FLAGYL 250 MG TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

METRONIDAZOLE

Available from:

SANOFI ISRAEL LTD

ATC code:

J01XD01

Pharmaceutical form:

FILM COATED TABLETS

Composition:

METRONIDAZOLE 250 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SANOFI - AVENTIS S.A., SPAIN

Therapeutic group:

METRONIDAZOLE

Therapeutic area:

METRONIDAZOLE

Therapeutic indications:

Trichomonias, acute intestinal amebiasis. Infections due to anaerobic bacteria, lambliasis.

Authorization date:

2022-08-31

Patient Information leaflet

PAG 1
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860682
RIELLS PACKAGING TEAM
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860682
PRO FGL 250MG IL
664339
823415
4170611
V1-15/09/2022
M.PACHO
313
Ocean Sans Pro SAN (9 pt)
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
FLAGYL 250 MG TABLETS
ACTIVE INGREDIENT AND ITS QUANTITY:
Each tablet contains metronidazole 250 mg
Inactive ingredients – see Section 2 “Important information about
some
of the ingredients of the medicine” and Section 6 “Further
information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine was prescribed to treat you. Do not pass it on to
others.
It may harm them, even if it seems to you that their medical condition
is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is used for the treatment of infections caused by amebae,
lambliasis, trichomonas, anaerobic bacteria, or bacteria sensitive to
metronidazole.
THERAPEUTIC GROUP: Antibacterial, antiparasitic antibiotic from the
5-nitroimidazole group. ATC code: J01XD01-P01AB01.
2. BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE IF:
- you are sensitive (allergic) to the active ingredient, or to any of
the
other ingredients of this medicine (see Section 6),
-
you are allergic (hypersensitive) to wheat, as this medicine contains
wheat starch (gluten),
-
the patient is a child under 6 years of age (see Section “Special
warnings regarding use of the medicine”).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
Before treatment with Flagyl 250 mg Tablets, inform the

Summary of Product characteristics

Flagyl-tabs-SPC-22.0
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FLAGYL 250 MG TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole
...........................................................................................................................
250.00 mg
For one film-coated tablet.
Excipient(s) with known effect: wheat starch (containing gluten) (see
section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Trichomonias, acute intestinal amebiasis.
Infections due to anaerobic bacteria, lambliasis.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY

Amebiosis
o
Adults
1.50 g/day in 3 intakes.
o
Children
30 to 40 mg/kg/day in 3 intakes.
In the event of amebic liver abscess, drainage or aspiration of pus
should be performed in conjunction
with metronidazole therapy.
Treatment duration is 7 consecutive days.

Trichomoniasis
o
In women (trichomonas urethritis and vaginitis), a 10-day treatment
period
associating:

0.50 g/day in 2 oral intakes,

1 pessary/day.
If PHARMACEUTICAL FORM of pessary is not optional, the physician
should consider alternative
therapies for these patients.
The sexual partner should be treated concomitantly, whether presenting
with clinical signs of
_Trichomonas vaginalis _infection or not, even if laboratory test
results are negative.
o
In men (trichomonas urethritis):
0.50 g/day in 2 oral intakes for 10 days
In very rare cases, it may be necessary to increase the daily dose to
0.750 g or 1 g.
o
Lambliasis
o
Adults
0.750 g to 1 g/day for 5 consecutive days.
o
Children:
6 to 10 years: 375 mg/day
10 to 15 years: 500 mg/day

Nonspecific vaginitis
500 mg (2X250mg) twice daily for 7 days
The partner should be treated concomitantly.

Treatment of infections caused by susceptible anaerobic
micro-organisms (first-line
treatment or replacement treatment)
o
Adults:
1 g to 1.5 g/day.
o
Children:
20 mg to 30 mg/kg/day.
4.3. CONTRAINDICATIO