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:
  • PPA1328/060/001
  • Authorization date:
  • 29-09-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA1328/060/001

CaseNo:2052901

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

B&SHealthcare

Unit4,BradfieldRoad,Ruislip,Middlesex,HA40NU,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Daonil5mgTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom31/03/2009until28/09/2011.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 31/03/2009 CRN 2052901 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Daonil5mgtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains5mgglibenclamide.

Excipientsincludelactose.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet.

ProductimportedfromFranceandSpain:

Whitebiplaneoblongtabletswith‘LDI’engravedoneachsideofthescorelineandinvertedononeside,theotherside

isplain.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Daonilisasulphonylureahypoglycaemicagent,indicatedfortheoraltreatmentofpatientswithnon-insulindependent

diabeteswhorespondinadequatelytodietarymeasuresalone.

4.2Posologyandmethodofadministration

GeneralInstructions

Thedosageofglibenclamidemustbethelowestpossibledosewhichiseffective.

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:

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-thepatientslife-stylechanges

-otherfactorsarise,whichcauseanincreasedsusceptibilitytohypoglycaemiaorhyperglycaemia.

ChangeoverfromotheroralantidiabeticstoDaonil

ChangeoverfromotheroralantidiabeticagentstoDaonilshouldbedoneunderthesupervisionofaspecialist,anddue

tothepotentialsummationofeffectsofbothmedications,entailsariskofhypoglycaemia.Abreakfrommedication

maythereforeberequiredwhenchangingovermedications.Thisshouldbedecidedbytheattendingphysician.

4.3Contraindications

Daonilshouldnotbeusedinpatientswhohaveorhaveeverhaddiabeticketoacidosisordiabeticcoma/precomaorin

patientswhohaveinsulin-dependentdiabetesmellitus,seriousimpairmentofrenal,hepaticoradrenocorticalfunction,

inpatientswhoarehypersensitivetoglibenclamideoranyoftheexcipients,orincircumstancesofunusualstress,e.g.

surgicaloperationsorduringpregnancy,whendietarymeasuresandinsulinareessential.

Daonilshouldnotbeusedinthefollowinggroups:

Patientswithsulphonylureaorsulphonamideintolerance.

'Brittle'orjuvenilediabetes.

Pregnancy.

Breastfeedingwomen.

Children.

Inpatientstreatedwithbosentan.

4.4Specialwarningsandprecautionsforuse

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

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

-undernouishment,irregularmealtimesormissedmeals

-imbalancebetweenphysicalexertionandcarbohydrateintake

-alterationsofdiet

-impairedrenalfunction

-seriousliverdysfunction

-overdosagewithDaonil

-uncompensateddisordersoftheendocrinesystemaffectingcarbohydratemetabolismorcounter-regulationof

hypoglycaemia(asforexampleincertaindisordersofthyroidfunctionandinanteriorpituitaryoradrenocortical

insufficiency)

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Thosesymptomsofhypoglycaemia,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

glibenclamidebelongtotheclassofsulfonylureaagents,cautionshouldbeusedinpatientswithG6PD-definciencyand

anon-sulfonylureaalternativeshouldbeconsidered.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ThehypoglycaemiceffectofglibenclamidemaybeenhancedbyACEinhibitors,anabolicsteroids,malesexhormones,

beta-adrenergicblockingagents,bezafibrate,chloramphenicol,clofibrate,coumarinderivatives,cyclophosphamide,

disopyramide,fenfluramine,fluoxetine,guanethidine,insulinandotheroralantidiabetics,MAOinhibitors,miconazole,

para-aminosalicyclicacid,phenylbutazone,azapropazone,tritoqualine,trofosfamide,probenecid,quinolone

antibacterials,salicylates,sulphinpyrazone,sulphonamides,tetracyclinecompoundsandtuberculostats.

Ordiminishedby:

Clonidine,corticosteroids,diazoxide,thiazideorloopdiuretics,andothersympathomimeticagents,glucagon,laxative

abuse,nicotinicacid(highdose),oralcontraceptives,phenothiazinederivatives,phenytoin,rifampicinandthyroid

hormones.Bothapotentiationandareductioninthebloodsugar-loweringeffecthavebeenreportedinpatientstreated

concomitantlywithclonidine,reserpine,barbituratesandH2-receptorantagonists.

Bothacuteandchronicalcoholintakemaypotentiateorweakenthebloodglucoseloweringactionofglibenclamidein

anunpredictedfashion.

Glibenclamidemayeitherpotentiateorweakentheeffectofcoumarinderivatives.

Thewarningsymptomsofahypoglycaemicattackmaybemaskedduringconcomitanttreatmentwithbeta-adrenergic

blockingagents,clonidine,orguanethidine.

Bosentan:Anincreasedincidenceofelevatedliverenzymeswasobservedinpatientsreceivingglibenclamide

concomitantlywithbosentan.

Bothglibenclamideandbosentaninhibitthebilesaltexportpump,leadingtointracellularaccumulationofcytotoxic

bilesalts.Thereforethiscombinationshouldnotbeused.

4.6Pregnancyandlactation

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,somnolenceandlossofconsciousnessuptoand

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Signsofadrenergiccounter-regulationmaybepresentsuchassweating,clammyskin,anxiety,tachycardia,

hypertension,palpitations,anginapectorisandcardiacarrhythmias.Theclinicalpictureofaseverehypoglycaemic

attackmayresemblethatofastroke.

Thesymptomsofhypoglycaemianearlyalwayssubsidewhenhypoglycaemiaiscorrected.

-Eyes

Temporaryvisualimpairment.

-Digestivetract

Gastrointestinalsymptomssuchasnausea,vomiting,sensationsofpressureorfullnessintheepigastrium,abdominal

painanddiarrhoeamayoccur.Inisolatedcases,theremaybeelevationofliverenzymelevelsandevenimpairmentof

liverfunction(e.g.withcholestasisandjaundiceandhepatitiswhichcanregressafterwithdrawalofDaonil,although

theymayleadtolife-threateningliverfailure.Treatmentwithsulphonylureashasbeenassociatedwithoccasional

disturbancesofliverfunctionandcholestaticjaundice.

-Blood

Potentiallylife-threateningchangesinthebloodpicturemayoccur.Theymayinclude–rarely–mildtosevere

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

granulocytopenia,agranulocytosisand(e.g.duetomyelosupression)pancytopenia.

-Otheradverseeffects

Occasionally,allergicorpseudoallergicreactionsmayoccur,e.g.intheformofitchingorrashes.Inisolatedcases,

mildreactionsintheformofurticariamaydevelopintoseriousandevenlife-threateningreactions.

Inisolatedcases,allergicvasculitismayariseand,insomecircumstance,maybelifethreatening.Inisolatedcases,

hypersensitivityoftheskintolightmayoccur,andsodiumconcentrationintheserummaydecrease.

4.9Overdose

Hypoglycaemiamaybetreatedintheconsciouspatientsbytheadministrationofglucose,orthreetofourlumpsof

tablesugarwithwater.Thismayberepeatedasnecessary.

Ifthepatientiscomatose,glucoseshouldbeadministeredasanintravenousinfusionandthepatientmonitored.Bolus

glucoseinjectionsarenotrecommendedbecauseofthepossibilityofreboundhypoglycaemia,whichmaybedelayed.

Alternatively,glucagonmaybeadministeredinadoseof1mgsubcutaneouslyorintramuscularlytorestore

consciousness.

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

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Maizestarch

Pregelatinizedmaizestarch

Talc

Colloidalanhydroussilica

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthecontainerandouterpackageoftheproducton

themarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

PVC/Aluminiumblisterpacksof100tablets

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7ParallelProductAuthorisationHolder

B&SHealthcare

Unit4

BradfieldRoad

Ruislip

Middlesex

HA40NU

UnitedKingdom

8ParallelProductAuthorisationNumber

PPA1328/60/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

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10DATEOFREVISIONOFTHETEXT

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