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National Drug Formulary

FLAGYSTATIN VAGINAL OVULE [SIN03798P]

Active ingredients: FLAGYSTATIN VAGINAL OVULE

View product's general information
Last updated 24 April 2026

Product Info

FLAGYSTATIN VAGINAL OVULE

[SIN03798P]

Product information

Active Ingredient and Strength

METRONIDAZOLE - 500 MG
NYSTATIN - 100,000 INTERNATIONAL UNITS

Dosage Form

SUPPOSITORY

Manufacturer and Country

PT KALVENTIS SINERGI FARMA - INDONESIA REP OF

Registration Number

SIN03798P

Licence Holder

DCH AURIGA SINGAPORE

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

G01AA01

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

INDICATIONS
Mixed vaginal infection due to Trichomonas vaginalis and C. albicans.

Dosing

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.

Contraindications

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.