Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD
Tablet
Each tablet contains METRONIDAZOLE 400 mg
1973-03-10
1 SCHEDULING STATUS: S4 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: FLAGYL 200 (Tablets) FLAGYL 400 (Tablets) FLAGYL SUSPENSION (200 mg/5 ml) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START TAKING FLAGYL: Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or your pharmacist. FLAGYL has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT FLAGYL CONTAINS: The active substance is metronidazole. FLAGYL 200 Each tablet contains: Metronidazole 200 mg Preservative: Methyl hydroxybenzoate 0,1 % _m/m _ OTHER INGREDIENTS ARE: Maize starch, calcium carbonate, methyl hydroxybenzoate, sodium lauryl sulphate, stearic acid and microcrystalline cellulose. FLAGYL 400 Each tablet contains: Metronidazole 400 mg 2 Preservative: Methyl hydroxybenzoate 0,1 % _m/m_ Contains tartrazine. OTHER INGREDIENTS ARE: Methyl hydroxybenzoate, maize starch, calcium carbonate, microcrystalline cellulose, potassium dihydrogen phosphate, sodium hydroxide, sodium lauryl sulphate, stearic acid and yellow dye (CI 19140). FLAGYL SUSPENSION Each 5 ml contains: Benzoyl metronidazole equivalent to metronidazole 200 mg Preservatives: Methyl hydroxybenzoate 0,08 % _m/v_ Propyl hydroxybenzoate 0,02 % _m/v _ Contains sugar (sucrose). OTHER INGREDIENTS ARE: Sodium dihydrogen phosphate, methyl hydroxybenzoate, propyl hydroxybenzoate, ethanol, sucrose, veegum h.v., lemon flavouring, oil of orange and water. WHAT FLAGYL IS USED FOR: FLAGYL contains metronidazole, and it works by killing bacteria and parasites that cause infections in your body. IT CAN BE USED TO: Treat infections caused by certain bacteria Prevent infections after surgery. If you or your child need any further information on your illness, speak to your doctor. 3 BEFORE YOU TAKE FLAGYL: DO NOT TAKE FLAGYL IF: You or your child are allergic (hypersensitive) to metronidazole or any of the Read the complete document
1 SCHEDULING STATUS: S4 PROPRIETARY NAME (AND DOSAGE FORM): FLAGYL 200 (Tablets) FLAGYL 400 (Tablets) FLAGYL SUSPENSION COMPOSITION: FLAGYL 200 Each tablet contains: Metronidazole 200 mg Preservative: Methyl hydroxybenzoate 0,1 % _m/m_ EXCIPIENTS: Maize starch, calcium carbonate, methyl hydroxybenzoate, sodium lauryl sulphate, stearic acid and microcrystalline cellulose. FLAGYL 400 Each tablet contains: Metronidazole 400 mg Preservative: Methyl hydroxybenzoate 0,1 % _m/m_ Contains tartrazine. EXCIPIENTS: Methyl hydroxybenzoate, maize starch, calcium carbonate, microcrystalline cellulose, potassium dihydrogen phosphate, sodium hydroxide, sodium lauryl sulphate, stearic acid and yellow dye (CI 19140). 2 FLAGYL SUSPENSION Each 5 ml contains: Benzoyl metronidazole equivalent to metronidazole 200 mg Preservatives: Methyl hydroxybenzoate 0,08 % _m/v_ Propyl hydroxybenzoate 0,02 % _m/v _ Contains sugar (sucrose). EXCIPIENTS: Sodium dihydrogen phosphate, methyl hydroxybenzoate, propyl hydroxybenzoate, ethanol, sucrose, veegum h.v., lemon flavouring, oil of orange and water. PHARMACOLOGICAL CLASSIFICATION: A 20.2.6 Antimicrobial (chemotherapeutic) agents: Medicines against protozoa PHARMACOLOGICAL ACTION: PHARMACODYNAMIC PROPERTIES: Metronidazole has antiprotozoal activity against _Trichomonas vaginalis_ and other protozoa, including _Entamoeba histolytica_ and _Giardia lamblia_. It does not affect the acidophilic flora of the vagina and it has no effect on Candida species. Metronidazole has bactericidal activity against obligate anaerobic bacteria, whether they are Gram-positive or -negative and bacilli or cocci. It has no antibacterial activity against aerobic and facultative anaerobic bacteria. Metronidazole does not interfere with the activity of antibacterial agents which are active against a variety of aerobes and facultative anaerobes. The following has been proposed as the mode of action of metronidazole: The parent compound penetrates the cell membrane unchanged, but once inside the cell the nitro group is reduce Read the complete document