Flagyl 200mg Tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Metronidazole

Saadav alates:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC kood:

P01AB01

INN (Rahvusvaheline Nimetus):

Metronidazole

Annus:

200 milligram(s)

Ravimvorm:

Film-coated tablet

Retsepti tüüp:

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

Terapeutiline ala:

metronidazole

Volitamisolek:

Marketed

Loa andmise kuupäev:

1977-04-01

Infovoldik

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

Toote omadused

Health Products Regulatory Authority
18 April 2023
CRN00DC7J
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flagyl 200mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of metronidazole.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
White to off-white circular biconvex, film-coated tablet impressed
‘Flagyl 200’, on one side. 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 administration.
Recommended Dosage:
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:
Health Products Regulatory Authority
18 April 2023
CRN00DC7J
Page 2 of 8
600 mg daily in 3 divided doses for 3 days.
Paediatric population:
_ Aged 7 to 10 years:_ 300 mg daily in 3 divided doses for 3 days.
_