DIAZEPAM

Main information

  • Trade name:
  • DIAZEPAM Tablets 5 Milligram
  • Dosage:
  • 5 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIAZEPAM Tablets 5 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0281/007/002
  • Authorization date:
  • 15-04-1981
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0281/007/002

CaseNo:2082243

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

PinewoodLaboratoriesLtd,T/APinewoodHealthcare

Ballymacarbry,Clonmel,Co.Tipperary,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Diazepam,5Milligram

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom25/05/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 25/05/2010 CRN 2082243 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Diazepam5mgTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains5mgofdiazepam.

Alsoincludes141mgoflactosemonohydrate

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet.

Yellow,circular,flat,bevelededgetabletswith‘Dover5’andabreaklineononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Standarddosage

Foroptimaleffect,thedosageshouldbecarefullyindividualized.Treatmentshouldbeginatthelowesteffectivedose

appropriatetotheparticularcondition.

Anxiety.

Insomnia:Benzodiazepinesareonlyindicatedwhenthedisorderissevere,disablingorsubjectingtheindividual

toextremedistress.

Inthecontrolofmusclespasmincludingthatassociatedwithtetanus.

Inthemanagementofepilepsy.

Aspre–operativemedicationinminorsurgery.

4.2Posologyandmethodofadministration

Anxiety

Treatmentshouldbeasshortaspossible.Thepatientshouldbereassessedregularlyandtheneedforcontinued

treatmentshouldbeevaluated,especiallyincasethepatientissymptomfree.Theoveralldurationoftreatment

generallyshouldnotbemorethan8–12weeks,includingataperingoffprocess.

Incertaincasesextensionbeyondthemaximumtreatmentperiodmaybenecessary;ifso,itshouldnottakeplace

withoutre-evaluationofthepatient’sstatuswithspecialexpertise.

Insomnia

Treatmentshouldbeasshortaspossible.Generallythedurationoftreatmentvariesfromafewdaystotwoweekswith

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Incertaincasesextensionbeyondthemaximumtreatmentperiodmaybenecessary;ifso,itshouldnottakeplace

withoutreevaluationofthepatient’sstatus.

Durationoftreatment

Thedurationoftreatmentshouldbeasshortaspossible(seePosology)dependingontheindication,butshouldnot

exceed4weeksforinsomniaand8to12weeksincaseofanxiety,includingtaperingoffprocess.Extensionbeyond

theseperiodsshouldnottakeplacewithoutre-evaluationofthesituation.

Itmaybeusefultoinformthepatientwhentreatmentisstartedthatitwillbeoflimiteddurationandtoexplain

preciselyhowthedosagewillbeprogressivelydecreased.Moreoveritisimportantthatthepatientshouldbeawareof

thepossibilityofreboundphenomena,therebyminimisinganxietyoversuchsymptomsshouldtheyoccurwhilethe

medicinalproductisbeingdiscontinued.

Thereareindicationsthat,inthecaseofbenzodiazepineswithashortdurationofaction,withdrawalphenomenacan

becomemanifestwithinthedosageinterval,especiallywhenthedosageishigh.Whenbenzodiazepineswithalarge

durationofactionarebeinguseditisimportanttowarnagainstchangingtoabenzodiazepinewithashortdurationof

action,aswithdrawalsymptomsmaydevelop.

Adults

Mildanxietystates

2mgthreetimesdaily.

Moderatetoseverestates

10to30mgdailyindivideddoses.

Insomnia

5to15mgbeforeretiring.

Musclespasm

2to15mgdailyindivideddoses.

Pre-medication

Theusualdoseis5mgthenightbefore,5mguponawakeninginthemorningand5mgtwohourspriortothedental

appointment.

Elderly

Dosesshouldnotnormallyexceedhalfthosenormallyrecommendedforadults.

Children

MuscleSpasm

Asforadults.

Pre-medication

Dosingscheduleasforadultsbutusinga2mgdose.

InfantsandNeonates

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SpecialGroups

Debilitatedpatients

Dosesshouldnotexceedhalfthosenormallyrecommendedforadults.

Treatmentshouldbestartedwiththelowestrecommendeddose.

Themaximumdoseshouldnotbeexceeded.

Thepatientshouldbecheckedregularlyatthestartofthetreatmentinordertodecreaseifnecessary,thedoseor

frequencyofadministrationtopreventoverdoseduetoaccumulation.

4.3Contraindications

Myastheniagravis.

HypersensitivitytoDiazepam(orotherbenzodiazepines)ortoanyoftheexcipients.

Severerespiratoryinsufficiency.

Sleepapnoeasyndrome.

Severehepaticinsufficiency.

Phobicorobsessionalstates.

Chronicpsychoses.

4.4Specialwarningsandprecautionsforuse

Tolerance

Somelossofefficacytothehypnoticeffectsofbenzodiazepinesmaydevelopafterrepeateduseforafewweeks.

Dependence

Useofbenzodiazepinesmayleadtothedevelopmentofphysicalandpsychicdependenceupontheseproducts.Therisk

ofdependenceincreaseswithdoseanddurationoftreatment;itisalsogreaterinpatientswithahistoryofalcoholor

drugabuse.

Oncephysicaldependencehasdeveloped,abruptterminationoftreatmentwillbeaccompaniedbywithdrawal

symptoms.Thesemayconsistofheadaches,musclepain,extremeanxiety,tension,restlessness,confusionand

irritability.Inseverecasesthefollowingsymptomsmayoccur:derealization,depersonalization,hyperacusis,

numbnessandtinglingoftheextremities,hypersensitivitytolight,noiseandphysicalcontact,hallucinationsor

epilepticseizures.

Reboundinsomniaandanxiety

Atransientsyndromewherebythesymptomsthatleadtotreatmentwithabenzodiazepinerecurinanenhancedform,

mayoccuronwithdrawaloftreatment.Itmaybeaccompaniedbyotherreactionsincludingmoodchanges,anxietyor

sleepdisturbancesandrestlessness.Sincetheriskofwithdrawalphenomena/reboundphenomenaisgreaterafter

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Amnesia

Benzodiazepinesmayinduceanterogradeamnesia.Theconditionoccursmostoftenseveralhoursafteringestingthe

productandthereforetoreducetheriskpatientsshouldensurethattheywillbeabletohaveanuninterruptedsleepof7

–8hours(seealsosection4.8UndesirableEffects).

Psychiatricand‘paradoxical’reactions

Reactionslikerestlessness,agitation,irritability,aggressiveness,delusion,rages,nightmares,hallucinations,psychoses,

inappropriatebehaviourandotheradversebehaviouraleffectsareknowntooccurwhenusingbenzodiazepines.Should

thisoccur,useofthedrugshouldbediscontinued.Theyaremorelikelytooccurinchildrenandtheelderly.

Specificpatientgroups

Benzodiazepinesshouldnotbegiventochildrenwithoutcarefulassessmentoftheneedtodoso;thedurationof

treatmentmustbekepttoaminimum.Elderlyshouldbegivenareduceddose(seesection4.2Posology).Alowerdose

isalsorecommendedforpatientswithchronicrespiratoryinsufficiencyduetotheriskofrespiratorydepression.

Benzodiazepinesarenotindicatedtotreatpatientswithseverehepaticinsufficiencyastheymayprecipitate

encephalopathy.

Benzodiazepinesarenotrecommendedfortheprimarytreatmentofpsychoticillness.

Benzodiazepinesshouldnotbeusedalonetotreatdepressionoranxietyassociatedwithdepression(suicidemaybe

precipitatedinsuchpatients).

Benzodiazepinesshouldbeusedwithextremecautioninpatientswithahistoryofalcoholordrugabuse.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

Duetothemyorelaxanteffect,thereisariskoffallsandconsequentlyofhipfracturesinelderlypatients.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notrecommended-Concomitantintakewithalcohol

Thesedativeeffectmaybeenhancedwhentheproductisusedincombinationwithalcohol.Thisaffectstheabilityto

driveorusemachines.

Takeintoaccount-CombinationwithCNSdepressants

Enhancementofthecentraldepressiveeffectmayoccurincasesofconcomitantusewithanti-psychotics

(neuroleptics),hypnotics,anxiolytics/sedatives,antidepressantagents,narcoticanalgestics,anti–epilepticdrugs,

anaestheticsandsedativeantihistamines.

Inthecaseofnarcoticanalgesicsenhancementoftheeuphoriamayalsooccurleadingtoanincreaseinpsychic

dependence.

Compoundswhichinhibitcertainhepaticenzymes(particularlycytochromeP450)mayenhancetheactivityof

benzodiazepines.Toalesserdegreethisalsoappliestobenzodiazepinesthataremetabolizedonlybyconjugation.

4.6Pregnancyandlactation

Animalstudieswithbenzodiazepineshaveshownminoreffectsonthefoetuswhileafewstudieshavereportedlate

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Iftheproductisprescribedtoawomanofchildbearingpotential,sheshouldbewarnedtocontactherphysician

regardingdiscontinuanceoftheproductifsheintendstobecomeorsuspectsthatsheispregnant.

If,forcompellingmedicalreasons,theproductisadministeredduringthelatephaseofpregnancy,orduringlabour,

effectsontheneonate,suchashypothermia,hypotoniaandmoderaterespiratorydepression,canbeexpected,dueto

thepharmacologicalactionofthecompound.

Moreover,infantsborntomotherswhotookbenzodiazepineschronicallyduringthelaterstagesofpregnancymay

havedevelopedphysicaldependenceandmaybeatsomeriskfordevelopingwithdrawalsymptomsinthepostnatal

period.

Sincebenzodiazepinesarefoundinthebreastmilk,benzodiazepinesshouldnotbegiventobreastfeedingmothers.

4.7Effectsonabilitytodriveandusemachines

Sedation,amnesia,impairedconcentrationandimpairedmuscularfunctionmayadverselyaffecttheabilitytodriveor

usemachines.Ifsufficientsleepdurationoccurs,thelikelihoodofimpairedalertnessmaybeincreased(seealsosection

4.5Interactions).

4.8Undesirableeffects

Themostcommonlyreportedundesirableeffectsarefatigue,drowsiness(whentheproductisusedasahypnoticit

shouldbestatedexplicitly:drowsinessduringtheday)andmuscleweakness.Thesephenomenaoccurpredominantlyat

thestartofthetherapyandusuallydisappearwithprolongedadministration.

Thefollowingmayalsooccur:numbedemotions,reducedalertness,ataxia,confusion,constipation,depression,

diplopia,dysarthria,,gastrointestinaldisturbances,headache,hypotension,incontinence,increaseordecreaseinlibido,

nausea,drymouthorhypersalivation,skinreactions,slurredspeech,tremor,urinaryretention,dizzinessandblurred

vision;veryrarely,elevatedtransaminasesandalkalinephosphateaswellascasesofjaundicehavebeenreported

occasionally.

Theelderlyareparticularlysensitivetotheactionsandadverseeffectsofcentrally-depressantdrugsandmay

experienceconfusion,especiallyiforganicbrainchangesarepresent;thedosageofdiazepamshouldnotexceedone-

halfthatrecommendedforotheradults.

Theelderlyandpatientswithimpairedhepaticfunctionwillbeparticularlysusceptibletotheadverseeffectslisted

above.Itisadvisabletoreviewtreatmentregularlyandtodiscontinueuseassoonaspossible.

Amnesia

Anterogradeamnesiamayoccurusingtherapeuticdosage,theriskincreasingathigherdosages.Amnesticeffectsmay

beassociatedwithinappropriatebehaviour(seesection4.4SpecialWarningsandPrecautions).

Depression

Pre-existingdepressionmaybeunmaskedduringbenzodiazepineuse.

Psychiatricand'paradoxical'reactions

Reactionslikerestlessness,agitation,irritability,aggressiveness,delusion,rages,nightmares,hallucinations,psychoses,

inappropriatebehaviourandotheradversebehaviouraleffectsareknowntooccurwhenusingbenzodiazepineor

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Dependence

Use(evenattherapeuticdoses)mayleadtothedevelopmentofphysicaldependence:discontinuationofthetherapy

mayresultinwithdrawalorreboundphenomena(seeWarningsandPrecautions).Psychicdependencemayoccur.

Abuseofbenzodiazepineshasbeenreported.

4.9Overdose

Aswithotherbenzodiazepines,overdoseshouldnotpresentathreattolifeunlesscombinedwithotherCNS

depressants(includingalcohol).

Inthemanagementofoverdosewithanymedicinalproduct,itshouldbeborneinmindthatmultipleagentshavebeen

taken.

Followingoverdosewithanymedicinalproduct,vomitingshouldbeinduced(withinonehour)ifthepatientis

consciousorgastriclavageundertakenwiththeairwayprotectedifthepatientisunconscious.Ifthereisnoadvantage

inemptyingthestomach,activatedcharcoalshouldbegiventoreduceabsorption.Specialattentionshouldbepaidto

respiratoryandcardiovascularfunctionsinintensivecare.

Overdoseofbenzodiazepinesisusuallymanifestedbydegreesofcentralnervoussystemdepressionrangingfrom

drowsinesstocoma.Inmildcases,symptomsincludedrowsiness,mentalconfusionandlethargy,inmoreserious

cases,symptomsmayincludeataxia,hypotonia,hypotension,respiratorydepression,rarelycomaandveryrarelydeath.

Flumazenilmaybeusefulasanantidote.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Psycholeptics,Anxiolytics

ATCcode:N05BA01

5.2Pharmacokineticproperties

Diazepamisreadilyandcompletelyabsorbedfromthegastro–intestinaltract,peakplasmaconcentrationsoccurring

withinabout30to90minutesoforaladministration;therateofabsorptionisage-relatedandtendstobedelayedinthe

elderly.Diazepamhasabiphasichalf–lifewithaninitialrapiddistributionphasefollowedbyaprolongedterminal

eliminationphaseof1or2days;itsactionisfurtherprolongedbytheevenlongerhalf–lifeof2to5daysofits

principleactivemetabolite,desmethyldiazepam(Nordiazepam),therelativeproportionofwhichincreasesinthebody

onlong–termadministration.Diazepamisveryextensivelyboundtoplasmaproteins.

5.3Preclinicalsafetydata

Notavailable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Maizestarch

Magnesiumstearate

Sodiumstarchglycollate

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25 0

Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

HighdensitypolyethyleneorpolypropylenetabletcontainerwithHDPEcap.

Packsizesof500and1000tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PinewoodLaboratoriesLimited,

Ballymacarbry,

Clonmel,

CountyTipperary.

8MARKETINGAUTHORISATIONNUMBER

PA0281/007/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:15thApril1981

Dateoflastrenewal:15 th

April2006

10DATEOFREVISIONOFTHETEXT

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