AMLID

Main information

  • Trade name:
  • AMLID Tablets 10 Milligram
  • Dosage:
  • 10 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMLID Tablets 10 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0281/122/002
  • Authorization date:
  • 22-07-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Amlid10mgtablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains10mgamlodipine(asamlodipinemaleate).

Excipients:Each10mgtabletalsocontains138mglactose.

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Tablet

Thetabletsarewhite,roundandbiconvex,scoredonbothsides.

Thescorelineisonlytofacilitatebreakingforeaseofswallowingandnottodivideintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Hypertension

Chronicstableanginapectoris

Vasospastic(Prinzmetal’s)angina

4.2Posologyandmethodofadministration

Posology

Adults

Forbothhypertensionandanginatheusualinitialdoseis5mgAmlidoncedailywhichmaybeincreasedtoa

maximumdoseof10mgdependingontheindividualpatient'sresponse.

Inhypertensivepatients,Amlidhasbeenusedincombinationwithathiazidediuretic,alphablocker,betablocker,oran

angiotensinconvertingenzymeinhibitor.Forangina,Amlidmaybeusedasmonotherapyorincombinationwithother

antianginalmedicinalproductsinpatientswithanginathatisrefractorytonitratesand/ortoadequatedosesofbeta

blockers.

NodoseadjustmentofAmlidisrequireduponconcomitantadministrationofthiazidediuretics,betablockers,and

angiotensin-convertingenzymeinhibitors.

Specialpopulations

Elderly

Amlidusedatsimilardosesinelderlyoryoungerpatientsisequallywelltolerated.Normaldosageregimensare

recommendedintheelderly,butincreaseofthedosageshouldtakeplacewithcare(seesections4.4and5.2).

Hepaticimpairment

Dosagerecommendationshavenotbeenestablishedinpatientswithmildtomoderatehepaticimpairment;therefore

doseselectionshouldbecautiousandshouldstartatthelowerendofthedosingrange(seesections4.4and5.2).The

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thelowestdoseandtitratedslowlyinpatientswithseverehepaticimpairment.

Renalimpairment

Changesinamlodipineplasmaconcentrationsarenotcorrelatedwithdegreeofrenalimpairment,thereforethenormal

dosageisrecommended.Amlodipineisnotdialysable.

Paediatricpopulation

Childrenandadolescentswithhypertensionfrom6yearsto17yearsofage

Therecommendedantihypertensiveoraldoseinpaediatricpatientsages6-17yearsis2.5mgoncedailyasastarting

dose,up-titratedto5mgoncedailyifbloodpressuregoalisnotachievedafter4weeks.Dosesinexcessof5mgdaily

havenotbeenstudiedinpaediatricpatients(seesections5.1and5.2).

Dosesofamlodipine2.5mgarenotpossiblewiththismedicinalproduct.

Childrenunder6yearsold

Nodataareavailable.

Methodofadministration

Tabletfororaladministration.Thetabletsshouldbetakenwithaglassofliquid(e.g.aglassofwater)withorwithout

food.

4.3Contraindications

Amlodipineiscontraindicatedinpatientswith:

hypersensitivitytodihydropyridinederivatives,amlodipineortoanyoftheexcipients.

severehypotension

shock(includingcardiogenicshock)

obstructionoftheoutflow-tractoftheleftventricle(e.g.highgradeaorticstenosis)

haemodynamicallyunstableheartfailureafteracutemyocardialinfarction.

4.4Specialwarningsandprecautionsforuse

Thesafetyandefficacyofamlodipineinhypertensivecrisishasnotbeenestablished.

Patientswithcardiacfailure

Patientswithheartfailureshouldbetreatedwithcaution.Inalong-term,placebocontrolledstudyinpatientssuffering

withsevereheartfailure(NYHAgradeIIIandIV)thereportedincidenceofpulmonaryoedemawashigherinthe

amlodipinetreatedgroupthanintheplacebogroup,butthiswasnotassociatedwithworseningoftheheartfailure(see

section5.1).Calciumchannelblockers,includingamlodipine,shouldbeusedwithcautioninpatientswithcongestive

heartfailure,astheymayincreasetheriskoffuturecardiovasculareventsandmortality.

Useinpatientswithimpairedhepaticfunction

ThehalflifeofamlodipineisprolongedandAUCvaluesarehigherinpatientswithimpairedliverfunction;dosage

recommendationshavenotbeenestablished.Amlodipineshouldthereforebeinitiatedatthelowerendofthedosing

rangeandcautionshouldbeused,bothoninitialtreatmentandwhenincreasingthedose.Slowdosetitrationand

carefulmonitoringmayberequiredinpatientswithseverehepaticimpairment.

Useinelderlypatients

Intheelderly,increaseofthedosageshouldtakeplacewithcare(seesection4.2and5.2).

Useinrenalfailure

Amlodipinemaybeusedinsuchpatientsatnormaldoses.Changesinamlodipineplasmaconcentrationsarenot

correlatedwithdegreeofrenalimpairment.Amlodipineisnotdialyzable.

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lactasedeficiencyorglucose-galactosemalabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Effectsofothermedicinalproductsonamlodipine

CYP3A4inhibitors:ConcomitantuseofamlodipinewithstrongormoderateCYP3A4inhibitors(proteaseinhibitors,

azoleantifungals,macrolideslikeerythromycinorclarithromycin,verapamilordiltiazem)maygiverisetosignificant

increaseinamlodipineexposure.TheclinicaltranslationofthesePKvariationsmaybemorepronouncedintheelderly.

Clinicalmonitoringanddoseadjustmentmaythusberequired.

CYP3A4inducers:ThereisnodataavailableregardingtheeffectofCYP3A4inducersonamlodipine.The

concomitantuseofCYP3A4inducers(e.g.,rifampicin,hypericumperforatum)maygivealowerplasmaconcentration

ofamlodipine.AmlodipineshouldbeusedwithcautiontogetherwithCYP3A4inducers.

Administrationofamlodipinewithgrapefruitorgrapefruitjuiceisnotrecommendedasbioavailabilitymaybe

increasedinsomepatientsresultinginincreasedbloodpressureloweringeffects.

Dantrolene(infusion):Inanimals,lethalventricularfibrillationandcardiovascularcollapseareobservedinassociation

withhyperkalemiaafteradministrationofverapamilandintravenousdantrolene.Duetoriskofhyperkalemia,itis

recommendedthattheco-administrationofcalciumchannelblockerssuchasamlodipinebeavoidedinpatients

susceptibletomalignanthyperthermiaandinthemanagementofmalignanthyperthermia.

Effectsofamlodipineonothermedicinalproducts

Thebloodpressureloweringeffectsofamlodipineaddstothebloodpressure-loweringeffectsofothermedicinal

productswithantihypertensiveproperties.

Inclinicalinteractionstudies,amlodipinedidnotaffectthepharmacokineticsofatorvastatin,digoxin,warfarinor

cyclosporin.

4.6Fertility,pregnancyandlactation

Pregnancy:

Thesafetyofamlodipineinhumanpregnancyhasnotbeenestablished.

Inanimalstudies,reproductivetoxicitywasobservedathighdoses(seesection5.3).

Useinpregnancyisonlyrecommendedwhenthereisnosaferalternativeandwhenthediseaseitselfcarriesgreaterrisk

forthemotherandfoetus.

Breast-feeding

Itisnotknownwhetheramlodipineisexcretedinbreastmilk.Adecisiononwhethertocontinue/discontinuebreast-

feedingortocontinue/discontinuetherapywithamlodipineshouldbemadetakingintoaccountthebenefitofbreast-

feedingtothechildandthebenefitofamlodipinetherapytothemother.

Fertility

Reversiblebiochemicalchangesintheheadofspermatozoahavebeenreportedinsomepatientstreatedbycalcium

channelblockers.Clinicaldataareinsufficientregardingthepotentialeffectofamlodipineonfertility.Inoneratstudy,

adverseeffectswerefoundonmalefertility(seesection5.3).

4.7Effectsonabilitytodriveandusemachines

Amlodipinecanhaveminorormoderateinfluenceontheabilitytodriveandusemachines.Ifpatientstaking

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recommendedespeciallyatthestartoftreatment.

4.8Undesirableeffects

Summaryofthesafetyprofile

Themostcommonlyreportedadversereactionsduringtreatmentaresomnolence,dizziness,headache,palpitations,

flushing,abdominalpain,nausea,ankleswelling,oedemaandfatigue.

Tabulatedlistofadversereactions

Thefollowingadversereactionshavebeenobservedandreportedduringtreatmentwithamlodipinewiththefollowing

frequencies:Verycommon(1/10);common(1/100to<1/10);uncommon(1/1,000to1/100);rare(1/10,000to

1/1,000);veryrare(1/10,000).

Withineachfrequencygrouping,adversereactionsarepresentedinorderofdecreasingseriousness.

Systemorganclass Frequency Adversereactions

Bloodandlymphatic

systemdisorders Veryrare Leukocytopenia,thrombocytopenia

Immunesystemdisorders Veryrare Allergicreactions

Metabolismandnutrition

disorders Veryrare Hyperglycaemia

Psychiatricdisorders Uncommon Insomnia,moodchanges(includinganxiety),

depression

Rare Confusion

Nervoussystemdisorders Common Somnolence,dizziness,headache(especiallyat

thebeginningofthetreatment)

Uncommon Tremor,dysgeusia,syncope,hypoesthesia,

paresthesia

Veryrare Hypertonia,

peripheralneuropathy

Eyedisorders Uncommon Visualdisturbance(includingdiplopia)

Earandlabyrinth

disorders Uncommon Tinnitus

Cardiacdisorders Common Palpitations

Veryrare Myocardialinfarction,arrhythmia(including

bradycardia,ventriculartachycardiaandatrial

fibrillation)

Vasculardisorders Common Flushing

Uncommon Hypotension

Veryrare Vasculitis

Respiratory,thoracicand

mediastinaldisorders Uncommon Dyspnoea,rhinitis

Veryrare Cough

Gastrointestinaldisorders Common Abdominalpain,nausea

Uncommon Vomiting,dyspepsia,alteredbowelhabits

(includingdiarroheaandconstipation),dry

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*mostlyconsistentwithcholestasis

Exceptionalcasesofextrapyramidalsyndromehavebeenreported.

4.9Overdose

Inhumans,experiencewithintentionaloverdoseislimited.

Symptoms:

Availabledatasuggestthatgrossoverdosagecouldresultinexcessiveperipheralvasodilationandpossiblyreflex

tachycardia.Markedandprobablyprolongedsystemichypotensionuptoandincludingshockwithfataloutcomehave

beenreported.

Treatment:

Clinicallysignificanthypotensionduetoamlodipineoverdosecallsforactivecardiovascularsupportincludingfrequent

monitoringofcardiacandrespiratoryfunction,elevationofextremities,andattentiontocirculatingfluidvolumeand

urineoutput.

Avasoconstrictormaybehelpfulinrestoringvasculartoneandbloodpressure,providedthatthereisno

contraindicationtoitsuse.Intravenouscalciumgluconatemaybebeneficialinreversingtheeffectsofcalciumchannel

blockade.

Gastriclavagemaybeworthwhileinsomecases.Inhealthyvolunteerstheuseofcharcoalupto2hoursafter

administrationofamlodipine10mghasbeenshowntoreducetheabsorptionrateofamlodipine.

Veryrare Pancreatitis,gastritis,gingivalhyperplasia

Hepatobiliarydisorders Veryrare Hepatitis,jaundice,hepaticenzymesincreased*

Skinandsubcutaneous

tissuedisorders Uncommon Alopecia,purpura,skindiscolouration,

hyperhidrosis,pruritus,rash,exanthema

Veryrare Angioedema,erythemamultiforme,urticaria,

exfoliativedermatitis,Stevens-Johnson

syndrome,Quinckeoedema,photosensitivity

Musculoskeletaland

connectivetissuedisorders Common Ankleswelling

Uncommon Arthralgia,myalgia,musclecramps,backpain

Renalandurinary

disorders Uncommon Micturitiondisorder,nocturia,increasedurinary

frequency

Reproductivesystemand

breastdisorders Uncommon Impotence,gynecomastia

Generaldisordersand

administrationsite

conditions Common Oedema,fatigue

Uncommon Chestpain,asthenia,pain,malaise

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Calciumchannelblockers,selectivecalciumchannelblockerswithmainlyvascular

effects.ATCCode:C08CA01

Amlodipineisacalciumioninfluxinhibitorofthedihydropyridinegroup(slowchannelblockerorcalciumion

antagonist)andinhibitsthetransmembraneinfluxofcalciumionsintocardiacandvascularsmoothmuscle.

Themechanismoftheantihypertensiveactionofamlodipineisduetoadirectrelaxanteffectonvascularsmooth

muscle.Theprecisemechanismbywhichamlodipinerelievesanginahasnotbeenfullydeterminedbutamlodipine

reducestotalischaemicburdenbythefollowingtwoactions:

1)Amlodipinedilatesperipheralarteriolesandthus,reducesthetotalperipheralresistance(afterload)againstwhichthe

heartworks.Sincetheheartrateremainsstable,thisunloadingoftheheartreducesmyocardialenergyconsumption

andoxygenrequirements.

2)Themechanismofactionofamlodipinealsoprobablyinvolvesdilatationofthemaincoronaryarteriesandcoronary

arterioles,bothinnormalandischaemicregions.Thisdilatationincreasesmyocardialoxygendeliveryinpatientswith

coronaryarteryspasm(Prinzmetal'sorvariantangina).

Inpatientswithhypertension,oncedailydosingprovidesclinicallysignificantreductionsofbloodpressureinboththe

supineandstandingpositionsthroughoutthe24hourinterval.Duetotheslowonsetofaction,acutehypotensionisnot

afeatureofamlodipineadministration.

Inpatientswithangina,oncedailyadministrationofamlodipineincreasestotalexercisetime,timetoanginaonset,and

timeto1mmSTsegmentdepression,anddecreasesbothanginaattackfrequencyandglyceryltrinitratetablet

consumption.

Amlodipinehasnotbeenassociatedwithanyadversemetaboliceffectsorchangesinplasmalipidsandissuitablefor

useinpatientswithasthma,diabetes,andgout.

Useinpatientswithcoronaryarterydisease(CAD)

Theeffectivenessofamlodipineinpreventingclinicaleventsinpatientswithcoronaryarterydisease(CAD)hasbeen

evaluatedinanindependent,multi-center,randomized,double-blind,placebo-controlledstudyof1997patients;

ComparisonofAmlodipinevs.EnalapriltoLimitOccurrencesofThrombosis(CAMELOT).Ofthesepatients,663

weretreatedwithamlodipine5-10mg,673patientsweretreatedwithenalapril10-20mg,and655patientsweretreated

withplacebo,inadditiontostandardcareofstatins,beta-blockers,diureticsandaspirin,for2years.Thekeyefficacy

resultsarepresentedinTable1.Theresultsindicatethatamlodipinetreatmentwasassociatedwithfewer

hospitalizationsforanginaandrevascularizationproceduresinpatientswithCAD.

Table1.IncidenceofsignificantclinicaloutcomesforCAMELOT

Cardiovasculareventrates,

No.(%) Amlopidinevs.Placebo

Outcomes Amlopidine Placebo Enalapril HazardRatio

(95%CI) PValue

PrimaryEndpoint

Adverse

cardiovascular

events 110(16.6) 151(23.1) 136(20.2) 0.69(0.54-0.88) .003

IndividualComponents

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Useinpatientswithheartfailure

HaemodynamicstudiesandexercisebasedcontrolledclinicaltrialsinNYHAClassII-IVheartfailurepatientshave

shownnoclinicaldeteriorationasmeasuredbyexercisetolerance,leftventricularejectionfractionandclinical

symptomatology.

Aplacebocontrolledstudy(PRAISE)designedtoevaluatepatientsinNYHAClassIII-IVheartfailurereceiving

digoxin,diureticsandACEinhibitorshasshownnoincreaseinriskofmortalityorcombinedmortalityandmorbidity

withheartfailure.

Inafollow-up,longterm,placebocontrolledstudy(PRAISE-2)inpatientswithNYHAIIIandIVheartfailurewithout

clinicalsymptomsorobjectivefindingssuggestiveorunderlyingischaemicdisease,onstabledosesofACEinhibitors,

digitalis,anddiuretics,noeffectontotalcardiovascularmortalitywasfound.Inthissamepopulationanassociation

withincreasedreportsofpulmonaryoedemawasfound.

Treatmenttopreventheartattacktrial(ALLHAT)

Arandomizeddouble-blindmorbidity-mortalitystudycalledtheAntihypertensiveandLipid-LoweringTreatmentto

PreventHeartAttackTrial(ALLHAT)wasperformedtocomparenewerdrugtherapies:amlodipine2.5-10mg/d

(calciumchannelblocker)orlisinopril10-40mg/d(ACE-inhibitor)asfirst-linetherapiestothatofthethiazide-diuretic,

chlorthalidone12.5-25mg/dinmildtomoderatehypertension.”

Atotalof33,357hypertensivepatientsaged55orolderwererandomizedandfollowedforameanof4.9years.The

patientshadatleastoneadditionalCHDriskfactor,including:previousmyocardialinfarctionorstroke(>6months

priortoenrollment)ordocumentationofotheratheroscleroticCVD(overall51.5%),type2diabetes(36.1%),HDL-C<

35mg/dL(11.6%),leftventricularhypertrophydiagnosedbyelectrocardiogramorechocardiography(20.9%),current

cigarettesmoking(21.9%).

TheprimaryendpointwasacompositeoffatalCHDornon-fatalmyocardialinfarction.Therewasnosignificant

differenceintheprimaryendpointbetweenamlodipine-basedtherapyandchlorthalidone-basedtherapy:RR0.9895%

CI(0.90-1.07)p=0.65.Amongsecondaryendpoints,theincidenceofheartfailure(componentofacomposite

combinedcardiovascularendpoint)wassignificantlyhigherintheamlodipinegroupascomparedtothechlorthalidone

group(10.2%vs.7.7%,RR1.38,95%CI[1.25-1.52]p<0.001).However,therewasnosignificantdifferenceinall-

causemortalitybetweenamlodipine-basedtherapyandchlorthalidone-basedtherapy.RR0.9695%CI[0.89-1.02]

p=0.20.

Useinchildren(aged6yearsandolder)

Inastudyinvolving268childrenaged6-17yearswithpredominantlysecondaryhypertension,comparisonofa2.5mg

dose,and5.0mgdoseofamlodipinewithplacebo,showedthatbothdosesreducedSystolicBloodPressure

revascularization

Hospitalization

forangina 51(7.7) 84(12.8) 86(12.8) 0.58(0.41-0.82) .002

NonfatalMI 14(2.1) 19(2.9) 11(1.6) 0.73(0.37-1.46) .37

StrokeorTIA 6(0.9) 12(1.8) 8(1.2) 0.50(0.19-1.32) .15

Cardiovascular

death 5(0.8) 2(0.3) 5(0.7) 2.46(0.48-12.7) .27

Hospitalization

forCHF 3(0.5) 5(0.8) 4(0.6) 0.59(0.14-2.47) .46

Resuscitated

cardiacarrest 0 4(0.6) 1(0.1) NA .04

New-onset

peripheral

vasculardisease 5(0.8) 2(0.3) 8(1.2) 2.6(0.50-13.4) .24

Abbreviations:CHF,congestiveheartfailure;CI,confidenceinterval;MI,myocardialinfarction;

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Thelong-termeffectsofamlodipineongrowth,pubertyandgeneraldevelopmenthavenotbeenstudied.Thelong-term

efficacyofamlodipineontherapyinchildhoodtoreducecardiovascularmorbidityandmortalityinadulthoodhavealso

notbeenestablished.

5.2Pharmacokineticproperties

Absorption,distribution,plasmaproteinbinding:Afteroraladministrationoftherapeuticdoses,amlodipineiswell

absorbedwithpeakbloodlevelsbetween6-12hourspostdose.Absolutebioavailabilityhasbeenestimatedtobe

between64and80%.Thevolumeofdistributionisapproximately21l/kg.Invitrostudieshaveshownthat

approximately97.5%ofcirculatingamlodipineisboundtoplasmaproteins.

Thebioavailabilityofamlodipineisnotaffectedbyfoodintake.

Biotransformation/elimination

Theterminalplasmaeliminationhalflifeisabout35-50hoursandisconsistentwithoncedailydosing.Amlodipineis

extensivelymetabolisedbythelivertoinactivemetaboliteswith10%oftheparentcompoundand60%ofmetabolites

excretedintheurine.

Useinhepaticimpairment

Verylimitedclinicaldataareavailableregardingamlodipineadministrationinpatientswithhepaticimpairment.

Patientswithhepaticinsufficiencyhavedecreasedclearanceofamlodipineresultinginalongerhalf-lifeandan

increaseinAUCofapproximately40-60%.

Useintheelderly

Thetimetoreachpeakplasmaconcentrationsofamlodipineissimilarinelderlyandyoungersubjects.Amlodipine

clearancetendstobedecreasedwithresultingincreasesinAUCandeliminationhalf-lifeinelderlypatients.Increases

inAUCandeliminationhalf-lifeinpatientswithcongestiveheartfailurewereasexpectedforthepatientagegroup

studied.

Useinchildren

ApopulationPKstudyhasbeenconductedin74hypertensivechildrenagedfrom1to17years(with34patientsaged

6to12yearsand28patientsaged13to17years)receivingamlodipinebetween1.25and20mggiveneitheronceor

twicedaily.Inchildren6to12yearsandinadolescents

5.3Preclinicalsafetydata

Reproductivetoxicology

Reproductivestudiesinratsandmicehaveshowndelayeddateofdelivery,prolongeddurationoflabouranddecreased

pupsurvivalatdosagesapproximately50timesgreaterthanthemaximumrecommendeddosageforhumansbasedon

mg/kg.

Impairmentoffertility

Therewasnoeffectonthefertilityofratstreatedwithamlodipine(malesfor64daysandfemales14dayspriorto

mating)atdosesupto10mg/kg/day(8times*themaximumrecommendedhumandoseof10mgonamg/m2basis).

Inanotherratstudyinwhichmaleratsweretreatedwithamlodipinebesilatefor30daysatadosecomparablewiththe

humandosebasedonmg/kg,decreasedplasmafollicle-stimulatinghormoneandtestosteronewerefoundaswellas

decreasesinspermdensityandinthenumberofmaturespermatidsandSertolicells.

Carcinogenesis,mutagenesis

Ratsandmicetreatedwithamlodipineinthedietfortwoyears,atconcentrationscalculatedtoprovidedailydosage

levelsof0.5,1.25,and2.5mg/kg/dayshowednoevidenceofcarcinogenicity.Thehighestdose(formice,similarto,

andforratstwice*themaximumrecommendedclinicaldoseof10mgonamg/m2basis)wasclosetothemaximum

tolerateddoseformicebutnotforrats.

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*Basedonpatientweightof50kg

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Povidone

Microcrystallinecellulose

Crospovidone

Sodiumstearylfumarate.

6.2Incompatibilities

Notapplicable

6.3Shelflife

3years

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

6.5Natureandcontentsofcontainer

Aluminium/aluminiumblisterswith10,20,28,30,50,98,100,300tablets,50x1tablets(unitdose).

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

PinewoodLaboratoriesLimited

Ballymacarbry

Clonmel

Co.Tipperary

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA0281/122/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:22July2005

Dateoflastrenewal:22July2010

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January2012 Irish Medicines Board

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