CEFUROXIME TEVA 250 Base Milligrams Film Coated Tablet

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CEFUROXIME AXETIL
Available from:
Teva Pharma B.V.
INN (International Name):
CEFUROXIME AXETIL
Dosage:
250 Base Milligrams
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization number:
PA0749/082/002
Authorization date:
0000-00-00

PACKAGE LEAFLET: INFORMATION FOR THE USER

CEFUROXIME TEVA 125 MG FILM-COATED TABLETS

CEFUROXIME TEVA 250 MG FILM-COATED TABLETS

CEFUROXIME TEVA 500 MG FILM-COATED TABLETS

Cefuroxime(as cefuroximeaxetil)

Read all of this leaflet carefully before you start taking this medicine because it contains important

information for you.

Keep this leaflet. You mayneed to read it again.

If you have anyfurther questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Donot pass it on to others. It mayharmthem, even if

their signs of illness are the same as yours.

If you get anyof the side effects talk to your doctor or pharmacist. This includes anypossible side effects

not listed in this leaflet.

WHAT IS IN THIS LEAFLET:

1.What CefuroximeTeva is and what it is used for

2.What you need to know before you take CefuroximeTeva

3.How to take CefuroximeTeva

4.Possible side effects

5.How to store CefuroximeTeva

6.Contents of the pack and other information

1. WHAT CEFUROXIME TEVA IS AND WHAT IT IS USED FOR

CefuroximeTeva is an antibiotic used in adultsand children. It works bykilling bacteria that cause

infections. It belongs to a group of medicines calledcephalosporins.

CefuroximeTeva is used to treat infections of:

the throat

sinus

middle ear

the lungs or chest

the urinarytract

the skin and soft tissues.

CefuroximeTeva can also be used:

to treat Lymedisease (an infection spread byparasites called ticks).

2. WHAT YOU NEED KNOW BEFORE YOU TAKE CEFUROXIME TEVA

Don’t take Cefuroxime Teva:

if you are allergic (hypersensitive) to anycephalosporin antibiotics or anyof the ingredients of

CefuroximeTeva.

if you have ever had a severe allergic (hypersensitive)reaction to anyother type of betalactamantibiotic

(penicillins, monobactams and carbapenems).

If you think this applies to you,don’t take Cefuroxime Tevauntil you have checked with your doctor.

1

If you are not sure whether anyof the above applytoyou speak to your doctor or pharmacist before taking

this medicine.

Warnings and precautions

Cefuroxime Teva is not recommended for children aged under 3 months, as the safetyand effectiveness

are not known in this age group.

You must look out for certain symptoms, such as allergic reactions, fungal infections (such as candida) and

severe diahorrea (pseudomembranous colitis) while youare taking CefuroximeTeva. This will reduce the

risk of anyproblems. See ‘Conditions you need to look out for’ in Section 4.

If you need a blood test

CefuroximeTeva can affect the results of a test for blood sugar levels, or a blood screen called the Coombs

test.

If you need a blood test:Tell the person taking the samplethat you are taking CefuroximeTeva.

Other medicines and Cefuroxime Teva

Tell your doctor or pharmacist if you are taking anyother medicines, if you’ve started taking anyrecentlyor

you start taking new ones. This includes medicines you can obtain without a prescription.

Medicines used to reducethe amount of acid in your stomach (e.g.antacidsused to treatheartburn) can

affect how CefuroximeTeva works.

-Probenecid

-Oral anticoagulants

Tell your doctor or pharmacist if you are taking anymedicine like this.

Contraceptive pills

CefuroximeTeva mayreduce the effectiveness of thecontraceptive pill. If you are taking the contraceptive

pill while you are being treated with CefuroximeTevayou also need to use a barrier method of contraception

(such as condoms). Ask your doctor for advice.

Pregnancy and breast-feeding and fertility

Tell your doctor before you take CefuroximeTeva:

if you are pregnant, think you might be pregnant or are planning to becomepregnant

if you are breastfeeding.

Your doctor will consider the benefitof treating you with CefuroximeTeva against the risk to your baby.

Driving and using machines

CefuroximeTevacan make you dizzyand have other side effects that make you less alert.Don’t drive or

use machinesif you do not feel well.

3. HOW TO TAKE CEFUROXIME TEVA

Alwaystake this medicine exactlyas your doctor orpharmacist has told you to. Check with your doctor or

pharmacist if you are not sure.

Take CefuroximeTeva after food. This will help to make the treatment more effective.

Swallow CefuroximeTeva tablets whole with somewater.

Don't chew, crush or split the tablets— this maymake the treatment less effective.

The usual dose:

Adults

The usual dose of CefuroximeTeva is 250 mgto 500 mgtwice dailydepending on the severityand type of

infection.

Children

The usual dose of CefuroximeTeva is 10 mg/kg (toa maximumof 125 mg) to 15 mg/kg (to a maximumof

250 mg) twice dailydepending on:

the severityand type of infection

Cefuroxime Teva is not recommended for children aged under 3 months, as the safetyand effectiveness

are not known in this age group.

Depending on the illness or how you or your child respondsto treatment, the initial dose maybe changed or

more than one course of treatment maybe needed.

Patients with kidney problems

If you have a kidneyproblem, your doctor maychange your dose.

Talk to your doctorif this applies to you.

If you take too much CefuroximeTeva

If you take too much CefuroximeTeva you mayhaveneurological disorders, in particular you maybemore

likely to have fits(seizures).

Don't delay. Contact your doctor or your nearesthospital emergency department immediately.If

possible, show themthe CefuroximeTeva pack.

If you forget to take CefuroximeTeva

Don't take an extra dose to make up for a missed dose. Just take your next dose at the usual time..

Don’t stop CefuroximeTeva without advice

It is important that you take the full course of CefuroximeTeva. Don’t stop unless your doctor advises you to

– even if you are feeling better. If you don't complete the full course of treatment, the infection maycome

back.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybodygets them.

Conditions you need to look out for

A small number of people taking CefuroximeTeva getan allergic reaction or potentiallyserious skin

reaction. Symptomsof these reactions include:

severe allergic reaction. Signs includeraised and itchy rash, swelling, sometimes of the face or

mouth causingdifficulty in breathing.

skin rash, which mayblister, and looks likesmall targets(central dark spot surrounded bya paler

area, with a dark ring around the edge).

a widespread rashwithblistersandpeeling skin. (These maybe signs of Stevens-Johnson syndrome

or toxic epidermal necrolysis).

fungal infections. Medicines like CefuroximeTeva cause an overgrowth of yeast (Candida) in the

bodywhich can lead to fungal infections (such as thrush). This side effect is more likelyif you take

CefuroximeTeva for a long time.

severe diarrhoea(Pseudomembranous colitis). Medicines like CefuroximeTeva can cause

inflammation of the colon (large intestine), causing severe diarrhoea, usuallywith blood and mucus,

stomach pain, fever

Jarisch-Herxheimer reaction. Somepatients mayget a high temperature (fever), chills, headache,

muscle pain and skin rash while being treated with CefuroximeTeva for Lymedisease. This is

known as the Jarisch-Herxheimer reaction. Symptomsusuallylast a few hours or up to one day.

Contact a doctor or nurse immediately if you get any of these symptoms.

Commonside effects

These mayaffect up to 1 in 10 people:

fungal infections (such as Candida)

headache

dizziness

diarrhoea

feeling sick

stomach pain.

Common side effects that mayshow up in blood tests:

an increase in a type of white blood cell (eosinophilia)

an increase in liver enzymes.

Uncommonside effects

These mayaffect up to 1 in 100 people:

being sick

skin rashes.

Uncommon side effects that mayshow up in blood tests:

a decrease in the number of blood platelets (cells that help blood to clot)

a decrease in the number of white blood cells

positive Coomb’s test.

Other side effects

Other side effects have occurred in a verysmall number of people, but their exact frequencyis unknown:

severe diarrhoea (pseudomembranous colitis)

allergic reactions

skin reactions (including severe)

high temperature (fever)

yellowing of the whites of the eyes or skin

inflammation of the liver (hepatitis).

Side effects that mayshow up in blood tests:

red blood cells destroyed too quickly(haemolytic anaemia).

If you get anyof the side effects tell your doctor or pharmacist.This includes anypossible side effects not

listed in this leaflet.

5. HOW TO STORE CEFUROXIME TEVA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expirydate that is stated on the blister or outer packaging. The expirydate

refers to the last dayof that month.

This medicinal product does not require anyspecial storage conditions.

Don’t throw awayanymedicines via wastewater or household waste. Ask your pharmacist how to throw

awaymedicines you no longer use. These measures will help to protect the environment.

6.CONTENTS OF THE PACK AND OTHER INFORMATION

What CefuroximeTeva contains:

The active ingredient is cefuroxime(as cefuroximeaxetil).

The other ingredients in the tablet core are pregelatinised starch, croscarmellose sodium, sodium

laurilsulfate, microcrystalline cellulose, anhydrouscolloidal silica and hydrogenated vegetable oil.

The other ingredients in the tablet coating are as follows:

Cefuroxime Teva 125 mg Film-coated Tablets:

Hypromellose (E464), titaniumdioxide (E171), propylene glycol (E1520).

Cefuroxime Teva 250 mg and 500 mg Film-coated Tablets:

Hypromellose (E464), titaniumdioxide (E171), propylene glycol (E1520), Brilliant Blue FCF aluminium

lake (E133), Indigo Carmine AluminiumLake (E132).

What CefuroximeTeva looks like and contents of the pack:

CefuroximeTeva 125mg Film-coated Tablets are white tooff-white coloured film-coated tablets engraved

with “125” on one side and “P124” on the other side.

CefuroximeTeva 250 mgFilm-coated Tablets are lightblue coloured film-coated tablets engraved with

“250” on one side and “P125” on on the other side.

CefuroximeTeva 500 mgFilm-coated Tablets are lightblue coloured film-coated tablets engraved with

“500” on one side and “P126” on the other side.

Your medicine is provided in blister packs. Pack sizes are as follows:

CefuroximeTeva 125 mgFilm-coated Tablets: 10, 12 and 14 tablets.

CefuroximeTeva 250 mgFilm-coated Tablets: 8, 10, 12, 14, 16, 20 and 24 tablets.

CefuroximeTeva 500 mgFilm-coated Tablets:6, 8, 10, 12, 14, 16, 20 and 24 tablets.

Not all pack sizes maybe marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is:

Teva PharmaB.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

The manufacturer is:

TEVA UK Ltd., Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, UK.

Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 74770 Opava-Komárov, Czech Republic.

Teva Operations Poland Sp. z.o.o., Mogilska 80 Str. 31-546 Kraków.

Merckle GmbH, Ludwig-Merckle-Straβe 3, 89143 Blaubeuren, Germany.

This medicinal product is authorised in the Member States of the EEA under the following names:

Ireland CefuroximeTeva 125 mgFilm-coated tablets

CefuroximeTeva 250 mgFilm-coated tablets

CefuroximeTeva 500 mgFilm-coated tablets

Italy CefuroximaTeva 125 mgcompresse rivestite con film

CefuroximaTeva 250 mgcompresse rivestite con film

CefuroximaTeva 500 mgcompresse rivestite con film

Poland CefuroximeTeva, 125mg, tabletki powlekane

Cefuroximum123ratio, 250mg,tabletki powlekane

Cefuroximum123ratio, 500mg,tabletki powlekane

Slovakia Cefuroxim- Teva 125 mg

Cefuroxim- Teva 250 mg

Cefuroxim- Teva 500 mg

Spain CefuroximaTeva 125 mgcomprimidos recubiertos con película EFG

CefuroximaTeva 250 mgcomprimidos recubiertos con película EFG

CefuroximaTeva 500 mgcomprimidos recubiertos con película EFG

United Kingdom Cefuroxime125 mgFilm-coated Tablets

Cefuroxime250 mgFilm-coated Tablets

Cefuroxime500 mgFilm-coated Tablets

This leaflet was last revised:June 2013.

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CefuroximeTeva250mgFilm-coatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each250mgfilm-coatedtabletcontains250mgcefuroxime(ascefuroximeaxetil)

Forthefulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet.

Lightbluecolouredfilm-coatedtabletsengravedwith“250”ononesideand“P125”ontheotherside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CefuroximeTevaisindicatedforthetreatmentoftheinfectionslistedbelowinadultsandchildrenfromtheageof3

months(seesections4.4and5.1).

Acutestreptococcaltonsillitisandpharyngitis.

Acutebacterialsinusitis.

Acuteotitismedia.

Acuteexacerbationsofchronicbronchitis.

Cystitis.

Pyelonephritis.

Uncomplicatedskinandsofttissueinfections.

TreatmentofearlyLymedisease.

Considerationshouldbegiventoofficialguidanceontheappropriateuseofantibacterialagents.

4.2Posologyandmethodofadministration

Posology

Theusualcourseoftherapyissevendays(mayrangefromfivetotendays).

Table1.Adultsandchildren(40kg<.

Indication Dosage

Acutetonsillitisandpharyngitis,acutebacterialsinusitis 250mgtwicedaily

Acuteotitismedia 500mgtwicedaily

Acuteexacerbationsofchronicbronchitis 500mgtwicedaily

Cystitis 250mgtwicedaily

Pyelonephritis 250mgtwicedaily

Uncomplicatedskinandsofttissueinfections 250mgtwicedaily

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Table2.Children(<40kg)

ThereisnoexperienceofusingCefuroximeTevainchildrenundertheageof3months.

Cefuroximeaxetiltabletsandcefuroximeaxetilgranulesfororalsuspensionarenotbioequivalentandarenot

substitutableonamilligram-per-milligrambasis(seesection5.2).

Renalimpairment:

Thesafetyandefficacyofcefuroximeaxetilinpatientswithrenalfailurehavenotbeenestablished.

Cefuroximeisprimarilyexcretedbythekidneys.Inpatientswithmarkedlyimpairedrenalfunctionitisrecommended

thatthedosageofcefuroximeshouldbereducedtocompensateforitsslowerexcretion.Cefuroximeiseffectively

removedbydialysis.

Table3.Recommendeddosesforcefuroximeaxetilinrenalimpairment

Hepaticimpairment

Therearenodataavailableforpatientswithhepaticimpairment.Sincecefuroximeisprimarilyeliminatedbythe

kidney,thepresenceofhepaticdysfunctionisexpectedtohavenoeffectonthepharmacokineticsofcefuroxime.

Methodofadministration

Oraluse

CefuroximeTevatabletsshouldbetakenafterfoodforoptimumabsorption.

CefuroximeTevatabletsarecoatedtomasktheirtaste:theyshouldnotbechewed.

CefuroximeTevatabletsshouldnotbecrushedandarethereforeunsuitablefortreatmentofpatientswhocannot

swallowtablets.Inchildrencefuroxomeaxetiloralsuspensionmaybeused.

4.3Contraindications

Indication Dosage

Acutetonsillitisandpharyngitis,acutebacterial

sinusitis 10mg/kgtwicedailytoamaximumof125

mgtwicedaily

Childrenagedtwoyearsorolderwithotitis

mediaor,whereappropriate,withmoresevere

infections 15mg/kgtwicedailytoamaximumof250

mgtwicedaily

Cystitis 15mg/kgtwicedailytoamaximumof250

mgtwicedaily

Pyelonephritis 15mg/kgtwicedailytoamaximumof250

mgtwicedailyfor10to14days

Uncomplicatedskinandsofttissueinfections 15mg/kgtwicedailytoamaximumof250

mgtwicedaily

Lymedisease 15mg/kgtwicedailytoamaximumof250

mgtwicedailyfor14days(10to21days)

Creatinineclearance T (hrs) Recommendeddosage

30mL/min/1.73m 1.4–2.4 nodoseadjustmentnecessary(standarddoseof125mgto

500mggiventwicedaily)

10-29mL/min/1.73m 4.6 standardindividualdosegivenevery24hours

<10mL/min/1.73m 16.8 standardindividualdosegivenevery48hours

Patientsonhaemodialysis 2–4 afurtherstandardindividualdoseshouldbegivenattheend

ofeachdialysis 1/2

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Patientswithknownhypersensitivitytocephalosporinantibiotics.

Historyofseverehypersensitivity(e.g.anaphylacticreaction)toanyothertypeofbetalactamantibacterialagent

(penicillins,monobactamsandcarbapenems).

4.4Specialwarningsandprecautionsforuse

Hypersensitivityreactions

Specialcareisindicatedinpatientswhohaveexperiencedanallergicreactiontopenicillinsorotherbeta-lactam

antibioticsbecausethereisariskofcross-sensitivity.Aswithallbeta-lactamantibacterialagents,seriousand

occasionallyfatalhypersensitivityreactionshavebeenreported.Incaseofseverehypersensitivityreactions,treatment

withcefuroximemustbediscontinuedimmediatelyandadequateemergencymeasuresmustbeinitiated.

Beforebeginningtreatment,itshouldbeestablishedwhetherthepatienthasahistoryofseverehypersensitivity

reactionstocefuroxime,toothercephalosporinsortoanyothertypeofbeta-lactamagent.Cautionshouldbeusedif

cefuroximeisgiventopatientswithahistoryofnon-severehypersensitivitytootherbeta-lactamagents.

Jarisch-Herxheimerreaction

TheJarisch-HerxheimerreactionhasbeenseenreportedfollowingcefuroximeaxetiltreatmentofLymedisease.It

resultsdirectlyfromthebactericidalactivityofcefuroximeaxetiloncausativebacteriaofLymedisease,the

spirochaeteBorreliaburgdorferi.Patientsshouldbeinformedofthiscommonandusuallyself-limitingreactionbeinga

consequenceofantibiotictreatmentofLymedisease(seesections4.8).

Overgrowthofnon-susceptiblemicroorganisms

Aswithotherantibiotics,useofcefuroximeaxetilmayresultintheovergrowthofCandida.Prolongedusemayalso

resultintheovergrowthofothernon-susceptiblemicroorganisms(e.g.enterococciandClostridiumdifficile),which

mayrequireinterruptionoftreatment(seesection4.8).

Antibacterialagent–associatedpseudomembranouscolitishavebeenreportedwithnearlyallantibacterialagents,

includingcefuroximeandmayrangeinseverityfrommildtolifethreatening.Thisdiagnosisshouldbeconsideredin

patientswithdiarrhoeaduringorsubsequenttotheadministrationofcefuroxime(seesection4.8).Discontinuationof

therapywithcefuroximeandtheadministrationofspecifictreatmentforClostridiumdifficileshouldbeconsidered.

Medicinalproductsthatinhibitperistalsisshouldnotbegiven(seesection4.8).

Interferencewithdiagnostictests

ThedevelopmentofapositiveCoomb’sTestassociatedwiththeuseofcefuroximemayinterferewithcrossmatching

ofblood(seesection4.8).

Asafalsenegativeresultmayoccurintheferricyanidetest,itisrecommendedthateithertheglucoseoxidaseor

hexokinasemethodsareusedtodetermineblood/plasmaglucoselevelsinpatientsreceivingcefuroximeaxetil

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Drugswhichreducegastricaciditymayresultinalowerbioavailabilityofcefuroximeaxetilcomparedwiththatofthe

fastingstateandtendtocanceltheeffectofenhancedabsorptionafterfood.

Cefuroximeaxetilmayaffectthegutflora,leadingtoloweroestrogenreabsorptionandreducedefficacyofcombined

oralcontraceptives.

Cefuroximeisexcretedbyglomerularfiltrationandtubularsecretion.Concomitantuseofprobenicidisnot

recommended.Concurrentadministrationofprobenecidsignificantlyincreasesthepeakconcentration,areaunderthe

serumconcentrationtimecurveandeliminationhalf-lifeofcefuroxime.

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4.6Fertility,pregnancyandlactation

Pregnancy

Therearelimiteddatafromtheuseofcefuroximeinpregnantwomen.Studiesinanimalshaveshownnoharmful

effectsonpregnancy,embryonalorfoetaldevelopment,parturitionorpostnataldevelopment.CefuroximeTevashould

beprescribedtopregnantwomenonlyifthebenefitoutweighstherisk.

Breastfeeding

Cefuroximeisexcretedinhumanmilkinsmallquantities.Adverseeffectsattherapeuticdosesarenotexpected,

althoughariskofdiarrhoeaandfungusinfectionofthemucousmembranescannotbeexcluded.Breastfeedingmight

havetobediscontinuedduetotheseeffects.Thepossibilityofsensitisationshouldbetakenintoaccount.Cefuroxime

shouldonlybeusedduringbreastfeedingafterbenefit/riskassessmentbythephysicianincharge.

Fertility

Therearenodataontheeffectsofcefuroximeaxetilonfertilityinhumans.Reproductivestudiesinanimalshave

shownnoeffectsonfertility.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.However,asthismedicinemay

causedizziness,patientsshouldbewarnedtobecautiouswhendrivingoroperatingmachinery.

4.8Undesirableeffects

ThemostcommonadversereactionsareCandidaovergrowth,eosinophilia,headache,dizziness,gastrointestinal

disturbancesandtransientriseinliverenzymes.

Thefrequencycategoriesassignedtotheadversereactionsbelowareestimates,asformostreactionssuitabledata(for

examplefromplacebo-controlledstudies)forcalculatingincidencewerenotavailable.Inadditiontheincidenceof

adversereactionsassociatedwithcefuroximeaxetilmayvaryaccordingtotheindication.

Datafromlargeclinicalstudieswereusedtodeterminethefrequencyofverycommontorareundesirableeffects.The

frequenciesassignedtoallotherundesirableeffects(i.e.thoseoccurringat<1/10,000)weremainlydeterminedusing

post-marketingdataandrefertoareportingrateratherthantruefrequency.Placebo-controlledtrialdatawerenot

available.Whereincidenceshavebeencalculatedfromclinicaltrialdata,thesewerebasedondrug-related(investigator

assessed)data.Withineachfrequencygrouping,undesirableeffectsarepresentedinorderofdecreasingseriousness.

Treatmentrelatedadversereactions,allgrades,arelistedbelowbyMedDRAbodysystemorganclass,frequencyand

gradeofseverity.Thefollowingconventionhasbeenutilisedfortheclassificationoffrequency:verycommon 1/10;

common 1/100to<1/10,uncommon 1/1,000to<1/100;rare 1/10,000to<1/1,000;veryrare<1/10,000andnot

known(cannotbeestimatedfromtheavailabledata).

Systemorganclass Common Uncommon Notknown

Infectionsand

infestations Candida

overgrowth Clostridium

difficileovergrowth

Bloodand

lymphaticsystem

disorders eosinophilia positive Coomb’s

test,

thrombocytopenia,

leukopenia

(sometimes

profound) haemolyticanaemia

Immunesystem

disorders drugfever,serum

sickness,anaphylaxis,

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Descriptionofselectedadversereactions

Cephalosporinsasaclasstendtobeabsorbedontothesurfaceofredcellsmembranesandreactwithantibodies

directedagainstthedrugtoproduceapositiveCoombs’test(whichcaninterferewithcross-matchingofblood)and

veryrarelyhaemolyticanaemia.

Transientrisesinserumliverenzymeshavebeenobservedwhichareusuallyreversible.

Paediatricpopulation

Thesafetyprofileforcefuroximeaxetilinchildrenisconsistentwiththeprofileinadults.

4.9Overdose

Overdosecanleadtoneurologicalsequelaeincludingencephalopathy,convulsionsandcoma.Symptomsofoverdose

canoccurifthedoseisnotreducedappropriatelyinpatientswithrenalimpairment(seesections4.2and4.4).

Serumlevelsofcefuroximecanbereducedbyhaemodialysisandperitonealdialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:antibacterialsforsystemicuse,second-generationcephalosporins

ATC-Code:J01DC02

Mechanismofaction

Cefuroximeaxetilundergoeshydrolysisbyesteraseenzymestotheactiveantibiotic,cefuroxime.

Cefuroximeinhibitsbacterialcellwallsynthesisfollowingattachmenttopenicillinbindingproteins(PBPs).This

resultsintheinterruptionofcellwall(peptidoglycan)biosynthesis,whichleadstobacterialcelllysisanddeath.

Mechanismofresistance

Bacterialresistancetocefuroximemaybeduetooneormoreofthefollowingmechanisms:

hydrolysisbybeta-lactamases.:including(butnotlimitedto)byextended-spectrumbeta-lactamases(ESBLs),

reaction

Nervoussystem

disorders headache,

dizziness

Gastrointestinal

disorders diarrhoea,

nausea,

abdominalpain vomiting pseudomembranous

colitis

Hepatobiliary

disorders transient

increasesof

hepaticenzyme

levels jaundice

(predominantly

cholestatic),hepatitis

Skinand

subcutaneoustissue

disorders skinrashes urticaria,pruritus,

erythema

multiforme,Stevens-

Johnsonsyndrome,

toxicepidermal

necrolysis

(exanthematic

necrolysis)

(seeImmunesystem

disorders),

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species

reducedaffinityofpenicillin-bindingproteinsforcefuroxime

outermembraneimpermeability,whichrestrictsaccessofcefuroximetopenicillinbindingproteinsingram-

negativeorganisms

bacterialeffluxpumps

Organismsthathaveacquiredresistancetootherinjectablecephalosporinsareexpectedtoberesistanttocefuroxime.

Dependingonthemechanismofresistance,organismswithacquiredresistancetopenicillinsmaydemonstratereduced

susceptibilityorresistancetocefuroxime.

Cefuroximeaxetilbreakpoints

Minimuminhibitoryconcentration(MIC)breakpointsestablishedbytheEuropeanCommitteeonAntimicrobial

SusceptibilityTesting(EUCAST)areasfollows:

ThecephalosporinbreakpointsforEnterobacteriaceaewilldetectallclinicallyimportantresistancemechanisms

(includingESBLandplasmidmediatedAmpC).Somestrainsthatproducebeta-lactamasesaresusceptibleor

intermediateto3rdor4thgenerationcephalosporinswiththesebreakpointsandshouldbe

reportedasfound,i.e.thepresenceorabsenceofanESBLdoesnotinitselfinfluencethecategorizationof

susceptibility.Inmanyareas,ESBLdetectionandcharacterizationisrecommendedormandatoryforinfectioncontrol

purposes.

UncomplicatedUTI(cystitis)only(seesection4.1).

Susceptibilityofstaphylococcitocephalosporinsisinferredfromthemethicillinsusceptibilityexceptforceftazidme

andcefiximeandceftibuten,whichdonothavebreakpointsandshouldnotbeusedforstaphylococcalinfections.

Thebeta-lactamsusceptabilityofbeta-haemolyticstreptococcigroupsA,B,CandGisinferredfromthepenicillin

susceptibility.

insufficientevidencethatthespeciesinquestionisagoodtargetfortherapywiththedrug.AnMICwithacomment

butwithoutanaccompanyingSorR-categorizationmaybereported.

S=susceptible,R=resistant

Microbilologicalsusceptibility:

Theprevalenceofacquiredresistancemayvarygeographicallyandwithtimeforselectedspeciesandlocalinformation

onresistanceisdesirable,particularlywhentreatingsevereinfections.Asnecessary,expertadviceshouldbesought

whenthelocalprevalenceofresistanceissuchthattheutilityoftheagentinatleastsometypesofinfectionsis

questionable.

Microorganism Breakpoints(mg/L)

S R

Enterobacteriaceae 1,2 8.0 >8

Staphylococcusspp

Note 3

Note 3

Strept-coccusA,B,CandG

Note 4

Note 4

Streptococcuspneumoniae 0.25 >0.5

Haemophilusinfluenzae 0.125 >4

Moraxellacatarrhalis 0.125 >1

Non-speciesrelatedbreakpoints 1

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Commonlysusceptiblespecies

Grampositiveaerobes:

Staphylococcusaureus(methicillin-susceptible)*

Streptococcusagalactiae

Streptococcuspyogenes

Gramnegativeaerobes:

Haemophilusinfluenzae

Haemophilusparainfluenzae

Moraxellacatarrhalis

Spirochaetes:

Borreliaburgdorferi

Microorganismsforwhichacquiredresistancemaybe

aproblem

Gram-positiveaerobes:

Streptococcuspneumoniae

Gram-negativeaerobes:

Citrobacterfreundii

Enterobacteraerogenes

Enterobactercloacae

Escherichiacoli

Klebsiellapneumoniae

Proteusmirabilis

Proteusspp.(otherthanP.vulgaris)

Providenciaspp.

Gram-positiveanaerobes:

Peptostreptococcusspp.

Propionibacteriumspp.

Gram-negativeanaerobes:

Fusobacteriumspp.

Bacteroidesspp.

Inherentlyresistantorganisms

Gram-positiveaerobes:

Enterococcusfaecalis

Enterococcusfaecium

Gram-negativeaerobes:

Acinetobacterspp.

Campylobacterspp.

Morganellamorganii

Proteusvulgaris

Pseudomonasaeruginosa

Serratiamarcescens

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*Allmethicillin-resistantS.aureusareresistanttocefuroxime.

5.2Pharmacokineticproperties

Absorption:

Afteroraladministrationcefuroximeaxetilisabsorbedfromthegastrointestinaltractandrapidlyhydrolysedinthe

intestinalmucosaandbloodcausingthereleaseoftheactivecompoundcefuroximeintothecirculation.Optimum

absorptionoccurswhencefuroximaxetilistakenshortlyafterameal

Followingadministrationofcefuroximeaxetiltabletspeakserumlevels(2.9µg/mLfora125mgdose,4.4µg/mLfora

250mgdose,7.7µg/mLfora500mgdoseand13.6µg/mLfora1000mgdose)occurapproximately2.4hoursafter

dosingwhentakenwithfood.Therateofabsorptionofcefuroximefromthesuspensionisreducedcomparedwiththe

tablets,leadingtolater,lowerpeakserumlevelsandreducedsystemicbioavailability(4to17%less).Cefuroxime

axetiloralsuspensionwasnotbioequivalenttocefuroximeaxetiltabletswhentestedinhealthyadultsandthereforeis

notsubstitutableonamilligram-per-milligrambasis(seesection4.2).Thepharmacokineticsofcefuroximeislinear

overtheoraldosagerangeof125to1000mg.Noaccumulationofcefuroximeoccurredfollowingrepeatoraldosesof

250to500mg.

Distribution:

Proteinbindinghasbeenstatedas33to50%dependingonthemethodologyused.Followingasingledoseof

cefuroximeaxetil500mgtabletto12healthyvolunteers,theapparentvolumeofdistributionwas50L(CV%=28%).

Concentrationsofcefuroximeinexcessoftheminimuminhibitorylevelsforcommonpathogenscanbeachievedinthe

tonsilla,sinustissues,bronchialmucosa,bone,pleuralfluid,jointfluid,synovialfluid,interstitialfluid,bile,sputum

andaqueoushumor.Cefuroximepassestheblood-brainbarrierwhenthemeningesareinflamed.

Biotransformation:

Cefuroximeisnotmetabolised.

Elimination:

Theserumhalf-lifeisbetween1and1.5hours.Cefuroximeisexcretedbyglomerularfiltrationandtubularsecretion.

Therenalclearanceisintheregionof125to148mL/min/1.73m 2

Specialpatientpopulations

Gender

Nodifferencesinthepharmacokineticsofcefuroximewereobservedbetweenmalesandfemales.

Elderly

Nospecialprecautionisnecessaryintheelderlypatientswithnormalrenalfunctionatdosagesuptothenormal

maximumof1gperday.Elderlypatientsaremorelikelytohavedecreasedrenalfunction;therefore,thedoseshould

beadjustedinaccordancewiththerenalfunctionintheelderly(seesection4.2).

Paediatrics

Inolderinfants(aged>3months)andinchildren,thepharmacokineticsofcefuroximearesimilartothatobservedin

adults.Thereisnoclinicaltrialdataavailableontheuseofcefuroximeaxetilinchildrenundertheageof3months.

Renalimpairment

Thesafetyandefficacyofcefuroximeaxetilinpatientswithrenalfailurehavenotbeenestablished.

Bacteroidesfragilis

Others:

Chlamydiaspp.

Mycoplasmaspp.

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impairedrenalfunction(i.e.C1cr<30mL/minute)itisrecommendedthatthedosageofcefuroximeshouldbereduced

tocompensateforitsslowerexcretion(seesection4.2).Cefuroximeiseffectivelyremovedbydialysis.

Hepaticimpairment

Therearenodataavailableforpatientswithhepaticimpairment.Sincecefuroximeisprimarilyeliminatedbythe

kidney,thepresenceofhepaticdysfunctionisexpectedtohavenoeffectonthepharmacokineticsofcefuroxime.

PK/PDrelationship

Forcephalosporins,themostimportantpharmacokinetic-pharmacodynamicindexcorrelatingwithinvivoefficacyhas

beenshowntobethepercentageofthedosinginterval(%T)thattheunboundconcentrationremainsabovethe

minimuminhibitoryconcentration(MIC)ofcefuroximeforindividualtargetspecies(i.e.%T>MIC).

5.3Preclinicalsafetydata

Non-clinicaldatarevealnospecialhazardforhumansbasedonstudiesofsafetypharmacology,repeateddosetoxicity,

genotoxicityandtoxicitytoreproductionanddevelopment.Nocarcinogenicitystudieshavebeenperformed;however,

thereisnoevidencetosuggestcarcinogenicpotential.

Gamma-glutamyltranspeptidaseactivityinraturineisinhibitedbyvariouscephalosporins,however,thelevelof

inhibitionislesswithcefuroxime.Thismayhavesignificanceintheinterferenceinclinicallaboratorytestsinhumans.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Core:

Pregelatinizedstarch

Croscarmellosesodium

Sodiumlaurilsulfate

Microcrystallinecellulose

Colloidalanhydroussilica

Hydrogenatedvegetableoil(TypeI)

Coat:

Hypromellose(E464)

Titaniumdioxide(E171)

Propyleneglycol(E1520)

BrilliantBlueFCFaluminiumlake(E133)

IndigoCarmineAluminiumLake(E132)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions

6.5Natureandcontentsofcontainer

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Packsizes:8,10,12,14,16,20,24tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

TevaPharmaB.V.

Computerweg10

3542DRUtrecht

Netherlands

8MARKETINGAUTHORISATIONNUMBER

PA0749/082/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12 th

February2010

Dateoflastrenewal:30 th

December2012

10DATEOFREVISIONOFTHETEXT

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Date Printed 23/10/2013 CRN 2131697 page number: 10

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