FLAGYL metronidazole 400 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metronidazole, Quantity: 400 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Metronidazole

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: hypromellose; magnesium stearate; purified talc; calcium hydrogen phosphate; macrogol 400; maize starch; povidone

Administration route:

Oral

Units in package:

21 x 400mg tablets, 5 x 400mg tablets

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. Note: 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 extraintestinal disease and that of symptomless cyst passers); giardiasis; acute ulcerative gingivitis.

Product summary:

Visual Identification: Round, white to off-white biconvex tablet, one side impressed with 'MTZ400' and breakline on reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-06-22

Patient Information leaflet

FLAGYL
®
F
l
a
g
y
l
®
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?
Flagyl contains the active ingredient metronidazole (tablet and
suppository). Flagyl 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? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FLAGYL?
Do not use if you have ever had an allergic reaction to Flagyl 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? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Flagyl 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?
Follow the instructions provided and use Flagyl until your doctor
tells you to stop.
More instructions can be found in Section 4. How do I use Flagyl? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FLAGYL?
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 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
be killed.
DRIVING
OR U

Summary of Product characteristics

Flagyl-ccdsv17-piv20-24mar22
1
AUSTRALIAN PRODUCT INFORMATION – FLAGYL
®
(METRONIDAZOLE) TABLET & SUPPOSITORY
1
NAME OF THE MEDICINE
metronidazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flagyl tablets contain 200 mg or 400 mg metronidazole.
Flagyl suppositories contain 500 mg metronidazole.
For the full list of excipients, see Section List of excipients.
3
PHARMACEUTICAL FORM
200 mg tablets: Round, white to off-white tablets, one face impressed
with ‘MTZ 200’ and a
break line on the other.
400 mg tablets: Round, white to off-white biconvex tablet, one side
impressed with 'MTZ 400'
and breakline on reverse.
500 mg suppositories: Cream coloured, smooth, torpedo-shaped solids,
which may have a hole
in the base.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ANAEROBIC INFECTIONS
_ORAL _
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.
_SUPPOSITORIES _
Treatment of anaerobic infection in patients for whom oral medication
is not possible or is
contraindicated. Prevention of anaerobic infection in high risk
situations in patients for whom
oral medication is not possible or is contraindicated.
Flagyl-ccdsv17-piv20-24mar22
2
Metronidazole may be used prophylactically to prevent infection of the
surgical site which may
have been contaminated or potentially contaminated with anaerobic
organisms. Procedures in
which this may be assumed to have happened include appendicectomy,
colonic surgery,
vaginal hysterectomy, abdominal surgery in the presence of anaerobes
in the peritoneal cavity
and surgery performed in the presence of anaerobic septicaemia.
NOTE:
Metronidazole is inactive against aerobic and fa