FLAGYL

Main information

  • Trade name:
  • FLAGYL Suppositories 0.5 Grams
  • Dosage:
  • 0.5 Grams
  • Pharmaceutical form:
  • Suppositories
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLAGYL Suppositories 0.5 Grams
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0540/100/006
  • Authorization date:
  • 30-09-1977
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FlagylSuppositories0.5g

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsuppositorycontains500mgofMetronidazole.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Suppository.

Cream-coloured,torpedo-shapedsuppositories.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthepreventionandtreatmentofinfectionsduetoanaerobicbacteria,particularlyspeciesofBacteroides,anaerobic

Streptococci,Fusobacteria,Clostridia,etc.

4.2Posologyandmethodofadministration

Rectal.

RecommendedDosage:

Adults:

1g8hourly.Substituteoralmedicationasearlyaspossible.Ifrectaladministrationisprolongedbeyond3

daysreducedoseto1g12hourlyforremainderofcourse.

Children:

7.5mg/kg8hourly.

Prophylaxisagainstanaerobicinfection-chieflyinthecontextofabdominal(especiallycolorectal)andgynaecological

surgery:

Adults:

1g8hourly.

Childrenonehalforaquarterofa500mgsuppository8hourly.

4.3Contraindications

Metronidazoleshouldbeusedwithcautioninpatientswithactiveorchronicsevereperipheralandcentralnervous

systemdiseaseduetotheriskofneurologicalaggravation.Useinpatientsknowntobehypersensitiveto

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4.4Specialwarningsandprecautionsforuse

TheuseofFlagylforprolongedtreatmentdurationshouldbecarefullyweighed

Ifprolongedtherapyisrequired,thephysicianshouldbearinmindthepossibilityofperipheralneuropathyor

leucopenia.Botheffectsareusuallyreversible.Highdosageregimeshavebeenassociatedwithtransient

epileptiformseizures.Cautionisrequiredinpatientswithactivediseaseofthecentralnervoussystemexceptfor

brainabscess.

Metronidazoleandametabolitehavebeenshowntobemutagenicinsometestswithnon-mammaliancells.

Intensiveorprolongedmetronidazoletherapyshouldbeconductedonlyunderconditionsofclosesurveillance

forclinicalandbiologicaleffectsandunderspecialistdirection.

Metronidazoleisremovedduringhaemodialysisandshouldbeadministeredaftertheprocedureisfinished.

Metronidazoleismainlymetabolisedbyhepaticoxidation.Substantialimpairmentofmetronidazoleclearance

mayoccurinthepresenceofadvancedhepaticinsufficiency.Therisk/benefitusingmetronidazoletotreat

trichomoniasisinsuchpatientsshouldbecarefullyconsidered.

Flagylshouldbeadministeredwithcautiontopatientswithhepaticencephalopathy.

Patientsshouldbewarnedthatmetronidazolemaydarkenurine(duetometronidazolemetabolite).

Patientsshouldbeadvisednottotakealcoholduringmetronidazoletherapyandforatleast48hoursafterwards

(seesection4.5Interactionwithothermedicinalproductsandotherformsofinteraction).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

1.Potentiationofcoumarinanticoagulanteffectsmayoccurwithmetronidazoleandanticoagulantactivityshouldbe

carefullymonitoredduringconcurrenttherapy.

2.Patientsshouldbeadvisednottotakealcoholduring,(ordrugscontainingalcohol)duringmetronidazoletherapy

andforatleast48hoursafterwardsbecauseofadisulfiram-like(antabuseeffect)reaction(flushing,vomiting,

tachycardia).

3.Disulfiram:psychoticreactionhavebeenreportedinpatientswhowereusingmetronidazoleanddisulfiram

concurrently.

4.Lithiumretentionobservedbyincreasedplasmalithiumlevels,accompaniedbyevidenceofpossiblerenaldamage

hasbeenreportedinpatientstreatedsimultaneouslywithlithiumandmetronidazole.Lithiumtreatmentshouldbe

taperedorwithdrawnbeforeadministeringmetronidazole.Plasmaconcentrationoflithium,creatinineand

electrolytesshouldbemonitoredinpatientsundertreatmentwithlithiumwhiletheyreceivemetronidazole.

5.Cyclosporin:riskofelevationofthecyclosporinserumlevels.Serumcyclosporinandserumcreatinineshouldbe

closelymonitoredwhencoadministrationisnecessary.

6.5-Fluorouracil:reducedclearanceof5fluorouracilresultinginincreasedtoxicityof5-flurorouracil.

7.PhenytoinorPhenobarbital:increasedeliminationofmetronidazoleresultinginreducedplasmalevels.

8.Busfulfan:plasmalevelsofbusulfanmaybeincreasedbymetronidazole,whichmayleadtoseverebusulfan

toxicity.

4.6Fertility,pregnancyandlactation

Metronidazoleshouldonlybeusedduringpregnancyorlactationfollowingcarefulevaluationandonlyifconsidered

essentialbythephysician.Ifused,highdosageregimesshouldbeavoided.Thedrugcrossestheplacentaandis

excretedinbreastmildinwhichconcentrationequalthoseinserum.Unnecessaryexposuretothedrugshouldbe

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4.7Effectsonabilitytodriveandusemachines

Patientsshouldbewarnedaboutthepotentialforconfusion,dizziness,hallucinations,convulsionsoreye

disorders (seesection4.8Undesirableeffects) ,andadvisednottodriveoroperatemachineryifthese

symptomsoccur.

4.8Undesirableeffects

Frequency,typeandseverityofadversereactionsinchildrenarethesameasinadults.

GastrointestinalDisorders

epigastricpain,nausea,vomiting,diarrhoea.

oralmucositis,tastedisorders,drymouth,anorexia.

reversiblecasesofpancreatitis.

Immunesystemdisorders

angioedema,anaphylacticshocks.

Nervoussystemdisorders

peripheralsensoryneuropathy.

headache,convulsions,dizziness.

reportsofencephalopathy(e.g.confusion)andsubacutecerebellarsyndrome(e.g.ataxia,dysathria,gait

impairment,nystagmusandtremor)which mayresolvewithdiscontinuationofthedrug.

asepticmeningitis

Psychiatricdisorders

psychoticdisordersincludingconfusion,hallucinations.

depressedmood

Eyedisorders

transientvisiondisorderssuchasdiplopia,myopia,blurredvision,decreasedvisualacuity.Changesincolor

vision.

Opticneuropathy/neuritis.

Bloodandlymphaticsystemdisorders

casesofagranulocytosis,neutropeniaandthrombocytopeniahavebeenreported.

Hepatobillarydisorders

casesofreversibleabnormalliverfunctiontestsandcholestatichepatitissometimeswithjaundicehavebeen

reported.

Skinandsubcutaneoustissuedisorders

rash,pruritus,flushing,urticaria

pustulareruptions

Generaldisordersandadministrationsiteconditions

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4.9Overdose

Singleoraldosesofmetronidazole,upto12ghavebeenreportedinsuicideattemptsandaccidentaloverdoses.

Symptomswerelimitedtovomiting,ataxiaandslightdisorientation.

Thereisnospecificantidoteformetronidazoleoverdosage.Incasesofsuspectedmassiveoverdosage,asymptomatic

andsupportivetreatmentshouldbeinstituted.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Flagyl-thedrughasantiprotozoalandantibacterialactionsincludingactivityagainstanaerobicbacteria,entamoeba

histolytica.

5.2Pharmacokineticproperties

Anitroimidazolederivativewellabsorbedandwidelydistributedinthebody.Itismetabolisedbyacid

oxidation,hydroxylationand glucuronidationandexcretedinurineandfaeceswithaT½ofabout7-

8hours.

5.3Preclinicalsafetydata

Metronidazolehasbeenshowntobecarcinogenicinthemouseandintherat.However,similarstudiesin

thehamsterhavegivennegativeresultsandepidemiologicalstudiesinhumanshaveprovidednoevidence

ofanincreasedcarcinogenicriskinhumans.Metronidazolehasbeenshowntobemutagenicinbacteriain

vitro.Instudiesconductedinmammaliancellsinvitroaswellasinrodentandinhumansinvivo,there

wasinadequateevidenceofmutageniceffects.

Therefore,theuseofFlagylforprolongedtreatmentdurationshouldbecarefullyweighed.(SeeSection4.4

“WarningsandPrecautions”).

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

SuppositoryBaseE75

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6.5Natureandcontentsofcontainer

PerformedPVC/polyethylenelaminates.

Mouldedplaguettesofcelluloseacetate,plasticizedwithapproximately22%

diethylphthalate/triphenylphosphatesealedwithheatusingglyceroltriacetateadhesive.

Packsize:boxes10x500mgsuppositories.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

sanofi-aventisIrelandLtd.

CitywestBusinessCampus

Dublin24.

8MARKETINGAUTHORISATIONNUMBER

PA540/100/6

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:30 th

September1977

Dateoflastrenewal:30 th

September2007

10DATEOFREVISIONOFTHETEXT

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