FALVIN * LAV VAG 5FL 150ML 0.2%

FALVIN * LAV VAG 5FL 150ML 0.2%

Therapeutic indications

Falvin 2% vaginal cream, Falvin 200 mg and 600 mg soft vaginal capsules, Falvin 0.2% vaginal solution: Candidiasis of the genital mucous membranes (vulvovaginitis, affected, infectious fluor). Falvin 1000 mg soft vaginal capsules: Vaginal trichomoniasis. Vaginal infections sustained in mixed form byTrichomonas vaginalisAndCandida albicans. Candidiasis of the genital mucous membranes (vulvovaginitis, affected, infectious fluor).

Dosage and method of use

Falvin 200 mg soft vaginal capsules - 1 soft vaginal capsule of 200 mg in the evening before bedtime, for 3 days, depending on the judgment of the doctor. Falvin 600 mg soft vaginal capsules - 1 vaginal soft capsule of 600 mg in the evening in a single dose. If symptoms persist, a second administration can be repeated after 3 days. Falvin 1000 mg soft vaginal capsules - in vaginal infections fromTrichomonasand in the mixed ones (Trichomonas+Candida) it is recommended to apply 1 vaginal soft capsule of 1000 mg followed by a second application after 24 hours, if necessary. In infections withCandida: 1 vaginal soft capsule of 1000 mg in the evening in a single dose. If symptoms persist, a second administration can be repeated after 3 days. The soft vaginal capsules are inserted deeply into the vagina (up to the level of the fornixes). Falvin 2% vaginal cream - introduce the contents of the applicator (about 5 g) deeply into the vagina. It is applied with an applicator (washable and reusable) before going to bed, if necessary also in the morning. In order to avoid reinfection, the simultaneous local treatment (glans and foreskin) of the partner with Falvin cream is recommended. Falvin 0.2% vaginal solution - 1-2 vaginal irrigations per day, for 7 days, as adjuvant therapy to the other formulations for the prevention of relapses.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6).

Side effects

When used as recommended, Falvin is only poorly absorbed and no systemic side effects are expected. Prolonged use of topical products can cause sensitization phenomena (see section 4.4). Undesirable effects are presented in the table below, listed by MedDRA system organ class and frequency: very common (≥1 / 10); common (≥1 / 100,

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

At the time of intravaginal introduction, a modest burning sensation may be found which disappears rapidly. The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. In this case, stop the treatment and consult your doctor to establish a suitable therapy. Soft vaginal capsules or vaginal cream should not be used with barrier contraceptives (see section 4.5).Important information about some of the ingredients:Falvin 2% vaginal cream and Falvin 0.2% vaginal solution contain propylene glycol. They can cause skin irritation. Falvin 2% vaginal cream contains cetyl alcohol. May cause local skin reactions (e.g. contact dermatitis). Falvin 2% vaginal cream contains hydrogenated lanolin. May cause local skin reactions (e.g. contact dermatitis). Falvin 0.2% vaginal solution contains benzalkonium chloride. Irritating, may cause local skin reactions. Falvin 200 mg soft vaginal capsules, Falvin 600 mg soft vaginal capsules and Falvin 1000 mg soft vaginal capsules contain sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. They can cause allergic reactions (even delayed).

Pregnancy and breastfeeding

Although vaginal absorption of fenticonazole is rather poor, it is recommended not to use the medicine during pregnancy.

Expiration and retention

Store at a temperature below 25 ° C.

Interactions with other drugs

Fatty excipients and oils contained in vaginal soft capsules or vaginal cream may harm latex contraceptives (see section 4.4).

Overdose

No cases of overdose have been reported.

Active principles

Falvin 2% vaginal cream 100 g of vaginal cream contains 2 g of fenticonazole nitrate Excipients with known effects: 100 g of vaginal cream contains 5 g of propylene glycol, 3 g of cetyl alcohol, 1 g of hydrogenated lanolin. Falvin 200 mg soft vaginal capsules Each soft vaginal capsule contains 200 mg of fenticonazole nitrate. Excipients with known effect: Each soft vaginal capsule contains 0.80 mg of sodium ethyl parahydroxybenzoate, 0.40 mg of sodium propyl parahydroxybenzoate. Falvin 600 mg soft vaginal capsules Each soft vaginal capsule contains 600 mg of fenticonazole nitrate. Excipients with known effect: Each soft vaginal capsule contains 1 mg of sodium ethyl parahydroxybenzoate, 0.50 mg of sodium propyl parahydroxybenzoate. Falvin 1000 mg soft vaginal capsules Each soft vaginal capsule contains 1000 mg of fenticonazole nitrate. Excipients with known effect: Each soft vaginal capsule contains 1.60 mg sodium ethyl parahydroxybenzoate, 0.70 mg sodium propyl parahydroxybenzoate. Falvin 0.2% vaginal solution 100 ml of vaginal solution contains 0.2 g of fenticonazole nitrate. Excipients with known effects: 100 ml of vaginal solution contain 10 g of propylene glycol, 0.01 g of benzalkonium chloride. For the full list of excipients, see section 6.1.

Excipients

Falvin 200 mg soft vaginal capsules Triglycerides of saturated fatty acids Anhydrous colloidal silica.Constituents of the envelope:Gelatin Glycerin Titanium dioxide Ethyl parahydroxybenzoate sodium Propyl parahydroxybenzoate sodium. Falvin 600 mg soft vaginal capsules Liquid paraffin White petroleum jelly Soy lecithin.Constituents of the envelope:Gelatin Glycerin Titanium dioxide Ethyl parahydroxybenzoate sodium Propyl parahydroxybenzoate sodium. Falvin 1000 mg soft vaginal capsules Liquid paraffin White petroleum jelly Soy lecithin.Constituents of the envelope:Gelatin Glycerin Titanium dioxide Ethyl parahydroxybenzoate sodium Propyl parahydroxybenzoate sodium. Falvin 2% vaginal cream Propylene glycol Hydrogenated lanolin Refined almond oil Polyglycolic ester of fatty acids Cetyl alcohol Glyceryl monostearate Sodium edetate Purified water. Falvin 0.2% vaginal solution Propylene glycol Benzalkonium chloride Alkilamidobetaine solution Purified water.