FLAGYL

Main information

  • Trade name:
  • FLAGYL Suppositories 1 g Grams
  • Dosage:
  • 1 g Grams
  • Pharmaceutical form:
  • Suppositories
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLAGYL Suppositories 1 g Grams
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0040/003/005
  • Authorization date:
  • 30-09-1977
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FlagylSuppositories1g.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each suppository contains1g ofMetronidazole.

Forexcipients, see6.1

3PHARMACEUTICALFORM

Suppository

Cream-coloured, torpedo-shaped suppositories.

4CLINICALPARTICULARS

4.1TherapeuticIndications

In theprevention and treatmentofinfectionsdueto anaerobicbacteria;particularly speciesofBacteroides, anaerobic

Streptococci,Fusobacteria,Clostridia, etc.

4.2Posologyandmethodofadminstration

Rectal.

Recommended Dosage:

Adults:

1g 8 hourly.Substituteoralmedication asearly aspossible.Ifrectaladministration prolonged beyond 3 daysreduce

doseto 1g 12 hourly forremainderofcourse.

Children:

7.5mg/kg 8 hourly.

Prophylaxisagainstanaerobicinfection-chiefly in thecontextofabdominal(especially colorectal)and gynaecological

surgery:

Adults:

1g 8 hourly.

Children onehalforaquarterofa500mg suppository 8 hourly.

4.3Contraindications

Metronidazoleshould beused with caution in patientswith activeorchronicsevereperipheraland centralnervous

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Usein patientsknown to behypersensitiveto metronidazole.

4.4Special warningsandspecialprecautionsforuse

1.Ifprolonged therapy isrequired, thephysician should bearin mind thepossibility ofperipheralneuropathy or

leucopenia.Both effectsareusually reversible.High dosageregimeshavebeen associated withtransient

epileptiformseizures.Caution isrequired in patientswith activediseaseofthecentralnervoussystemexceptfor

brain abscess.

2.Metronidazoleand ametabolitehavebeen shown to bemutagenicin sometestswith non mammalian cells.

3.Intensiveorprolonged metronidazoletherapy should beconductedonly underconditionsofclosesurveillancefor

clinicaland biologicaleffectsand underspecialistdirection.

4.Metronidazoleisremoved during haemodialysisand should beadministered aftertheprocedureisfinished.

5.Metronidazoleismainly metabolised by hepaticoxidation.Substantialimpairmentofmetronidazoleclearance

may occurin thepresenceofadvanced hepaticinsufficiency.Therisk/benefitofusing metronidazoleto treat

trichomoniasisin such patientsshould becarefully considered.

6.Flagylshould beadministered with caution to patientswith hepaticencephalopathy.

7.Patientsshould bewarned thatmetronidazolemay darken urine(dueto metronidazolemetabolite).

8.Patientsshould beadvised notto takealcoholduring metronidazoletherapy andforatleast48 hoursafterwards

(seesection 4.5 interaction with othermedicamentsand otherformsofinteraction).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

1.Potentiation ofcoumarin anticoagulanteffectsmay occurwithmetronidazoleand anticoagulantactivity should be

carefully monitored during concurrenttherapy.

2.Patientsshould beadvised notto takealcoholduring, (ordrugscontaining alcohol)during metronidazoletherapy

and foratleast48 hoursafterwardsbecauseofadisulfiram-like(antabuseeffect)reaction (flushing, vomiting,

tachycardia).

3.Disulfiram:psychoticreaction havebeen reported in patientswho wereusing metronidazoleand disulfiram

concurrently.

4.Lithiumretention observed byincreased plasmalithiumlevels, accompanied by evidenceofpossiblerenaldamage

hasbeen reported in patientstreated simultaneously withlithiumand metronidazole.Lithiumtreatmentshould be

tapered orwithdrawn beforeadministering metronidazole.Plasmaconcentration oflithium, creatinineand

electrolytesshould bemonitored in patientsundertreatmentwith lithiumwhilethey receivemetronidazole.

5.Cyclosporin:risk ofelevation ofthecyclosporin serumlevels.Serumcyclosporin and serumcreatinineshould be

closely monitored when coadministration isnecessary.

6.5-Fluorouracil:reduced clearanceof5 fluorouracilresulting in increased toxicity of5-flurorouracil.

7.Phenytoin orPhenobarbital:increased elimination ofmetronidazoleresulting inreduced plasmalevels.

8.Busfulfan:plasmalevelsofbusulfan may beincreased by metronidazole, which may lead to severebusulfan

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4.6Pregnancyandlactation

Metronidazoleshould only beused during pregnancy orlactation following carefulevaluation and only ifconsidered

essentialby thephysician. Ifused, high dosageregimesshould beavoided.Thedrug crossestheplacentaand is

excreted in breastmild in whichconcentration equalthoseinserum. Unnecessaryexposureto thedrug should be

avoided.

4.7Effectsonabilitytodriveandusemachines

Patientsshould bewarned aboutthepotentialforconfusion,dizziness, hallucinationsconvulsionsortransientvisual

disorders, and advised notto driveoroperatemachinery ifthesesymptomsoccur.

4.8Undesirableeffects

Gastrointestinaleffects

epigastricpain, nausea, vomiting, diarrhoea.

Glossitis, oralmuscositis, tastedisorders, dry mouth, anorexia.

exceptionaland reversiblecasesofpancreatitis.

Hypersensitivityreactions

rash, pruritus, flushing, urticaria.

fever, angioedema, exceptionalanaphylacticshocks.

Very rarepustulareruptions.

Peripheraland centralnervoussystem

peripheralsensoryneuropathy.

Headache, convulsions, dizziness.

Very rarereportsofEncephalopathy (e.g. confusion)and subacutecerebellarsyndrome(and subacutecerebellar

syndrome(e.g. ataxia,dysathria, gaitimpairment, nystagmusand tremor)which may resolvewith discontinuation of

thedrug).

Psychiatricdisorders

psychoticdisordersincludingconfusion, hallucinations

Vision Disorder

transientvision disordersuch asdiplopia, myopia

Haematology

very rarecasesofagranulocytosis, neutropeniaand thrombocytopeniahavebeen reported.

Liver

very rarecasesofreversibleabnormalliverfunction testsand cholestatichepatitishavebeen reported.

4.9Overdose

Singleoraldosesofmetronidazole, up to 12 g havebeen reported in suicideattemptsand accidentaloverdoses.

Symptomswerelimited to vomiting, ataxiaandslightdisorientation.

Thereisno specificantidoteformetronidazoleoverdosage. In casesofsuspectedmassiveoverdosage, asymptomatic

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Flagyl-thedrug hasantiprotozoaland antibacterialactionsincluding activity againstanaerobicbacteria, entamoeba

histolytica.

5.2Pharmacokineticproperties

Anitroimidazolederivativewellabsorbed and widely distributed in thebody.Itismetabolised by acid oxidation,

hydroxylation and glucuronidation and excreted in urineand faeceswith aT

ofabout7-8 hours.

5.3Preclinical safetydata

Metronidazolehasbeen shown to becarcinogenicin themouseand in therat.However, similarstudiesin thehamster

havegiven negativeresultsand extensivehuman epidemiologicalstudieshaveprovided no evidenceofincreased

carcinogenicrisk in humans.Metronidazolehasbeen shown to bemutagenicin bacteriain vitro.In studiesconducted

in mammalian cellsin vitroaswellasin rodentand in humansin vivo, therewasinadequateevidenceofmutagenic

effects.

Therefore, theuseofFlagylforlongertreatmentthan usually requiredshould becarefully weighed.(See“Warnings

and Precautions”).

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

6.2Incompatibilities

None

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25°C. Storein theoriginalcontainer.

6.5Natureandcontentsofcontainer

Performed PVC/polyethylenelaminates.

Moulded plaguettesofcelluloseacetate, plasticized with approximately 22%

diethylphthalate/triphenylphosphatesealed with heatusing glyceroltriacetateadhesive.

Pack size:Boxes10 x 1g suppositories.

6.6Instructionsforuseandhandling

Suppository BaseE75

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7MARKETINGAUTHORISATIONHOLDER

May and Baker

RPRHouse

50 KingsHillAvenue

WestMalling

Kent

ME19 4AH

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

PA40/3/5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:30 th

September1977

Dateoflastrenewal:30 th

September2002

10DATEOFREVISIONOFTHETEXT

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