DYAZIDE

Main information

  • Trade name:
  • DYAZIDE Tablets 50/ 25 Milligram
  • Dosage:
  • 50/ 25 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DYAZIDE Tablets 50/25 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1328/116/001
  • Authorization date:
  • 25-06-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PPA1328/116/001

CaseNo:2064917

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

B&SHealthcare

Unit4,BradfieldRoad,Ruislip,Middlesex,HA40NU,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Dyazide50mg/25mgTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom25/06/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 29/06/2009 CRN 2064917 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dyazide50mg/25mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains50mgofTriametereneand25mgofhydrochlorothiazide

Excipients-Containssunsetyellow(E110)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

ProductimportedfromtheUK:

Peachcoloured,compressed,flat,circular,bevel-edgedtabletwithasinglescorelineononesurfaceandthecode‘E93’

ontheother.

Thescorelineisonlytofacilitatebreakingforeaseofswallowingandnottodivideintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Itisrecommendedforthetreatmentofmildtomoderatehypertension,aloneorincombinationwithother

antihypertensivedrugs.Itisalsorecommendedinthecontrolofoedemaduetocardiacfailure,cirrhosisoftheliveror

thenephroticsyndrome.Itcanalsobeusedtocontroltheoedemaassociatedwithcorticosteroidtreatment,butonly

whentheconcomitantuseofdiureticsisconsideredessential.

4.2Posologyandmethodofadministration

Routeofadministration:oral.

Adults:Inhypertension

Therecommendeddosageisonetabletadayafterthemorningmeal.If“Dyazide”isaddedtoalreadyestablished

therapywithanotherantihypertensivedrug,thedosageofthelattershouldbereduced,andlateradjustedifnecessary.

Ifanotherantihypertensivedrugisaddedto“Dyazide”therapy,thedosageofthelatterwillnotnormallybereduced.

Adults:Inoedema

One“Dyazide”tabletadayafterthemorningmeal.

Elderly

Dosageasforadults.“Dyazide”hasbeenwidelyusedandisusuallywelltoleratedinpatientsovertheageof60years.

Thenormallyoccurringreductioninglomerularfiltrationwithageshouldbeborneinmind(seesection4.4).

4.3Contraindications

Donotgive“Dyazide”topatientswithhyperkalaemia,progressiverenalfailure,increasinghepaticdysfunction.

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Potassiumsupplementsorotherpotassium-conversingdrugssuchasspironolactoneoramiloride,andalsoACE

inhibitors,shouldnotbegivenroutinelywith“Dyazide”.“Dyazide”shouldnotbeusedduringlactationorinneonates

oryounginfants.

4.4Specialwarningsandprecautionsforuse

Use“Dyazide”withcautioninpatientswithhepaticorrenalinsufficiencyorurinarytractobstructionandinthose

predisposedtogoutsincebothcomponentscanelevateuricacidlevels.Thiazidescanprovokehyperglycaemiaand

glycosuria,particularlyinpatientswithlatentdiabetes,andadjustmentofthedosageofhypoglycaemicagentsmaybe

necessaryindiabeticpatients.Dosageofconcomitantcardiacglycosidesmayneedtobeadjusted.

Patientswhoarebeingtreatedwith“Dyazide”requireregularsupervisionwithmonitoringofbloodandelectrolyte

statetoavoidinadequatepotassiumsupplementationorexcessivelossoffluid.Thisisimportantintheelderly,those

withrenalimpairmentandthosereceivingconcomitanttreatmentwithNSAIDs(seesection4.8).

Triamterenehasbeenfoundinrenalstonesbothaloneandinassociationwithotherusualcalculuscomponents.There

isnoevidencethatstoneformationisincreasedinpatientstakingtriamterene-containingdrugs.

ThesetabletscontainSunsetyellow(E110),whichmaycauseallergicreactions.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thiazidesreduceexcretionoflithiumandmaythusprecipitateintoxication.

Inviewofthepotassium-retainingeffectoftriamterene,theconcurrentuseofpotassiumsupplements,spironolactone,

amilorideorAngiotensinConvertingEnzyme(ACE)inhibitorsshouldbeavoided.

Concurrentuseof“Dyazide”withNon-SteroidalAnti-InflammatoryDrugs(NSAIDs)ororalhypoglycaemicsmay

decreasetheirefficacyorincreasetheirtoxicity.

Theconcomitantadministrationof“Dyazide”withcardiacglycosidesorhypotensiveagentsmaynecessitate

adjustmentofthedosageofthosedrugs.

4.6Pregnancyandlactation

Bothtriamtereneandthiazideshavebeenshowntopassthroughtheplacentainhumansandalsotopassintobreast

milk.Inrareinstancesthrombocytopenia,pancreatitisorhypoglycaemiahavebeenreportedinnewborninfantsof

motherstreatedwiththiazides.Theuseof“Dyazide”inpregnantpatientsshouldthereforebeavoidedunlessessential

andnursingmothersshouldnotbetreatedwith“Dyazide”.

4.7Effectsonabilitytodriveandusemachines

Therearenoknowneffectsof“Dyazide”ontheabilitytodriveandoperatemachinery.

4.8Undesirableeffects

Bloodandlymphaticsystem:Rarecasesofthrombocytopenicpurpuraandmegaloblasticanaemiahavebeenreported

withtriamterene.Rarely,blooddyscrasiasincludingagranulocytosis,thrombocytopeniaandleucopenia.

Immunesystemdisorder:Hypersensitivityreactions,rashhavebeenreported.

Photosensitivitycanoccur.Anaphylaxisisaremotepossiblity.VeryrarecasesofSLEhavebeenreportedassociated

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Metabolismandnutritiondisorders:Thiazidediureticscanalsocauseincreaseinplasmalipidlevels.

Nervoussystemdisorders:Dizziness,headache.

Cardiacdisorder:Undesirabledecreaseinbloodpressure(orthostatichypotension).

Gastrointestinaldisorders:Nausea,vomiting,diarrhoea,drymouth.

Hepato-biliarydisorder:Thiazidesalonehavecausedjaundice,acutepancreatitis.

Musculoskeletal,connectivetissueandbonedisorder:Musclecramps,weakness.

Renalandurinarydisorder:Incommonwithmostdiuretics,"Dyazide"mayreduceglomerularfiltrationrateandcause

atemporaryincreaseinbloodureaandcreatininelevels:againthismayalsoindicateexcessivedosageortobe

secondarytotheconditionundertreatment.

Long-termusehasconfirmedthatlittlechangeshavebeenobservedinfrequently,andmarkedfluctuationsinserum

potassiumareuncommon.

Metabolicacidosisoccasionallyoccurs.Electrolyteimbalancemayalsoindicateexcessivedosageortobesecondaryto

theconditionundertreatment.

Renalfailure,reversibleonstoppingtreatmenthasbeenreportedveryrarelyandhasbeenduetoacuteinterstitial

nephritisoraninteractionbetweentriamtereneandsomeNSAISs.

4.9Overdose

Symptomsofelectrolyteimbalance,hypertension,gastrointestinaldisturbanceandmuscularweaknessmayoccur.

Treatmentconsistsoftheinductionofvomitingand/orgastriclavage,correctionoffluiddepletionandelectrolyte

imbalance,andsymptomaticandsupportivetherapy.Ifhypertensionpersistsafteradequatefluidreplacement,

dopaminemaybeusedandexpertadvicesought.Cardiacrhythmshouldbemonitoredandappropriatemeasuretobe

takentocorrecthyperkalaemiaasnecessary.Renaldialysismaybesomebenefitincasesofsevereoverdosage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

“Dyazide”containstriamtereneandhydrochlorothiazide.Triamtereneisapotassiumconversingdiureticthoughttoact

bydirectlyinhibitingtheexchangeofsodiumforpotassiumandhydrogeninthedistalrenaltubule.

Hydrochlorothiazideisathiazidediureticwhichreducesthereabsorptionofelectrolytesfromtherenaltubules,thereby

increasingtheexcretionofsodiumandchlorideions,andconsequentlyofwater.Potassiumionsareexcretedtoalesser

extent.

5.2Pharmacokineticproperties

Onsetofdiuresistakesplacewithinonehour,peakhoursattwotothreehoursandtapersoffduringthesubsequent

seventoninehours.

Triamtereneisincompletelybutfairrapidlyabsorbedfromthegastrointestinaltract.Ithasbeenestimatedtohave

plasmahalf-lifeofabouttwohours.Itisextensivelymetabolisedandismainlyexcretedintheformofmetaboliteswith

someunchangedtriamterene;variableamountsarealsoexcretedinthebile.Hydrochlorothiazideisincompletelybut

fairlyrapidlyabsorbedfromthegastro-intestinaltract.Itisexcretedintheurine.

5.3Preclinicalsafetydata

Recentreviewofpre-clinicalanimalstudieshassuggestedthattriamtereneiscarcinogenicinbothsexesofmiceandin

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Maizestarch

Povidone30

SodiumlaurylSulphate

SunsetYellow(E110)

SodiumStarchGlycollateTypeA

MagnesiumStearate

PurifiedWater

6.2Incompatibilities

Notapplicable

6.3ShelfLife

Theshelf-lifeexpirydateofthisproductisthedateshownonthecontainerandouterpackageoftheproductonthe

marketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Storeintheoriginalpackageinordertoprotectfromlight

6.5Natureandcontentsofcontainer

OpaquePVC/PVdC/Aluminiumfoilblisterpackinanoverlabelledoutercontainercontaining30tablets

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements

7ParallelProductAuthorisationHolder

B&SHealthcare

Unit4,BradfieldRoad

Ruislip,

Middlesex

TW33JA

UnitedKingdom

8ParallelProductAuthorisationNumber

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25 th

June2009

Irish Medicines Board

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Date Printed 29/06/2009 CRN 2064917 page number: 6