GERAMOX

Main information

  • Trade name:
  • GERAMOX Powder for Oral Suspension 250 MG/ 5ml
  • Dosage:
  • 250 MG/ 5ml
  • Pharmaceutical form:
  • Powder for Oral Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GERAMOX Powder for Oral Suspension 250 MG/5ml
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0405/005/004
  • Authorization date:
  • 20-11-1989
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0405/005/004

CaseNo:2043367

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

Generics(UK)Limited

12StationClose,PottersBar,HertfordshireEN61TL,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Geramox250mg/5mlPowderforOralSuspension

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom30/04/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 26/05/2010 CRN 2043367 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Geramox250mg/5mlPowderforOralSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlofreconstitutedsuspensioncontainsAmoxicillinTrihydrateequivalentto250mgofAmoxicillin.

Excipients:Each5mlcontains15mgaspartameand1149mgsorbitol.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderfororalsuspension.

Whitetooffwhitefreeflowingpowderwithanodourofraspberry.Whenreconstituteditreadilyproducesawhiteto

creamcolouredcompletelyhomogenoussuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

InthetreatmentofinfectionsduetoorganismssensitivetoAmoxicillinandintheoralprophylaxisofendocarditis

relatedtodentalprocedures,andacuteuncomplicatedgonorrhoea.

4.2Posologyandmethodofadministration

Geramoxsuspensionisfororaluse.

TREATMENT

Adultstheelderlyandchildrenover10yearsofage

Theusualtotaldailydosageis750mginthreedivideddoses.

Inthetreatmentofuncomplicatedgonorrhoeaasingledoseof3gmaybeused.

Children

6-10years

Theusualtotaldailydosageis375-750mgindivideddoses.

2-5years

375mgdailyindivideddoses.

Under2years

100-300mgdailyindivideddoses.

Dosagemaybedoubledincasesofsevereinfections.

Irish Medicines Board

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Adultsandtheelderly

Asingledoseof3gpriortothedentalprocedure.

Children

Asingledoseof1to1.5gpriortotheprocedure.

Note:Inpatientswithrenalinsufficiencytotaldailydosagemayneedreductionifexcretionofdrugisdelayed.

4.3Contraindications

Useinpatientswithhypersensitivitytopenicillins,includingAmpicillin,orCephalosporins.

4.4Specialwarningsandprecautionsforuse

Prolongeduseofananti-infectiveagentmayresultinsuperinfectionbyorganismsresistanttothatanti-infective.

PatientswithinfectiousmononucleosisfrequentlydeveloprasheswithAmpicillintherapy.Asimilartendencymaybe

apparentwithAmoxicillin.

Patientswithrarehereditaryproblemsoffructoseintoleranceshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Methotrexateexcretionisreducedbypenicillins.Patientsshouldbemonitoredcarefullyforsignsofmethotrexate

toxicity.

Probeneciddecreasestherenalexcretionofpenicillins.Plasmaconcentrationsareenhancedifprobenecidisgiven

concomitantly.

Pencillinsmaydecreasetheefficacyofcombinedoralcontraceptives.Patientsshouldbewarnedofthis.

4.6Pregnancyandlactation

Theproductshouldnotbeusedduringpregnancyunlessconsideredessentialbythephysician.Amoxicillinisexcreted

inbreastmilk,presentingtheriskofcandidiasisandalsoofcentralnervoustoxicityduetopre-maturityoftheblood

brainbarrier.Thereisatheoreticalpossibilityoflatersensitisation.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Side-effectsaswithotherpenicillins,areuncommonandmainlyofamildandtransitorynature;Gastro-intestinal

effectsincludediarrhoea,indigestion,nausea,epigastricdiscomfortandcandidainfection.

Urticarialanderythematousrasheshavebeenreported.Anurticarialrashsuggestspenicillinhypersensitivity,an

erythematousrashmayariseinpatientsreceivingamoxicillinwhohaveglandularfeverorwhohavechroniclymphatic

leukaemia.Ifarashoccurstreatmentshouldbediscontinued.

Incommonwithotherbeta-lactamantibiotics,angioedemaandanaphylaxisinhypersensitivepatientshavebeen

reported.

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4.9Overdose

Grossoverdoseshouldnotpresentproblemsifadequatefluidintakeandurinaryoutputaremaintained;however

crystalluriaareapossibility.Morespecificmeasuresmaybenecessaryinpatientswithimpairedrenalfunction:the

antibioticisremovedbyhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

AmoxicillinTrihydrateisabroadspectrumantibiotic.

5.2Pharmacokineticproperties

AmoxicillinTrihydrateiswellabsorbedafteroraladministration;reachingpeaklevels1-2hourslater,andexcretedin

theurine.

5.3Preclinicalsafetydata

Therearenopreclinicalsafetydataofrelevancetotheprescriberthatareadditionaltothoseincludedinothersections

oftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumbenzoate

Raspberryflavoursugarfree(Permaseal10458-31)

Sodiumcitrate

Disodiumedetate

Aspartame(E951)

Propyleneglycolalginate

Colloidalsilicondioxide

Sorbitol(E420)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

DryPowder:2years.

Afterreconstitutionaccordingtodirections:14days.

6.4Specialprecautionsforstorage

DryPowder:Donotstoreabove25°C.

Afterreconstitutionaccordingtodirections:Storeinarefrigeratorat2°C-8°C.

6.5Natureandcontentsofcontainer

Irish Medicines Board

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Todispenseadd80mlofwatertomakeupto100ml,invertbottleandshakewell.

Whitetooffwhitefreeflowingpowderwithanodourofraspberry.

Whenreconstitutedasdirected,awhitetocreamcoloured,completelyhomogenoussuspensionisreadilyproduced.

7MARKETINGAUTHORISATIONHOLDER

Generics[UK]Ltd.

12StationClose

PottersBar

Hertfordshire

EN61TL

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA405/5/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:20November1989

Dateoflastrenewal:30April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 26/05/2010 CRN 2043367 page number: 5