AZITHROMYCIN PFIZER 250 Milligram Capsules Hard

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
AZITHROMYCIN DIHYDRATE
Available from:
Pfizer Limited
INN (International Name):
AZITHROMYCIN DIHYDRATE
Dosage:
250 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization number:
PA0019/093/001
Authorization date:
0000-00-00

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AzithromycinPfizer250mgCapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontainsazithromycindihydrateequivalentto250mgazithromycin.

Alsocontains151.55mglactoseanhydrous

Forafulllistofexcipients,seeSection6.1.

3PHARMACEUTICALFORM

Capsule,hard

White,hardgelatincapsulesmarked‘Pfizer’and‘ZTM250’.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Azithromycinisindicatedforthetreatmentofthefollowinginfectionswhenknownorlikelytobeduetooneormore

susceptiblemicroorganisms(seesection5.1Pharmacodynamicproperties):

bronchitis

community-acquiredpneumonia

sinusitis

pharyngitis/tonsillitis(seesection4.4Specialwarningsandprecautionsforuse,regardingstreptococcalinfections)

otitismedia

skinandsofttissueinfections

uncomplicatedgenitalinfectionsduetoChlamydiatrachomatis.

Considerationsshouldbegiventoofficialguidanceregardingtheappropriateuseofantibacterialagents.

4.2Posologyandmethodofadministration

Methodofadministration:

AzithromycinPfizershouldbegivenasasingledailydose.IncommonwithmanyotherantibioticsAzithromycin

PfizerCapsulesshouldbetakenatleast1hourbeforeor2hoursafterfood.

Childrenover45kgbodyweightandadults,includingelderlypatients:Thetotaldoseofazithromycinis1500mg

whichshouldbegivenoverthreedays(500mgoncedaily).InuncomplicatedgenitalinfectionsduetoChlamydia

trachomatis,thedoseis1000mgasasingleoraldose.

Inchildrenunder45kgbodyweight:AzithromycinPfizerCapsulesarenotsuitableforchildrenunder45kg.

Renalfailure:

Nodoseadjustmentisnecessaryinpatientswithmildtomoderaterenalimpairment(GFR10-80ml/min).

Cautionshouldbeexercisedwhenazithromycinisadministeredtopatientswithsevererenalimpairment(GFR<10

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Hepaticfailure:

Sinceazithromycinismetabolisedintheliverandexcretedinthebile,thedrugshouldnotbegiventopatients

sufferingfromsevereliverdisease.Nostudieshavebeenconductedregardingtreatmentofsuchpatientswith

azithromycin(seeSection4.4Specialwarningsandprecautionsforuse).

AzithromycinPfizerCapsulesarefororaladministrationonly.

4.3Contraindications

AzithromycinPfizeriscontra-indicatedinpatientswithhypersensitivitytoazithromycinoranyofthemacrolideor

ketolideantibiotics,erythromycin,ortoanyexcipientsthereofas(forexample)listedinSection6.1(Listof

Excipients).

AzithromycinPfizeriscontra-indicatedinpatientswithseriousimpairmentofhepaticfunction.

Becauseofthetheoreticalpossibilityofergotism,AzithromycinPfizerandergotderivativesshouldnotbeco-

administered.

4.4Specialwarningsandprecautionsforuse

Aswitherythromycinandothermacrolides,rareseriousallergicreactions,includingangioneuroticoedemaand

anaphylaxis(rarelyfatal),havebeenreported.SomeofthesereactionswithAzithromycinPfizerhaveresultedin

recurrentsymptomsandrequiredalongerperiodofobservationandtreatment.

ProlongedcardiacrepolarisationandQTinterval,impartingariskofdevelopingcardiacarrhythmiaandtorsadesde

pointes,havebeenseenintreatmentwithothermacrolides.Asimilareffectwithazithromycincannotbecompletelyruled

outinpatientsatincreasedriskforprolongedcardiacrepolarisation(seesection4.8UndesirableEffects).

Aswithanyantibioticpreparation,observationforsignsofsuperinfectionwithnon-susceptibleorganismsincluding

fungiisrecommended.

Clostridiumdifficileassociateddiarrhea(CDAD)hasbeenreportedwithuseofnearlyallantibacterialagents,including

azithromycin,andmayrangeinseverityfrommilddiarrheatofatalcolitis.Treatmentwithantibacterialagentsalters

thenormalfloraofthecolonleadingtoovergrowthofCdifficile.

C.difficileproducestoxinsAandBwhichcontributetothedevelopmentofCDAD.Hypertoxinproducingstrainsof

C.difficilecauseincreadedmorbidityandmortality,astheseinfectionscanberefractorytoantimicrobialtherapyand

mayrequiercolectomy.CDADmustbeconsideredinallpatientswhopresentwithdiarrheafollowingantibioticuse.

CarefulmedicalhistoryisnesessarysinceCDADhasbeenreportedtooccurovertwomonthsaftertheadministration

ofantibacterialagents.

Streptococcalinfections:Penicillinisusuallythefirstchoicefortreatmentofpharyngitis/tonsillitisdueto

Streptococcuspyogenesandalsoforprophylaxisofacuterheumaticfever.Azithromycinisingeneraleffectiveagainst

streptococcusintheoropharynx,butnodataareavailablethatdemonstratetheefficacyofazithromycininpreventing

acuterheumaticfever.

Useinrenalimpairment:Inpatientswithsevererenalimpairment(GFR<10ml/min)a33%increaseinsystemic

exposuretoazithromycinwasobserved(seesection5.2PharmacokineticProperties) .

Useinhepaticimpairment:Inpatientswithmildormoderatehepaticimpairment,thereisnoevidenceofmarked

changeinserumpharmacokineticsofazithromycincomparedtothosewithnormalhepaticfunction.Inthesepatients

urinaryrecoveryofazithromycinappearstoincrease,perhapstocompensateforreducedhepaticclearance.

Hencenodoseadjustmentisrecommendedforpatientswithmildtomoderatehepaticimpairment.Nonetheless,since

theliveristheprincipalrouteofeliminationforazithromycin,theuseofAzithromycinPfizershouldbeundertaken

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Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

AzithromycinPfizercapsulesarefororaladministrationonly.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Antacids:Whenstudyingtheeffectofsimultaneouslyadministeredantacidonthepharmacokineticsofazithromycin,

nooverallchangehasbeenobservedinthebioavailability,althoughthepeakconcentrationsofazithromycinmeasured

intheplasmafellby25%.InpatientsreceivingAzithromycinPfizerandantacids,AzithromycinPfizershouldbe

takenatleast1hourbeforeor2hoursaftertheantacid.

Carbamazepine:Inapharmacokineticinteractionstudyinhealthyvolunteers,nosignificanteffectwasobservedon

theplasmalevelsofcarbamazepineoritsactivemetabolite.

Cimetidine:Asingledoseofcimetidineadministered2hoursbeforeAzithromycinPfizerhadnoeffectonthe

pharmacokineticsofazithromycin.

Ciclosporin:Inapharmacokineticstudywithhealthyvolunteersthatwereadministereda500mg/dayoraldoseof

azithromycinfor3daysandwerethenadministeredasingle10mg/kgoraldoseofciclosporin,theresulting

ciclosporinC

andAUC

werefoundtobesignificantlyelevated(by24%and21%respectively),howeverno

significantchangeswereseeninAUC

.Consequently,cautionshouldbeexercisedbeforeconsideringco-

administrationofthesetwodrugs.Ifcoadministrationisnecessary,ciclosporinlevelsshouldbemonitoredandthe

doseadjustedaccordingly.

Digoxin:Someofthemacrolideantibioticshavebeenreportedtoimpairthemetabolismofdigoxin(inthegut)in

somepatients.Therefore,inpatientsreceivingconcomitantAzithromycinPfizeranddigoxinthepossibilityofraised

digoxinlevelsshouldbeborneinmind,anddigoxinlevelsmonitored.

Ergotderivatives:Becauseofthetheoreticalpossibilityofergotism,AzithromycinPfizerandergotderivatives

shouldnotbecoadministered.

Methylprednisolone:Inapharmacokineticinteractionstudyinhealthyvolunteers,AzithromycinPfizerhadno

significanteffectonthepharmacokineticsofmethylprednisolone.

Nelfinavir:Coadministrationofazithromycin(1200mg)andnelfinaviratsteadystate(750mgthreetimesdaily)

resultedinincreasedazithromycinconcentrations.Noclinicallysignificantadverseeffectswereobservedandnodose

adjustmentisrequired.

Terfenadine:BecauseoftheoccurrenceofseriousdysrhythmiassecondarytoprolongationoftheQTcintervalin

patientsreceivingotheranti-infectivesinconjunctionwithterfenadine,pharmacokineticinteractionstudieshavebeen

performed.Thesestudieshavereportednoevidenceofaninteractionbetweenazithromycinandterfenadine.There

havebeenrarecasesreportedwherethepossibilityofsuchaninteractioncouldnotbeentirelyexcluded;howeverthere

wasnospecificevidencethatsuchaninteractionhadoccurred.

Aswithothermacrolides,AzithromycinPfizershouldbeadministeredwithcautionincombinationwithterfenadine.

Theophylline:TheophyllinelevelsmaybeincreasedinpatientstakingAzithromycinPfizer.

Coumarin-typeoralanticoagulants:Inapharmacodynamicinteractionstudy,AzithromycinPfizerdidnotalterthe

anticoagulanteffectofasingle15mgdoseofwarfarinadministeredtohealthyvolunteers.

Therehavebeenreportsreceivedinthepost-marketingperiodofpotentiatedanticoagulationsubsequenttoco-

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Althoughacausalrelationshiphasnotbeenestablished,considerationshouldbegiventothefrequencyofmonitoring

prothrombintimewhenazithromycinisusedinpatientsreceivingcoumarin-typeoralanticoagulants.

Zidovudine:Single1000mgdosesandmultiple1200mgor600mgdosesofazithromycindidnotaffecttheplasma

pharmacokineticsorurinaryexcretionofzidovudineoritsglucuronidemetabolite.However,administrationof

azithromycinincreasedtheconcentrationsofphosphorylatedzidovudine,theclinicallyactivemetabolite,inperipheral

bloodmononuclearcells.Theclinicalsignificanceofthisfindingisunclear,butitmaybeofbenefittopatients.

Didanosine:Co-administrationofdailydosesof1200mgazithromycinwith400mgdidanosinein6HIV-positive

subjectsdidnotappeartoaffectthesteady-statepharmacokineticsofdidanosineascomparedwithplacebo.

Rifabutin:Co-administrationofazithromycinandrifabutindidnotaffecttheserumconcentrationsofeitherdrug.

Neutropeniawasobservedinsubjectsreceivingconcomitanttreatmentofazithromycinandrifabutin.Although

neutropeniahasbeenassociatedwiththeuseofrifabutin,acausalrelationshiptocombinationwithazithromycinhas

notbeenestablished(seesection4.8.Undesirableeffects).

Fluconazole:Coadministrationofasingledoseof1200mgazithromycindidnotalterthepharmacokineticsofasingle

doseof800mgfluconazole.Totalexposureandhalf-lifeofazithromycinwereunchangedbythecoadministrationof

fluconazole,however,aclinicallyinsignificantdecreaseinC

(18%)ofazithromycinwasobserved.

Indinavir:Coadministrationofasingledoseof1200mgazithromycinhadnostatisticallysignificanteffectonthe

pharmacokineticsofindinaviradministeredas800mgthreetimesdailyfor5days.

Trimethoprim/sulfamethoxazole:Coadministrationoftrimethoprim/sulfamethoxazole(160mg/800mg)for7days

withazithromycin1200mgonDay7hadnosignificanteffectonpeakconcentrations,totalexposureorurinary

excretionofeithertrimethoprimorsulfamethoxazole.Azithromycinserumconcentrationsweresimilartothoseseenin

otherstudies.

4.6Fertility,pregnancyandlactation

Useinpregnancy:Animalreproductionstudieshavebeenperformedatdosesuptomoderatematernallytoxicdose

concentrations.Inthesestudies,noevidenceofharmtothefoetusduetoazithromycinwasfound.Thereareno

adequateandwellcontrolledstudiesinpregnantwomen.

Sinceanimalstudiesarenotnecessarilypredictiveofhumanresponse,azithromycinshouldbeusedduringpregnancy

onlyifclearlyneeded.

Useinlactation:Nodataonsecretionofazithromycininbreastmilkareavailable.Asmanydrugsareexcretedin

humanmilk,AzithromycinPfizershouldnotbeusedinthetreatmentoflactatingwomenunlessthephysicianfeelsthat

thepotentialbenefitsjustifythepotentialriskstotheinfant,andwhereadequatealternativesarenotavailable.

4.7Effectsonabilitytodriveandusemachines

ThereisnoevidencetosuggestthatAzithromycinPfizermayhaveaneffectonapatient’sabilitytodriveoroperate

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4.8Undesirableeffects

AzithromycinPfizeriswelltoleratedwithalowincidenceofside-effects.

Bloodandlymphaticsystemdisorders

Rare(>1/10000,<1/1000)

Thrombocytopenia.Inclinicaltrialstherehavebeenoccasionalreportsofperiodsoftransient,mildneutropenia.

However,acausalrelationshipwithazithromycintreatmenthasnotbeenconfirmed.

Psychiatricdisorders

Rare(>1/10000,<1/1000)

Agressiveness,agitation,anxietyandnervousness.

Nervoussystemdisorders

Uncommon(>1/1000,<1/100)

Dizziness/vertigo,somnolence,headache,convulsions(whichhavealsobeenfoundtobecausedbyothermacrolides),

syncope

Rare(>1/10000,<1/1000)

Paraesthesia,astheniaandhypoesthesia

Insomniaandhyperactivity.

Therehavebeenrarereportsoftaste/smellperversionandtaste/smelllossduringpostmarketingsurveillance;acausal

relationshiptoazithromycinhasnotbeenestablished.

Earandlabyrinthdisorders

Rare(>1/10000,<1/1000)

Macrolideantibioticshavebeenreportedtohavecausedhearingdamage.Insomepatientsreceivingazithromycin

impairedhearing,deafnessandringingintheearshavebeenreported.Manyofthesecasesrelatetoexperimental

studiesinwhichazithromycinwasusedatlargedosesoverprolongedperiods.Accordingtoavailablefollow-up

reports,themajorityoftheseproblemshoweverwerereversible.Vertigohasbeenobservedduringpostmarketing

surveillance.

Cardiacdisorders

Rare(>1/10000,<1/1000)

Palpitationsandarrythmiasincludingventriculartachycardia(asseenwithmacrolides)havebeenreported.Therehave

beenrarereportsofQTprolongationandtorsadesdepointes(seeSection4.4Specialwarningsandprecautionsfor

use).

Vasculardisorders

Rare(>1/10000,<1/1000)

Hypotension.

Gastrointestinaldisorders

Common(>1/100,<1/10)

Nausea,vomiting,diarrhoea,abdominaldiscomfort(pain/cramps).

Uncommon(>1/1000,<1/100)

Loosestools,flatulence,digestivedisorders,anorexia,dyspepsia.

Rare(>1/10000,<1/1000)

Constipation,discolourationofthetongue,pancreatitis.

Pseudomembranouscolitishasbeenreported.

Hepatobiliarydisorders

Rare(>1/10000,<1/1000)

Hepatitisandcholestaticjaundicehavebeenreported,includingabnormalliverfunctiontestvalues,aswellasrare

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Skinandsubcutaneoustissuedisorders

Uncommon(>1/1000,<1/100)

Allergicreactionsincludingpruritusandrash.

Rare(>1/10000,<1/1000)

Allergicreactionsincludingangioneuroticoedema,urticariaandphotosensitivity;seriousskinreactionssuchas

erythemamultiforme,StevensJohnsonsyndromeandtoxicepidermalnecrolysis.

Musculoskeletal,connectivetissueandbonedisorders

Uncommon(>1/1000,<1/100)

Arthralgia.

Renalandurinarydisorders

Rare(>1/10000,<1/1000)

Interstitialnephritisandacuterenalfailure.

Reproductivesystemandbreastdisorders

Uncommon(>1/1000,<1/100)

Vaginitis.

Generaldisorders

Rare(>1/10000,<1/1000)

Anaphylaxisincludingoedema(leadsinrarecasestodeath,seesection4.4Specialwarningsandprecautionsforuse),

candidiasis,fatigue,malaise.

4.9Overdose

Adverseeventsexperiencedinhigherthanrecommendeddosesweresimilartothoseseenatnormaldoses.Inthe

eventofoverdosage,generalsymptomaticandsupportivemeasuresareindicatedasrequired.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Generalproperties

Antibacterialsforsystemicuse.ATCcode:J01FA10

Modeofaction:

Zithromaxisamacrolideantibioticbelongingtotheazalidegroup.Themoleculeisconstructedbyaddinganitrogen

atomtothelactoneringoferythromycinA.Thechemicalnameofazithromycinis9-deoxy-9a-aza-9a-methyl-9a-

homoerythromycinA.Themolecularweightis749.0.Themechanismofactionofazithromycinisbaseduponthe

suppressionofbacterialproteinsynthesisbymeansofbindingtotheribosomal50ssub-unitandinhibitionofpeptide

translocation.

Mechanismofresistance:

Resistancetoazithromycinmaybeinherentoracquired.Therearethreemainmechanismsofresistanceinbacteria:

targetsitealteration,alterationinantibiotictransportandmodificationoftheantibiotic.

CompletecrossresistanceexistsamongStreptococcuspneumoniae,betahaemolyticstreptococcusofgroupA,

EnterococcusfaecalisandStaphylococcusaureus,includingmethicillinresistantS.aureus(MRSA)toerythromycin,

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Breakpoints

Azithromycinsusceptibilitybreakpointsfortypicalbacterialpathogensare:

NCCLS:

Susceptible 2mg/l;resistant 8mg/l

Haemophilusspp.:susceptible 4mg/l

StreptococcuspneumoniaeandStreptococcuspyogenes:

Susceptible 0.5mg/l;resistant 2mg/l

Susceptibility

Theprevalenceofacquiredresistancemayvarygeographicallyandwithtimeforselectedspeciesandlocalinformation

onresistanceisdesirable,particularlywhentreatingsevereinfections.Asnecessary,expertadviceshouldbesought

whenthelocalprevalenceofresistanceissuchthattheutilityoftheagentinatleastsometypesofinfectionsis

questionable.

Table:AntibacterialspectrumofAzithromycin

Commonlysusceptiblespecies

AerobicGram-positivemicroorganisms

Staphylococcusaureus

Methycillin-susceptible

Streptococcuspneumoniae

Penicillin-susceptible

Streptococcuspyogenes(GroupA)

AerobicGram-negativemicroorganisms

Haemophilusinfluenzae

Haemophilusparainfluenzae

Legionellapneumophila

Moraxellacatarrhalis

Pasteurellamultocida

Anaerobicmicroorganisms

Clostridiumperfringens

Fusobacteriumspp.

Prevotellaspp.

Porphyromonasspp.

Othermicroorganisms

Chlamydiatrachomatis

Speciesforwhichacquiredresistancemaybeaproblem

AerobicGram-positivemicroorganisms

Streptococcuspneumoniae

Penicillin-intermediate

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*Methycillin-resistantstaphylococcihaveaveryhighprevalenceofacquiredresistancetomacrolidesandhavebeen

placedherebecausetheyarerarelysusceptibletoazithromycin.

5.2Pharmacokineticproperties

Absorption

Bioavailabilityafteroraladministrationisapproximately37%.Peakplasmaconcentrationsareattained2-3hoursafter

takingthemedicinalproduct.

Distribution

Orallyadministeredazithromyciniswidelydistributedthroughoutthebody.Inpharmacokineticstudiesithasbeen

demonstratedthattheconcentrationsofazithromycinmeasuredintissuesarenoticeablyhigher(asmuchas50times)

thanthosemeasuredinplasma,whichindicatesthattheagentstronglybindstotissues.

Bindingtoserumproteinsvariesaccordingtoplasmaconcentrationandrangesfrom12%at0.5microgram/mlupto

52%at0.05microgramazithromycin/mlserum.Themeanvolumeofdistributionatsteadystate(VVss)hasbeen

calculatedtobe31.1l/kg.

Elimination

Theterminalplasmaeliminationhalf-lifecloselyreflectstheeliminationhalf-lifefromtissuesof2-4days.

Approximately12%ofanintravenouslyadministereddoseofazithromycinisexcretedunchangedinurinewithinthe

followingthreedays.Particularlyhighconcentrationsofunchangedazithromycinhavebeenfoundinhumanbile.

Alsoinbile,tenmetabolitesweredetected,whichwereformedthroughN-andO-demethylation,hydroxylationof

desosamineandaglyconeringsandcleavageofcladinoseconjugate.Comparisonoftheresultsofliquid

chromatographyandmicrobiologicalanalyseshasshownthatthemetabolitesofazithromycinarenotmicrobiologically

active.

Inanimaltests,highconcentrationsofazithromycinhavebeenfoundinphagocytes.Ithasalsobeenestablishedthat

duringactivephagocytosishigherconcentrationsofazithromycinarereleasedfrominactivephagocytes.Inanimal

modelsthisresultsinhighconcentrationsofazithromycinbeingdeliveredtothesiteofinfection.

5.3Preclinicalsafetydata

Phospholipidosis(intracellularphospholipidaccumulation)hasbeenobservedinseveraltissues(e.g.eye,dorsalroot

ganglia,liver,gallbladder,kidney,spleen,and/orpancreas)ofmice,rats,anddogsgivenmultipledosesof

azithromycin.Phospholipidosishasbeenobservedtoasimilarextentinthetissuesofneonatalratsanddogs.Theeffect

hasbeenshowntobereversibleaftercessationofazithromycintreatment.Thesignificanceofthefindingforanimals

andforhumansisunknown.

Carcinogenicpotential:

Long-termstudiesinanimalshavenotbeenperformedtoevaluatecarcinogenicpotentialasthedrugisindicatedfor

short-termtreatmentonlyandtherewerenosignsindicativeofcarcinogenicactivity.

Mutagenicpotential:

Inherentlyresistantorganisms

AerobicGram-positivemicroorganisms

Enterococcusfaecalis

StaphylococciMRSA,MRSE*

Anaerobicmicroorganisms

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Reproductivetoxicity:

Inanimalstudiesforembryotoxiceffectsofthesubstance,noteratogeniceffectwasobservedinmiceandrats.Inrats,

azithromycindosesof100and200mg/kgbodyweight/dayledtomildretardationoffoetalossificationandinmaternal

weightgain.Inperi-andpostnatalstudiesinrats,mildretardationfollowingtreatmentwith50mg/kg/day

azithromycinandabovewasobserved.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Capsulecontents:

Lactoseanhydrous

Maizestarch

Magnesiumstearate

Sodiumlaurilsulfate

Capsuleshell:

Gelatin

Titaniumdioxide(E171)

Printingink:

Blackironoxide(E172)

Shellac

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Aluminium/PVCblisterstripsincartons:5years

PEcontainerwithchild-resistantclosure:4years

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

AzithromycinPfizerCapsulesareavailableas:

PVC/Aluminiumopaqueblisterstrips–2,4,or6capsulesperpack.

PEcontainerwithchild-resistantclosure–100capsulespercontainer.

Notallpack-sizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

PfizerLimited

RamsgateRoad

Sandwich

KentCT139NJ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA19/93/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19thJuly2013

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