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FLAGYSTATIN VAGINAL OVULE

Prescription Only
Drug type: Therapeutic
ATC code: G01AA01
Dosage form: SUPPOSITORY
Route of administration: VAGINAL
Active ingredient: METRONIDAZOLE; NYSTATIN; METRONIDAZOLE; NYSTATIN

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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.

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 7th month of pregnancy.

Registrant
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Approval Date
1990-02-01
Approval Number
SIN03798P
Manufacturer
P.T. Aventis Pharma
Licence Holder
SANOFI-AVENTIS SINGAPORE PTE. LTD.