Flagyl 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metronidazole

Available from:

Sanofi

ATC code:

P01AB01

INN (International Name):

Metronidazole

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011100; GTIN: 5000283652342

Patient Information leaflet

PAG 2
Avance bobina
PAG 1
150 x 315 mm
838141
LC 149
Dirección de Lectura
Dirección de Lectura
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLAGYL
TM
400MG TABLETS
Metronidazole
Is this leaflet hard to see or read? Phone
0800 035 2525 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 further questions, please 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 you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in the leaflet. 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
The name of this medicine is Flagyl 400mg Tablets (called
Flagyl in this leaflet). Flagyl contains a medicine called
metronidazole. This belongs to a group of medicines
called antibiotics.
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
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:
X You are allergic (hypersensitive) to metronidazole,
nitroimidazoles (e.g. tinidazole) or any of the other
ingredients of this medicine (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face,
throat or tongue.
Do not take Flag

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Flagyl 400mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg metronidazole.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Flagyl tablets 400 mg:
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
Flagyl is indicated in the prophylaxis and treatment of infections in
which anaerobic
bacteria have been identified or are suspected to be the cause.
Flagyl is active against a wide range of pathogenic micro-organisms
notably species
of _Bacteroides_, _Fusobacteria_, _Clostridia_, _Eubacteria_,
anaerobic cocci and
_Gardnerella vaginalis_.
It is also active against _Trichomonas_, _Entamoeba histolytica_,
_Giardia lamblia_ and
_Balantidium coli_.
Flagyl is indicated in adults and children for the following
indications:
1.
The prevention of post-operative infections due to anaerobic bacteria,
particularly species of _Bacteroides_ and anaerobic streptococci.
2.
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess,
necrotising
pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic
cellulitis, and
post-operative wound infections from which pathogenic anaerobes have
been
isolated.
3.
Urogenital trichomoniasis in the female (trichomonal vaginitis) and in
the male.
4.
Bacterial vaginosis (also known as non-specific vaginitis, anaerobic
vaginosis or
Gardnerella vaginitis).
5.
All forms of amoebiasis (intestinal and extra-intestinal disease and
that of
symptomless cyst passers).
6.
Giardiasis.
7.
Acute ulcerative gingivitis.
8.
Anaerobically-infected leg ulcers and pressure sores.
9.
Acute dental infections (e.g. acute pericoronitis and acute apical
infections).
Considerations should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
1.
Prophylaxis against anaerobic infection:
Chief