AZROMAX

Main information

  • Trade name:
  • AZROMAX Coated Tablets 500 Milligram
  • Dosage:
  • 500 Milligram
  • Pharmaceutical form:
  • Coated Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AZROMAX Coated Tablets 500 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0577/066/002
  • Authorization date:
  • 13-05-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Azromax 500mgFilm-Coated Tablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each film-coatedtabletcontains500 mg azithromycin (as527.36 mgazithromycin monohydrate).

Forexcipientsseesection 6.1.

3PHARMACEUTICALFORM

Film-coatedtablet

Azromax 500mgFilm-Coated Tabletsarewhite, capsuleshaped tabletswith‘AZ’‘500’on oneside, and‘G’on the

reverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Azithromycin isindicated in thefollowing infectionscaused by microorganismsthataresensitiveto azithromycin:

Lowerrespiratory tractinfections, such asbronchitisand mildto moderately

severecommunity acquired pneumonia

Upperrespiratory tractinfections, such assinusitisand pharyngitis/tonsillitis(seesection 4.4)

Acuteotitismedia

Skin and softtissueinfections

UncomplicatedChlamydiatrachomatisurethritisand cervicitis.

When giving antibiotictreatmentconsideration mustbetaken ofbacterialresistanceand oftheofficial/localregulations

relating to theappropriateuseofantimicrobialtherapy.

4.2Posologyandmethodofadminstration

Azithromycin tabletsshould begiven asasingledaily dose. Thetabletscan betaken with orwithoutfood. The

duration oftreatmentin each oftheinfectiousdiseasesisgiven below.

Children and adolescentsover45 kg bodyweight, adultsand theelderly:

Thetotaldosageofazithromycin is1500 mg which isspread overthreedays(500 mg oncedaily). Alternatively, the

dosagecan bespread overfivedays(500 mg asasingledoseon thefirstday and thereafter250 mg oncedaily).

In uncomplicatedChlamydiatrachomatisurethritisand cervicitisthedosageis1000mg asasingleoraldose.

Children and adolescentsunder45 kg bodyweight:

Tabletsarenotindicated forthesepatients. Otherpharmaceuticalformsofazithromycin, e.g. suspensionsmay beused.

Elderly:

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Patientswith Renalimpairment:

No doseadjustmentisnecessary in patientswith mild to moderaterenalfailure(creatinineclearance40 ml/min)(see

section 4.4, Specialwarningsand specialprecautionsforuse)

Patientswith hepaticimpairment:

Adoseadjustmentisnotnecessary forpatientswith mild to moderately impaired liverfunction (seesection 4.4 Special

warningsand specialprecautionsforuse).

4.3Contraindications

Theuseofazithromycin iscontraindicated in patientswith hypersensitivity to azithromycin, to oneoftherelated

macrolideantibioticsorto any oftheexcipients.

4.4Special warningsandspecialprecautionsforuse

Allergicreactions:In rarecasesazithromycin isreported to havecaused seriousallergic(rarely fatal)reactionssuch as

angioneuroticoedemaand anaphylaxis. Someofthesereactionshavecaused recurrentsymptomsand haverequired

longerobservation and treatment.

Renalfailure:No studieshavebeen conducted on patientswith acreatinineclearanceof<40 ml/min, and consequently

caution mustbeexercisedin theuseofazithromycin forthesepatients.

Hepaticfailure:Sinceazithromycin ismetabolised in theliverand excreted in thebile, themedicinalproductshould

notbegiven to patientssuffering fromsevereliverdisease. No studieshavebeen conducted regarding thetreatmentof

such patientswith Azromax 500 mg film-coatedtablets.

When severeliverimpairmentoccurs, thetreatmentwith azithromycin should beceased.

Ergotalkaloidsand Azromax 500 mg film-coatedtablets:Theconcurrentuseofergotalkaloidsand macrolide

antibioticshasbeen found to acceleratethedevelopmentofergotism.Theinteractionsbetween ergotalkaloidsand

azithromycin havenotbeen studied. Thedevelopmentofergotismishoweverpossible, so thatAzithromycin and ergot

alkaloid derivativesshould notbeadministered simultaneously.

QTprolongation

Prolonged cardiacrepolarisation and QTintervalhavebeen seen in treatmentwith othermacrolides. Asimilareffect

with azithromycin cannotbecompletely ruled outin patientsatincreased risk ofcardiaceffects. Therefore:

Azromax 500 mgfilm-coatedtabletsshould notbeused in patientswith congenitalordocumented acquired QT

prolongation.

Azromax 500 mgfilm-coatedtabletsshould notbeused concurrently with otheractivesubstancesthatprolong

QTintervalsuch asantiarrhythmicsofclassesIAand III, cisaprideand terfenadine.

Azromax 500 mgfilm-coatedtabletsshould notbeused in patientswith electrolytedisturbance, particularly in

casesofhypokalaemiaand hypomagnesemia

Azromax 500 mgfilm-coatedtabletsshould notbeused in patientswith clinically relevantbradycardia, cardiac

arrhythmiaorseverecardiacinsufficiency

Pharyngitis/tonsillitis:Azithromycin isnotthesubstanceoffirstchoiceforthetreatmentofpharyngitisand tonsillitis

caused byStreptococcuspyogenes. Forthisand fortheprophylaxisofacuterheumaticfeverpenicillin isthetreatment

offirstchoice.

Azithromycin isnotindicated forthetreatmentofinfected burn wounds.

In caseofsexually transmitted diseasesaconcomitantinfection byT. palladiumshould beexcluded.

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agentssuch asfungi. Asuperinfection may requirean interruption oftheazithromycin treatmentand initiation of

adequatemeasures.

Neurologicalorpsychiatricdiseases:Azithromycin should beadministered with caution to patientssuffering from

neurologicalorpsychiatricdiseases.

Pseudomembranouscolitis:Aftertheuseofmacrolideantibioticspseudomembranouscolitishasbeen reported. This

diagnosisshould thereforebeconsidered forpatientswho sufferfromdiarrhoeaafterstartofthetreatmentwith

azithromycin. Should pseudomembranouscolitisbeinduced byazithromycin, thenanti-peristalticsshould be

contraindicated.

Long termuse:Thereisno experienceregarding thesafety and efficacy oflong termuseofazithromycin forthe

mentioned indications. In caseofrapid recurrentinfections, treatmentwith anotherantibioticshould beconsidered.

Azithromycin tabletsarenotsuitablefortreatmentofsevereinfectionswhereahigh concentration oftheantibioticin

theblood israpidly needed.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Antacids:When studying theeffectofsimultaneously administered antacid on thepharmacokineticsofazithromycin,

no overallchangehasbeen observed in thebioavailability, although thepeak concentrationsofazithromycin measured

in theplasmadid fallby 30 %. Antacidsand azithromycin should notbeadministered simultaneously.

Ergotamine:Thecombined useofergotamineand Azithromycin may in theory causeergotism, and consequently their

combined useisnotrecommended (seealso section 4.4).

Coumarin-likeoralanticoagulants:An increased tendency towardshaemorrhaging hasbeen reported in connection

with theconcurrentuseofazithromycin and warfarin orcoumarin-likeoralanticoagulants. Attention shouldbepaid to

thefrequency ofprothrombin timemonitoring.

Digoxin:In somepatientscertain macrolideantibioticshavebeen reportedto haveimpaired themetabolismofdigoxin

in theintestine.Consequently, inthecaseofpatientsreceiving Azithromycin and digoxin, thepossibility ofarisein the

digoxin concentrationsshould bebornein mind.

Zidovudine:1000 mg singledosesand 1200 mg or600 mg multipledosesofazithromycin had only aslighteffectupon

thepharmacokineticsofzidovudineoritsglucuronidemetabolitein theplasmaorupon excretion in theurine.

However, theadministration ofazithromycin increased theconcentrationsofphosphorylated zidovudine, theclinically

activemetabolite, in mononuclearcellsin theperipheralcirculation. Theclinicalsignificanceofthisfinding isunclear,

butitmay beofbenefitto patients.

Didanosine:Daily dosagesof1200 mg azithromycin co-administered with didanosinein 6 volunteersappeared to have

no effecton thepharmacokineticsofdidanosinecompared to placebo.

Rifabutin:Theconcurrentadministration ofazithromycin and rifabutin may affecttheserumlevelsofboth active

substances. Neutropeniawasobserved in patientswho werebeing treated concurrently withazithromycin and rifabutin.

Theophylline:Azithromycin hasnotaffected thepharmacokineticsoftheophyllinewhen healthy volunteersreceived

Azithromycin andtheophyllinesimultaneously.Theophyllinelevelsmay beincreased in patientstakingazithromycin.

Even though azithromycin doesnotappearto inhibittheenzymeCYP3A4, caution isadvised when combining the

medicinalproductwith quinidine, cyclosporine, cisapride, astemizole, terfenadine, ergotalkaloids, pimozideorother

medicinalproductswith anarrowtherapeuticindex predominantly metabolised by CYP3A4.

Cyclosporin:Sincepharmacokineticand clinicalstudieson thepossiblecombined effectsofazithromycin and

cyclosporin havenotbeen carried out, thetherapeuticsituation should becarefully considered beforetheseactive

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should becarefully monitored and thedosageshould beadjusted accordingly.

Terfenadine:In pharmacokineticstudiesthereareno reportsofinteractionsbetween azithromycin and terfenadine.

Therehavebeen rarecasesreported wherethepossibility ofsuch an interaction couldnotbeentirely excluded;

howevertherewasno specificevidencethatsuch an interaction had occurred.Azithromycin should beadministered

with caution in combination with terfenadine.

Cisapride:Cisaprideismetabolized in theliverby theenzymeCYP3A4. Becausemacrolidesinhibitthisenzyme,

concomitantadministration ofcisapridemay causetheincreaseofQTintervalprolongation, ventriculararrhythmias

and torsadedepointes.

Astemizol, Triazolam, Midazolam, Alfentanil:

No dataareavailableon interactionswith Astemizol, Triazolam, Midazolamand Alfentanil.Caution should be

exercised with concomitantuseoftheseagentsand azithromycin in viewofthedescribed potentiation ofitseffect

during concomitantuseofthemacrolideantibioticerythromycin.

4.6Pregnancyandlactation

Thereareno adequateand wellcontrolled studiesin pregnantwomen. Animalreproduction studiesshowpassage

acrosstheplacenta. No teratogeniceffectswereobserved in ratreproduction studies(seefurthersection 5.3). Since

animalstudiesarenotalwayspredictiveofhuman response, azithromycin should beused with caution during

pregnancy andonly ifadequatealternativesarenotavailable.

Limited dataindicatethatazithromycin isexcretedin breastmilk. Adecision should bemadewhetherto discontinue

breastfeeding ordiscontinueazithromycintaking into accounttheimportanceoftreatmentto thenursingmother.

4.7Effectsonabilitytodriveandusemachines

No studieson theeffectson theability to driveand usemachineshavebeen performed. However, thepossibility of

undesirableeffectslikedizzinessand convulsionsshould betaken into accountwhen performing theseactivities.

4.8Undesirableeffects

About13%ofpatientsincluded in clinicaltrialsreported adverseeventsmostcommonly gastro-intestinaldisorders.

Systemorgan

class Common

>1/100,<1/10 Uncommon

>1/1000,<1/100 Rare

>1/10000,<1/1000

Bloodand

lymphatic-

system

disorders

thrombocytopenia

haemolyticanaemia

transientmildreductionsinneutrophil

countshaveoccasionallybeenobservedin

clinicaltrialsforwhichacausal

relationshipwithAzithromycintreatment

hasnotbeenconfirmed

Psychiatric

disorders

aggression

agitation

anxiety

nervousness

depersonalisation,inelderlypatients

deliriummayoccur.

Nervoussystem

disorders

dizziness/vertigo

somnolence

headache

convulsions

disruptiontothe

patient'ssenseofsmell

paraesthesia,syncopeandasthenia

insomnia

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4.9Overdose

Theundesirableeffectsatdosagesin excessoftherecommended dosagesweresimilarto thoseafternormaldosages.

Thetypicalsymptomsofan overdosewith macrolideantibioticsincludereversiblelossofhearing, severenausea,

vomiting and diarrhoea. In casesofoverdosetheadministration ofmedicinalcharcoalandgeneralsymptomatic

andtaste

Earand

labyrinth

disorders

macrolideantibioticshavebeen

reportedtohavecausedhearingdamage.

Insomepatientsreceivingazithromycin,

impairedhearing,deafnessandringingin

theearshavebeenreported.Manyofthese

casesrelatetoexperimentalstudiesin

whichAzithromycinwasusedinlarge

dosesoverprolongedperiods.According

toavailablefollow-upreports,themajority

oftheseproblems,however,were

reversible

Cardiac

disorders

palpitations

arrhythmiaincludingassociated

ventriculartachycardia.

thereisapotentialriskofQT

prolongationandtorsadedepointes,

particularlyinpatientswhoaresusceptible

totheseconditions

Gastrointestinal

disorders

nausea/vomiting

diarrhoea

abdominal

discomfort

(pain/cramps)

loosestools(asa

resultofinfrequent

dehydration)

flatulence

anorexia

digestivedisorders

constipation

tonguediscolouration

pancreatitis

discolourationoftheteeth

pseudomembranouscolitis

Hepatobiliary

disorders

abnormalliverfunctiontestvalues

hepatitis

cholestaticjaundice

rarecasesofhepaticnecrosisand

hepaticfailurewhichhaverarelyresulted

indeath

Skinand

subcutaneous

tissuedisorders

allergicreactions

includingpruritusand

rash

allergicreactionsincluding

angioneuroticoedema,urticariaand

photosensitivity;seriousskinreactions

includingerythemamultiforme,Stevens-

Johnsonsyndromeandtoxicepidermal

necrolysis

Musculoskeletal,

connective

tissueandbone

disorders

arthralgia

Renaland

urinarytract

disorders

interstitialnephritis

acuterenalfailure

Reproductive

systemand

breastdisorders

vaginitis

General

disordersand

administration

siteconditions

anaphylaxisincludingoedema(rarely

fatal)

asthenia

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse, macrolides.

ATCcode:J01FA10

Azithromycin isamacrolideantibioticbelonging to theazalidegroup. Themoleculeisconstructed by adding a

nitrogen atomto thelactonering oferythromycin A. Thechemicalnameofazithromycin is9-deoxy-9a-aza-9a-methyl-

9a-homoerythromycin A. Themolecularweightis749.0.

Themechanismofaction ofazithromycin isbased upon thesuppressionofbacterialprotein synthesis, by binding to the

ribosomal50Ssub-unitand thusinhibiting thetranslocation ofpeptides.

Breakpoints

Azithromycin susceptibility breakpointsfortypicalbacterialpathogens:

NCCLS:

susceptible2 mg/l;intermediate4 mg/l;resistant8 mg/l

Haemophilusspp.:susceptible4 mg/l

StreptococcuspneumoniaeandStreptococcuspyogenes:

susceptible0.5 mg/l;intermediate1 mg/l;resistant2 mg/l

Notethatnationalbreakpointsmay differfromthoserecommended by NCCLS

Therearecurrently no recommended NCCLSbreakpointsto azithromycin forNeisseria gonorrhoeaeandMoraxella

catarrhalis.

Thereareno currently recommended NCCLSbreakpointsfortheatypicalpathogensagainstwhich azithromycin has

demonstrated clinically significantactivity, such asChlamydiaspp.,MycobacteriumaviumComplex,Mycoplasma

spp.,Borreliaspp.andHelicobacterpylori.

Theprevalenceofresistancemay vary geographically and with timeforselected speciesand localinformation on

resistanceisdesirable, particularly when treating severeinfections. Thisinformation providesonly anapproximate

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Table:Antibacterialspectrumofazithromycin

Species Rangeofacquiredresistance

(%)

Commonlysusceptiblespecies.

AerobicGram-positive

Corynebacteriumdiphteriae -

Staphylococcusaureus–methicillinsusceptible 0-19

Coagulase-neg.staphylococci-methicillin

susceptible -

Streptococcuspneumoniae 5-37

Erythromycin-sensitive -

Penicillin-sensitive 3-23

Streptococcuspyogenes 0-43

Erythromycin-sensitive 21

Streptococciviridansgroup 20-32

AerobicGram-negative

Bordetellapertussis -

Escherichiacoli–ETEC -

Escherichiacoli–EAEC -

Haemophilusinfluenzae 0-2

Haemophilusducreyi -

Legionellaspp. -

Moraxellacatarrhalis 0-2

Erythromycin-sensitive -

Erythromycin-intermediate -

Neisseriagonorrhoeae 0

Pasteurellamutocida -

Anaerobic

Clostridiumperfringens -

Fusobacteriumnucleatum

Fusobacteriumnecrophorum -

Prevotellaspp. -

Porphyromonasspp. -

Propionibacteriumspp. -

Othermicroorganisms

Borreliaburgdorferi -

Chlamydiapneumoniae -

Chlamydiatrachomatis -

Helicobacterpylori -

Listeriaspp. -

MycobacteriumaviumComplex

Mycoplasmapneumoniae -

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Otherinformation

(Cross)resistance

Acompletecrossresistanceexistsamong erythromycin, azithromycin, othermacrolidesand lincosamidesfor

Streptococcuspneumoniae, beta-haemolyticstreptococcusofgroup A,Enterococcusspp. andStaphylococcusaureus,

including methicillin resistantS. aureus(MRSA).

Penicillin sensitiveS. pneumoniaearemorelikely to besusceptibleto azithromycin than arepenicillin resistantstrains

ofS. pneumoniae.Methicillin resistantS. aureus(MRSA)islesslikely to besusceptibleto azithromycin than

methicillin sensitiveS. aureus(MSSA).

Theinduction ofsignificantresistancein bothin vitroandin vivomodelsis1 dilution risein MICsforS. pyogenes,

H. influenzae, andEnterobacteriaceaeafterninesub lethalpassagesofactivesubstanceandthreedilution increasefor

S. aureusand developmentofin vitroresistancedueto mutation israre.

5.2Pharmacokineticproperties

Absorption:

Following oraladministration, thebioavailability ofazithromycin isapproximately 37 %. Peak plasmalevelsare

Speciesforwhichacquiredresistancemaybeaproblem.

AerobicGram-positive

Streptococcuspneumoniae

Penicillin-intermediate 20-62

Penicillin-resistant 23-78

Erythromycin-intermediate -

Streptococcuspyogenes

Erythromycin-intermediate -

Streptococciviridansgroup

Penicillin-intermediate -

AerobicGram-negative

Moraxellacatarrhalis-erythromycin-resistant

Anaerobic

Peptostreptococcusspp. -

resistantInherentlyresistantorganisms

AerobicGram-positive

Corynebacteriumspp. -

Enterococcusspp. -

StaphylococciMRSA,MRSE Resistant

Streptococcuspneumoniae

Erythromycin-resistant -

Penicillin&Erythromycinresistant -

Streptococcuspyogenes

Erythromycin-resistant -

Streptococciviridansgroup

Penicillin-resistant -

Erythromycin-resistant -

AerobicGram-negative

Pseudomonasaeruginosa -

Anaerobic

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Distribution:

Orally administered azithromycin iswidely distributed overthewholebody. Pharmacokineticstudieshaveshown

considerably higherazithromycin concentrationsin thetissues(up to 50 timesthemaximumconcentration observed in

theplasma)than in theplasma. Thisindicatesthatthesubstanceisextensively bound in thetissues(steady-state

volumeofdistribution approximately 31 l/kg). Themean maximumconcentration observed (C

)afterasingledose

of500 mg isapproximately 0.4µg/ml, 2-3 hoursafteradministration. With therecommended dosageno accumulation

in theserum/plasmaoccurs. Accumulation doesoccurin thetissueswherethelevelsaremuch higherthan in the

serum/plasma. Threedaysafteradministration of500 mg asasingledoseorin divided doses, concentrationsof1.3-4.8

µg/g, 0.6-2.3µg/g, 2.0-2.8µg/g and 0-0.3µg/mlarefound in lung, prostate, tonsiland serumrespectively. Mean peak

concentration measured in peripheralleucocytes, arehigherthan theMIC

ofthemostcommon pathogens.

In experimentalin-vitroandin-vivostudies, azithromycin accumulatesin phagocytes;releaseispromoted by active

phagocytosis. In animalmodelsthisprocessappeared to contributeto theaccumulation ofazithromycin in tissue. The

binding ofazithromycin to plasmaproteinsisvariable, and variesfrom52 %at0.05µg/mlto 18 %at0.5µg/ml,

depending on theserumconcentration.

Metabolismand Excretion:

Theterminalplasmaelimination half-lifefollowsthetissuedepletion half-lifeof2 to 4 days. In elderly volunteers(>65

years), higher(29 %)AUCvalueswerealwaysobserved aftera5-day coursethan in youngervolunteers(<45 years).

However, thesedifferencesarenotconsidered to beclinically relevant;no doseadjustmentisthereforerecommended.

Approximately 12 %ofan intravenously administered doseisexcreted in unchanged formwith theurineoveraperiod

of3 days;themajorproportion in thefirst24 hours. Concentrationsofup to 237µg/mlazithromycin, 2 daysaftera5-

day courseoftreatment, havebeen found in human bile, togetherwith

10 metabolites(formed by N-and O-demethylation, by hydroxylation ofthedesosamineand aglyconerings, and by

splitting ofthecladinoseconjugate). Acomparison ofHPLCand microbiologicalmethodsofdetermination suggests

thatthemetabolitesdo notplay arolein themicrobiologicalactivity ofazithromycin.

Pharmacokineticsin Specialpopulations

RenalInsufficiency:

Following asingleoraldoseofazithromycin 1g, mean C

and AUC

0-120 increased by 5.1%and 4.2%respectively,

in subjectswith mild to moderaterenalimpairment(glomerularfiltration rateof10-80 ml/min)compared with normal

renalfunction (GFR>80ml/min). In subjectswith severerenalimpairment, themean C

and AUC

0-120 increased

61%and 35%respectively compared to normal.

Hepaticinsufficiency:

In patientswith mild to moderatehepaticimpairment, thereisno evidenceofamarked changein serum

pharmacokineticsofazithromycin compared to normalhepaticfunction. In thesepatients, urinary recovery of

azithromycin appearsto increaseperhapsto compensateforreduced hepaticclearance.

Elderly:

Thepharmacokineticsofazithromycin in elderly men wassimilarto thatofyoung adults;however, in elderly women,

although higherpeak concentrations(increased by 30-50%)wereobserved, no significantaccumulation occurred.

Infants, toddlers, children and adolescents:

Pharmacokineticshavebeen studied in children aged 4 months–15 yearstaking capsules, granulesorsuspension. At

10 mg/kg on day 1 followed by 5 mg/kg on days2-5, theCmax achieved isslightly lowerthan adultswith 224µg/lin

children aged 0.6-5 yearsand after3 daysdosing and 383µg/lin thoseaged 6-15 years. Thet

of36h in theolder

children waswithin theexpected rangeforadults.

5.3Preclinical safetydata

In animalstudiesusing exposures40 timesthoseachieved attheclinicaltherapeuticdosages, azithromycin wasfound

to havecaused reversiblephospholipidosis, butasaruletherewereno associated toxicologicalconsequences.The

relevanceofthisfinding to humansreceiving azithromycin in accordancewith therecommendationsisunknown.

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Carcinogenicpotential:

Long-termstudiesin animalshavenotbeen performed to evaluatecarcinogenicpotential.

Mutagenicpotential:

Therewasno evidenceofapotentialforgeneticand chromosomemutationsin in-vivo and in -vitro testmodels.

Reproductivetoxicity:

No teratogeniceffectswereobserved in embryotoxicity studiesin ratsafteroraladministration ofazithromycin. In rats,

azithromycin dosagesof100 and 200 mg/kg bodyweight/day led to mild retardationsin foetalossification and in

maternalweightgain. In peri-and postnatalstudiesin rats, mild retardationsfollowing treatmentwith 50 mg/kg/day

azithromycin and abovewereobserved.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tablets:

Pregelatinised maizestarch,

anhydrouscalciumhydrogen phosphate,

croscarmellosesodium,

magnesiumstearate

sodiumlaurilsulfate

Coating:

hypromellose,

ethylcellulose,

diethylphthalate

titaniumdioxide(E171).

6.2Incompatibilities

Notapplicable

6.3ShelfLife

2 years

6.4Special precautionsforstorage

Storein theoriginalpackage, keep blistersin outercartonin orderto protectfromlightand moisture.

6.5Natureandcontentsofcontainer

1, 2, 3, 4, 6, 30, 100tabletsin aPVdC/PVC-Alu blister

Notallpack sizesmay bemarketed.

6.6Instructionsforuseandhandling

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7MARKETINGAUTHORISATIONHOLDER

McDermottLaboratoriesLimited

T/AGerard Laboratories

35/36 BaldoyleIndustrialEstate,

GrangeRoad,

Dublin 13,

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA577/66/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 13th May 2005

10DATEOFREVISIONOFTHETEXT

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