Flagyl 400mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Metronidazole

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

P01AB01

INN (International Name):

Metronidazole

Dosage:

400 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

metronidazole

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLAGYL
TM 200MG TABLETS
FLAGYL
TM 400MG TABLETS
Metronidazole
Is this leaflet hard to see or read? Phone [phone] for help
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
•
If any side effects get serious, or if you notice any side effect not
listed in this leaflet, please tell your
doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Flagyl is and what it is used for
2.
What you need to know before you take Flagyl
3.
How to take Flagyl
4.
Possible side effects
5.
How to store Flagyl
6.
Contents of the pack and other information
1.
WHAT FLAGYL IS AND WHAT IT IS USED FOR
Flagyl belongs to a group of medicines called anti-microbials. Flagyl
is used in the treatment and
prevention of severe infections that are caused by anaerobic bacteria,
particularly species of
_Bacteroides, _
anaerobic
_ Streptococci, Fusobacteria, Clostridia, _
etc
It works by killing bacteria and parasites that cause infections in
your body.
It can be used to:
•
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.
•
Prevent infections after surgery.
•
In the prevention and treatment of infections due to anaerobic
bacteria (bacteria that are able to
survive in the absence of oxygen)
If you need any further information on your illness, speak to your
doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLAGYL
DO NOT TAKE FLAGYL:
•
If you are allergic (hypersensitive) to metronidazole or any of the
other ingredients of this
medicine (listed in section 6). Signs of an allergic reaction inc

Summary of Product characteristics

Health Products Regulatory Authority
18 April 2023
CRN00DC7J
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flagyl 400mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg of metronidazole.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
White to off-white biconvex, capsule-shaped film-coated tablet
imprinted ‘Flagyl 400’, plain reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Metronidazole is indicated in adults and children for the following
indications:

In the treatment of urogenital trichomoniasis

In the treatment of acute ulcerative gingivitis.

In the treatment of infections due to E. histolytica (including
carrier states).

In the treatment of infections due to G. Lamblia (including carrier
states).

In the prevention and treatment of infections due to anaerobic
bacteria, particularly species of Bacteroides,
anaerobic streptococci, fusobacteria, clostridia, etc.

In the treatment of acute dental infections.

In the treatment of non-specific vaginitis.
Metronidazole is indicated in adults only for the following
indications:

In the treatment of chronic pressure sores and ulcers with possible
infection due to anaerobes.
_Consideration should be given to official guidance on the appropriate
use of antibacterial agents._
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral
Recommended Dosages:
UROGENTIAL TRICHOMONIASIS
Adults and children over 10 years:
2000 mg as a single dose or 200 mg 3 times daily for 7 days or 400 mg
twice daily for 5 – 7 days
Children <10 years:
40 mg/kg orally as a single dose or 15 – 30 mg/kg/day divided in 2
– 3 doses for 7 days; not to exceed 2000 mg/dose
ACUTE ULCERATIVE GINGIVITIS
Adults and children over 10 years:
600 mg daily in 3 divided doses for 3 days.
Paediatric population:
Health Products Regulatory Authority
18 April 2023
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Page 2 of 7
_Aged 7 to 10 years: _300 mg daily in 3 divided doses for 3 days.
_Aged 3 to 7 years: _200