FALVIN LAV VAG 5FL 150ML 0.2%

FALVIN

active ingredients

Falvin 2% vaginal cream 100 g vaginal cream contain 2 g fenticonazole nitrato.Eccipienti with known effects: 100 g vaginal cream contain 5 g propylene glycol, 3 g cetilic alcohol, 1 g hydrogenated lanolin. Falvin 200 mg soft vaginal capsules Each vaginal soft capsule contains 200 mg of nitrated fenticonazole. Excipients with known effects: Each vaginal soft capsule contains 0,80 mg of sodium parahydroxybenzoate ethyl, 0,40 mg of sodium parahydroxybenzoate propile. Falvin 600 mg soft vaginal capsules Each vaginal soft capsule contains 600 mg of nitrate fenticonazole. Excipients with known effects: Each vaginal soft capsule contains 1 mg of sodium parahydroxybenzoate ethyl, 0.50 mg of sodium parahydroxybenzoate propile. Falvin 1000 mg soft vaginal capsules Each vaginal soft capsule contains 1000 mg of nitrated fenticonazole. Excipients with known effects: Each vaginal soft capsule contains 1,60 mg of sodium parahydroxybenzoate ethyl, 0,70 mg of sodium parahydroxybenzoate propile. Falvin 0.2% vaginal solution 100 ml of vaginal solution contain 0.2 g of nitrate fenticonazole. Excipients with known effects: 100 ml of vaginal solution contain 10 g propylene glycol, 0.01 g benzalconio chloride. For the full list of excipients, see paragraph 6.1.

Excellent

Falvin 200 mg soft vaginal capsules Triglycerides of saturated fatty acids Silice colloidal anidra. Constituents of the enclosure: Gelatin Glycerin Titanium Dioxide Etile parahydroxybenzoate sodium Propile parahydroxybenzoate sodium. Falvin 600 mg soft vaginal capsules Liquid paraffin White Vaseline Soybean Lecithin. Constituents of the enclosure: Gelatin Glycerin Titanium Dioxide Etile parahydroxybenzoate sodium Propile parahydroxybenzoate sodium. Falvin 1000 mg soft vaginal capsules Liquid paraffin White Vaseline Soybean Lecithin. Constituents of the enclosure: Gelatin Glycerin Titanium Dioxide Etile parahydroxybenzoate sodium Propile parahydroxybenzoate sodium. Falvin 2% vaginal cream Propylene glycol Hydrogenated lanolin Refined almond oil Polyglycolic aesthetic of fatty acids Alcool cetilic Gliceril monostearate Sodium edetato Purified water. Falvin 0.2% vaginal solution Propylene glycol Benzalconio chloride Alchilamidobetaine purified water solution.

Therapeutic indications

Falvin 2% vaginal cream, Falvin 200 mg and 600 mg soft vaginal capsules, Falvin 0.2% vaginal solution: Candidiasis of genital mucous membranes (vulvovaginiti, affected, infectious fluorine). Falvin 1000 mg soft vaginal capsules: Vaginal tricomoniasis. Vaginal infections supported in mixed form by Trichomonas vaginalis and Candida albicans. Candidiasis of genital mucous membranes (vulvovaginiti, affected, infectious fluorine).

Contraindications

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

Population

Falvin 200 mg soft vaginal capsules - 1 vaginal soft capsule 200 mg per night before bedtime, for 3 days, depending on the doctor's judgment. Falvin 600 mg soft vaginal capsules - 1 vaginal soft capsule of 600 mg per night in one administration. In case of persistence of symptomatology, a second administration may be repeated after 3 days. Falvin 1000 mg soft vaginal capsules - in vaginal infections from Trichomonas and in those mixtures (Trichomonas + Candidate) it is recommended to apply 1 1000 mg vaginal soft capsule followed by a second application after 24 hours, if necessary. In infections Candidate: 1 vaginal soft capsule of 1000 mg per night in one administration. In case of persistence of symptomatology, a second administration may be repeated after 3 days. Vaginal soft capsules must be introduced deeply into the vagina (up to the level of fornics). Falvin 2% vaginal cream - introduce the content of the applicator (about 5 g) deeply into the vagina. It is applied by applicator (washable and reusable) before bedtime, if necessary also in the morning. In order to avoid a reinfection we recommend the contemporary local treatment (glande and foreskin) of the partner with Falvin cream. Falvin 0.2% vaginal solution - 1-2 vaginal irrigations per day, for 7 days, such as assisting therapy other formulations for relapse prevention.

Conservation

Store at a temperature below 25°C.

Warnings

At the time of the endovaginal introduction, there is a modest burning sensation that disappears quickly. The use, especially if prolonged, of products for topical use, can give rise to phenomena of sensitization. In this case stop treatment and consult your doctor to establish suitable therapy. Vaginal soft capsules or vaginal cream should not be used with barrier contraceptives (see paragraph 4.5). Important information about some excipients: Falvin 2% vaginal cream and Falvin 0.2% vaginal solution contain propylene glycol. They can cause skin irritation. Falvin 2% vaginal cream contains cetilic alcohol. It can cause local skin reactions (e.g. contact dermatitis). Falvin 2% vaginal cream contains hydrogenated lanolin. It can cause local skin reactions (e.g. contact dermatitis). Falvin 0.2% vaginal solution contains benzalconio chloride. Irritating, it can cause local skin reactions. Falvin 200 mg soft vaginal capsules, Falvin 600 mg soft vaginal capsules and Falvin 1000 mg soft vaginal capsules contain ethyl parahydroxybenzoate sodium and propile parahydroxybenzoate sodium. They can cause allergic reactions (also delayed).

Interactions

Fat excipients and oils contained in vaginal soft capsules or vaginal cream may damage latex contraceptives (see paragraph 4.4).

Effects

When used as recommended, Falvin is only poorly absorbed and there are no systemic side effects. Prolonged use of topical products can cause sensitization phenomena (see paragraph 4.4). The table below shows the side effects, listed according to the classification for systems and organs according to MedDRA and according to the frequency: very common (≥1/10); common (≥1/100, Classification for systems and organs Frequency Preferred term Pathologies of the reproductive apparatus and of the breast Very rare Vulvovaginal burning sensation Pathologies of skin and subcutaneous tissue Very rare Eritema, Prurito, Rash Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

No overdose cases have been reported.

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

Source: Farmadati