ENZOFEN
(Fenticonazole)




COMPOSITION

A vaginal capsule contains:

Active ingredient: fenticonazole nitrate 600 mg.

Excipients: liquid paraffin, white Vaseline, soya lecithin.

The composition of capsule: gelatin, glycerin, titan dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.

THERAPEUTIC INDICATIONS

- vulvovaginal candidiasis;

- vaginal trichomoniasis.

CONTRAINDICATIONS

- hypersensitivity to any of the component;

The drug should not be administered during menstruations.

ADVERSE EFFECTS

Allergic reactions: urticaria, rash, erythema.

Local reactions: burning, itching, irritation in the administration site.

Enzofen, as a rule, is well-tolerated, the adverse reactions are transient and do not require drug withdrawal.

DOSAGE AND ADMINISTRATION

For intravaginal administration.

Adults:

One capsule (600 mg as a single dose) is inserted into vagina, in lying position in the evening before sleep. If needed, repeated administration is possible 3 days later.

In case of treatment of the infections induced by Trichomonas vaginalis, repeated administration of the capsule (600 mg) is possible 24 hours later.

In case of insufficient efficacy, the retreatment course may be provided 10 days later.

SPECIAL INDICATIONS

In case of long-term administration of the drug, sensibilization may develop. In this case the drug should be withdrawn, and the patient should apply to physician. In case of the absence of the effect during 3 weeks, the treatment should be withdrawn and the diagnosis should be clarified. It is appropriate to initiate the course of treatment after menstruation.

PREGNANCY AND LACTATION

Due to insufficient data regarding the safety of Enzofen during pregnancy and lactation, the administration during these periods is not recommended.

MANUFACTURED FORM AND PACKAGE

Vaginal capsules

2 capsules in a blister. 1 blister with a leaflet in a carton box.

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