FLAGYSTATIN VAGINAL OVULE

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

METRONIDAZOLE; NYSTATIN

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

G01AA01

Dosage:

500 mg

Pharmaceutical form:

SUPPOSITORY

Composition:

METRONIDAZOLE 500 mg; NYSTATIN 100000 iu

Administration route:

VAGINAL

Prescription type:

Prescription Only

Manufactured by:

PT Kalventis Sinergi Farma

Authorization status:

ACTIVE

Authorization date:

1990-02-01

Summary of Product characteristics

SG/FLA/0923/Manufacturer name & address change
Flagystatin®
Metronidazole & Nystatin
PRESENTATION
Vaginal Ovules: Each ovule contains metronidazole 500 mg and nystatin
100,000 units.
Tartrazine-free.
INDICATIONS
Mixed vaginal infection due to Trichomonas vaginalis and C. albicans.
CONTRAINDICATIONS
Hypersensitivity to FLAGYSTATIN (metronidazole and nystatin), or to
imidazoles, or any
of its constituents, including any non-medicinal ingredient, or
component of the container.
For
a
complete listing, see DOSAGE
FORMS, STRENGTHS, COMPOSITION AND
PACKAGING.
Combined
treatment
with
oral
metronidazole
should
be
avoided
in
cases
of
active
neurological disorders or a history of blood dyscrasia, hypothyroidism
or hypoadrenalism
unless, in the opinion of the physician, the benefits outweigh the
possible hazard to the
patient.
SERIOUS WARNINGS AND PRECAUTIONS BOX
DOSAGE
One vaginal ovule daily, inserted deep into vagina, before retiring
for 10 consecutive days.
In order to facilitate disintegration, moisten the vaginal tablet
under water for a second or
two just before introduction in the vagina.
If after 10 days of treatment a cure has not been achieved, a second
10 day course of
treatment should be given. If Trichomonas vaginalis has not been
completely eliminated,
oral metronidazole 250 mg should be administered twice daily for 10
days.
The applicator should not be used after the 7
th
month of pregnancy.
OVERDOSAGE
Symptoms
Serious Warnings and Precautions

Cases of severe hepatotoxicity/acute hepatic failure, including cases
with a fatal
outcome, with very rapid onset after treatment initiation, in patients
with Cockayne
syndrome have been reported with products containing metronidazole for
systemic
use. In this population, FLAGYSTATIN should therefore only be used
after careful
benefit-risk assessment and only if no alternative treatment is
available (see 7
WARNINGS AND PRECAUTIONS).
SG/FLA/0923/Manufacturer name & address change
No case of accidental massive ingestion of FLAGYSTATIN has been
reported yet.
However,