FLAGYL SUSPENSION

Страна: Южна Африка

Език: английски

Източник: South African Health Products Regulatory Authority (SAHPRA)

Предлага се от:

Sanofi-Aventis South Africa (Pty) Ltd

дозиране:

See ingredients

Лекарствена форма:

SUSPENSION

Композиция:

EACH 5 ml SUSPENSION CONTAINS BENZOYL METRONIDAZOLE 320 mg EQUIVALENT TO 200 mg METRONIDAZOLE

Статус Оторизация:

Registered

Дата Оторизация:

1976-02-02

Листовка

Flagyl suspension: Implementable summary received 24.10.2021
FINAL PIL (CLEAN COPY) DATED 24.10.2021
PAGE 1 OF 12
PATIENT INFORMATION LEAFLET:
SCHEDULING STATUS:
S4
FLAGYL SUSPENSION : each 5 mL of suspension contains benzoyl
metronidazole equivalent
to metronidazole 200 mg
Contains sugar: sucrose 3 g/5 mL
Preservatives: methyl hydroxybenzoate 0,08 % _m/v _and propyl
hydroxybenzoate 0,02 % _m/v _
For excipients, see section 6.1._ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
TAKING FLAGYL:
•
Keep this leaflet. You may need to read it again
•
If you have any further questions, please ask your doctor or [your]
pharmacist, nurse or
other health care provider
•
FLAGYL has been prescribed for you or your child personally and you
should not share
your medicine with other people. It may harm them, even if their
symptoms are the same
as yours.
WHAT IS IN THIS LEAFLET:
1 What FLAGYL is and what it is used for
2 What you need to know before you take or give FLAGYL to your child
3 How to receive FLAGYL
4 Possible side effects
5 How to store FLAGYL
6 Contents of the pack and other information.
Flagyl suspension: Implementable summary received 24.10.2021
FINAL PIL (CLEAN COPY) DATED 24.10.2021
PAGE 2 OF 12
1. WHAT FLAGYL IS AND WHAT IT USED FOR:
FLAGYL contains metronidazole, and it works by killing bacteria and
parasites that cause
infections in your body.
IT CAN BE USED TO:
•
Treat infections caused by certain bacteria
•
Prevent infections after surgery.
If you or your child need any further information on your illness,
speak to your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OR GIVE FLAGYL TO YOUR CHILD:
DO NOT TAKE FLAGYL OR GIVE FLAGYL TO YOUR CHILD IF:
•
You or your child are allergic (hypersensitive) to metronidazole or
any of the other
ingredients in FLAGYL. Signs of an allergic reaction include: a rash,
swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
•
You or your child are taking the medicine, busulfan (treatment for
cancer of blood cells).
(

Данни за продукта

Flagyl suspension: Amended in line e-mail request received with
implementable summary dated 24.10.2021
Date submitted: 04.11.2021 FINAL APPROVED PI (CLEAN COPY) DATED 24.10.2021
PAGE 1 OF 16
SCHEDULING STATUS: S4
1. NAME OF THE MEDICINE:
FLAGYL SUSPENSION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each 5 ml of suspensions contains: benzoyl metronidazole equivalent to
metronidazole 200
mg
Contains sugar: sucrose 3 g/5 mL
Preservatives: methyl hydroxybenzoate 0,08 % _m/v _and
propyl hydroxybenzoate 0,02 % _m/v _
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM:
Off-white, coarse, oral suspension with an orange and lemon odour.
4. CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
a) In the oral treatment of:
urogenital trichomoniasis
non-specific vaginitis
all forms of amoebiasis
giardiasis
acute ulcerative gingivitis (Vincent's)
acute pericoronitis.
Flagyl suspension: Amended in line e-mail request received with
implementable summary dated 24.10.2021
Date submitted: 04.11.2021 FINAL APPROVED PI (CLEAN COPY) DATED 24.10.2021
PAGE 2 OF 16
b)
Treatment of infections in which anaerobic bacteria have been
identified or are
suspected as pathogens, particularly _Bacteroides fragilis_ and other
species of
Bacteroides and including other species for which metronidazole is
bactericidal, such
as fusobacteria, clostridia, eubacteria and anaerobic streptococci.
FLAGYL has been used successfully for anaerobic infections in the
following
conditions: pelvic inflammatory disease and postoperative wound
infections. Combined
therapy is often indicated as there are usually mixed infections.
c)
Prevention of postoperative infections due to anaerobic bacteria:
i) Given before and after gynaecological surgery
ii) Given before and after appendectomy
iii) Given before and after colonic surgery
d)
Treatment of _Helicobacter pylori_-associated gastritis and duodenal
ulcer. FLAGYL is
used in combination with bismuth subsalicylate or colloidal bismuth
subcitrate and
appropriate antibiotic therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTR