Flagyl 200mg Tablets

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

METRONIDAZOLE

Pieejams no:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATĶ kods:

J01XD01

SNN (starptautisko nepatentēto nosaukumu):

METRONIDAZOLE 200 mg

Zāļu forma:

FILM-COATED TABLET

Kompozīcija:

METRONIDAZOLE 200 mg

Receptes veids:

POM

Ārstniecības joma:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorizācija statuss:

Withdrawn

Autorizācija datums:

2005-08-16

Lietošanas instrukcija

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11503470-04
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 o

Produkta apraksts

1
TRADE NAME OF THE MEDICINAL PRODUCT
Flagyl 200mg Tablets.
2
QUALITATIVE AND QUANTITIATIVE COMPOSITION
Each tablet contains 200mg of metronidazole.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film coated tablet.
White to off-white circular biconvex, film-coated tablets impressed
‘Flagyl 200’, on one side.
Plain reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metronidazole is indicated in adults and children for the following
indications:
In the treatment of urogenital trichomoniasis
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 administration.
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
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 in 3 divided doses for 3 days.
Amoebiasis
Adults and children over 10 years:
400 to 800mg 3 times daily for 5-10 days.
Children:
Aged 7 to 10 years:
20