Lomexin*crema Vag 78g 2%+1appl

NAME
LOMEXIN

PHARMACOTHERAPEUTIC CATEGORY
Antimicrobials and antiseptics, excluding associations with corticosteroids.

ACTIVE PRINCIPLES
Fenticonazole nitrate.

EXCIPIENTS
Vaginal cream 2%: propylene glycol; hydrogenated lanolin; refined almond oil; polyglycol ester of fatty acids; cetyl alcohol; glyceryl monostearate; sodium edetate; purified water. Vaginal solution 0.2%: propylene glycol; benzalkonium chloride; alkylamidobetaine solution; purified water. Soft vaginal capsules 200 mg: triglycerides of saturated fatty acids; anhydrous colloidal silica. Constituents of the shell: gelatin; glycerine; titanium dioxide; sodium ethyl parahydroxybenzoate; sodium propyl parahydroxybenzoate. Soft vaginal capsules 600 mg: liquid paraffin; white petroleum jelly; soy lecithin. Constituents of the shell: gelatin; glycerine; titanium dioxide; sodium ethyl parahydroxybenzoate; sodium propyl parahydroxybenzoate. Soft vaginal capsules 1000 mg: liquid paraffin; white petroleum jelly; soy lecithin. Constituents of the shell: gelatin; glycerine; titanium dioxide; sodium ethyl parahydroxybenzoate; sodium propyl parahydroxybenzoate.

INDICATIONS
Vaginal cream 2%, vaginal soft capsules 200 mg and 600 mg, vaginal solution 0.2%: candidiasis of the genital mucosa (vulvovaginitis, colpitis, infectious fluor). Soft vaginal capsules 1000 mg: vaginal trichomoniasis. Vaginal infections caused in mixed form by Trichomonas vaginalis and Candida albicans. Candidiasis of the genital mucous membranes (vulvovaginitis, affected, infectious fluor).

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the listed excipients; pregnancy.

DOSAGE
Vaginal cream 2%: 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 the cream is recommended. Vaginal solution 0.2%: 1-2 vaginal irrigations per day, for 7 days, as adjuvant therapy to the other formulations for the prevention of relapses. Soft vaginal capsules 200 mg: 1 soft vaginal capsule of 200 mg in the evening before bedtime, for three days, depending on the medical judgment. Soft vaginal capsule 600 mg: 1 soft vaginal capsule of 600 mg in the evening in a single dose. In case of persistence of symptoms, a second administration can be repeated after 3 days. Soft vaginal capsules 1000 mg: in vaginal infections with Trichomonas and in mixed infections (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 Candida infections: 1 vaginal soft capsule of 1000 mg in the evening in a single dose. In case of persistence of symptoms, 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).

STORAGE
None.

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 institute a suitable therapy. Soft vaginal capsules or vaginal cream should not be used with barrier contraceptives. 2% vaginal cream and 0.2% vaginal solution contain propylene glycol. They can cause skin irritation. Vaginal cream 2% contains cetyl alcohol. It can cause local skin reactions (eg contact dermatitis). The 2% vaginal cream contains hydrogenated lanolin. It can cause local skin reactions (eg contact dermatitis). The 0.2% vaginal solution contains benzalkonium chloride. Irritant, it can cause local skin reactions. Soft vaginal capsules 200 mg, soft vaginal capsules 600 mg and soft vaginal capsules 1000 mg contain sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. They can cause allergic reactions (even delayed).

INTERACTIONS
The fatty excipients and oils contained in the vaginal soft capsules or in the vaginal cream can damage latex contraceptives.

SIDE EFFECTS
When used as recommended, the drug is only poorly absorbed and no systemic side effects are expected. Prolonged use of topical products can cause sensitization phenomena. The table below lists undesirable effects, listed by MedDRA system organ class and frequency: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1 / 1,000, <1/100); rare (> = 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); not known. Reproductive system and breast disorders. Very rare: vulvovaginal burning sensation. Skin and subcutaneous tissue disorders. Very rare: erythema, pruritus, rash. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

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