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Tarivid200mgTablets
SummaryofProductCharacteristicsUpdated23Dec2013|SANOFI

1.Nameofthemedicinalproduct
Tarivid200mgFilmcoatedTablets

2.Qualitativeandquantitativecomposition
Tarivid200mgFilmcoatedTabletscontain200mgofofloxacin.
Forafulllistofexcipients,seesection6.1.

3.Pharmaceuticalform
Filmcoatedtablets

4.Clinicalparticulars
4.1Therapeuticindications
Ofloxacinisasynthetic4fluoroquinoloneantibacterialagentwithbactericidalactivityagainstawiderangeofGram
negativeandGrampositiveorganisms.Itisindicatedforthetreatmentofthefollowinginfectionswhencausedby
sensitiveorganisms:Upperandlowerurinarytractinfectionslowerrespiratorytractinfectionsuncomplicatedurethral
andcervicalgonorrhoeanongonococcalurethritisandcervicitis,skinandsofttissueinfections.
4.2Posologyandmethodofadministration
Generaldosagerecommendations:Thedoseofofloxacinisdeterminedbythetypeandseverityoftheinfection.The
dosagerangeforadultsis200mgto800mgdaily.Upto400mgmaybegivenasasingledose,preferablyinthe
morning,largerdosesshouldbegivenastwodivideddoses.Generally,individualdosesaretobegivenat
approximatelyequalintervals.TarividFilmcoatedtabletsshouldbeswallowedwithliquidtheyshouldnotbetaken
withintwohoursofmagnesium/aluminiumcontainingantacids,sucralfate,zincorironpreparationssincereductionof
absorptionofofloxacincanoccur.
Lowerurinarytractinfection:200400mgdaily.
Upperurinarytractinfection:200400mgdailyincreasing,ifnecessary,to400mgtwiceaday.
Lowerrespiratorytractinfection:400mgdailyincreasing,ifnecessary,to400mgtwicedaily.
Uncomplicatedurethralandcervicalgonorrhoea:Asingledoseof400mg.
Nongonococcalurethritisandcervicitis:400mgdailyinsingleordivideddoses.
Skinandsofttissueinfections:400mgtwicedaily.
Impairedrenalfunction:Followinganormalinitialdose,dosageshouldbereducedinpatientswithimpairmentofrenal
function.Whencreatinineclearanceis2050ml/minute(serumcreatinine1.55.0mg/dl)thedosageshouldbereduced
byhalf(100200mgdaily).Ifcreatinineclearanceislessthan20ml/minute(serumcreatininegreaterthan5mg/dl)100
mgshouldbegivenevery24hours.Inpatientsundergoinghaemodialysisorperitonealdialysis,100mgshouldbegiven
every24hours.
Impairedliverfunction:Theexcretionofofloxacinmaybereducedinpatientswithseverehepaticdysfunction.
Elderly:Noadjustmentofdosageisrequiredintheelderly,otherthanthatimposedbyconsiderationofrenalorhepatic
function(Seesection4.4QTintervalprolongation).
Children:Ofloxacinisnotindicatedforuseinchildrenorgrowingadolescents.
Durationoftreatment:Durationoftreatmentisdependentontheseverityoftheinfectionandtheresponsetotreatment.
Theusualtreatmentperiodis510daysexceptinuncomplicatedgonorrhoea,whereasingledoseisrecommended.
Treatmentshouldnotexceed2monthsduration.
4.3Contraindications
Ofloxacinshouldnotbeusedinpatientswithknownhypersensitivityto4quinoloneantibacterialsoranyofthetablet
excipients.
Ofloxacinshouldnotbeusedinpatientswithapasthistoryoftendinitis.
Ofloxacin,likeother4quinolones,iscontraindicatedinpatientswithahistoryofepilepsyorwithaloweredseizure
threshold.
Ofloxaciniscontraindicatedinchildrenorgrowingadolescents,andinpregnantorbreastfeedingwomen,sinceanimal
experimentsdonotentirelyexcludetheriskofdamagetothecartilageofjointsinthegrowingsubject.
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Patientswithlatentoractualdefectsinglucose6phosphatedehydrogeneseactivitymaybepronetohaemolytic
reactionswhentreatedwithquinoloneantibacterialagents.
4.4Specialwarningsandprecautionsforuse
OfloxacinisnotthedrugoffirstchoiceforpneumoniacausedbyPneumococciorMycoplama,oranginatonsillaris
causedbyhaemolyticStreptococci.
Hypersensitivityandallergicreactionshavebeenreportedforfluoroquinolonesafterfirstadministration.Anaphylactic
andanaphylactoidreactionscanprogresstolifethreateningshock,evenafterthefirstadministration.Inthesecases
ofloxacinshouldbediscontinuedandsuitabletreatment(e.gtreatmentforshock)shouldbeinitiated.
Clostridiumdifficileassociateddisease
Diarrhoea,particularlyifsevere,persistentand/orbloody,duringoraftertreatmentwithofloxacin,maybesymptomatic
ofpseudomembranouscolitis.Ifpseudomembranouscolitisissuspected,ofloxacinmustbestoppedimmediately.
Appropriatespecificantibiotictherapymustbestartedwithoutdelay(e.g.oralvancomycin,oralteicoplaninor
metronidazole).Productsinhibitingtheperistalsisarecontraindicatedinthisclinicalsituation
Patientspredisposedtoseizures
Incaseofconvulsiveseizures,treatmentwithofloxacinshouldbediscontinued(seesection4.5loweringofthecerebral
seizurethreshold).
CardiacDisorders
VeryrarecasesofQTintervalprolongationhavebeenreportedinpatientstakingfluoroquinolones.Cautionshouldbe
takenwhenusingfluoroquinolones,includingofloxacin,inpatientswithknownriskfactorsforprolongationoftheQT
intervalsuchas,forexample:
congenitallongQTsyndrome
concomitantuseofdrugsthatareknowntoprolongtheQTinterval(e.g.ClassIAandIIIantiarrhythmics,tricyclic
antidepressants,macrolides,antipsychotics)
uncorrectedelectrolyteimbalance(e.g.hypokalaemia,hypomagnesaemia)
cardiacdisease(e.g.heartfailure,myocardialinfarction,bradycardia)
ElderlypatientsandwomenmaybemoresensitivetoQTcprolongingmedications.Therefore,cautionshouldbetaken
whenusingfluoroquinolones,includingOfloxacin,inthesepopulations.
(Seesection4.2Elderly,section4.5,section4.8section4.9).
Patientsbeingtreatedwithofloxacinshouldnotexposethemselvesunnecessarilytostrongsunlightandshouldavoid
UVrays(sunlamps,solaria).
Patientswithhistoryofpsychoticdisorder
Psychoticreactionshavebeenreportedinpatientsreceivingfluoroquinolones.Insomecasesthesehaveprogressedto
suicidalthoughtsorselfendangeringbehaviourincludingsuicideattempt,sometimesafterasingledose.Intheevent
thatapatientdevelopsthesereactions,ofloxacinshouldbediscontinuedandappropriatemeasuresinstituted.
Ofloxacinshouldbeusedwithcautioninpatientswithahistoryofpsychoticdisorderorinpatientswithpsychiatric
disease.
Patientswithimpairedliverfunction
Ofloxacinshouldbeusedwithcautioninpatientswithimpairedliverfunction,asliverdamagemayoccur.Casesof
fulminanthepatitispotentiallyleadingtoliverfailure(includingfatalcases)havebeenreportedwithfluoroquinolones.
Patientsshouldbeadvisedtostoptreatmentandcontacttheirdoctorifsignsandsymptomsofhepaticdisease
developsuchasanorexia,jaundice,darkurine,pruritisortenderabdomen.(Seesection4.8:Undesirableeffects)
PatientstreatedwithvitaminKantagonists
Duetopossibleincreaseincoagulationtests(PT/INR)and/orbleedinginpatientstreatedwithfluoroquinolones,
includingofloxacin,incombinationwithavitaminKantagonist(e.g.warfarin),coagulationtestsshouldbemonitored
whenthesedrugsaregivenconcomitantly(seesection4.5)
Myastheniagravis
Ofloxacinshouldbeusedwithcautioninpatientswithahistoryofmyastheniagravis.
Administrationofantibiotics,especiallyofprolonged,mayleadtoproliferationofresistantmicroorganisms.The
patient'sconditionmustthereforebecheckedatregularintervals.Ifasecondaryinfectionoccurs,appropriatemeasures
mustbetaken.
Peripheralneuropathy
Sensoryorsensorimotorperipheralneuropathyhasbeenreportedinpatientsreceivingfluoroquinolones,including
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ofloxacin.Ofloxacinshouldbediscontinuedifthepatientexperiencessymptomsofneuropathyinordertopreventthe
developmentofanirreversiblecondition.
Hypoglycaemia
Aswithallquinolones,hypoglycaemiahasbeenreported,usuallyindiabeticpatientsreceivingconcomitanttreatment
withanoralhypoglycaemicagent(e.g.glibenclamide)orwithinsulin.Inthesediabeticpatients,carefulmonitoringof
bloodglucoseisrecommended.
Patientswithglucose6phosphatedehydrogenasedeficiency
Patientswithlatentordiagnosedglucose6phosphatedehydrogenasedeficiencymaybepredisposedtohaemolytic
reactionsiftheyaretreatedwithquinolones.Ofloxacinshouldthereforebeadministeredwithcautioninsuchpatients.
Patientswithrarehereditarydisorders
Patientswithrarehereditarydisordersofgalactoseintolerance,theLapplactasedeficiencyorglucosegalactose
malabsorptionshouldnottakethismedicine.
4.5Interactionwithothermedicinalproductsandotherformsofinteraction
DrugsknowntoprolongQTinterval
Ofloxacin,likeotherfluoroquinolones,shouldbeusedwithcautioninpatientsreceivingdrugsknowntoprolongtheQT
interval(e.g.ClassIAandIIIantiarrhythmics,tricyclicantidepressants,macrolides,antipsychotics)(Seesection4.4).
Antacids,Sucralfate,MetalCations
Coadministeredmagnesium/aluminiumantacids,sucralfate,zincorironpreparationscanreduceabsorption.Therefore,
ofloxacinshouldbetaken2hoursbeforesuchpreparations.
ProlongationofbleedingtimehasbeenreportedduringconcomitantadministrationofTarividandanticoagulants.
Theremaybeafurtherloweringofthecerebralseizurethresholdwhenquinolonesaregivenconcurrentlywithother
drugswhichlowertheseizurethreshold,e.g.theophylline.Howeverofloxacinisnotthoughttocauseapharmacokinetic
interactionwiththeophylline,unlikesomeotherfluoroquinolones.
Furtherloweringofthecerebralseizurethresholdmayalsooccurwithcertainnonsteroidalantiinflammatorydrugs.
Incaseofconvulsiveseizures,treatmentwithofloxacinshouldbediscontinued.
Ofloxacinmaycauseaslightincreaseinserumconcentrationsofglibenclamideadministeredconcurrentlypatients
treatedwiththiscombinationshouldbecloselymonitored.
Withhighdosesofquinolones,impairmentofexcretionandanincreaseinserumlevelsmayoccurwhenco
administeredwithotherdrugsthatundergorenaltubularsecretion(e.g.probenecid,cimetidine,frusemideand
methotrexate).
Interactionwithlaboratorytests:
Determinationofopiatesorporphyrinsinurinemaygivefalsepositiveresultsduringtreatmentwithofloxacin.Itmaybe
necessarytoconfirmpositiveopiateorporphyrinscreensbymorespecificmethods.
VitaminKantagonists
CoagulationtestsshouldbemonitoredinpatientstreatedwithvitaminKantagonistsbecauseofapossibleincreasein
theeffectofcoumarinderivatives.
4.6Pregnancyandlactation
Basedonalimitedamountofhumandata,theuseoffluoroquinolonesinthefirsttrimesterofpregnancyhasnotbeen
associatedwithanincreasedriskofmajormalformationsorotheradverseeffectsonpregnancyoutcome.Animal
studieshaveshowndamagetothejointcartilageinimmatureanimalsbutnoteratogeniceffects.Thereforeofloxacin
shouldnotbeusedduringpregnancy.(Seesection4.3:Contraindications)
Ofloxacinisexcretedintohumanbreastmilkinsmallamounts.Becauseofthepotentialforarthropathyandother
serioustoxicityinthenursinginfant,breastfeedingshouldbediscontinuedduringtreatmentwithofloxacin.(Seesection
4.3:Contraindications)
4.7Effectsonabilitytodriveandusemachines
Sincetherehavebeenoccasionalreportsofsomnolence,impairmentofskills,dizzinessandvisualdisturbances,
patientsshouldknowhowtheyreacttoTarividbeforetheydriveoroperatemachinery.Theseeffectsmaybeenhanced
byalcohol.

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4.8Undesirableeffects

Systemorgan
class

Common

Uncommon

Rare

Veryrare

Notknown

(1/100to
<1/10)

(1/1,000to
<1/100)

(1/10,000to
<1/1,000)

(<1/10,000)

(cannotbeestimated
fromavailabledata)*

Infectionsand
infestations

Fungal
infection,
Pathogen
resistance

Bloodandthe
lymphaticsystem
disorders

Anaemia

Agranulocytosis

Haemolyticanaemia,
Leukopenia,
Eosinophilia,
Thrombocytopenia

Bonemarrowfailure

Immunesystem
disorders

Anaphylactic
reaction*,
Anaphylactoid
reaction*,
Angioedema*

Anaphylacticshock *,
Anaphylactoidshock *

Metabolismand
Nutritiondisorders

Anorexia

Hypoglycaemiain
diabeticstreatedwith
hypoglycaemic
agents(seeSection
4.4)

Psychiatric
disorders

Agitation,
Sleep
disorder,
Insomnia

Psychoticdisorder
(fore.g.
hallucination),
Anxiety,
Confusionalstate,
Nightmares,
Depression

Psychoticdisorder
anddepressionwith
selfendangering
behaviourincluding
suicidalideationor
suicideattempt(see
Section4.4)

Nervoussystem
disorders

Dizziness,
Headache

Somnolence,
Paraesthesia,
Dysgeusia,
Parosmia

Peripheralsensory
neuropathy *

Peripheralsensory
motorneuropathy *
Convulsion*,Extra
pyramidalsymptoms
orotherdisordersof
muscularcoordination

Eyedisorders

Eyeirritation

Visualdisturbance

Earandlabyrinth
disorders

Vertigo

Tinnitus,Hearingloss

Cardiacdisorders

Tachycardia

Ventricular
arrhythmias,torsades
depointes(reported
predominantlyin
patientswithrisk
factorsforQT
prolongation),ECG
QTprolonged(see
section4.4and4.9)

Vasculardisorders

appliesonlyto
thesolutionfor
infusion:

Hypotension

appliesonlytothe
solutionforinfusion:

Phlebitis
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Duringinfusionof
ofloxacin,tachycardia
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andhypotensionmay
occur.Sucha
decreaseinblood
pressuremay,invery
rarecases,be
severe.
Respiratory,
thoracicand
mediastinal
disorders

Cough,Naso Dyspnoea,
pharyngitis
Bronchospasm

Allergicpneumonitis,
Severedyspnoea

Gastrointestinal
disorders

Abdominal
pain,
Diarrhoea,
Nausea,
Vomiting

Enterocolitis,
sometimes
haemorrhagic

Pseudomembranous
colitis *

Hepatobilary
disorders

Hepaticenzymes Jaundicecholestatic
increased(ALAT,
ASAT,LDH,
gammaGTand/or
alkaline
phosphatase)

Hepatitis,whichmay
besevere*

Bloodbilirubin
increased
Skinand
subcutaneous
tissuedisorders

Pruritus,Rash Urticaria,Hot
flushes,
Hyperhidrosis
Pustularrash

Erythemamultiforme,
Toxicepidermal
necrolysis,Photo
sensitivityreaction*,
Drugeruption

StevensJohnson
syndrome
Acutegeneralized
exanthemous
pustulosisdrugrash

Vascularpurpura,
Vasculitis,whichcan
leadinexceptional
casestoskin
necrosis
Musculoskeletal
andConnective
tissuedisorders

Tendonitis

Arthralgia,Myalgia,
Tendonrupture(e.g.
Achillestendon)
whichmayoccur
within48hoursof
treatmentstartand
maybebilateral.

Rhabdomyolysis
and/orMyopathy,
Muscularweakness
Muscletear,muscle
rupture

RenalandUrinary
disorders

Serumcreatinine
increased

Acuterenalfailure

Acuteinterstitial
nephritis

Congenitaland
familial/genetic
disorders

Attacksofporphyria
inpatientswith
porphyria

Generaldisorders
andadministration
siteconditions

appliesonlyto
thesolutionfor
infusion:

Infusionsite
reaction(pain,
reddening)
*postmarketingexperience
Reportingofsuspectedadversereactions
Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued
monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportany
suspectedadversereactionsviaYellowCardSchemeat:www.mhra.gov.uk/yellowcard
4.9Overdose
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ThemostimportantsignstobeexpectedfollowingacuteoverdosageareCNSsymptomssuchasconfusion,dizziness,
impairmentofconsciousnessandconvulsiveseizuresaswellasgastrointestinalreactionssuchasnauseaand
mucosalerosions.
Inthecaseofoverdosestepstoremoveanyunabsorbedofloxacineggastriclavage,administrationofadsorbantsand
sodiumsulphate,ifpossibleduringthefirst30minutes,arerecommendedantacidsarerecommendedforprotectionof
thegastricmucosa.
Eliminationofofloxacinmaybeincreasedbyforceddiuresis.
Intheeventofoverdose,symptomatictreatmentshouldbeimplemented.ECGmonitoringshouldbeundertaken,
becauseofthepossibilityofQTintervalprolongation.

5.Pharmacologicalproperties
5.1Pharmacodynamicproperties
Pharmacotherapeuticgroup:Quinoloneantibacterials,Fluoroquinolones.ATCcodeJ01MA01
Ofloxacinisaquinolonecarboxylicacidderivativewithawiderangeofantibacterialactivityagainstbothgramnegative
andgrampositiveorganisms.Itisactiveafteroraladministration.ItinhibitsbacterialDNAreplicationbyblockingDNA
topoisomerases,inparticularDNAgyrase.
Therapeuticdosesofofloxacinaredevoidofpharmacologicaleffectsonthevoluntaryorautonomicnervoussystems.
Microbiologicalresultsindicatethatthefollowingpathogensmayberegardedassensitive:Staphylococcusaureus
(includingmethicillinresistantstaphylococci),Staphylococcusepidermidis,Neisseriaspecies,Escherichiacoli,
Citrobacter,Klebsiella,Enterobacter,Hafnia,Proteus(indolenegativeandindolepositivestrains),Haemophilus
influenzae,Chlamydiae,Legionella,Gardnerella.
VariablesensitivityisshownbyStreptococci,Serratiamarcescens,PseudomonasaeruginosaandMycoplasmas.
Anaerobicbacteria(e.g.Fusobacteriumspecies,Bacteroidesspecies,Eubacteriumspecies,Peptococci,
Peptostreptococci)arenormallyresistant.
5.2Pharmacokineticproperties
Ofloxacinisalmostcompletelyabsorbedafteroraladministration.Maximalbloodlevelsoccur13hoursafterdosing
andtheeliminationhalflifeis46hours.Ofloxacinisprimarilyexcretedunchangedintheurine.
Inrenalinsufficiencythedoseshouldbereduced.
Noclinicallyrelevantinteractionswereseenwithfoodandnointeractionwasfoundbetweenofloxacinandtheophylline.
5.3Preclinicalsafetydata
NotApplicable

6.Pharmaceuticalparticulars
6.1Listofexcipients
Maizestarch
Lactose
Hyprolose
CarmelloseNS300
Magnesiumstearate
Hypromellose(2910)
Titaniumdioxide(E171)
Talc
Macrogol8000
6.2Incompatibilities
Notapplicable.
6.3Shelflife
3years
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6.4Specialprecautionsforstorage
Nospecialconditionsforstorage.
6.5Natureandcontentsofcontainer
Blisterpacksof10,20and100tablets.
Notallpacksizesmaybemarketed.
6.6Specialprecautionsfordisposalandotherhandling
Nospecialrequirements.

7.Marketingauthorisationholder
AventisPharmaLimited
OneOnslowStreet
Guildford
Surrey
GU14YS
UK
ortradingas:
SanofiaventisorSanofi
OneOnslowStreet
Guildford
Surrey
GU14YS
UK

8.Marketingauthorisationnumber(s)
PL04425/0216

9.Dateoffirstauthorisation/renewaloftheauthorisation
April2002

10.Dateofrevisionofthetext
12December2013

Legalstatus
POM

CompanyContactDetails
SANOFI
Address
1OnslowStreet,Guildford,Surrey,GU14YS,UK

Telephone
+44(0)1483505515

Fax
+44(0)1483535432

MedicalInformationDirectLine
+44(0)8453727101

MedicalInformationemail
ukmedicalinformation@sanofi.com

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