarcinogenicriskinhumansis,therefore,ofuncertainsignificance.

Gabapentinhasnogenotoxicpotential.ItwasnotmutagenicintheAmesbacterialplateincorporationassayoratthe

HGPRTlocusinmammaliancellsinthepresenceorabsenceofmetabolicactivation.Gabapentindidnotinduce

structuralchromosomeaberrationsinmammaliancellsinvitroorinvivo,anddidnotinducemicronucleusformationin

thebonemarrowofhamsters.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Talc

Pregelatinisedmaizestarch

Capsuleshellconsistsof:

Gelatin

Erythrosin(E172)

YelloworangeS(E110)

Titaniumdioxide(E171)

Capsuleinkcontains:

Shellac

Blackironoxide(E172)

PropyleneGlycol

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalpackage.

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6.5Natureandcontentsofcontainer

TransparentorwhiteopaquePVdCcoatedPVC/Aluminiumfoilblisterstripsinpacksizesof20,30,50,84,100and

500tablets.Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NortonHealthcareLtd

T/AIVAXPharmaceuticalsUK

RidingsPoint

WhistlerDrive

Castleford

WestYorkshire

WF105HX

8MARKETINGAUTHORISATIONNUMBER

PA0282/074/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:17May2001

Dateoflastrenewal:17March2006

10DATEOFREVISIONOFTHETEXT

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