Flagyl-S

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

METRONIDAZOLE

Предлага се от:

Sanofi Malta Limited

АТС код:

P01AB01

INN (Международно Name):

METRONIDAZOLE

Лекарствена форма:

ORAL SUSPENSION

Композиция:

METRONIDAZOLE 200 milligram(s)/5 millilitre

Вид предписание :

POM

Терапевтична област:

ANTIPROTOZOALS

Статус Оторизация:

Authorised

Дата Оторизация:

2005-09-30

Листовка

1
FLAGYL™-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.
-
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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If any side effects gets serious, or if you notice any side effect not
listed in this leaflet, please tell your doctor
or pharmacist.
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 infection in
your body.
It can be used to:
•
Treat infections of the 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 sensitive or allergic to metronidazole or any of the
ingredients listed below in Section 6. Signs of an
allergic reaction include: rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.
•
If you are pregnant or breast feeding or think you might be pregnant.
•
If you are sufferin

Данни за продукта

1
NAME OF THE MEDICINAL PRODUCT
Flagyl-S
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active component of this suspension is metronidazole benzoate 320
mg/5 ml, equivalent to 200
mg/5 ml metronidazole.
Excipients:
Each
5ml
also
contains
3.01g
sucrose,
4.00mg
methyl
parahydroxybenzoate,
1.00mg propyl parahydroxybenzoate and 0.04ml ethanol.
For a 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:
1.
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
2.
Acute ulcerative gingivitis
Adults & Children over 10 years:
600 mg daily in 3 divided doses for 3 days.
Children:
Aged 7 to 10 years:
300 mg daily in 3 divided doses for 3 days.
Aged 3 to 7 years:
200 mg daily in 2 divided doses for 3 days.
Aged 1 to 3 years:
150 mg i