AGELAN 2.5 Milligram Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
INDAPAMIDE HEMIHYDRATE
Available from:
Mercury Pharmaceuticals (Ireland) Ltd
INN (International Name):
INDAPAMIDE HEMIHYDRATE
Dosage:
2.5 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization number:
PA0073/102/001
Authorization date:
2009-12-21

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AgelanTablets2.5mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontainsindapamidehemihydrate2.5mg.

Forafulllistofexcipients,see6.1.

3PHARMACEUTICALFORM

Sugar-coatedtablets.

Pink,circular,sugarcoatedtablets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofessentialhypertension.

4.2Posologyandmethodofadministration

Agelantabletsarefororaladministration,only.

Adults:2.5mg(1tablet)dailytakeninthemorning.Thisdoseshouldnotbeexceededasthereisnoadditional

antihypertensiveeffect.Ifbloodpressureisnotcontrolled,thenanantihypertensiveagentofanotherclassshouldbe

used.

Elderly:Indapamidemayhaveamoreprolongedeliminationtime.Sincetheelderlyaremoresusceptibletoelectrolyte

imbalanceandfluidlossitisadvisabletomonitorthesepatientsfrequentlyforevidenceofsucheffects.

4.3Contraindications

Useinpatientswithsevereimpairmentofhepaticfunction,orseveredegreesofrenalinsufficiency.

Useinpatientswithhypokalaemia.

Useinpatientshypersensitivetotheactiveingredient.

4.4Specialwarningsandprecautionsforuse

Patientswhoarebeingtreatedwiththispreparationrequireregularsupervisionwithmonitoringoffluidandelectrolyte

statetoavoidinadequatepotassiumsupplementationorexcessivelossoffluid.

Thepreparationshouldonlybeusedwithparticularcautioninelderlypatientsorthosewithpotentialobstructionofthe

urinarytract,orwithdisordersrenderingtheirelectrolytebalanceprecarious.

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adjustmentofcontrolofhypoglycaemicagentsincasesofdiabetesmellitus.

Aswithallantihypertensiveagents,acautiousdosagescheduleisindicatedinpatientswithseverecoronaryorcerebral

arteriosclerosisorrecentcerebrovascularaccident.

Inpatientswithhyperlipidaemia,serumlipidsshouldbemonitoredregularly.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Whenusedincombinationwithotherantihypertensivedrugs,thedosageoftheselattermayrequirereduction.

Agelanmaypotentiatetheactionofdiuretics,andwhenusedincombinationwiththesedrugs,theremaybeaneedfor

potassiumsupplementation.

Concurrentusewithlithiumtherapymayincreasetoxicityofthelatterduetoincreasedbloodlevelsandaparadoxical

anti-diureticeffect.

Diureticinducedhypokalaemiamaybeaggravatedbycorticosteroids,ACTH,carbenoxolone,amphotericinB.

Diureticandanti-hypertensiveeffectswillbediminishedbyconcurrentuseofnon-steroidalanti-inflammatorydrugs.

Deteriorationinrenalfunctionmayalsooccur.

Diureticspotentiatetheactionofcurarederivativesandantihypertensivedrugs(e.g.guanethidine,methyldopa,beta-

blockers,vasodilators,calciumantagonistsandACEinhibitors).

4.6Pregnancyandlactation

Agelanshouldnotberecommendedforuseduringthefirsttrimesterofpregnancyorduringlactationunlessthe

physicianconsidersitnecessary.Teratogenicstudiesinanimalshaveshownnoadverseeffectsbutexperienceofuse

inpregnantpatientsislimited.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Sideeffectsincludemusclecramps,fatigue,allergicreactions,especiallyskinlesionsandsyncope.Hypokalaemiamay

occur,lessfrequentlyhyperuricaemia.

4.9Overdose

Possiblesignsofoverdosageincludeelectrolyteimbalance,hypotension,gastrointestinaldisturbanceandmuscular

weakness.Thereisnospecificantidotetoindapamideandtreatmentofoverdosageissymptomaticandsupportive.

Thestomachmaybeemptiedbyemesisorbygastricaspirationandlavage.Particularattentionshouldbepaidto

correctinganyelectrolyteabnormalities.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Agelantabletscontainindapamide,anon-thiazideindolederivativeofchlorosulphonamide.Attherapeuticdoses,

indapamideinducessomemilddiureticeffect.Indapamidehasbeenshowntodecreasevascularsmoothmuscle

reactivityandperipheralresistance.Indosesof2.5mgdaily,indapamaidehasbeenshowntoexertanantihypertensive

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antihypertensiveeffect.

5.2Pharmacokineticproperties

Indapamideisrapidlyandcompletelyabsorbedfromthegastro-intestinaltract.Itispreferentiallyandreversiblytaken

upbycirculatingerythrocytesandabout71to79%ofthedrugisboundtoplasmaproteins.Indapamidehasaterminal

half-lifeofabout14hours.Itisextensivelymetabolised.About70%ofanoraldoseisexcretedviathekidneysand

about23%bythegastrointestinaltract.

5.3Preclinicalsafetydata

NofurtherrelevantinformationotherthanthatwhichisincludedintheothersectionsoftheSummaryofProduct

Characteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

LactoseMonohydrate

CalciumHydrogenPhosphateDihydrate

MaizeStarch

MagnesiumStearate

CroscarmelloseSodium

Talc

Shellac

CastorOil

TitaniumDioxide(E171)

Sucrose

Methylparahydroxybenzoate

Propylparahydroxybenzoate

Acacia

OpaluxAS-F-1312andmacrogol6000

OpaluxconsistsofsucroseBP,purifiedwater,sodiumbenzoate,polyvinylpyrrolidone,talc,titaniumdioxide,ponceau

4Raluminiumlake(E124),erythrosinealuminiumlake(E127).

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

Storeinadryplace.

Storeintheoriginalpackageinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

BlisterpackswhichconsistofstripsmadefromhardPVCwithafoillid.

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

None.

7MARKETINGAUTHORISATIONHOLDER

AntigenPharmaceuticalsLimited

Roscrea,Co.Tipperary

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA0073/102/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25February1988

Dateoflastrenewal: 25February2008

10DATEOFREVISIONOFTHETEXT

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Date Printed 12/04/2010 CRN 2080835 page number: 4

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