AMOXIL FORTE SYRUP 250 MG/ 5ML

Main information

  • Trade name:
  • AMOXIL FORTE SYRUP 250 MG/ 5ML
  • Dosage:
  • 250 MG/ 5ml
  • Pharmaceutical form:
  • Syrup
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMOXIL FORTE SYRUP 250 MG/ 5ML
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/033/008
  • Authorization date:
  • 01-04-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1077/033/008

CaseNo:2073852

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GlaxoSmithKline(Ireland)Limited

StonemasonsWay,Rathfarnham,Dublin16,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AmoxilForteSyrup250mg/5ml

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom24/11/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 24/11/2009 CRN 2073852 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AmoxilForteSyrup250mg/5ml.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlcontains250mgamoxicillin(astrihydrate).

Excipients:alsocontainssorbitol(E420),sulphurdioxide(E220)andethanol.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderfororalsuspension.

Anoff-whitefreeflowingpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofinfectionsduetoorganismssensitivetoamoxicillin.

`Amoxil`isabroadspectrumantibiotic,indicatedforthetreatmentofcommonlyoccurringbacterialinfectionssuchas:

Upperrespiratorytractinfections

Otitismedia

Acuteandchronicbronchitis

Lobarandbronchopneumonia

Cystitis,urethritis,pylelonephritis

Bacteriuriainpregnancy

Gynaecologicalinfectionsincludingpuerperalsepsisandsepticabortion

AcuteuncomplicatedGonorrhoea

Peritonitis

Intra-abdominalsepsis

Septicaemia

Bacterialendocarditis

Typhoidandparatyphoidfever

Skinandsofttissueinfections

Dentalabscess(asadjuncttosurgicalmanagement)

Inchildrenwithurinarytractinfection,theneedforinvestigationshouldbeconsidered.

Parenteraltherapyisindicatediftheoralrouteisconsideredimpracticableorunsuitableandparticularlyfortheurgent

treatmentofsevereepisodesoftheaboveconditions.

Prophylaxisofendocarditis

`Amoxil`maybeusedforthepreventionofbacteraemia,associatedwiththeproceduressuchasdentalextraction,in

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4.2Posologyandmethodofadministration

Routeofadministration:oral

Theabsorptionof‘Amoxil’isvirtuallyunimpairedbythepresenceoffood.

Standardadultdosage:

Theusualdailydosageis750mgindivideddoses(i.e.250mgthreetimesdailybytheoralroute).

Incasesofsevereinfectionthedosagemaybedoubled,or`Amoxil`givenbyinjection.

Highdosagetherapy:(maximumrecommendedoraldosage6gdailyindivideddoses):Adosageof3gtwicedailyis

recommendedinappropriatecasesforthetreatmentofsevereorrecurrentpurulentinfectionoftherespiratorytract.

Shortcoursetherapy:Simpleacuteurinarytractinfection:two3gdoseswith10-12hoursbetweenthedoses.

Gonorrhoea:3gasasingledose.

DentalAbscess:two3gdoseswith8hoursbetweenthedoses.

Childrenuptotenyearsofage:

Theusualtotaldailydosageis375mgindivideddoses(i.e.125mgthreetimesdailybytheoralroute).

Dosagemaybeincreasedincasesofsevereinfection.

Insevereorrecurrentacuteotitismedia,especiallywherecompliancemaybeaproblem,750mgtwiceadayfortwo

daysmaybeusedasanalternativecourseoftreatmentinchildrenagedthreetotenyears

Prophylaxisofendocarditis:

Fordentalprocedureswhereanoraldoseisappropriate.

Adults:-3g`Amoxil`orally,1hourbeforeprocedure.Aseconddosemaybegiven6hourslater,ifconsidered

necessary.

Children:Aged5-10:halftheadultdose(i.e.1.5ggivenasasingle60mldoseof‘Amoxil’syrup(125mg/5ml).

Under5:quartertheadultdose.

Renalimpairment:Inrenalimpairmenttheexcretionoftheantibioticwillbedelayedanddependingonthedegreeof

impairment,itmaybenecessarytoreducethetotaldailydosage.

AmoxicillinPaediatricSuspensionisrecommendedforchildrenunder6monthsofage.

Glomerularfiltrationrate

Adults Oraltreatment

>30ml/min Noadjustmentnecessary

10-30ml/min Amox.Max500mgb.d.

<10ml/min Amox.Max500mg/day

Childrenunder40kg Oraltreatment

>30ml/min Noadjustmentnecessary

10-30ml/min 15mg/kggivenb.i.d.

(maximum500mg/twicedaily)

<10ml/min 15mg/kggivenasasingledaydose

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4.3Contraindications

Useinpatientswithahistoryofhypersensitivitytobeta-lactamantibioticsincludingpenicillinsorcephalosporins.

4.4Specialwarningsandprecautionsforuse

Beforeinitiatingtherapywithamoxicillin,carefulenquiryshouldbemadeconcerningprevioushypersensitivity

reactionstopenicillins,cephalosporins.Cross-sensitivitybetweenpenicillinsandcephalosporinsiswelldocumented.

Seriousandoccasionallyfatalhypersensitivityreactions(anaphylaxis)havebeenreportedinpatientsreceivingbeta-

lactamantibiotics.Ifanallergicreactionoccurs,amoxicillinshouldbediscontinuedandappropriatealternativetherapy

instituted.

Amoxicillinshouldbeavoidedifinfectionsmononucleosis(glandularfever)issuspectedsincetheoccurrenceofa

morbilliformrashhasbeenassociatedwiththisconditionfollowingtheuseofamoxicillin.

Prolongeduseofananti-infectivemayoccasionallyresultinovergrowthofnon-susceptibleorganisms.

Abnormalprolongationofprothrombintime(increasedINR)hasbeenreportedrarelyinpatientsreceivingamoxicillin

andoralanticoagulants.Appropriatemonitoringshouldbeundertakenwhenanticoagulantsareprescribed

concurrently.Adjustmentsinthedoseoforalanticoagulantsmaybenecessarytomaintainthedesiredlevelof

anticoagulation.

Dosageshouldbeadjustedinpatientswithrenalimpairment(seeSection4.2).

Inpatientswithreducedurineoutput,crystalluriahasbeenobservedveryrarely,predominantlywithparenteral

therapy.Duringtheadministrationofhighdosesofamoxicillin,itisadvisabletomaintainadequatefluidintakeand

urinaryoutputinordertoreducethepossibilityofamoxicillincrytalluria.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Probeneciddecreasestherenaltubularexcretionofamoxicillin.Concurrentusewithamoxicillinmayresultin

increasedandprolongedbloodlevelsofamoxicillin.

Concurrentadministrationofallopurinolduringtreatmentwithamoxicillincanincreasethelikelihoodofallergicskin

reactions.

Incommonwithotherantibiotics,amoxicillinmayaffectthegutflora,leadingtoloweroestrogenreabsorptionand

reducedefficacyofcombinedoralcontraceptives.

Intheliteraturetherearerarecasesofincreasedinternationalnormalisedratioinpatientsmaintainedonacenocoumarol

orwarfarinandprescribedacourseofamoxicillin.Ifco-administrationisnecessary,theprothrombintimeor

internationalnormalisedratioshouldbecarefullymonitoredwiththeadditionorwithdrawalofamoxicillin.

4.6Pregnancyandlactation

Useinpregnancy:

Animalstudieswith`Amoxil`haveshownnoteratogeniceffects.Theproducthasbeeninextensiveclinicaluse

since1972anditssuitabilityinhumanpregnancyhasbeenwelldocumentedinclinicalstudies.Amoxicillinmaybe

usedinpregnancywhenthepotentialbenefitsoutweighthepotentialrisksassociatedwithtreatment.

Useinlactation:

Amoxicillinmaybeadministeredduringtheperiodoflactation.Withtheexceptionoftheriskofsensitisation

associatedwiththeexcretionoftracequantitiesofamoxicillininbreastmilk,therearenoknowdetrimentaleffectsfor

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4.7Effectsonabilitytodriveandusemachines

Adverseeffectsontheabilitytodriveoroperatemachineryhavenotbeenobserved.

4.8Undesirableeffects

Thefollowingconventionhasbeenutilisedfortheclassificationofundesirableeffects:Verycommon(morethan

1/10),common(morethan1/100,lessthan1/10),uncommon(morethan1/1000,lessthan1/100),rare(morethan

1/10,000,lessthan1/1000),veryrare(lessthan1/10,000).

Themajorityoftheside-effectslistedbelowarenotuniquetoamoxicillinandmayoccurwhenusingotherpenicillins.

Unlessotherwisestated,thefrequencyofadverseevents(AEs)hasbeenderivedfrommorethan30yearsofpost-

marketingreports.

Bloodandlymphaticsystemdisorders

Veryrare: Reversibleleucopenia(includingsevereneutropeniaor

agranulocytosis),reversiblethrombocytopeniaandhaemolytic

anaemia.

Prolongationofbleedingtimeandprothrombintime.

Immunesystemdisorders

Veryrare: Aswithotherantibiotics,severeallergicreactions,including

angioneuroticoedema,anaphylaxis(seeWarningsand

Precautions),serumsicknessandhypersensitivityvasculitis.

Ifahypersensitivityreactionisreported,thetreatmentmustbediscontinued.(See

alsoSkinandsubcutaneoustissuedisorders).

Nervoussystemdisorders

Veryrare: Hyperkinesia,dizzinessandconvulsions.Convulsionsmay

occurinpatientswithimpairedrenalfunctionorinthose

receivinghighdoses.

InfectionsandInfestations

Veryrare: Mucocutaneouscandidiasis

Gastrointestinaldisorders

#Common: Diarrhoeaandnausea.

#Uncommon: Vomiting.

Veryrare: Antibioticassociatedcolitis(includingpseudomembraneous

colitisandhaemorrhagiccolitis).

Blackhairytongue

Superficialtoothdiscolourationhasbeenreportedinchildren.

Goodoralhygienemayhelptopreventtoothdiscolourationas

itcanusuallyberemovedbybrushing(forsuspensionand

chewabletabletformulationsonly)

Hepato-biliarydisorders

Veryrare: Hepatitisandcholestaticjaundice.AmoderateriseinAST

and/orALT.

ThesignificanceofariseinASTand/orALTisunclear.

Skinandsubcutaneoustissuedisorders

#Common: Skinrash.

#Uncommon: Urticariaandpruritus.

Veryrare: Skinreactionssuchaserythemamultiforme,Stevens-Johnson

syndrome,toxicepidermalnecrolysis,bullousandexfoliative

dermatitisandacutegeneralisedexanthematouspustulosis

(AGEP).

(SeealsoImmunesystemdisorders).

RenalandUrinarytractdisorders

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4.9Overdose

Grossoverdosagewillproduceveryhighurinaryconcentrations,moresoafterparenteraladministration.Symptomsof

water/electrolyteimbalanceshouldbetreatedsymptomatically.Problemsareunlikelytooccurifadequatefluidintake

andurinaryoutputaremaintained;however,amoxicillincrystalluriainsomecasesleadingtorenalfailure,hasbeen

observed(seeSection4.4,SpecialWarningsandSpecialPrecautionsforUse).Morespecificmeasuresmaybe

necessaryinpatientswithimpairedrenalfunction:theantibioticisremovedbyhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

`Amoxil`isabroad-spectrumantibioticwhichpossessesthesafetyprofileofthepenicillinsandisrapidlybactericidal

againstawiderangeofGram-negativeandGram-positiveorganisms.

5.2Pharmacokineticproperties

`Amoxil`iswellabsorbedbytheoralandparenteralroutes,peakbloodlevelsareachievedonetotwohoursafter

administration.Oraladministrationproduceshighserumlevelsindependentofthetimeatwhichthefoodistaken.

`Amoxil`givesgoodpenetrationintothebronchialsecretionsandthehighurinaryconcentrationsofunchanged

antibiotic.Theaverageserumhalflifeis60minutes.Eliminationismainlyviatheurine.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sorbitol(E420)

Disodiumedetate

Sodiumbenzoate(E211)

Sodiumsaccharin

Anhydroussilicondioxide

Colloidalanhydroussilica

Xanthangum(E415)

Peach,strawberryandlemondryflavours

(containingsulphurdioxide(E220)andethanol).

6.2Incompatibilities

#TheincidenceoftheseAEswasderivedfromclinicalstudiesinvolvingatotalof

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6.3ShelfLife

Unopened:5years.

Reconstituted:14days.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

Clearglassbottles(Ph.Eur.TypeIII)(150mlvolume)witheitherametalcapwithflowed-insealingcompound,a

polypropylenewadlesscaporaROPP,internallylacqueredclosurecontainingaflowed-inPVCliner.

Contains100ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Attimeofdispensing,thedrypowdershouldbereconstitutedtoformawhitetooffwhiteoralsuspension,asdetailed

below:

Volumeofwater Nominalbottle Finalvolumeof

tobeaddedto size reconstituted

reconstitute oralsuspension.

85ml 150ml 100ml

Whennecessarydilutetohalf-strengthusingwater.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Limited

StonemasonsWay

Rathfarnham

Dublin16

8MARKETINGAUTHORISATIONNUMBER

PA1077/33/8

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1977

Dateoflastrenewal:01April2007

10DATEOFREVISIONOFTHETEXT

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