Flagyl-S

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Metronidazole benzoate 64 mg/mL Equivalent to 40 mg/ml metronidazole.;  ;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Metronidazole benzoate 64 mg/mL (Equivalent to 40 mg/ml metronidazole.)

Dosage:

200 mg/5mL

Pharmaceutical form:

Oral suspension

Composition:

Active: Metronidazole benzoate 64 mg/mL Equivalent to 40 mg/ml metronidazole.     Excipient: Aluminium magnesium silicate Citrus limon Ethanol Methyl hydroxybenzoate Monobasic sodium phosphate dihydrate Propyl hydroxybenzoate Purified water Sucrose liquid Terpeneless orange oil

Units in package:

Bottle, glass, 1x100ml, 100 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aventis Pharma Dagenham Ltd

Product summary:

Package - Contents - Shelf Life: Bottle, glass, - 100 mL - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1980-12-22

Patient Information leaflet

Flagyl®
1
FLAGYL®
(FLAJ-ILL)
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 (suppository) and
metronidazole benzoate (liquid). 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

Summary of Product characteristics

flagyl-ccdsv17-dsv17-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Flagyl 500 mg suppositories
Flagyl-S 200 mg/5 mL oral suspension
2
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.
3
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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
The prevention of post-operative infections due to anaerobic bacteria,
particularly species
of bacteroides and anaerobic streptococci.
2.
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess,
necrotising
pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic
cellulitis, and post-
operative wound infections from which pathogenic anaerobes have been
isolated.
3.
Urogenital trichomoniasis in the female (trichomonal vaginitis) and in
the male.
flagyl-ccdsv17-dsv17-20jun22
Page 2
4.
Bacterial vaginosis (also known as non-specific vaginitis, anaerobic
vaginosis or
_Gardnerella vaginitis_
).
5.
All forms of amoebiasis (intestinal and extra-intestinal disease and
that of symptomless
cyst passers).
6.
Giardiasis.
7.
Acute ulcerative gingivitis.
8.
Anaerobically-infected leg ulcers and pressure sores.
9.
Acute dental infections due to anaerobic organisms (e.g. acute
pericoronitis and acute
apical infections).
4.2
DOSE AND METHOD OF ADMINISTRATION
Flagyl suppositories are unsuitable for initiating treatment of
serious conditions owing to slower
absorption and lower plasma concentrations of metronidazole.
Flagyl suspension should be taken at least one hour before a meal.
ANAE