AUGMENTIN-DUO 400/57 MG/5ml Powder for Oral Suspension

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM
Available from:
IMED Healthcare Ltd.
ATC code:
J01CR02
INN (International Name):
AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM
Dosage:
400/57 MG/5ml
Pharmaceutical form:
Powder for Oral Suspension
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Combinations of penicillins, incl. beta-lactamase inhibitors
Authorization status:
Authorised
Authorization number:
PPA1463/015/002
Authorization date:
2012-05-11

Packageleaflet-information for theuser

Augmentin-Duo400 mg/57mg/5mlPowderforOral

Suspension

Amoxicillin/clavulanicacid

Readallofthisleafletcarefullybeforeyoustartgivingyourchildthismedicinebecauseitcontainsimportant

informationforthem.

-Keepthisleaflet.Youmayneedtoreaditagain.

-Ifyouhaveanyfurtherquestions,askyourdoctor,pharmacistornurse.

-Thismedicineisusuallyprescribedforababyorchild.Donotpassitontoothers.Itmayharmthem,even

iftheirsignsofillness arethesameasyourchild’s.

-Ifyourchildgetsanysideeffects,talktoyourdoctor,pharmacistornurse.Thisincludesanypossibleside

effectsnotlistedinthisleaflet.Seesection4.

Whatisinthisleaflet:

1.WhatAugmentinisandwhatitisusedfor

2.WhatyouneedtoknowbeforeyougiveAugmentin

3.HowtogiveAugmentin

4.Possiblesideeffects

5.HowtostoreAugmentin

6.Contentsofthepackandotherinformation

1WHATAUGMENTINISANDWHATITISUSEDFOR

Augmentinisanantibioticandworksbykillingbacteriathatcauseinfections.Itcontainstwodifferent

medicinescalledamoxicillinandclavulanicacid.Amoxicillinbelongstoagroupofmedicinescalled

“penicillins”thatcansometimesbestoppedfromworking(madeinactive).Theotheractivecomponent

(clavulanicacid)stopsthisfromhappening.

Augmentinisusedinbabiesandchildrentotreatthefollowinginfections:

middleearandsinusinfections

respiratorytractinfections

urinarytractinfections

skinandsofttissueinfectionsincludingdentalinfections

boneandjointinfections.

2WHATYOUNEEDTOKNOWBEFOREYOUGIVEAUGMENTIN

DonotgiveyourchildAugmentin:

iftheyareallergictoamoxicillin,clavulanicacid,penicillinoranyoftheotheringredientsofthismedicine

(listedinsection6)

iftheyhaveeverhadasevereallergic(hypersensitive)reactiontoanyotherantibiotic.Thiscanincludea

skinrashorswellingofthefaceorneck

iftheyhaveeverhadliverproblemsorjaundice(yellowingoftheskin)whentakinganantibiotic.

➜DonotgiveAugmentintoyourchildifanyoftheaboveapplytoyourchild.Ifyouarenotsure,talkto

theirdoctororpharmacistbeforegivingAugmentin.

TakespecialcarewithAugmentin

Checkwiththeir doctor,pharmacistornursebeforegivingyourchildthismedicineifthey:

haveglandularfever

arebeingtreatedforliverorkidneyproblems

arenotpassingwaterregularly.

Ifyouarenotsureifanyoftheaboveapplytoyourchild,talktotheirdoctororpharmacistbeforegiving

Augmentin.

Insomecases,yourdoctormayinvestigatethetypeofbacteriathatiscausingyourchild’sinfection.

Dependingontheresults,yourchildmaybegivenadifferentstrengthofAugmentinoradifferentmedicine.

Conditionsyouneedtolookoutfor.

Augmentincanmakesomeexistingconditionsworse,orcauseserioussideeffects.Theseincludeallergic

reactions,convulsions(fits)andinflammationofthelargeintestine.Youmustlookoutforcertainsymptoms

while yourchildistakingAugmentin,toreducetheriskofanyproblems.See‘Conditionsyouneedtolook

outfor ’inSection4.

Bloodorurine tests

Ifyourchildishavingbloodtests(suchasredbloodcellstatustestsorliverfunctiontests)orurinetests,let

thedoctorornurseknowthattheyaretakingAugmentin.ThisisbecauseAugmentincanaffecttheresults

ofthesetypesoftests.

OthermedicinesandAugmentin

Tellyourdoctororpharmacistifyourchildistaking,hasrecentlytakenormighttakeanyothermedicines.

Thisincludesmedicinesthatcanbeboughtwithoutaprescriptionandherbalmedicines.

Ifyourchildistakingallopurinol(usedforgout)withAugmentin,itmaybemorelikelythattheywillhavean

allergicskinreaction.

Ifyourchildistakingprobenecid(usedforgout),yourdoctormaydecidetoadjustthedoseofAugmentin.

Ifmedicinestohelpstopbloodclots(suchaswarfarin)aretakenwithAugmentinthenextrabloodtestsmay

beneeded.

Augmentincanaffecthowmethotrexate(amedicineusedtotreatcancerorrheumaticdiseases)works.

Augmentincanaffecthowmycophenolatemofetil(amedicineusedtopreventtherejectionoftransplanted

organs)works.

Pregnancy,breast-feedingandfertility

Ifyourchildwhoisabouttotakethismedicineispregnantorbreast-feeding,thinkstheymaybepregnant

orareplanningtohaveababy,askyourdoctororpharmacistforadvicebeforetakingthismedicine.

Drivingandusingmachines

Augmentincanhavesideeffectsandthesymptomsmaymakeyouunfittodrive.

Donotdriveoroperatemachineryunlessyouarefeelingwell.

Augmentincontainsaspartameandmaltodextrin:

Augmentincontainsaspartame(E951)whichisasourceofphenylalanine.Thismaybeharmfulfor

childrenborn withaconditioncalled’phenylketonuria’.

Augmentincontainsmaltodextrin(glucose).Ifyouhavebeentoldbyyourdoctorthatyourchildhasan

intolerancetosomesugars,contactyourdoctorbeforetakingthismedicinalproduct.

3HOWTOGIVEAUGMENTIN

Alwaysgivethismedicineexactlyasyourdoctororpharmacisthastoldyou.Youshouldcheckwithyour

doctororpharmacistifyouarenotsure.

Adultsandchildrenweighing40kgorover

Thissuspensionisnotusuallyrecommendedforadultsandchildrenweighing40kgandover.Askyour

doctororpharmacistforadvice.

Childrenweighinglessthan40kg

Alldosesareworkedoutdependingonthechild’sbodyweightinkilograms.

YourdoctorwilladviseyouhowmuchAugmentinyoushouldgivetoyourbabyorchild.

Youmaybeprovidedwithaplasticmeasuringspoonorplasticmeasuringcupordosingsyringe.You

shouldusethistogivethecorrectdosetoyourbabyorchild.

Recommendeddose–25mg/3.6mgto45mg/6.4mgforeachkilogramofbodyweightaday,givenin

twodivideddoses.

Higherdose–upto70mg/10mgforeachkilogramofbodyweightaday,givenintwodivideddoses.

Patientswithkidneyandliverproblems

Ifyourchildhaskidneyproblemsthedosemightbelowered.Adifferentstrengthoradifferentmedicine

maybechosenbyyourdoctor.

Ifyourchildhasliverproblemstheymayhavemorefrequentbloodteststoseehowtheir liverisworking.

HowtogiveAugmentin

Alwaysshakethebottlewellbeforeeachdose

Giveatthestartofamealorslightlybefore

DonotgiveyourchildAugmentinformorethan2weeks.Ifyourchildstillfeelsunwelltheyshouldgoback

toseethedoctor.

IfyougivemoreAugmentinthanyoushould

IfyougiveyourchildtoomuchAugmentin,signsmightincludeanupsetstomach(feelingsick,beingsickor

diarrhoea)orconvulsions.Talktotheir doctorassoonaspossible.Takethemedicinebottletoshowthe

doctor.

IfyouforgettogiveAugmentin

Ifyouforgettogiveyourchildadose,giveitassoonasyouremember.Youshouldnotgiveyourchildthe

nextdosetoosoon,butwaitabout4hoursbeforegivingthenextdose.

IfyourchildstopstakingAugmentin

KeepgivingyourchildAugmentinuntilthetreatmentisfinished,eveniftheyfeelbetter.Yourchildneeds

everydosetohelpfighttheinfection.Ifsomebacteriasurvivetheycancausetheinfectiontocomeback.

Ifyouhaveanyfurtherquestionsontheuseofthisproduct,askyourdoctorpharmacistornurse.

4POSSIBLESIDEEFFECTS

Likeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.Thesideeffects

belowmayhappenwiththismedicine.

Conditionsyouneedtolook outfor

Allergicreactions:

skinrash

inflammationofbloodvessels(vasculitis)whichmaybevisibleasredorpurpleraisedspotsontheskin,

butcanaffectotherpartsofthebody

fever,jointpain,swollenglandsintheneck,armpitorgroin

swelling,sometimesofthefaceormouth(angioedema),causingdifficultyinbreathing

collapse.

Contactadoctorimmediatelyifyourchildgetsanyofthesesymptoms.StoptakingAugmentin.

Inflammationoflargeintestine

Inflammationofthelargeintestine,causingwaterydiarrhoeausuallywithbloodandmucus,stomachpain

and/orfever.

Contactyourdoctorassoonaspossibleforadviceifyourchildgetsthesesymptoms.

Commonsideeffects

Thesemayaffectupto1in10people

thrush(candida-ayeastinfectionofthevagina,mouthorskinfolds)

feelingsick(nausea),especiallywhentakinghighdoses

➜ifaffectedtakeAugmentinbeforefood.

vomiting

diarrhoea(inchildren).

Uncommonsideeffects

Thesemayaffectupto1in100people

skinrash,itching

raiseditchyrash(hives)

indigestion

dizziness

headache.

Uncommonsideeffectsthatmayshowupinbloodtests:

increaseinsomesubstances(enzymes)producedbytheliver.

Rareside effects

Thesemayaffectupto1in1000people

skinrash,whichmayblister,andlookslikesmalltargets(centraldarkspotssurroundedbyapalerarea,

withadarkringaroundtheedge –erythemamultiforme)

➜ifyounoticeanyofthesesymptomscontactadoctorurgently.

Rareside effectsthatmayshowupinbloodtests:

lownumberofcellsinvolvedinbloodclotting

lownumberofwhitebloodcells.

Othersideeffects

Othersideeffectshaveoccurredinaverysmallnumberofpeoplebuttheirexactfrequencyisunknown.

Allergicreactions(seeabove)

Inflammationofthelargeintestine(seeabove)

Inflammationoftheprotectivemembranesurroundingthebrain(asepticmeningitis)

Seriousskinreactions:

-awidespreadrashwithblistersandpeelingskin,particularlyaroundthemouth,nose,eyesandgenitals

(Stevens-Johnsonsyndrome),andamoresevereform,causingextensivepeelingoftheskin(morethan

30%ofthebodysurface –toxicepidermalnecrolysis)

-widespreadredskinrashwithsmallpus-containingblisters(bullousexfoliativedermatitis)

-ared,scalyrashwithbumpsundertheskinandblisters(exanthemouspustulosis).

Contactadoctorimmediatelyifyourchildgetsanyofthesesymptoms.

inflammationoftheliver(hepatitis)

jaundice,causedbyincreasesinthebloodofbilirubin(asubstanceproducedintheliver)whichmaymake

your child’sskinandwhitesoftheeyesappearyellow

inflammationoftubesinthekidney

bloodtakeslongertoclot

hyperactivity

convulsions(inpeopletakinghighdosesofAugmentinorwhohavekidneyproblems)

blacktonguewhichlookshairy

stainedteeth(inchildren),usuallyremovedbybrushing.

Sideeffectsthatmayshowupinbloodorurinetests:

severereductioninthenumberofwhitebloodcells

lownumberofredbloodcells(haemolyticanaemia)

crystalsinurine.

Reportingofsideeffects

Ifyougetanysideeffects,talktoyourdoctor,pharmacistornurse. Thisincludesanypossiblesideeffects

notlistedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviaHPRAPharmacovigilance,Earlsfort

Terrace,IRL-Dublin2;Tel:+35316764971;Fax:+35316762517.Website: www.hpra.ie ; E-mail:

medsafety@hpra.ie .Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthis

medicine.

5HOWTOSTOREAUGMENTIN

Storeintheoriginalpackageinordertoprotectfrommoisture.

Thedrypowdershouldbestoredintheoriginalcontainer.

Donotstoreabove25°C.

Reconstitutedsuspensionsshouldbestoredat2°C –8°C (butnotfrozen)foruptosevendays.

Keepoutofthereachandsightofchildren.

DonotuseAugmentin-DuoSuspenionaftertheexpirydatewhichisstatedonthecartonandbottlelabel

afterEXP.

Theexpirydatereferstothelastdayofthatmonth.

Donotthrowawayanymedicinesviawastewaterorhouseholdwaste.Askyourpharmacisthowtothrow

awaymedicinesyounolongeruse.Thesemeasureswillhelpprotecttheenvironment.

6CONTENTSOFTHEPACKANDOTHERINFORMATION

WhatAugmentincontains

Theactivesubstancesareamoxicillintrihydateequivalentto400mgamoxicillinandpotassiumclavulanate

equivalentto57mgofclavulanicacid.Amoxicillinisanantibioticandclavulanicacidisabeta-lactamase

inhibitor,whichiscommonlycombinedwiththepenicillingroupantibioticstoovercomeantibioticresistance.

Whenreconstituted,each5mloforalsuspensioncontainsamoxicillintrihydrateequivalentto400mgof

amoxicillinandpotassiumclavulanateequivalentto57mgofclavulanicacid.

Theotheringredientsinthismedicineare:Crospovidone,Croscarmellosesodium,Xanthangum,Colloidial

anhydroussilica,Magnesiumstearate,Sodiumbenzoate,Aspartame(E951),Strawberryflavour(containing

maltodextrin),Silicondioxide

WhatAugmentinlookslikeandcontentsofthepack

Clearglassbottlecontainingadrywhitepowderwithyellowishgrainsandacharacteristicodourfor

reconstitutionto35mlor70ml.

Thismaybesuppliedwithaplasticmeasuringspoonorplasticmeasuringcupordosingsyringe.

Notallpacksizesmaybemarketed

ParallelProductAuthorisationHolderandManufacturer

ProductprocuredfromwithintheEUbythe ParallelProductAuthorisationHolder:

IMEDHealthcareLtd,Unit625KilshaneAvenue,NorthwestBusinessPark,Ballycoolin,Dublin15,Ireland

Manufacturer:

SmithKlineBeechamPharmaceuticals,ClarendonRoad,Worthing,WestSussex,BN148QH,United

Kingdom.

Repackagedby:

CastHealthcareLtd,UnitB6TheBusinessCentre,5-7TobermoreRoad,Draperstown,BT457AG,UK

ThismedicinalproductisauthorisedintheMemberStatesoftheEEAunderthefollowingnames:

Austria –Augmentin,

Cyprus –Augmentin,

CzechRepublic-AugmentinDuo

Estonia –Augmentin

Finland –Augmentin,

Greece –Augmentin

Hungary-AugmentinDuo

Iceland –Augmentin

Ireland –AugmentinDuo

Italy –Augmentin,Clavulin

Latvia –Augmentin

Malta –Augmentin,

Poland –Augmentin

Portugal –AugmentinDuo,

Romania –AugmentinBIS

SlovakRepublic-AugmentinDUO

Slovenia –Augmentin

Sweden –Spektramox

UnitedKingdom –AugmentinDuo

ThisleafletwaslastapprovedinApril2014

©2010GlaxoSmithKlinegroupofco mpanies“AllRightsReserved”

‘Augmentin-Duo’isatrademarkoftheGlaxoSmithKlinegroupofcompanies

Advice/medicaleducation

Antibioticsareusedtotreatinfectionscausedbybacteria.Theyhavenoeffectagainstinfectionscausedby

viruses.

Sometimesaninfectioncausedbybacteriadoesnotrespondtoacourseofanantibiotic.Oneofthe

commonestreasonsforthistooccurisbecausethebacteriacausingtheinfectionareresistanttothe

antibioticthatisbeingtaken.Thismeansthattheycansurviveandevenmultiplydespitetheantibiotic.

Bacteriacanbecomeresistanttoantibioticsformanyreasons.Usingantibioticscarefullycanhelptoreduce

thechanceofbacteriabecomingresistanttothem.

Whenyourdoctorprescribesacourseofanantibioticitisintendedtotreatonlyyourcurrentillness.Paying

attentiontothefollowingadvicewillhelppreventtheemergenceofresistantbacteriathatcouldstopthe

antibioticworking.

1.Itisveryimportantthatyoutaketheantibioticattherightdose,attherighttimesandfortherightnumber

ofdays.Readtheinstructionsonthelabelandifyoudonotunderstandanythingaskyourdoctoror

pharmacisttoexplain.

2.Youshouldnottakeanantibioticunlessithasbeenprescribedspecificallyforyouandyoushoulduseit

onlytotreattheinfectionforwhichitwasprescribed.

3.Youshouldnottakeantibioticsthathavebeenprescribedforotherpeopleeveniftheyhadaninfection

thatwassimilartoyours.

4.Youshouldnotgiveantibioticsthatwereprescribedforyoutootherpeople.

5.Ifyouhaveanyantibioticleftoverwhenyouhavetakenthecourseasdirectedbyyourdoctoryoushould

taketheremaindertoapharmacyforappropriatedisposal.

Instructions forreconstitution

Checkcapsealisintactbeforeusing.Shakebottletoloosenpowder.Addvolumeofwater(asindicated

below)invertandshakewell.Alternativelyshakebottletoloosenpowderthenfillthebottlewithwatertojust

belowthelineonthebottleorlabel.Invertandshakewell,thentopupwithwaterexactlytotheline.Invert

andagainshakewell.

Strength Volume ofwaterto be

added atreconstitution(ml) Finalvolume ofreconstituted

oralsuspension (ml)

400mg/57mg/5ml 32 35

64 70

Shakethebottlewellbeforeeachdose.

Packageleaflet-information for theuser

Augmentin-Duo400 mg/57mg/5mlPowderforOral

Suspension

Amoxicillin/clavulanicacid

Readallofthisleafletcarefullybeforeyoustartgivingyourchildthismedicinebecauseitcontainsimportant

informationforthem.

-Keepthisleaflet.Youmayneedtoreaditagain.

-Ifyouhaveanyfurtherquestions,askyourdoctor,pharmacistornurse.

-Thismedicineisusuallyprescribedforababyorchild.Donotpassitontoothers.Itmayharmthem,even

iftheirsignsofillness arethesameasyourchild’s.

-Ifyourchildgetsanysideeffects,talktoyourdoctor,pharmacistornurse.Thisincludesanypossibleside

effectsnotlistedinthisleaflet.Seesection4.

Whatisinthisleaflet:

1.WhatAugmentinisandwhatitisusedfor

2.WhatyouneedtoknowbeforeyougiveAugmentin

3.HowtogiveAugmentin

4.Possiblesideeffects

5.HowtostoreAugmentin

6.Contentsofthepackandotherinformation

1WHATAUGMENTINISANDWHATITISUSEDFOR

Augmentinisanantibioticandworksbykillingbacteriathatcauseinfections.Itcontainstwodifferent

medicinescalledamoxicillinandclavulanicacid.Amoxicillinbelongstoagroupofmedicinescalled

“penicillins”thatcansometimesbestoppedfromworking(madeinactive).Theotheractivecomponent

(clavulanicacid)stopsthisfromhappening.

Augmentinisusedinbabiesandchildrentotreatthefollowinginfections:

middleearandsinusinfections

respiratorytractinfections

urinarytractinfections

skinandsofttissueinfectionsincludingdentalinfections

boneandjointinfections.

2WHATYOUNEEDTOKNOWBEFOREYOUGIVEAUGMENTIN

DonotgiveyourchildAugmentin:

iftheyareallergictoamoxicillin,clavulanicacid,penicillinoranyoftheotheringredientsofthismedicine

(listedinsection6)

iftheyhaveeverhadasevereallergic(hypersensitive)reactiontoanyotherantibiotic.Thiscanincludea

skinrashorswellingofthefaceorneck

iftheyhaveeverhadliverproblemsorjaundice(yellowingoftheskin)whentakinganantibiotic.

➜DonotgiveAugmentintoyourchildifanyoftheaboveapplytoyourchild.Ifyouarenotsure,talkto

theirdoctororpharmacistbeforegivingAugmentin.

TakespecialcarewithAugmentin

Checkwiththeir doctor,pharmacistornursebeforegivingyourchildthismedicineifthey:

haveglandularfever

arebeingtreatedforliverorkidneyproblems

arenotpassingwaterregularly.

Ifyouarenotsureifanyoftheaboveapplytoyourchild,talktotheirdoctororpharmacistbeforegiving

Augmentin.

Insomecases,yourdoctormayinvestigatethetypeofbacteriathatiscausingyourchild’sinfection.

Dependingontheresults,yourchildmaybegivenadifferentstrengthofAugmentinoradifferentmedicine.

Conditionsyouneedtolookoutfor.

Augmentincanmakesomeexistingconditionsworse,orcauseserioussideeffects.Theseincludeallergic

reactions,convulsions(fits)andinflammationofthelargeintestine.Youmustlookoutforcertainsymptoms

while yourchildistakingAugmentin,toreducetheriskofanyproblems.See‘Conditionsyouneedtolook

outfor ’inSection4.

Bloodorurine tests

Ifyourchildishavingbloodtests(suchasredbloodcellstatustestsorliverfunctiontests)orurinetests,let

thedoctorornurseknowthattheyaretakingAugmentin.ThisisbecauseAugmentincanaffecttheresults

ofthesetypesoftests.

OthermedicinesandAugmentin

Tellyourdoctororpharmacistifyourchildistaking,hasrecentlytakenormighttakeanyothermedicines.

Thisincludesmedicinesthatcanbeboughtwithoutaprescriptionandherbalmedicines.

Ifyourchildistakingallopurinol(usedforgout)withAugmentin,itmaybemorelikelythattheywillhavean

allergicskinreaction.

Ifyourchildistakingprobenecid(usedforgout),yourdoctormaydecidetoadjustthedoseofAugmentin.

Ifmedicinestohelpstopbloodclots(suchaswarfarin)aretakenwithAugmentinthenextrabloodtestsmay

beneeded.

Augmentincanaffecthowmethotrexate(amedicineusedtotreatcancerorrheumaticdiseases)works.

Augmentincanaffecthowmycophenolatemofetil(amedicineusedtopreventtherejectionoftransplanted

organs)works.

Pregnancy,breast-feedingandfertility

Ifyourchildwhoisabouttotakethismedicineispregnantorbreast-feeding,thinkstheymaybepregnant

orareplanningtohaveababy,askyourdoctororpharmacistforadvicebeforetakingthismedicine.

Drivingandusingmachines

Augmentincanhavesideeffectsandthesymptomsmaymakeyouunfittodrive.

Donotdriveoroperatemachineryunlessyouarefeelingwell.

Augmentincontainsaspartameandmaltodextrin:

Augmentincontainsaspartame(E951)whichisasourceofphenylalanine.Thismaybeharmfulfor

childrenborn withaconditioncalled’phenylketonuria’.

Augmentincontainsmaltodextrin(glucose).Ifyouhavebeentoldbyyourdoctorthatyourchildhasan

intolerancetosomesugars,contactyourdoctorbeforetakingthismedicinalproduct.

3HOWTOGIVEAUGMENTIN

Alwaysgivethismedicineexactlyasyourdoctororpharmacisthastoldyou.Youshouldcheckwithyour

doctororpharmacistifyouarenotsure.

Adultsandchildrenweighing40kgorover

Thissuspensionisnotusuallyrecommendedforadultsandchildrenweighing40kgandover.Askyour

doctororpharmacistforadvice.

Childrenweighinglessthan40kg

Alldosesareworkedoutdependingonthechild’sbodyweightinkilograms.

YourdoctorwilladviseyouhowmuchAugmentinyoushouldgivetoyourbabyorchild.

Youmaybeprovidedwithaplasticmeasuringspoonorplasticmeasuringcupordosingsyringe.You

shouldusethistogivethecorrectdosetoyourbabyorchild.

Recommendeddose–25mg/3.6mgto45mg/6.4mgforeachkilogramofbodyweightaday,givenin

twodivideddoses.

Higherdose–upto70mg/10mgforeachkilogramofbodyweightaday,givenintwodivideddoses.

Patientswithkidneyandliverproblems

Ifyourchildhaskidneyproblemsthedosemightbelowered.Adifferentstrengthoradifferentmedicine

maybechosenbyyourdoctor.

Ifyourchildhasliverproblemstheymayhavemorefrequentbloodteststoseehowtheir liverisworking.

HowtogiveAugmentin

Alwaysshakethebottlewellbeforeeachdose

Giveatthestartofamealorslightlybefore

DonotgiveyourchildAugmentinformorethan2weeks.Ifyourchildstillfeelsunwelltheyshouldgoback

toseethedoctor.

IfyougivemoreAugmentinthanyoushould

IfyougiveyourchildtoomuchAugmentin,signsmightincludeanupsetstomach(feelingsick,beingsickor

diarrhoea)orconvulsions.Talktotheir doctorassoonaspossible.Takethemedicinebottletoshowthe

doctor.

IfyouforgettogiveAugmentin

Ifyouforgettogiveyourchildadose,giveitassoonasyouremember.Youshouldnotgiveyourchildthe

nextdosetoosoon,butwaitabout4hoursbeforegivingthenextdose.

IfyourchildstopstakingAugmentin

KeepgivingyourchildAugmentinuntilthetreatmentisfinished,eveniftheyfeelbetter.Yourchildneeds

everydosetohelpfighttheinfection.Ifsomebacteriasurvivetheycancausetheinfectiontocomeback.

Ifyouhaveanyfurtherquestionsontheuseofthisproduct,askyourdoctorpharmacistornurse.

4POSSIBLESIDEEFFECTS

Likeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.Thesideeffects

belowmayhappenwiththismedicine.

Conditionsyouneedtolook outfor

Allergicreactions:

skinrash

inflammationofbloodvessels(vasculitis)whichmaybevisibleasredorpurpleraisedspotsontheskin,

butcanaffectotherpartsofthebody

fever,jointpain,swollenglandsintheneck,armpitorgroin

swelling,sometimesofthefaceormouth(angioedema),causingdifficultyinbreathing

collapse.

Contactadoctorimmediatelyifyourchildgetsanyofthesesymptoms.StoptakingAugmentin.

Inflammationoflargeintestine

Inflammationofthelargeintestine,causingwaterydiarrhoeausuallywithbloodandmucus,stomachpain

and/orfever.

Contactyourdoctorassoonaspossibleforadviceifyourchildgetsthesesymptoms.

Commonsideeffects

Thesemayaffectupto1in10people

thrush(candida-ayeastinfectionofthevagina,mouthorskinfolds)

feelingsick(nausea),especiallywhentakinghighdoses

➜ifaffectedtakeAugmentinbeforefood.

vomiting

diarrhoea(inchildren).

Uncommonsideeffects

Thesemayaffectupto1in100people

skinrash,itching

raiseditchyrash(hives)

indigestion

dizziness

headache.

Uncommonsideeffectsthatmayshowupinbloodtests:

increaseinsomesubstances(enzymes)producedbytheliver.

Rareside effects

Thesemayaffectupto1in1000people

skinrash,whichmayblister,andlookslikesmalltargets(centraldarkspotssurroundedbyapalerarea,

withadarkringaroundtheedge –erythemamultiforme)

➜ifyounoticeanyofthesesymptomscontactadoctorurgently.

Rareside effectsthatmayshowupinbloodtests:

lownumberofcellsinvolvedinbloodclotting

lownumberofwhitebloodcells.

Othersideeffects

Othersideeffectshaveoccurredinaverysmallnumberofpeoplebuttheirexactfrequencyisunknown.

Allergicreactions(seeabove)

Inflammationofthelargeintestine(seeabove)

Inflammationoftheprotectivemembranesurroundingthebrain(asepticmeningitis)

Seriousskinreactions:

-awidespreadrashwithblistersandpeelingskin,particularlyaroundthemouth,nose,eyesandgenitals

(Stevens-Johnsonsyndrome),andamoresevereform,causingextensivepeelingoftheskin(morethan

30%ofthebodysurface –toxicepidermalnecrolysis)

-widespreadredskinrashwithsmallpus-containingblisters(bullousexfoliativedermatitis)

-ared,scalyrashwithbumpsundertheskinandblisters(exanthemouspustulosis).

Contactadoctorimmediatelyifyourchildgetsanyofthesesymptoms.

inflammationoftheliver(hepatitis)

jaundice,causedbyincreasesinthebloodofbilirubin(asubstanceproducedintheliver)whichmaymake

your child’sskinandwhitesoftheeyesappearyellow

inflammationoftubesinthekidney

bloodtakeslongertoclot

hyperactivity

convulsions(inpeopletakinghighdosesofAugmentinorwhohavekidneyproblems)

blacktonguewhichlookshairy

stainedteeth(inchildren),usuallyremovedbybrushing.

Sideeffectsthatmayshowupinbloodorurinetests:

severereductioninthenumberofwhitebloodcells

lownumberofredbloodcells(haemolyticanaemia)

crystalsinurine.

Reportingofsideeffects

Ifyougetanysideeffects,talktoyourdoctor,pharmacistornurse. Thisincludesanypossiblesideeffects

notlistedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviaHPRAPharmacovigilance,Earlsfort

Terrace,IRL-Dublin2;Tel:+35316764971;Fax:+35316762517.Website: www.hpra.ie ; E-mail:

medsafety@hpra.ie .Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthis

medicine

5HOWTOSTOREAUGMENTIN

Storeintheoriginalpackageinordertoprotectfrommoisture.

Thedrypowdershouldbestoredintheoriginalcontainer.

Donotstoreabove25°C.

Reconstitutedsuspensionsshouldbestoredat2°C –8°C (butnotfrozen)foruptosevendays.

Keepoutofthereachandsightofchildren.

DonotuseAugmentin-DuoSuspenionaftertheexpirydatewhichisstatedonthecartonandbottlelabel

afterEXP.

Theexpirydatereferstothelastdayofthatmonth.

Donotthrowawayanymedicinesviawastewaterorhouseholdwaste.Askyourpharmacisthowtothrow

awaymedicinesyounolongeruse.Thesemeasureswillhelpprotecttheenvironment.

6CONTENTSOFTHEPACKANDOTHERINFORMATION

WhatAugmentincontains

Theactivesubstancesareamoxicillintrihydateequivalentto400mgamoxicillinandpotassiumclavulanate

equivalentto57mgofclavulanicacid.Amoxicillinisanantibioticandclavulanicacidisabeta-lactamase

inhibitor,whichiscommonlycombinedwiththepenicillingroupantibioticstoovercomeantibioticresistance.

Whenreconstituted,each5mloforalsuspensioncontainsamoxicillintrihydrateequivalentto400mgof

amoxicillinandpotassiumclavulanateequivalentto57mgofclavulanicacid.

Theotheringredientsinthismedicineare:Crospovidone,Croscarmellosesodium,Xanthangum,Colloidial

anhydroussilica,Magnesiumstearate,Sodiumbenzoate,Aspartame(E951),Strawberryflavour(containing

maltodextrin),Silicondioxide

WhatAugmentinlookslikeandcontentsofthepack

Clearglassbottlecontainingadrywhitepowderwithyellowishgrainsandacharacteristicodourfor

reconstitutionto35mlor70ml.

Thismaybesuppliedwithaplasticmeasuringspoonorplasticmeasuringcupordosingsyringe.

Notallpacksizesmaybemarketed

ParallelProductAuthorisationHolderandManufacturer

ProductprocuredfromwithintheEUbythe ParallelProductAuthorisationHolder:

IMEDHealthcareLtd,Unit625KilshaneAvenue,NorthwestBusinessPark,Ballycoolin,Dublin15,Ireland

Manufacturer:

SmithKlineBeechamPharmaceuticals,ClarendonRoad,Worthing,WestSussex,BN148QH,United

Kingdom.

Repackagedby:

IMEDPharmaLtd,Unit625KilshaneAvenue,NorthwestBusinessPark,Ballycoolin,Dublin15,Ireland.

ThismedicinalproductisauthorisedintheMemberStatesoftheEEAunderthefollowingnames:

Austria –Augmentin,

Cyprus –Augmentin,

CzechRepublic-AugmentinDuo

Estonia –Augmentin

Finland –Augmentin,

Greece –Augmentin

Hungary-AugmentinDuo

Iceland –Augmentin

Ireland –AugmentinDuo

Italy –Augmentin,Clavulin

Latvia –Augmentin

Malta –Augmentin,

Poland –Augmentin

Portugal –AugmentinDuo,

Romania –AugmentinBIS

SlovakRepublic-AugmentinDUO

Slovenia –Augmentin

Sweden –Spektramox

UnitedKingdom –AugmentinDuo

ThisleafletwaslastapprovedinApril2014

©2010GlaxoSmithKlinegroup ofcompanies“AllRightsReserved”

‘Augmentin-Duo’isatrademarkoftheGlaxoSmithKlinegroupofcompanies

Advice/medicaleducation

Antibioticsareusedtotreatinfectionscausedbybacteria.Theyhavenoeffectagainstinfectionscausedby

viruses.

Sometimesaninfectioncausedbybacteriadoesnotrespondtoacourseofanantibiotic.Oneofthe

commonestreasonsforthistooccurisbecausethebacteriacausingtheinfectionareresistanttothe

antibioticthatisbeingtaken.Thismeansthattheycansurviveandevenmultiplydespitetheantibiotic.

Bacteriacanbecomeresistanttoantibioticsformanyreasons.Usingantibioticscarefullycanhelptoreduce

thechanceofbacteriabecomingresistanttothem.

Whenyourdoctorprescribesacourseofanantibioticitisintendedtotreatonlyyourcurrentillness.Paying

attentiontothefollowingadvicewillhelppreventtheemergenceofresistantbacteriathatcouldstopthe

antibioticworking.

1.Itisveryimportantthatyoutaketheantibioticattherightdose,attherighttimesandfortherightnumber

ofdays.Readtheinstructionsonthelabelandifyoudonotunderstandanythingaskyourdoctoror

pharmacisttoexplain.

2.Youshouldnottakeanantibioticunlessithasbeenprescribedspecificallyforyouandyoushoulduseit

onlytotreattheinfectionforwhichitwasprescribed.

3.Youshouldnottakeantibioticsthathavebeenprescribedforotherpeopleeveniftheyhadaninfection

thatwassimilartoyours.

4.Youshouldnotgiveantibioticsthatwereprescribedforyoutootherpeople.

5.Ifyouhaveanyantibioticleftoverwhenyouhavetakenthecourseasdirectedbyyourdoctoryoushould

taketheremaindertoapharmacyforappropriatedisposal.

Instructions forreconstitution

Checkcapsealisintactbeforeusing.Shakebottletoloosenpowder.Addvolumeofwater(asindicated

below)invertandshakewell.Alternativelyshakebottletoloosenpowderthenfillthebottlewithwatertojust

belowthelineonthebottleorlabel.Invertandshakewell,thentopupwithwaterexactlytotheline.Invert

andagainshakewell.

Strength Volume ofwaterto be

added atreconstitution(ml) Finalvolume ofreconstituted

oralsuspension (ml)

400mg/57mg/5ml 32 35

64 70

Shakethebottlewellbeforeeachdose.

Document Outline

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Augmentin-Duo 400 mg/57 mg/5ml Powder for Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 80mg amoxicillin and

potassium clavulanate equivalent to 11.4mg clavulanic acid.

Each 5ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 400mg amoxicillin and potassium

clavulanate equivalent to 57mg clavulanic acid.

Excipients: aspartame (E951), maltodextrin

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Powder for oral suspension.

Product imported from Poland:

Dry white powder for reconstitution with yellowish grains & a characteristic odour.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and

5.1):

Acute bacterial sinusitis (adequately diagnosed)

Acute otitis media

Acute exacerbations of chronic bronchitis (adequately diagnosed)

Community acquired pneumonia

Cystitis

Pyelonephritis

Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.

Bone and joint infections, in particular osteomyelitis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms

of an individual component.

The dose of Augmentin that is selected to treat an individual infection should take into account:

The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)

The severity and the site of the infection

The age, weight and renal function of the patient as shown below.

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The use of alternative presentations of Augmentin (e.g. those that provide higher doses of amoxicillin and/or different

ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1).

For children < 40 kg, this formulation of Augmentin provides a maximum daily dose of 1000-2800 mg

amoxicillin/143-400 mg clavulanic acid, when administered as recommended below. If it is considered that a higher

daily dose of amoxicillin is required, it is recommended that another preparation of Augmentin is selected in order to

avoid administration of unnecessarily high daily doses of clavulanic acid (see

sections 4.4 and 5.1).

The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis)

require longer periods of treatment. Treatment should not be extended beyond 14 days without review (see section 4.4

regarding prolonged therapy).

Children

40kg should be treated with the adult formulations of Augmentin

Children < 40 kg

Children may be treated with Augmentin tablets, suspensions or paediatric sachets.

Recommended doses:

25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day given as two divided doses;

up to 70 mg/10 mg/kg/day given as two divided doses may be considered for some infections (such as otitis

media, sinusitis and lower respiratory tract infections).

No clinical data are available for Augmentin 7:1 formulations regarding doses higher than 45 mg/6.4 mg per kg per day

in children under 2 years

There are no clinical data for Augmentin 7:1 formulations for patients under 2 months of age.

Dosing recommendations in this population therefore cannot be made.

Elderly

No dose adjustment is considered necessary.

Renal impairment

No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.

In patients with creatinine clearance less than 30 ml/min, the use of Augmentin presentations with an amoxicillin to

clavulanic acid ratio of 7:1 is not recommended, as no recommendations for dose adjustments are available.

Hepatic impairment

Dose with caution and monitor hepatic function at regular intervals (see sections 4.3 and 4.4).

Method of administration

Augmentin is for oral use.

Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of

amoxicillin/clavulanic acid.

Therapy can be started parenterally according to the SmPC of the IV-formulation and continued with an oral

preparation.

Shake to loosen powder, add water as directed, invert and shake.

Shake the bottle before each dose (see section 6.6).

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4.3 Contraindications

Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients listed in section 6.1.

History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a

cephalosporin, carbapenem or monobactam).

History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid (see section 4.8).

4.4 Special warnings and precautions for use

Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous

hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents (see sections 4.3 and 4.8).

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin

therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in

atopic individuals. If an allergic reaction occurs, amoxicillin/clavulanic acid therapy must be discontinued and

appropriate alternative therapy instituted.

In the case that an infection is proven to be due to an amoxicillin-susceptible organisms(s) then consideration should be

given to switching from amoxicillin/clavulanic acid to amoxicillin in accordance with official guidance.

This presentation of Augmentin is not suitable for use when there is a high risk that the presumptive pathogens have

resistance to beta-lactam agents that is not mediated by beta-lactamases susceptible to inhibition by clavulanic acid.

This presentation should not be used to treat penicillin-resistant S. pneumoniae.

Convulsions may occur in patients with impaired renal function or in those receiving high doses (see 4.8).

Amoxicillin/clavulanic acid should be avoided if infectious mononucleosis is suspected since the occurrence of a

morbilliform rash has been associated with this condition following the use of amoxicillin.

Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom

of acute generalised exanthemous pustulosis (AGEP) (see Section 4.8). This reaction requires Augmentin

discontinuation and contra-indicates any subsequent administration of amoxicillin.

Amoxicillin/clavulanic acid should be used with caution in patients with evidence of hepatic impairment (see sections

4.2, 4.3 and 4.8).

Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged

treatment. These events have been very rarely reported in children. In all populations, signs and symptoms usually

occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment

has ceased. These are usually reversible.

Hepatic events may be severe and in extremely rare circumstances, deaths have been reported. These have almost

always occurred in patients with serious underlying disease or taking concomitant medications known to have the

potential for hepatic effects (see section 4.8).

Antibiotic-associated colitis has been reported with nearly all antibacterial agents including amoxicillin and may range

in severity from mild to life threatening (see section 4.8). Therefore, it is important to consider this diagnosis in patients

who present with diarrhoea during or subsequent to the administration of any antibiotics. Should antibioticassociated

colitis occur, Augmentin should immediately be discontinued, a physician be consulted and an appropriate therapy

initiated. Anti-peristaltic drugs are contra-indicated in this situation.

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Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function is advisable during

prolonged therapy.

Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin/clavulanic acid.

Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the

dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see section 4.5 and 4.8).

In patients with renal impairment, the dose should be adjusted according to the degree of impairment (see section 4.2).

In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral

therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and

urinary output in order to reduce the possibility of amoxicillin crystalluria. In patients with bladder catheters, a regular

check of patency should be maintained (see section 4.9).

During treatment with amoxicillin, enzymatic glucose oxidase methods should be used whenever testing for the

presence of glucose in urine because false positive results may occur with non-enzymatic methods.

The presence of clavulanic acid in Augmentin may cause a non-specific binding of IgG and albumin by red cell

membranes leading to a false positive Coombs test.

There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients

receiving amoxicillin/clavulanic acid who were subsequently found to be free of Aspergillus infection. Cross-reactions

with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have

been reported. Therefore, positive test results in patients receiving amoxicillin/clavulanic acid should be interpreted

cautiously and confirmed by other diagnostic methods.

Augmentin 400mg/57mg/5ml powder for oral suspension contains 3.32 mg of aspartame (E951) per ml, a source of

phenylalanine. This medicine should be used with caution in patients with phenylketonuria.

This medicinal product contains maltodextrin (glucose). Patients with rare glucose-galactose malabsorption should not

take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Oral anticoagulants

Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction.

However, in the literature there are cases of increased international normalised ratio in patients maintained on

acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin

time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.

Moreover, adjustments in the dose of oral anticoagulants may be necessary (see sections 4.4 and 4.8).

Methotrexate

Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

Probenecid

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin.

Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic

acid.

Mycophenolate mofetil

In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active metabolite mycophenolic

acid (MPA) of approximately 50% has been reported following commencement of oral amoxicillin plus clavulanic

acid. The change in pre-dose level may not accurately represent changes in overall MPA exposure.

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Therefore, a change in the dose of mycophenolate mofetil should not normally be necessary in the absence of clinical

evidence of graft dysfunction. However, close clinical monitoring should be performed during the combination and

shortly after antibiotic treatment.

4.6 Fertility, pregnancy and lactation

Pregnancy

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal

development, parturition or postnatal development (see section 5.3). Limited data on the use of amoxicillin/clavulanic

acid during pregnancy in humans do not indicate an increased risk of congenital malformations. In a single study in

women with preterm, premature rupture of the foetal membrane it was reported that prophylactic treatment with

amoxicillin/clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates. Use

should be avoided during pregnancy, unless considered essential by the physician.

Breastfeeding

Both substances are excreted into breast milk (nothing is known of the effects of clavulanic acid on the breast-fed

infant). Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breast-fed infant, so

that breast-feeding might have to be discontinued. Amoxicillin/clavulanic acid should only be used during

breastfeeding after benefit/risk assessment by the physician in charge.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

However, undesirable effects

may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines

(see section 4.8).

4.8 Undesirable effects

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting.

The ADRs derived from clinical studies and post-marketing surveillance with Augmentin, sorted by MedDRA System

Organ Class are listed below.

The following terminologies have been used in order to classify the occurrence of undesirable effects.

Very common (

1/10)

Common (

1/100 to <1/10)

Uncommon (

1/1,000 to <1/100)

Rare (

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

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Infections and infestations

Mucocutaneous candidosis

Common

Overgrowth of non-susceptible organisms

Not known

Blood and lymphatic system disorders

Reversible leucopenia (including

neutropenia)

Rare

Thrombocytopenia

Rare

Reversible agranulocytosis

Not known

Haemolytic anaemia

Not known

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Prolongation of bleeding time and

prothrombin time

Not known

Immune system disorders

Angioneurotic oedema

Not known

Anaphylaxis

Not known

Serum sickness-like syndrome

Not known

Hypersensitivity vasculitis

Not known

Nervous system disorders

Dizziness

Uncommon

Headache

Uncommon

Reversible hyperactivity

Not known

Convulsions

Not known

Aseptic meningitis

Not Known

Gastrointestinal disorders

Diarrhoea

Common

Nausea

Common

Vomiting

Common

Indigestion

Uncommon

Antibiotic-associated colitis

Not known

Black hairy tongue

Not known

Tooth discolouration

Not known

Hepatobiliary disorders

Rises in AST and/or ALT

Uncommon

Hepatitis

Not known

Cholestatic jaundice

Not known

Skin and subcutaneous tissue disorders

Skin rash

Uncommon

Pruritus

Uncommon

Urticaria

Uncommon

Erythema multiforme

Rare

Stevens-Johnson syndrome

Not known

Toxic epidermal necrolysis

Not known

Bullous exfoliative-dermatitis

Not known

Acute generalised exanthemous pustulosis

(AGEP)

Not known

Renal and urinary disorders

Interstitial nephritis

Not known

Crystalluria

Not known

See section 4.4

See section 4.4

Nausea is more often associated with higher oral doses.

If gastrointestinal reactions

are evident, they may be reduced by taking Augmentin at the start of a meal.

Including pseudomembranous colitis and haemorrhagic colitis (see section 4.4)

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Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Symptoms and signs of overdose

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident.

Amoxicillin

crystalluria, in some cases leading to renal failure, has been observed (see section 4.4).

Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Amoxicillin has been reported to precipitate in bladder catheters, predominantly after intravenous administration of

large doses.

A regular check of patency should be maintained (see section 4.4)

Treatment of intoxication

Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.

Amoxicillin/clavulanic acid can be removed from the circulation by haemodialysis.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase inhibitors; ATC code: J01CR02.

Mechanism of action

Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as

penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural

component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is

usually followed by cell lysis and death.

Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum

of activity of amoxicillin alone does not include organisms which produce these enzymes.

A moderate rise in AST and/or ALT has been noted in patients treated with beta-

lactam class antibiotics, but the significance of these findings is unknown.

These events have been noted with other penicillins and cephalosporins (see section

4.4).

If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued

(see section 4.4).

See section 4.9

See section 4.3

See section 4.4

Superficial tooth discolouration has been reported very rarely in children. Good oral

hygiene may help to prevent tooth discolouration as it can usually be removed by

brushing.

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Clavulanic acid is a beta-lactam structurally related to penicillins. It inactivates some beta-lactamase enzymes thereby

preventing inactivation of amoxicillin.

Clavulanic acid alone does not exert a clinically useful antibacterial effect.

PK/PD relationship

The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy

for amoxicillin.

Mechanisms of resistance

The two main mechanisms of resistance to amoxicillin/clavulanic acid are:

Inactivation by those bacterial beta-lactamases that are not themselves inhibited by clavulanic acid, including class

B, C and D.

Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.

Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in

Gram-negative bacteria.

Breakpoints

MIC breakpoints for amoxicillin/clavulanic acid are those of the European Committee on Antimicrobial Susceptibility

Testing (EUCAST)

The prevalence of resistance may vary geographically and with time for selected species, and local information on

resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when

the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Organism

Susceptibility Breakpoints (

g/ml)

Susceptible

Intermediate

Resistant

Haemophilus influenzae

1

> 1

Moraxella catarrhalis

1

> 1

Staphylococcus aureus

2

> 2

Coagulase-negative

staphylococci

2

0.25

> 0.25

Enterococcus

1

> 8

Streptococcus A, B, C, G

5

0.25

> 0.25

Streptococcus pneumoniae

3

> 2

Enterobacteriaceae

1,4

> 8

Gram-negative Anaerobes

1

> 8

Gram-positive Anaerobes

1

> 8

Non-species related

breakpoints

1

> 8

The reported values are for Amoxicillin concentrations.

For susceptibility testing purposes,

the concentration of Clavulanic acid is fixed at 2 mg/l.

The reported values are Oxacillin concentrations.

Breakpoint values in the table are based on Ampicillin breakpoints.

The resistant breakpoint of R>8 mg/l ensures that all isolates with resistance mechanisms are

reported resistant.

Breakpoint values in the table are based on Benzylpenicillin breakpoints.

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Commonly susceptible species

Aerobic Gram-positive micro-organisms

Enterococcus faecalis

Gardnerella vaginalis

Staphylococcus aureus (methicillin-susceptible)

Streptococcus agalactiae

Streptococcus pneumoniae

Streptococcus pyogenes and other beta-haemolytic streptococci

Streptococcus viridans group

Aerobic Gram-negative micro-organisms

Capnocytophaga spp.

Eikenella corrodens

Haemophilus influenzae

Moraxella catarrhalis

Pasteurella multocida

Anaerobic micro-organisms

Bacteroides fragilis

Fusobacterium nucleatum

Prevotella spp.

Species for which acquired resistance may be a problem

Aerobic Gram-positive micro-organisms

Enterococcus faecium $

Aerobic Gram-negative micro-organisms

Escherichia coli

Klebsiella oxytoca

Klebsiella pneumoniae

Proteus mirabilis

Proteus vulgaris

Inherently resistant organisms

Aerobic Gram-negative micro-organisms

Acinetobacter sp.

Citrobacter freundii

Enterobacter sp.

Legionella pneumophila

Morganella morganii

Providencia spp.

Pseudomonas sp.

Serratia sp.

Stenotrophomonas maltophilia

Other micro-organisms

Chlamydophila pneumoniae

Chlamydophila psittaci

Coxiella burnetti

Mycoplasma pneumoniae

$ Natural intermediate susceptibility in the absence of acquired mechanism of

resistance.

All methicillin-resistant staphylococci are resistant to amoxicillin/clavulanic acid

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5.2 Pharmacokinetic properties

Absorption

Amoxicillin and clavulanic acid, are fully dissociated in aqueous solution at physiological pH. Both components are

rapidly and well absorbed by the oral route of administration. Absorption of amoxicillin/clavulanic acid is optimised

when taken at the start of a meal. Following oral administration, amoxicillin and clavulanic acid are approximately

70% bioavailable. The plasma profiles of both components are similar and the time to peak plasma concentration

(Tmax) in each case is approximately one hour.

The pharmacokinetic results for a study, in which amoxicillin/clavulanic acid (875 mg/125 mg tablets given twice

daily) was administered in the fasting state to groups of healthy volunteers are presented below.

Amoxicillin and clavulanic acid serum concentrations achieved with amoxicillin/clavulanic acid are similar to those

produced by the oral administration of equivalent doses of amoxicillin or clavulanic acid alone.

Distribution

About 25% of total plasma clavulanic acid and 18% of total plasma amoxicillin is bound to protein. The apparent

volume of distribution is around 0.3-0.4 l/kg for amoxicillin and around 0.2 l/kg for clavulanic acid.

Following intravenous administration, both amoxicillin and clavulanic acid have been found in gall bladder, abdominal

tissue, skin, fat, muscle tissues, synovial and peritoneal fluids, bile and pus. Amoxicillin does not adequately distribute

into the cerebrospinal fluid.

From animal studies there is no evidence for significant tissue retention of drug-derived material for either component.

Amoxicillin, like most penicillins, can be detected in breast milk. Trace quantities of clavulanic acid can also be

detected in breast milk (see section 4.6).

Both amoxicillin and clavulanic acid have been shown to cross the placental barrier (see section 4.6).

Biotransformation

Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up to 10 to 25% of

the initial dose.

Streptococcus pneumoniae that are resistant to penicillin should not be treated with

this presentation of amoxicillin/clavulanic acid (see sections 4.2 and 4.4).

Strains with decreased susceptibility have been reported in some countries in the EU

with a frequency higher than 10%.

Mean (

SD) pharmacokinetic parameters

Active substance(s)

administered

Dose

(0-24h)

T 1/2

(mg)

(µg/ml)

((µg.h/ml)

Amoxicillin

AMX/CA

875 mg/125 mg

11.64

2.78

1.50

(1.0-2.5)

53.52

12.31

1.19

0.21

Clavulanic acid

AMX/CA

875 mg/125 mg

2.18

0.99

1.25

(1.0-2.0)

10.16

3.04

0.96

0.12

AMX – amoxicillin, CA – clavulanic acid

* Median (range)

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0

Clavulanic acid is extensively metabolized in man and eliminated in urine and faeces and as carbon dioxide in expired

air.

Elimination

The major route of elimination for amoxicillin is via the kidney, whereas for clavulanic acid it is by both renal and non-

renal mechanisms.

Amoxicillin/clavulanic acid has a mean elimination half-life of approximately one hour and a mean total clearance of

approximately 25 l/h in healthy subjects.

Approximately 60 to 70% of the amoxicillin and approximately 40 to 65% of

the clavulanic acid are excreted unchanged in urine during the first 6 h after administration of single Augmentin

250 mg/125 mg or 500 mg/125 mg tablets.

Various studies have found the urinary excretion to be 50-85% for

amoxicillin and between 27-60% for clavulanic acid over a 24 hour period.

In the case of clavulanic acid, the largest

amount of drug is excreted during the first 2 hours after administration.

Concomitant use of probenecid delays amoxicillin excretion but does not delay renal excretion of clavulanic acid (see

section 4.5).

The elimination half-life of amoxicillin is similar for children aged around 3 months to 2 years and older children and

adults. For very young children (including preterm newborns) in the first week of life the interval of administration

should not exceed twice daily administration due to immaturity of the renal pathway of elimination. Because elderly

patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to

monitor renal function.

Gender

Following oral administration of amoxicillin/clavulanic acid to healthy males and female subjects, gender has no

significant impact on the pharmacokinetics of either amoxicillin or clavulanic acid.

Renal impairment

The total serum clearance of amoxicillin/clavulanic acid decreases proportionately with decreasing renal function. The

reduction in drug clearance is more pronounced for amoxicillin than for clavulanic acid, as a higher proportion of

amoxicillin is excreted via the renal route. Doses in renal impairment must therefore prevent undue accumulation of

amoxicillin while maintaining adequate levels of clavulanic acid (see section 4.2).

Hepatic impairment

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.

5.3 Preclinical safety data

Nonclinical data reveal no special hazard for humans based on studies of safety pharmacology, genotoxicity and

toxicity to reproduction.

Repeat dose toxicity studies performed in dogs with amoxicillin/clavulanic acid demonstrate gastric irritancy and

vomiting, and discoloured tongue.

Carcinogenicity studies have not been conducted with Augmentin or its components.

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1

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Crospovidone

Carmellose sodium

Xanthan gum

Colloidial anhydrous silica

Magnesium stearate

Sodium benzoate (E211)

Aspartame (E951)

Strawberry flavour (containing maltodextrin)

Silicon dioxide

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf-life expiry date of this product is the date shown on the container and outer carton of the product on the

market in the country of origin.

Reconstituted suspension: 7 days when stored in a refrigerator (2°C-8°C).

6.4 Special precautions for storage

Store in the original package in order to protect from moisture.

The dry powder should be stored in the original container.

Do not store above 25°C.

Reconstituted suspension should be stored at 2°C-8°C (but not frozen) for up to seven days.

6.5 Nature and contents of container

Overlabelled cardboard outer containing a clear glass bottle. Pack size 35ml or 70ml. This may be supplied with a

plastic measuring spoon or plastic measuring cup or dosing syringe. Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

Check cap seal is intact before using.

Shake bottle to loosen powder.

Add volume of water (as indicated below) invert and shake well.

Alternatively, shake bottle to loosen powder then fill the bottle with water to just below the line on bottle or label.

Invert and shake well then top up with water exactly to the line. Invert and again shake well.

Shake the bottle well before each dose.

Strength

Volume of water to be added at

reconstitution (ml)

Final volume reconstituted oral

suspension (ml)

400mg/57mg/5ml

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2

7 PARALLEL PRODUCT AUTHORISATION HOLDER

IMED Healthcare Ltd.

Unit 625 Kilshane Avenue

Northwest Business Park

Ballycoolin

Dublin 15

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1463/015/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 11

May 2012

10 DATE OF REVISION OF THE TEXT

July 2014

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