Flagyl Tablets 400mg

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

METRONIDAZOLE

Tillgänglig från:

Sanofi Malta Limited

ATC-kod:

J01XD01

INN (International namn):

METRONIDAZOLE

Läkemedelsform:

FILM-COATED TABLET

Sammansättning:

METRONIDAZOLE 400 milligram(s)

Receptbelagda typ:

POM

Terapiområde:

ANTIBACTERIALS FOR SYSTEMIC USE

Bemyndigande status:

Authorised

Tillstånd datum:

2005-08-16

Bipacksedel

-1-
11503470-03
FLAGYL™ 200MG TABLETS
FLAGYL™ 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.
-
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

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Flagyl tablets 400 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active component of these tablets is metronidazole BP 400 mg.
3.
PHARMACEUTICAL FORM
Flagyl tablets 400 mg Film coated tablet:
White to off-white, biconvex, capsule shaped, film coated tablets
impressed “Flagyl
400” on one face, plain reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metronidazole is indicated in adults and children for the following
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
antobacterials.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral route of administration.
Flagyl tablets should be swallowed with water (not chewed). It is
recommended that
the tablets be taken during or after a meal.
_Anaerobic infections: _ The duration of a course of Flagyl treatment
is about 7 days but
it will depend upon the seriousness of the patient’s condition as
assessed clinically and
bacteriologically.
_Treatment:_
Adults: 800 mg followed by 400 mg 8 hourly.
Children:
Children > 8 weeks to 12 years of age: The usual daily dose is
20-30mg/kg/day as a
single dose or divided into 7.5mg/kg every 8 hours. The daily dose may
be increased to
40mg/kg, depending on the severi