Flagyl-S 200mg/5ml Oral Suspension

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Metronidazole

Commercializzato da:

Sanofi-Aventis Ireland Limited T/A SANOFI

Codice ATC:

P01AB01

INN (Nome Internazionale):

Metronidazole

Dosaggio:

200 mg/5ml

Forma farmaceutica:

Oral suspension

Tipo di ricetta:

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

Area terapeutica:

metronidazole

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1977-04-01

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLAGYL
TM
-S
200MG/5ML ORAL SUSPENSION
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-S Suspension is and what it is used for
2.
What you need to know before you take Flagyl-S Suspension
3.
How to take Flagyl-S Suspension
4.
Possible side effects
5.
How to store Flagyl-S Suspension
6.
Contents of the pack and other information
1.
WHAT FLAGYL-S SUSPENSION IS AND WHAT IT IS USED FOR
Flagyl-S Suspension belongs to a group of medicines called
anti-microbials. Flagyl-S Suspension 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-S
SUSPENSION
DO NOT TAKE FLAGYL-S SUSPENSION:
•
If you are allergic (hypersensitive) to metronidazole or

Scheda tecnica

Health Products Regulatory Authority
09 November 2023
CRN00D06X
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flagyl-S 200mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of Suspension contains Metronidazole Benzoate equivalent to
200 mg of Metronidazole.
Excipients of known effect
Each 5 ml also contains 3.01 g sucrose, 4.00 mg methyl
parahydroxybenzoate, 1.00 mg propyl parahydroxybenzoate and 31.4
mg ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension.
A white to cream-yellow oral suspension easily redispersible with
gentle shaking
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Metronidazole is indicated in adults and children for the following
indications:

In the treatment of urogenital trichomonaisis.

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 Dosage:
UROGENTIAL TRICHOMONIASIS
Adults and children over 10 years:
2000mg as a single dose or 200 mg 3 times daily for 7 days or 400mg
twice daily for 5-7 days
Children < 10 years:
40mg/kg orally as a single dose or 15 -30 mg/kg/day divided in 2-3
doses for 7 days; not to exceed 2000mg/dose
Health Products Regulatory Authority
09 November 2023
CRN00D06X
Page 2 of 8
ACUTE ULCERATIVE GINGIVITIS
Adul