Each capsule contains: Fenticonazole nitrate 200 mg.
Excipients with known effect: 800 μg sodium ethyl parahydroxybenzoate, 400 μg sodium propyl parahydroxybenzoate.
Excipients/Inactive Ingredients: triglycerides medium chain, colloidal anhydrous silica.
Capsule shell: gelatin, glycerol, titanium dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.
Pharmacotherapeutic group: gynaecological antiinfectives and antiseptics; imidazole derivatives. ATC code: G01AF12.
Pharmacology: Pharmacodynamics: Fenticonazole is a broad-spectrum antimycotic agent with high fungistatic and fungicidal activity against dermatophytes (all species of Trichophyton, Microsporum, Epidermophyton), Candida albicans and other mycotic agents of the skin and the mucosa. Fenticonazole has also an antibacterial activity against Gram positive bacteria and an antiparasitic action against Trichomonas vaginalis.
It exerts its antimycotic activity by inhibiting the secretion of protease acid by Candida albicans, damaging the cytoplastic membrane and blocking cytochrome oxidase and peroxidases.
Pharmacokinetics: After the vaginal administration of fenticonazole in humans, the absorption is negligible: pharmacokinetics studies conducted in two groups of patients treated with fenticonazole nitrate 1000 mg, administered vaginally, show that the absorption in patients with vulvovaginal candidiasis is on average of 1.81 ± 0.57%, while in healthy volunteers with normal vaginal mucosa or in patients with cervical carcinoma, the absorption is on average 0.58% and 1.12% respectively of the dose.
Toxicology: Preclinical safety data: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development. Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
For the treatment of vulvovaginal candidiasis.
For vaginal use, only.
Posology: One 200 mg vaginal capsule, soft should be inserted deeply into the vagina at bedtime for 3 consecutive days.
Paediatric population: The safety and efficacy of Lomexin in children under 16 years have not been established. No data are available. The dose recommendation for children above 16 years is the same as for adults.
No case of overdose has been reported.
Lomexin is intended for local application and not for oral use. In the event of accidental oral ingestion abdominal pain and vomiting may occur.
Hypersensitivity to the active substance or to any of the excipients listed in Description.
Some excipients of the vaginal capsule (parahydroxybenzoates) may cause allergic reactions (possibly delayed).
Should local sensitisation or an allergic reaction occur, the treatment should be discontinued.
The patients should be advised to consult their physician if: the symptoms have not been relieved within one week; in case of recurrent symptoms (more than 2 infections in the last 6 months); previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease; age under 16 or over 60; known hypersensitivity to imidazoles or other vaginal antifungal products; any abnormal or irregular vaginal bleeding; any blood staining of a vaginal discharge; any vulval or vaginal sore, ulcer or blister; any associated lower abdominal pain or dysuria; any adverse effects such us erythema, pruritus or rash associated with treatment.
The vaginal capsule should not be used in conjunction with barrier contraceptives, spermicides, intravaginal douches or other vaginal products (see Interactions). Appropriate therapy is indicated when the partner is also infected.
Fenticonazole should be used in pregnancy and breast-feeding under the supervision of a physician (see Use in Pregnancy & Lactation).
Effects on ability to drive and use machines: Lomexin has no or negligible influence on the ability to drive and use machines.
Pregnancy: There are limited amount of data from the use of fenticonazole in pregnant women. Studies in animals have shown no teratogenic effects, and embriotoxic and fetotoxic effects have been observed only at very high doses administered orally. Low systemic exposure of fenticonazole is expected following vaginal treatment (see Pharmacology: Pharmacokinetics under Actions). Fenticonazole should be used in pregnancy under the supervision of a physician.
During pregnancy the applicator should not be used.
Breast-feeding: Animal studies via the oral route have shown that fenticonazole and/or its metabolites can be excreted in the milk. Even if no data are available showing that vaginal administration of fenticonazole in humans determines its and/or its metabolites excretions into the milk, a risk for the baby cannot be excluded. Fenticonazole should be used during the lactation under the supervision of a physician.
Fertility: No human studies of the effects of fenticonazole on fertility have been conducted, however animal studies have not demonstrated any effects of the drug on fertility.
When used as recommended, Lomexin is only poorly absorbed and systemic undesirable reactions are not expected. A mild, transient burning sensation may occur after application. Prolonged use of topical products can cause sensitisation (see Precautions).
In the table as follows, adverse reactions are reported and listed by MedDRA system organ class and frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (frequency cannot be estimated from available data). (See table.)
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Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
No interaction studies have been performed.
Fat excipients and oils contained in the vaginal capsule could damage contraceptives made of latex. Patients should be advised to use alternative contraceptive methods/precautions while using this product.
Associations not recommended: Spermicides: any local vaginal treatment is likely to inactivate a local contraceptive spermicide.
Special precautions for disposal and other handling: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: Not applicable.
Do not store above 30°C.
Shelf life: 3 years.
G01AF12 - fenticonazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.