FLAGYL SUSPENSION

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

METRONIDAZOLE AS BENZOATE

Tilgængelig fra:

SANOFI ISRAEL LTD

ATC-kode:

J01XD01

Lægemiddelform:

SUSPENSION

Sammensætning:

METRONIDAZOLE AS BENZOATE 25 MG/ML

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

UNITHER LIQUID MANUFACTURING, FRANCE

Terapeutisk gruppe:

METRONIDAZOLE

Terapeutisk område:

METRONIDAZOLE

Terapeutiske indikationer:

Infections caused by anaerobic bacterias, amebiosis, lambliasis and trichomonas.

Autorisation dato:

2022-02-28

Indlægsseddel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
FLAGYL SUSPENSION
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each 1 mL contains:
Metronidazole benzoate 40 mg
Corresponding to Metronidazole 25 mg
Each measuring spoon (5 mL) contains:
Metronidazole 125 mg
Inactive and allergenic ingredients in the preparation – see
Section 2 “Important information about some of the ingredients
of the medicine” and Section 6 “Further information”.
READ THE 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 has been 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 due to
amebae, lambliasis, trichomonas, anaerobic bacteria, or bacteria
sensitive to metronidazole.
The medicine contains an active ingredient called metronidazole,
which belongs to a group of medicines called antibiotics.
The agent works by killing bacteria and parasites that cause
infection in your body.
In certain cases, your partner will require simultaneous medicinal
treatment, even if he/she does not have symptoms – please
consult the doctor.
THERAPEUTIC GROUP: antibacterial, anti-parasitic antibiotic from
the nitro-5-imidazoles family.
ATC code: J01XD01-P01AB01.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
-
you are sensitive (allergic) to the active ingredient
metronidazole, or to a medicinal product from the imidazole
family (family of antibiotics to which metronidazole
belongs) or to any of the additional ingredients contained
in the medicine (see Section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
Before treatment with Flagyl Suspension, tell the doctor if you have:
-
neurological disorders,
-
psychia

Produktets egenskaber

Flagyl-SUS-SPC-24.0
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FLAGYL ORAL SUSPENSION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole benzoate
..............................................................................................................40
mg/ml
Corresponding to
Metronidazole……………………………………………………………………25
mg/ml
1 measuring spoon (5 ml) contains 125 mg of metronidazole.
Excipients with known effect: ethanol (96 per cent), sucrose, methyl
parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infections caused by anaerobic bacterias, amebiosis, lambliasis and
trichomonas.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
•
Amoebiasis
o
Adults
1.50 g Metronidazole / daily as three divided doses.
o
Paediatric population
30 to 40 mg Metronidazole / kg / day in three divided doses.
In patients with hepatic amoebiasis, in the abscess, stage, abscess
drainage should be performed in conjunction
with metronidazole therapy.
Treatment duration is 7 consecutive days.
•
Trichomoniasis
o
In women (urethritis and vaginitis due to Trichomonas), preferably,
ten-day treatment
combining the following:
▪
0.50 g Metronidazole / day by oral route as two divided doses.
▪
1 pessary/day.
If PHARMACEUTICAL FORM of pessary
is
not optional,
the
physician should consider
alternative therapies for these patients.
It is important that the partner be treated concomitantly, regardless
of whether there are clinical
signs of Trichomonas vaginalis infestation, even without a positive
laboratory test result.
o
In men (Urethritis trichomonal):
0.50 g Metronidazole / day by oral route as 2 divided doses for 10
days.
In exceptional cases, it may be necessary to increase the daily dose
to 0.750 g or 1 g
Metronidazole.
•
Lambliasis
o
Adults
0.750 g to 1 g Metronidazole / day for five consecutive da