DIACLIDE 80MG TABLETS

Main information

  • Trade name:
  • DIACLIDE 80MG TABLETS
  • Dosage:
  • 80 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIACLIDE 80MG TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0577/030/001
  • Authorization date:
  • 21-07-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Diaclide80mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

EachtabletcontainsGliclazide80mg.

Excipients:Eachtabletcontains40mgLactoseMonohydrate

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablets

Whiteround,flat,beveledged,scoredtablets,marked‘GZ80’ononesidewitha‘G’ontheother.

Thescorelineallowsthetabletstobedividedintoequalhalves.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Diaclideisusedforthetreatmentofmaturityonsetdiabetesmellitus,wheretherapywithinsulinisnotrequiredand

dietarymodificationshavefailedtocontrolhyperglycaemia.

4.2Posologyandmethodofadministration

Diaclideisfororaladministration.

Adults

Thetotaldosemayvaryfrom40-320mgdaily.Asingledoseshouldnotexceed160mg(2tablets)andwhenhigher

dosesarerequiredatwicedailysplitdosageisadvisedandshouldbedividedaccordingtothemainmealsoftheday.

Thefinaldosingregimenwillbedecidedbythedoctorandwillbedependentuponindividualpatientrequirements.

Thetabletistobetakenwithfoodandinconjunctionwithacalorieandcarbohydraterestricteddiet.Diaclidemaybe

usedincombinationwithbiguanidehypoglycaemicdrugsifnecessary.

Elderly

Asforadults.

Children

Diaclideiscontraindicatedinchildren.

4.3Contraindications

Diaclideshouldnotbeusedinpregnantwomenorwomenwhoarebreastfeeding,children,patientswithknown

hypersensitivitytogliclazideorothersulphonylureas,diabetescomplicatedbyketoacidosis,severerenal,hepatic,

adrenalorthyroiddysfunctionorinpatientswithunstableorbrittlediabetes.

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ThedosageofDiaclidemayrequireadjustmentinpatientssufferingfrominfection,traumaorshockorduring

anaesthesia.

Patientswithsuchconditionmayrequireinsulintomaintaincontrol.Closeobservationandcarefulinitiationis

mandatorywhoareelderly,debilitate,malnourished.Severehypoglycaemiamayoccurinsuchpatientsrequiring

correctivetherapyoveraperiodtoseveraldays.Alcoholism,insulinoma,adrenal,thyroidandpituitaryinsufficiency

increasethesensitivitytosulphonylureasandmaydisposetowardshypoglycaemia.

Inordertoreducetheriskofhypoglcaemiaitisthereforerecommended:

Toinitiatetreatmentfornon-insulindiabeticsbydietaloneifthisispossible.

Totakeintoaccounttheageofthepatients:bloodsugarlevelsnotstrictlycontrolledbydietalonemaybeacceptablein

theelderly.

ParticularcaremustbetakenduringtheinitialperiodofstabilizationwiththedoseofDiaclideadjustedaccordingto

thebloodglucoseresponseandthe24hoururinaryglucose.

Inpatientssufferingfromhepaticorrenaldysfunction,reductionofthedosagemaybenecessary.

TreatmentofpatientswithG6PD-deficiencywithsulfonylureaagentscanleadtohaemolyticanaemia.SinceDiaclide

belongstotheclassofsulfonylureaagents,cautionshouldbeusedinpatientswithG6PD-deficiencyandanon-

sulfonylureaalternativeshouldbeconsidered.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

CareshouldbetakenwhengivingDiaclidewithdrugswhichareknowntoalterthediabeticstateorpotentiatethe

actionofgliclazide.Chloramphenicol,miconazole(oralforms),ketoconazole,clofibrate,disopyramide,probenecid,

insulin,biguanides,fluconazole, phenylbutazone,salicylates,long-actingsulphonamides,coumarinderivatives,

beta -blockers,monoamineoxidaseinhibitorsandcimetidinemaypotentiatethehypoglycaemiceffectofgliclazide.

Corticosteroids,oralcontraceptives,phenothiazinederivatives,thyroidhormones,thiazidediureticsandabuseof

laxativesmaydiminishtheeffectofDiaclide.Fibrates(patientsstabilizedonDiaclideshouldbeveryclosely

monitoredwhenstartingorendingatherapywithfibrates).Intolerancetoalcohol(disulframlikereaction:flushing,

sensationofwarmth,giddiness,nauseaandoccasionallytachycardia)mayoccur.Chronicalcoholabusemayasaresult

ofliverenzymeinductionstimulatethemetabolismofsulphonylureadrugsandshortenplasmahalf-lifeanddurationof

action.

Rarecasesofleucopenia,agranulocytosis,thrombocytopeniaandanaemiahavebeenreported.Casesofporphyria

cutaneatardaandofphotosensitivityhavealsobeenreportedwithsulphonylureadrugs.

4.6Fertility,pregnancyandlactation

Diaclideshouldnotbeusedinpregnancyorduringbreastfeeding.

Althoughitisnotknownwhethergliclazideisexcretedinmilk,othersulphonylureashavebeendetectedinmilkand

thereisnoevidencethatgliclazidediffersinthisrespect.

4.7Effectsonabilitytodriveandusemachines

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4.8Undesirableeffects

Atdosagesusedinthetreatmentofmaturityonsetdiabetesmellitus,themostfrequentlyreportedsideeffectis

hypoglycaemia,whichinmostcasesistheresultofoverdoseorinadequatedietratherthananadverseeffectofthe

drugandthereforecanbecorrectedbydosagereduction.

Thefollowingfrequenciesareusedforthedescriptionoftheoccurrenceofadversereactions:verycommon(>1/10),

common(>1/100to<1/10),uncommon(>1/1,000to<1/100),rare(>1/10,000to<1/1,000),veryrare(<1/10,000,not

known).

Withineachfrequencygrouping,undesirableeffectsarepresentedinorderofdecreasingseriousness.

*Hypoglycaemia

Allsulphonylureascanproducehypoglycaemia.Thiscanbeprolongedbygliclazideandmayleadtosevere

hypoglycaemiawithlife-threateningcoma.Incasesofveryslowprogressionofnervouslesion(autonomous

neuropathy)orsympatholyticconcomitanttherapy(see“Specialwarningandprecautionsforuse”and“Interactions”),

typicalpremonitorysymptomsofhypoglycaemiamaybeweakerorabsent.

Hypoglycaemiaischaracterisedbydecreaseinbloodsugartolessthanapprox.50to40mg/dl.

Thefollowingpremonitorysymptomscanalertthepatientorher/hissurroundingsofatoogreatbloodsugardecrease:

Bloodandlymphatic

systemdisorders Rare(>1/10,000to

<1/1,000): Leucopoenia,agranulocytosis,

thrombocytopoenia,haemolyticanaemia,

aplasticanaemia.

Nervoussystem

disorders Rare(>1/10,000to

<1/1,000): Dizzines.

Gastrointestinal

disorders Common(>1/100to

<1/10): Gastrointestinalupset(suchasabdominalpain,

nauseaorvomiting,dyspepsia,diarrhoea,

constipation).Itcanbeavoidedorminimisedif

gliclazideistakenwithbreakfast.

Skinand

subcutaneoustissue

disorders Rare(1/10,000to

<1/1,000): Skinreactions(erythema,pruritus,bullous

reactions).

Metabolismand

nutritiondisorders Common(>1/100to

<1/10): Hypoglycemia*(seeadditionalinformation

below).

Rare(>1/10,000to

<1/1,000): Slightdisulfiram-likereactionsaftertaking

alcohol.

Hepatobiliary

disorders Rare(>1/10,000to

<1/1,000): Sulphonylureascanoccasionallycause

disturbancesofliverfunctions,whichrarely

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headache,somnolence,sleepdisorder,anxiety,depression,touchiness,alteredbehaviour,unsteadymovements,

transientneurologicalsymptoms(e.g.speechandvisualdisorders,paralyticsymptomsorsensitivitydisorders).In

severehypoglycaemiathepatientmayloseself-controlandconsciousness.Inthiscasethepatient'sskinisoftencool

andshe/hetendstohavecramps.

Fortreatmentofhypoglycaemiasee“Overdose”.

4.9Overdose

Accidentalordeliberateoverdoseofsulphonylureas,includinggliclazide,canproducehypoglycaemia(forsymptoms

see4.8).

Treatment:

Mildhypoglycaemiasymptoms,withoutlossofconsciousnessorneurologicalfinding,shouldbetreatedaggressively

withoralglucoseandadjustmentsindrugdosageand/ormealpatterns.Closemonitoringshouldcontinueuntilthe

physicianisassuredthatthepatientisoutofdanger.Severehypoglycaemicreactionswithcoma,seizure,orother

neurologicalimpairmentoccurinfrequently,butconstitutemedicalemergenciesrequiringimmediatehospitalization.If

hypoglycaemiccomaisdiagnosedorsuspected,thepatientshouldbegivenarapidintravenousinjectionof

concentrated(50%)glucosesolution.Thisshouldbefollowedbyacontinousinfusionofamorediluted(10%)glucose

solutionataratewhichwillmaintainthebloodglucoseatalevelabove100mg/dl.Patientsshouldbecloselymonitored

foraminimumof48h,and,dependingonthestatusofthepatientatthistime,thephysicianshoulddecidewhether

furthermonitoringisrequired.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCCode:A10BB09

Gliclazideactsprimarilybyenhancingthereleaseofinsulinfromthepancreaticbetacellsalthoughitalsohassome

extrapancreatichypoglycaemicactions(potentiationoftheeffectsofinsulinandreductionofhepaticglucoseoutput).

Gliclazidealsohasbeneficialvasculareffects,includingareductioninplateletadhesivenessandaggregationand

increasedfibrinolysis.

5.2Pharmacokineticproperties

Therateofabsorptionofgliclazidefromthegastrointestinaltractvariesconsiderably.Gliclazideisextensivelybound

toplasmaproteins.Theplasmahalf-lifeisapproximately6-14hours,theaveragebeingabout10hours.Gliclazideis

extensivelymetabolisedintheliverandbothunchangeddrugandmetabolitesareexcretedintheurineandthefaeces.

5.3Preclinicalsafetydata

Notoxicologicalchangeswerenotedinguineapigs,dogs,ratsandmonkeystreatedwithgliclazideforuptooneyear

atdoses50foldhigherthanthetherapeuticdoseinman.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

MicrocrystallineCellulose

PovidoneK29/32

Sodiumstarchglycolate

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Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

DiaclidetabletsareavailableinPVC/PVdCblisterpacksof60tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

McDermottLaboratoriesLtd.

Tradingas:

GerardLaboratories

35-36BaldoyleIndustrialEstate

GrangeRoad

Dublin13

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA577/30/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21July2000

Dateoflastrenewal:31stMarch2008

10DATEOFREVISIONOFTHETEXT

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