DIAMICRON 80MG TABLETS

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0068/002/001
  • Authorization date:
  • 30-01-1976
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Diamicron80mgTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains80mggliclazide.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet.

White,circular,flat,bevel-edged,crossscoredcompressedtablets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofdiabetesmellitusofthematurityonsettype,whichisnotadequatelycontrolledbydietarymeans,

anddoesnotrequireinsulintherapy.

4.2Posologyandmethodofadministration

Adultsonly:

Thefinaldosageregimendependsupontheindividualrequirementsofthepatientandisatthediscretionofthe

physician.

Thedosewillbegenerallybetween80and320mgdaily.

Biguanidehypoglycaemicagentsmaybeaddedtotheregimenifrequired.

4.3Contraindications

knownhypsersensitivitytogliclazideortoanyoftheexcipients,othersulphonylureas,sulphonamides,

type1diabetes,

diabeticpre-comaandcoma,diabeticketo-acidosis,

severerenalorhepaticinsufficiency:inthesecasestheuseofinsulinisrecommended.

Treatmentwithmiconazole(seeSection“Interactionswithothermedicinalproductsandotherformsof

interaction”),

Pregnancyandlactation(seeSection“PregnancyandLactation”).

4.4Specialwarningsandprecautionsforuse

HYPOGLYCAEMIA:

Thistreatmentshouldbeprescribedonlyifthepatientislikelytohavearegularfoodintake(includingbreakfast).Itis

importanttohavearegularcarbohydrateintakeduetotheincreasedriskofhypoglycaemiaifamealistakenlate,ifan

inadequateamountoffoodisconsumedorifthefoodislowincarbohydrate.Hypoglycaemiaismorelikelytooccur

duringloc-caloriediets,followingprolongedorstrenuousexercise,alcoholintakeorifacombinationof

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Hypoglycaemiamayoccurfollowingadministrationofsuphonylureas(see4.8.Undesirableeffects).Somecasesmay

besevereandprolonged.Hospitalisationmaybenecessaryandglucoseadministrationmayneedtobecontinuedfor

severaldays.

Carefulselectionofpatients,ofthedoseused,andclearpatientdirectionsarenecessarytoreducetheriskof

hypoglycaemicepisodes.

Factorswhichincreasetheriskofhypoglycaemia:

patientrefusesor(particularlyinelderlysubjects)isunabletoco-operate,

malnutrition,irregularmealtimes,skippingmeals,periodsoffastingordietarychanges,

imbalancebetweenphysicalexerciseandcarbohydrateintake,

renalinsufficiency,

severehepaticinsufficiency,

overdoseofDiamicron80mgTablets,

certainendocrinedisorders:thyroiddisorders,hypopituitarismandadrenalinsufficiency,

concomitantadministrationofcertainothermedicines(seeInteractions).

Renalandhepaticinsufficiency:thepharmacokineticsand/orpharmacodynamicsofgliclazidemaybealteredin

patientswithhepaticinsufficiencyorsevererenalfailure.Ahypoglycaemicepisodeoccurringinthesepatientsmaybe

prolonged,soappropriatemanagementshouldbeinitiated.

Patientinformation:

Therisksofhypoglycaemia,togetherwithitssymptoms,treatment,andconditionsthatpredisposetoitsdevelopment,

shouldbeexplainedtothepatientandtofamilymembers.

Thepatientshouldbeinformedoftheimportanceoffollowingdietaryadvice,oftakingregularexercise,andofregular

monitoringofbloodglucoselevels.

Poorbloodglucosecontrol:bloodglucosecontrolinapatientreceivingantidiabetictreatmentmaybeaffectedbyany

ofthefollowing:fever,trauma,infectionorsurgicalintervention.Insomecases,itmaybenecessarytoadminister

insulin.

Thehypoglycaemicefficacyofanyoralantidiabeticagent,includinggliclazide,isattenuatedovertimeinmany

patients:thismaybeduetoprogressionintheseverityofthediabetes,ortoareducedresponsetotreatment.This

phenomenonisknownassecondaryfailurewhichisdistinctfromprimaryfailure,whenanactivesubstanceis

ineffectiveasfirst-linetreatment.Adequatedoseadjustmentanddietarycomplianceshouldbeconsideredbefore

classifyingthepatientassecondaryfailure.

Laboratorytests:Measurementofglycatedhaemoglobinlevels(orfastingvenousplasmaglucose)isrecommendedin

assessingbloodglucosecontrol.Bloodglucoseself-monitoringmayalsobeuseful.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactosedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

TreatmentofpatientswithG6PD-deficiencywithsulfonylureaagentscanleadtohaemolyticanaemia.Sincegliclazide

belongstotheclassofsulfonylureaagents,cautionsshouldbeusedinpatientswithG6PG-deficiencyandanon-

sulfonylureaalternativeshouldbeconsidered.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

1)Thefollowingproductsarelikelytoincreasetheriskofhypoglycaemia

Contra-indicatedcombination

Miconazole(systemicroute,oromucosalgel):increasesthehypoglycaemiceffectwithpossibleonsetof

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Combinationswhicharenotrecommended

Phenylbutazone(systemicroute):increasesthehypoglycaemiceffectofsulphonylureas(displacestheirbinding

toplasmaproteinsand/orreducestheirelimination).

Itispreferabletouseadifferentanti-inflammatoryagent,orelsetowarnthepatientandemphasisethe

importanceofself-monitoring.Wherenecessary,adjustthedoseduringandaftertreatmentwiththeanti-

inflammatoryagent.

Alcohol:increasesthehypoglycaemicreaction(byinhibitingcompensatoryreactions)thatcanleadtotheonset

ofhypoglycaemiccoma.Avoidalcoholormedicinescontainingalcohol.

Combinationsrequiringprecautionsforuse

Potentationofthebloodglucoseloweringeffectandthus,insomeinstances,hypoglycaemiamayoccurwhenoneof

thefollowingdrugsistaken,forexample:

Otherantidiabeticagents(insulins,acarbose,biguanides),beta-blockers,fluconazole,angiotensinconvertingenzyme

inhibitors(captopril,enalapril),H2-receptorantagonists,MAOIs,sulfonamides,andnonsteroidalanti-inflammatory

agents.

2)Thefollowingproductsmaycauseanincreaseinbloodglucoselevels

Combinationwhichisnotrecommended

Danazol:diabetogeniceffectofdanazol.

Iftheuseofthisactivesubstancecannotbeavoided,warnthepatientandemphasisetheimportanceofurineand

bloodglucosemonitoring.Itmaybenecessarytoadjustthedoseoftheanitdiabeticagentduringandafter

treatmentwithdanazol.

Cominationsrequiringprecautionsduringuse

Chlorpromazine(neurolepticagent):highdoses(>100mgperdayofchlorpromazine)increasebloodglucose

levels(reducedinsulinrelease).

Warnthepatientandemphasisetheimportanceofbloodglucosemonitoring.Itmaybenecessarytoadjustthe

doseoftheantidiabeticactivesubstanceduringandaftertreatmentwiththeneurolepticagent.

Glucocorticoids(systemicandlocalroute:intra-articular,cutaneousandrectalpreparations)andtetracosactrin:

increaseinbloodclucoselevelswithpossibleketosis(reducedtolerancetocarbohydratesdueto

glucocorticoids).Warnthepatientandemphasisetheimportanceofbloodglucosemonitoring,particularlyatthe

startoftreatment.Itmaybenecessarytoadjustthedoseoftheantidiabeticactivesubstanceduringandafter

treatmentwithglucocorticoids.

Ritodrine,salbutamol,terbutaline:(I.V.)

Increasebloodglucoselevelsduetobeta-2agonisteffects.Emphasistheimportanaceofmonitoringblood

glucoselevels.Ifnecessary,switchtoinsulin.

3)Combinationwhichmustbetakenintoaccount

Anticoagulanttherapy(Warfarin…):

Sulfonylureasmayleadtopotentiationofanticoagulationduringconcurrenttreatment.Adjustmentofthe

anticoagulantmaybenecessary.

4.6Pregnancyandlactation

Pregnancy

Thereisnoexperiencewiththeuseofgliclazideduringpregnancyinhumans,eventhoughtherearefewdatawith

othersufonylurea.Inanimalstudies,gliclazideisnotteratogenic.

Controlofdiabetesshouldbeobtainedbeforethetimeofconceptiontoreducetheriskofcongenitalabnormalities

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Oralhypoglycaemicagentsarenotsuitable,insulinisthedrugoffirstchoicefortreatmentofdiabetesduring

pregnancy.Itisrecommendedthatoralhypoglycaemictherapyischangedtoinsulinbeforeapregnancyisattempted,

orassoonaspregnancyisdiscovered.

Lactation

Itisnotknownwhethergliclazideoritsmetabolitesareexcretedinbreastmilk.Giventheriskofneonatal

hypoglycaemia,theproductiscontra-indicatedinbreast-feedingmothers.

4.7Effectsonabilitytodriveandusemachines

Patientsshouldbemadeawareofthesymptomsofhypoglycaemiaandshouldbecarefulifdrivingoroperating

machinery,especiallyatthebeginningoftreatment.

4.8Undesirableeffects

Basedontheexperiencewithgliclazideandwithothersulphonylureas,thefollowingundesirableeffectshavetobe

mentioned.

Hypoglycaemia

Asforothersulfonylureas,treatmentwithDiamicron80mgTabletscancausehypoglycaemia,ifmealtimesare

irregularand,inparticular,ifmealsareskipped.

Possiblesymptomsofhypoglycaemiaare:headache,intensehunger,nausea,vomiting,lassitude,sleepdisorders,

agitation,aggression,poorconcentration,reducedawarenessandslowedreaction,depression,confusion,visualand

speechdisorders,aphasia,tremor,paresis,sensorydisorders,dizziness,feelingofpowerlessness,lossofself-control,

delirium,convulsions,shallowrespiration,bradycardia,drowsinessandlossofconsciousness,possiblyresultingin

comaandlethaloutcome.

Inaddition,signsofadrenergiccounter-regulationmaybeobserved:sweating,clammyskin,anxiety,tachycardia,

hypertension,palpitations,anginapectorisandcardiacarrhythmia.

Usually,symptomsdisappearafterintakeofcarbohydrates(sugar).However,artificialsweetenershavenoeffect.

Experiencewithothersulphonylureasshowsthathypoglycaemiacanrecurevenwhenmeasuresproveeffective

initially.

Ifahypoglycaemicepisodeissevereorprolonged,andevenifitistemporarilycontrolledbyintakeofsugar,

immediatemedicaltreatmentorevenhospitalisationarerequired.

Gastro-intestinaldisturbancesincludingabdominalpain,nausea,vomitingdyspepsia,diarrhoea,andconstipationhave

beenreported:iftheseshouldoccurtheycanbeavoidedorminimisedifgliclazideistakenwithbreakfast.

Thefollowingundesirableeffectshavebeenmorerarelyreported:

Skinandsubcutaneoustissuedisorders:rash,pruritus,urticaria,erythema,maculopapularrashes,bullous

reactions.

Bloodandlymphaticsystemdisorders:Changesinhaematologyarerare.Theymayincludeanaemia,

leucopenia,thrombocytopenia,granulocytopenia.Theseareingeneralreversibleupondiscontinuationof

medication.

Hepato-biliarydisorders:raisedhepaticenzymelevels(AST,ALT,Alkalinephosphatise),hepatitis(isolated

reports).Discontinuetreatmentifcholestaticjaundiceappears.

Thesesymptomsusuallydisappearafterdiscontinuationoftreatment.

Eyedisorders

Transientvisualdisturbancesmayoccurespeciallyoninitiationoftreatment,duetochangesinbloodglucoselevels.

Classattributioneffects:

Casesoferythrocytopenia,agranulocytosis,haemolyticanaemia,pancytopeniaandallergicvasculitis,havebeen

describedforothersulphonylureas.Withothersulfonylureascaseswerealsoobservedofelevatedliverenzymelevels

andevenimpairmentofliverfunction(e.g.withcholestasisandjaundice)andhepatitiswhichregressedafter

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4.9Overdose

Anoverdoseofsulphonylureasmaycausehypoclycamia.

Moderatesymptomsofhypoglycaemia,withoutanylossofconsciousnessorneurologicalsigns,mustbecorrectedby

carbohydrateintake,doseadjustmentand/orchangeofdiet.Strictmonitoringshouldbecontinueduntilthedoctoris

surethatthepatientisoutofdanger.

Severehypoglycaemicreactions,withcoma,convulsionsandotherneruolocialdisordersarepossibleandmustbe

treatedasamedicalemergency,requiringimmediatehospitalisation.

Ifhypoglycaemiccomaisdiagnosedorsuspected,thepatientshouldbegivenarapidI.V.injectionof50mLof

concentratedglucosesolution(20to30%).Thisshouldbefollowedbycontinuousinfusionofamorediluteglucose

solution(10%)ataratethatwillmaintainbloodglucoselevelsabove1g/L.Patientsshouldbemonitoredcloselyand,

dependingonthepatient’sconditionafterthistime,thedoctorwilldecideiffurthermonitoringisnecessary.Dialysis

isofnobenefittopatientsduetothestrongbindingofgliclazidetoproteins.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

SULFONAMIDES,UREADERIVATIVES,ATCcode:A10BB09

Gliclazideisahypoglycaemicsulphonylureaoralantidiabeticactivesubstancedifferingfromotherrelatedcompounds

yanN-containingheterocyclicringwithanendocylicbond.

Gliclazidereducesbloodglucoselevelsbystimulatinginsulinsecretionfromthe-cellsoftheisletsofLangerhans.

IncreaseinpostprandialinsulinandC-peptidesecretionpersistsaftertwoyearsoftreatment.Inadditiontothese

metabolicproperties,gliclazidehashaemovascularproperties.

Effectsoninsulinrelease

Intype2diabetics,gliclaziderestoresthefirstpeakofinsulinsecretioninresponsetoglucoseandincreasesthesecond

phaseofinsulinsecretion.

Asignificantincreaseininsulinresponseisseeninresponsetostimulationinducedbyamealorglucose.

Haemovascularproperties:

Gliclazidedecreasesmicrothrombosisbytwomechanismswhichmaybeinvolvedincomplicationsofdiabetes:

Apartialinhibitionofplateletaggregationandadhesion,withadecreaseinthemarkersofplateletactivation

(betathromboglobulin,thromboxaneB

AnactiononthevascularendotheliumfibrinolyticactivitywithanincreaseintPAactivity.

5.2Pharmacokineticproperties

Thedrug'splasmalevelpeaksat4-6hours,itisextensivelymetabolisedandexcretedthroughthekidneywithahalf

lifeofabout10hours.Itisstronglyproteinbound.

5.3Preclinicalsafetydata

Preclinicaldatarevealnospecialhazardsforhumansbasedonconventionalstudiesofrepeateddosetoxicityand

genotoxicity.Longtermcarninogenicitystudieshavenotbeendone.Noteratogenicchangeshavebeenshownin

animalstudies,butlowerfoetalbodyweightwasobservedinanimalsreceivingdoses25foldhigherthanthemaximum

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Maizestarch

Pregelatinisedmaizestarch

Magnesiumstearate

Talc

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

Boxof60tabletsinblisterstrips(PVC/Aluminium).

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ServierLaboratories(Ireland)Limited,

FirstFloor,Block2

WestPierBusinessCampus

OldDunlearyRoad

DunLaoghaire

Co.Dublin

8MARKETINGAUTHORISATIONNUMBER

PA0068/002/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:30January1976

Dateoflastrenewal:30January2006

10DATEOFREVISIONOFTHETEXT

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