FLAGYL Suppositories, Oral suspension Ref.[865] Active ingredients: Methronidazole

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2022  Publisher: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, PO Box 62027, Sylvia Park Auckland 1644, Freecall: 0800 283 684, Email: medinfo.australia@sanofi.com

Product name and form

Flagyl 500 mg suppositories.

Flagyl-S 200 mg/5 mL oral suspension.

Pharmaceutical Form

Suppository and oral suspension.

Flagyl suppositories are creamy in colour, smooth faced and torpedo shaped.

Flagyl-S is a white to cream-yellow (buff) coloured suspension easily dispersible with gentle shaking.

Qualitative and quantitative composition

Flagyl suppositories contain 500 mg metronidazole.

Flagyl-S suspension contains 320 mg metronidazole benzoate, equivalent to 200 mg metronidazole, in each 5 mL.

Flagyl-S suspension also contains 3.01 g sucrose, 4.00 mg methyl parahydroxybenzoate, 1.00 mg propyl parahydroxybenzoate and 0.04 mL ethanol, in each 5 mL.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Methronidazole

Metronidazole is an anti-infectious drug belonging to the pharmacotherapeutic group of nitroimidazole derivatives, which have effect mainly on strict anaerobes. This effect is probably caused by interaction with DNS and different metabolites.

List of Excipients

Flagyl suppositories contain hard fat as the excipient.

Flagyl-S oral solution contains the following excipients:

  • sucrose
  • ethanol
  • monobasic sodium phosphate dihydrate
  • aluminium magnesium silicate
  • methyl hydroxybenzoate
  • propyl hydroxybenzoate
  • terpeneless orange oil
  • citrus limon
  • purified water

Pack sizes and marketing

Suppositories

Pack size: blister pack 10 suppositories.

Suspension

Pack size: 100 mL glass bottle.

Marketing authorization holder

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, PO Box 62027, Sylvia Park Auckland 1644, Freecall: 0800 283 684, Email: medinfo.australia@sanofi.com

Marketing authorization dates and numbers

Flagyl suppositories: 25 August 1977
Flagyl-S oral suspension: 22 December 1980

Drugs

Drug Countries
FLAGYL Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Malta, Mexico, Nigeria, Netherlands, New Zealand, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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