DAONIL

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA0465/149/001
  • Authorization date:
  • 13-01-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Daonil5mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains5mgglibenclamide.

Excipients:containslactosemonohydrate79.0mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

ProductimportedfromSpain:

Whitebiplanaroblongtabletswith‘LDI’engravedoneithersideofabreaklineandinvertedononesideandtheother

sideisplain.

Thebreak-lineallowsthetabletstobedividedintoequalhalves.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Daonilisasulphonylureahypoglycaemicagent,indicatedfortheoraltreatmentofpatientswithnon-insulindependent

diabeteswhorespondinadequatelytodietarymeasuresalone.

4.2Posologyandmethodofadministration

Thedosageofglibenclamidemustbethelowestpossiblewhichiseffective.

Theusualtotaldailydosageis2.5mgto15mgdailywithausualinitialdoseof5mgdaily.Weeklyadjustmentscanbe

madetoincreasethedosagetotheoptimallevel.Dosesof10mgorlessmaybetakenasasingledoseimmediately

beforebreakfast,butshouldthedailydoseexceed10mg,theremaindershouldbetakenimmediatelybeforethe

eveningmeal.

Theelderlyusuallyrequirelowerdosage.

DoseOmission

Aphysicianshouldbeconsultedintheeventthatadosehasnotbeentakenattheprescribedtime,amealhasbeen

skippedoranextradosehasbeentaken.Itisveryimportantnottoskipmealsafterthetabletshavebeentaken.

Secondarydosageadjustment

Asanimprovementincontrolofdiabetesis,initself,associatedwithhigherinsulinsensitivity,glibenclamide

requirementsmayfallastreatmentproceeds.Toavoidhypoglycaemia,timelydosereductionorcessationofDaonil

therapymustthereforebeconsidered.

Correctionofdosagemustalsobeconsidered,whenever:

-Thepatientsweightchanges.

-Thepatientslife-stylechanges.

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ChangeoverfromotheroralantidiabeticstoDaonil

ChangeoverfromotheroralantidiabeticagentstoDaonilshouldbedoneunderthesupervisionofaspecialist,anddue

tothepotentialsummationofeffectsofbothmedications,entailsariskofhypoglycaemia.Abreakfrommediationmay

thereforeberequiredwhenchangingovermedications.Thisshouldbedecidedbytheattendingphysician.

4.3Contraindications

Daonilshouldnotbeusedinpatientswhohaveorhaveeverhaddiabeticketoacidosisordiabeticcoma/precomaorin

patientswhohaveinsulin-dependentdiabetesmellitus,seriousimpairmentofrenal,hepaticoradrenocorticalfunction,

inpatientswhoarehypersensitivetoglibenclamide,oranyoftheotherexcipients,incircumstancesofunusualstress,

e.g.surgicaloperationsorduringpregnancy,whendietarymeasuresandinsulinareessential.

Daonilshouldnotbeusedinthefollowinggroups:

Patientswithsulphonylureaorsulphonamideintolerance.

'Brittle'orjuvenilediabetes.

Pregnancy.

Breastfeedingwoman.

Children.

Inpatientstreatedwithbostentan.

4.4Specialwarningsandprecautionsforuse

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucosegalactose

malabsorptionshouldnottakethismedicine.

Personsallergictoothersulphonamidederivativesmaydevelopanallergicreactiontoglibenclamideaswell.

DuringtreatmentwithDaonil,glucoselevelsinbloodandurinemustbemeasuredregularly.

Adjustmentofthedosageofhypoglycaemicagentsmayberequiredinpatientssufferingfromintercurrentinfections,

trauma,shockoranaesthesia.

Formajorsurgery,insulintherapyshouldbesubstitutedfororalhypoglycaemics.

Hepaticorrenaldysfunctionmayrequirereductionindosage.

Patientsforwhomsulphonylureatherapyisintendedshouldbecarefullyselected,andlimitedtothosewhocannotbe

controlledondietarymeasuresalone,donotrequireinsulin,anddonotsufferfromthosedisorders,thecourseofwhich

mightbeaffectedbythistherapy.

Elderly,debilitatedpatientsandthosewithadrenalorpituitaryinsufficiencyareparticularlysusceptibletothe

hypoglycaemicactionofglucoseloweringdrugs.

Inexceptionalstresssituations(e.g.trauma,surgery,febrileinfections),bloodglucoseregulationmaydeteriorate,anda

temporarychangetoinsulinmaybenecessarytomaintaingoodmetaboliccontrol.

Asisnecessaryduringtreatmentwithanyblood-glucose-loweringdrug,thepatientandthedoctormustbeawareofthe

riskofhypoglycaemia.Factorsfavouringhypoglycaemiainclude:

-Unwillingnessorincapacityofthepatienttoco-operate.

-Undernourishment,irregularmealtimesormissedmeal.

-Imbalancebetweenphysicalexertionandcarbohydrateintake.

-Alterationsofdiet.

-Impairedrenalfunction.

-Seriousliverdysfunction.

-OverdosagewithDaonil.

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hypoglycaemic(asforexampleincertaindisordersofthyroidfunctionandinanteriorpituitaryof

adrenocorticalinsufficiency).

-Concurrentadministrationofcertainothermedicines.

Thosesymptomsofhypoglycaemic,whichreflectthebody’sadrenergiccounter-regulationmaybemilderorabsent

wherehypoglycaemiadevelopsgradually,wherethereisautonomicneuropathyorwherethepatientisreceiving

concurrenttreatmentwithbeta-blockers,clonidine,reserpine,guanethidine,orothersympatholyticdrugs.

Hypoglycaemiacan,almostalways,bepromptlycontrolledbyimmediateintakeofcarbohydrates.

Despiteinitiallysuccessfulcounter-measures,hypoglycaemiamayrecur.Patientsmust,therefore,remainunderclose

observation.

Severehypoglycaemia,oraprotractedepisode,whichcanonlybetemporarilycontrolledbyusualamountsofsugar,

furtherrequiresimmediatetreatmentandfollow-upbyadoctorand,insomecircumstances,in-patienthospitalcare.

TreatmentofpatientswithG6PD-deficiencywithsulfonylureaagentscanleadtohaemolyticanaemia.Since

glibenclamidebelongstotheclassofsulfonylureaagents,cautionshouldbeusedinpatientswithG6PD-deficiencyand

anon-sulfonylureaalternativeshouldbeconsidered.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Potentiationoftheblood-glucose-loweringeffectandthus,insomeinstanceshypoglycaemiamayoccurwhentaking

otherdrugs,including:

Insulinandother,oralantidiabetics,ACEinhibitors,anabolicsteriodsandmalesexhormones,chloramphenicol,

coumarinderivatives,cyclophosphamide,disopryamide,fenfluramine,fenyramidol,fibrates,fluoxetine,ifosfamide,

MAOinhibitors,miconazole,para-aminosalicyclicacid,pentoxifylline,phenylbutazone,azapropazone,

oxyphenbutazone,probenecid,quinolones,salicylates,sulfinpyrazone,sulfonamides,sympatholyticagentssuchas

beta-blockersandguanethidine,clarithromycin,tetracyclines,tritoqualine,trosfosfamide.

Weakeningoftheblood-glucose-loweringeffectand,thus,raisedbloodglucoselevelsmayoccurwhentakingother

drugs,including:

Acetazolamide,barbiturates,corticosteroids,diazoxide,diuretics,epinephrineandothersympathamimeticagents,

glucogon,laxatives,nicotinicacid,oestrogensandprogestogens,phenothiazines,phenytoin,thyroidhormones,

rifampicin.

-receptorantagonists,clonadineandresperinemayleadtoeitherpotentiationorweakeningoftheblood-

glucoseloweringeffect.

Undertheinfluenceofsympatholyticdrugssuchasbeta-blockers,clonidine,guanethidine,andresperine,thesignsof

adrenergiccounter-regulationtohypoglycaemicmaybereducedorabsent.

Glibenclamidemayincreasecyclosporineplasmaconcentrationandpotentiallyleadtoitsincreasedtoxicity.

Bothacuteandchronicalcoholintakemaypotentiateorweakenthebloodglucoseloweringactionofglibenclamidein

anunpredictedfashion.

Glibenclamidemayeitherpotentiateorweakentheeffectofcoumarinderivatives.

Bosentan:Anincreasedincidenceofelevatedliverenzymeswasobservedinpatientsreceivingglibenclamide

concomitantlywithbosentan.

Bothglibenclamideandbosentaninhibitthebilesaltexportpump,leadingtointracellularaccumulationofcytotoxic

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4.6Fertility,pregnancyandlactation

Daonilmustnotbetakenduringpregnancyorbybreastfeedingwomen.Thepatientmustchangeovertoinsulinduring

pregnancy.Animalstudiesshowedsometeratogeniceffects.Patientsplanningapregnancymustinformtheir

physician.Itisrecommendedthatsuchpatientschangeovertoinsulin.

4.7Effectsonabilitytodriveandusemachines

Alertnessandreactionsmaybeimpairedbyhypoorhyperglycaemicepisodes,especiallywhenbeginningorafter

alteringtreatment,orwhenDaonilisnottakenregularly.Thismayaffecttheabilitytodriveoroperatemachinery.

4.8Undesirableeffects

Hypoglycaemia

Hypoglycaemia,sometimesprolongedandevenlife-threatening,mayoccurasaresultofthebloodglucoselowering

actionofDaonil.Possiblesymptomsofhypoglycaemiaincludeheadache,ravenoushunger,nausea,vomiting,

lassitude,sleepiness,disorderedsleep,restlessness,aggressiveness,impairedconcentration,alertness,andreactions,

depression,confusion,speechdisorders,aphasia,visualdisorders,tremor,pareses,sensorydisturbances,dizziness,

helplessness,lossofselfcontrol,delirium,cerebralconvulsions,somnolenceandlossofconsciousnessuptoan

includingcoma,shallowrespirationandbradycardia.

Signsofadrenergiccounter-regulationmaybepresentsuchassweating,clammyskin,anxiety,tachycardia,

hypertension,palpitations,anginapectorisandcardiacarrhythmias.Theclinicalpictureofaseverehypoglycaemic

attackmayresemblethatofastroke.Thesymptomsofhypoglycaemianearlyalwayssubsidewhenhypoglycaemiais

corrected.

Eyes

Temporaryvisualimpairment.

Digestivetract

Gastrointestinalsymptomssuchasnausea,vomiting,sensationsofpressureorfullnessintheepigastrium,abdominal

painanddiarrhoeamayoccur.Inisolatedcases,theremaybeelevationofliverenzymelevelsandevenimpairmentof

liverfunction(e.g.withcholestatsisandjaundiceandhepatitiswhichcanregressafterwithdrawalofDaonil,although

theymayleadtolife-threateningliverfailure).Treatmentwithsulphonylureashasbeenassociatedwithoccasional

disturbancesofliverfunctionandcholestaticjaundice.

Blood

Potentiallylife-threateningchangesinbloodpicturemayoccur.Theymayinclude-rarely-mildtoseverethrombopenia

(e.g.presentingaspurpura)-isolatedcases-haemolyticanaemia,erythrocytopenia,leucopenia,granulocytopenia,

agranulocytosisand(e.g.duetomyelosuppression)pancytopenia.

Otheradverseeffects

Occasionally,allergicorpseudoallergicreactionsmayoccur,e.g.intheformitchingorrashes.Inisolatedcases,mild

reactionsintheformofurticariamaydevelopintoseriousandevenlife-threateningreactions.

Inisolatedcases,allergicvasculitismayariseand,insomecircumstances,maybelifethreatening.Inisolatedcases,

hypersensitivityoftheskintolightmayoccur,andsodiumconcentrationintheserummaydecrease.

4.9Overdose

Hypoglycaemiamaybetreatedintheconsciouspatientsbytheadministrationofglucose,orthreetofourlumpsof

tablesugarwithwater.Thismayberepeatedasnecessary.

Ifthepatientiscomatose,glucoseshouldbeadministeredasanintravenousinfusionandthepatientmonitored.Bolus

glucoseinjectionsarenotrecommendedbecauseofthepossibilityofreboundhypoglycaemia,which

maybedelayed.Alternatively,glucagonmaybeadministeredinadoseof1mgsubcutaneouslyorintramuscularlyto

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Thepharmacodynamiceffectofglibenclamideistolowerbloodglucoselevels.

Mechanismsproposedforthiseffectinclude:

Stimulationofinsulinreleasefrompancreaticbeta-cells.

Increasinginsulinbindingreceptordensityinperipheraltissues.

Plasmaglucoselevelsaffecttheinsulin-releasingresponseinglibenclamide;(ahighglucoselevelincreasesthe

response).Theminimumactiveconcentrationforeffectisconsideredtobe30-50nanograms/mlglibenclamide.

Investigationsoftherelationshipbetweeninsulin,glucoselevelsandglibenclamideinthehypoglycaemiceffect

continue.

5.2Pharmacokineticproperties

Asulphonylureahypoglycaemicagentrapidlyabsorbedandinducingitseffectwithin3hourswithadurationofupto

15hoursalthoughtheT 1

ofdrugis5to10hours.Thedrugismetabolisedextensivelyintheliverandexcretedvia

bileandurine.Itisstronglyprotein-bound.

5.3Preclinicalsafetydata

Noneofclinicalrelevance.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

MaizeStarch

Pregelatinisedmaizestarch

Talc

Colloidalanhydroussilica

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelflineexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Storeinoriginalpackage.

6.5Natureandcontentsofcontainer

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

PCOManufacturing

Unit10,AshbourneBusinessPark

Rath

Ashbourne

Co.Meath

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA0465/149/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13January2006

Dateoflastrenewal:12January2011

10DATEOFREVISIONOFTHETEXT

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