FLAGYL S benzoyl metronidazole 64 mg/mL suspension oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metronidazole benzoate, Quantity: 64 mg/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Metronidazole benzoate

Pharmaceutical form:

Oral Liquid, suspension

Composition:

Excipient Ingredients: ethanol; monobasic sodium phosphate; aluminium magnesium silicate; methyl hydroxybenzoate; sucrose; propyl hydroxybenzoate; Orange Oil Terpeneless; Flavour

Administration route:

Oral

Units in package:

100mls bottle

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Anaerobic infections Treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly Bacteroides fragilis and other species of bacteroides, and other species such as fusobacteria, eubacteria, clostridia and anaerobic streptococci. Flagyl has been used successfully in septicaemia; bacteraemia; brain abscess; necrotising pneumonia; osteomyelitis; puerperal sepsis; pelvic abscess; pelvic cellulitis; postoperative wound infections. Notes. 1. Because of the slow absorption and delayed peak plasma level, Flagyl suspension is not recommended for use in the acute situation. 2. Metronidazole is inactive against aerobic and facultative anaerobic bacteria. Other Indications Oral treatment of urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male, and for the treatment of bacterial vaginosis. The male consort of females suffering from urogenital trichomoniasis should be treated concurrently; all forms of amoebiasis( intestinal and extraintestin

Product summary:

Visual Identification: White or cream suspension with slight yellow tinge; Container Type: Bottle; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-21

Patient Information leaflet

FLAGYL
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING FLAGYL S?
Flagyl S contains the active ingredient metronidazole benzoate
(liquid). Flagyl S is used to treat certain infections caused by
bacteria
and other organisms in different parts of the body. It is also used to
prevent or treat certain infections that may occur during surgery.
For more information, see Section 1. Why am I using Flagyl S? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FLAGYL S?
Do not use if you have ever had an allergic reaction to Flagyl S or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Flagyl S? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Flagyl S and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE FLAGYL S?
Follow the instructions provided and use Flagyl S until your doctor
tells you to stop.
More instructions can be found in Section 4. How do I use Flagyl S? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FLAGYL S?
THINGS YOU
SHOULD DO
•
Tell your doctor straight away if the symptoms of your infection do
not improve or become worse, if you
become pregnant or if you are about to start taking any new medicines.
•
Stop taking this medicine and tell your doctor straight away if you
have irrational thoughts, hallucinations,
feeling confused or feeling depressed, including thoughts of self-harm
or suicide.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking Flagyl S if you feel better. If you do not complete
the full course prescribed by your
doctor, all of the bacteria/organisms causing your infection may not

Summary of Product characteristics

flagyl-s ccdsv17-piv19-31mar22
1
AUSTRALIAN PRODUCT INFORMATION –
FLAGYL S (METRONIDAZOLE BENZOATE) ORAL SUSPENSION
1
NAME OF THE MEDICINE
Metronidazole benzoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flagyl S suspension 6.4% w/v (metronidazole 200 mg/5 mL) contains
320mg of metronidazole
benzoate, equivalent to 200mg of metronidazole, per 5mL.
Metronidazole benzoate is
1-(2-benzoyloxyethyl)-2-methyl-5-nitroimidazole.
List of excipients with known effect: hydroxybenzoates, sugars.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
A white or cream suspension with a slight yellow tinge, and with an
odour of orange and
lemon.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ANAEROBIC INFECTIONS
Treatment of infections in which anaerobic bacteria have been
identified or are suspected as
pathogens, particularly
_Bacteroides fragilis_
and other species of bacteroides, and other species
such as fusobacteria, eubacteria, clostridia and anaerobic
streptococci. Flagyl has been used
successfully in septicaemia; bacteraemia; brain abscess; necrotising
pneumonia; osteomyelitis;
puerperal sepsis; pelvic abscess; pelvic cellulitis; postoperative
wound infections.
NOTES:
a) Because of the slow absorption and delayed peak plasma level,
Flagyl S suspension is not
recommended for use in the acute situation.
b) Metronidazole is inactive against aerobic and facultative anaerobic
bacteria.
OTHER INDICATIONS
Oral treatment of urogenital trichomoniasis in the female (trichomonal
vaginitis) and in the
male, and for the treatment of bacterial vaginosis. The male consort
of females suffering from
urogenital trichomoniasis should be treated concurrently; all forms of
amoebiasis (intestinal
flagyl-s ccdsv17-piv19-31mar22
2
and extraintestinal disease and that of symptomless cyst passers);
giardiasis; acute ulcerative
gingivitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Flagyl S suspension is administered orally.
It is recommended that the dose should be taken at least one hour
before a meal.
Rins