Metrogyl

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Metronidazole 200mg

Available from:

Viatris Limited

Dosage:

200 mg

Pharmaceutical form:

Tablet

Composition:

Active: Metronidazole 200mg Excipient: Colloidal silicon dioxide Disodium edetate Ethylcellulose Guar gum Lactose monohydrate Magnesium stearate Sodium starch glycolate

Prescription type:

Prescription

Therapeutic indications:

Metronidazole is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause. Metronidazole is active against a wide range of pathogenic micro-organisms notably species of Bacteroides, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and Gardnerella vaginalis. It is also active against Trichomonas, Entamoeba histolytica, Giardia lamblia and Balantidium coli. Metronidazole is indicated in adults and children for the following indications: 1. The prevention of postoperative 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. 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).

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP screw cap with an induction inner seal - 250 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

2018-08-16

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
METROGYL
_METRONIDAZOLE TABLETS, 200 MG & 400 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking METROGYL.
This leaflet answers some common
questions about METROGYL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking METROGYL
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT METROGYL IS
USED FOR
METROGYL is used in the
treatment of various infections
caused by bacteria or other
organisms, in different parts of the
body.
It can be used to:

prevent or treat infections
that may occur during
surgery.

treat infections of the blood,
brain, lung, bones, genital
tract, pelvic area, stomach
and intestines.

treat gum ulcers and other
dental infections.

treat infected leg ulcers and
pressure sores.
METROGYL contains the active
ingredient metronidazole_._ It belongs
to a group of medicines called
antiprotozoals and antibacterials.
This medicine works by killing or
stopping the growth of bacteria and
other organisms causing these
infections._ _
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE
METROGYL
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE METROGYL IF YOU
HAVE AN ALLERGY TO:

any medicine containing
metronidazole or any other
imidazoles

any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
th

Summary of Product characteristics

Page 1 of 10
NEW ZEALAND DATA SHEET
METROGYL
1. PRODUCT NAME
Metrogyl 200 mg and 400 mg tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Metrogyl tablet contains 200 mg or 400 mg of metronidazole.
Excipients with known effect: Metrogyl tablets contain sulfites,
galactose and sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Metrogyl 200 mg tablets: white tablets marked with MZ/200 on one side,
G on the reverse.
Metrogyl 400 mg tablets: yellow tablets marked with MZ/400 on one
side, G on the reverse.
The score line is not intended for breaking the tablet.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Metronidazole is indicated in the prophylaxis and treatment of
infections in which anaerobic bacteria
have been identified or are suspected to be the cause.
Metronidazole is active against a wide range of pathogenic
micro-organisms notably species of
_Bacteroides_, _Fusobacteria_, _Clostridia_, _Eubacteria_, anaerobic
cocci and _Gardnerella vaginalis_.
It is also active against _Trichomonas_, _Entamoeba histolytica_,
_Giardia lamblia _and _Balantidium coli_.
Metronidazole is indicated in adults and children for the following
indications:
1.
The prevention of postoperative 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.
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).
Page 2 of 10
6.
Giardiasis.
7.
Acute ulcerative gingivitis.
8.
Anaerobically infected leg ulcers and pressure sores.
9.
Acute dental infecti