RECORDATI SUMMARY OF PRODUCT CHARACTERISTICS Gynaecological Fenticonazole – September 2016 1 RECORDATI 1. NAME OF THE MEDICINAL PRODUCT Lomexin 20 mg/g vaginal cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of vaginal cream contains 20 mg of fenticonazole nitrate. The applicator delivers about 5 g of vaginal cream, which contains 100 mg of fenticonazole nitrate. Excipients with known effect: propylene glycol, hydrogenated lanolin, cetyl alcohol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Vaginal cream. White homogeneous cream. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications For the treatment of vulvovaginal candidiasis in adolescents more than 16 year and adults. For treatment in women over 60 years, prior consultation with a physician is required. 4.2 Posology and method of administration For vaginal use only. The content of the applicator (about 5 g) should be inserted deeply in the vagina once daily at bedtime (or twice daily at bedtime and in the morning) for 3 consecutive days. In case of vulvitis the cream can be thinly applied topically to the vulva. The partner can also be treated locally with the cream, if appropriate. 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. INSTRUCTIONS FOR USE – 20 mg/g vaginal cream 1. Screw the applicator onto the tube in place of the cap. 2. Squeeze the tube gently at its lower end, so as to fill the applicator. If there is a certain resistance in the piston, pull it delicately. Unless otherwise prescribed by the physician, the applicator must be completely filled. 3. Remove the applicator from the tube and close it immediately with the cap. 4. In a lying down position, with knees raised and spread apart, delicately insert the applicator into the vagina as deeply as possible. Push the piston in completely, then pull out the applicator without touching the piston. Gynaecological Fenticonazole – September 2016 2 RECORDATI 4.3 Contraindications Hypersensitivity to fenticonazole nitrate or to any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use Some excipients of the vaginal cream (propylene glycol, hydrogenated lanolin, cetyl alcohol) may cause local skin reactions. 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 blisters - any associated lower abdominal pain or dysuria - any adverse effects such as erythema, pruritus or rash associated with treatment. The vaginal cream should not be used in conjunction with barrier contraceptives (see section 4.5). Appropriate therapy is indicated when the partner is also infected. Fenticonazole should be used in pregnancy and breastfeeding under the supervision of a physician (see section 4.6). 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed. Gynaecological Fenticonazole – September 2016 3 RECORDATI Fat excipients and oils contained in the vaginal cream could damage contraceptives made of latex (see section 4.4). Patients should be advised to use alternative contraceptive methods /precautions while using this product. 4.6 Fertility, Pregnancy and lactation Pregnancy There are limited amount of data from the use of fenticonazole in pregnant women. Studies in animals have shown no teratogenic effects, and embryotoxic and fetotoxic effects have been observed only at very high doses administered orally (see section 5.3). Low systemic exposure of fenticonazole is expected following vaginal treatment (see section 5.2). Fenticonazole should be used in pregnancy under the supervision of a physician. During pregnancy the applicator should not be used. Breastfeeding Animal studies via the oral route have shown that fenticonazole and/or its metabolites can be excreted in the milk (see section 5.3). Even if no data are available showing that vaginal administration of fenticonazole in humans determines its and/or its metabolites excretion 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 (see section 5.3). 4.7 Effects on ability to drive and use machines Not relevant. 4.8 Undesirable effects 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 section 4.4). In the table below, 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). System Organ Class Frequency Preferred Terms Reproductive system and breast disorders Very rare Vulvovaginal burning sensation Erythema Skin and subcutaneous tissue disorders Very rare Pruritus Rash Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation 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 listed in Appendix V. 4.9 Overdose Gynaecological Fenticonazole – September 2016 4 RECORDATI 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. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: gynaecological antiinfectives and antiseptics; imidazole derivatives, ATC code: G01AF12 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. 5.2 Pharmacokinetic properties After the vaginal administration of Fenticonazole in humans, the absorption is negligible: pharmacokinetic 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. 5.3 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. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Propylene glycol, hydrogenated lanolin, refined almond oil, fatty acid polyglycol esters, cetyl alcohol, glyceryl monostearate, sodium edetate, purified water. 6.2 Incompatibilities Not applicable. 6.3 Shelf life 3 years. After opening: 30 days. 6.4 Special precautions for storage Gynaecological Fenticonazole – September 2016 5 RECORDATI This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container 1 tube of 35 g cream with 7 applicators (for single use). 6.6 Special precautions for disposal and other handling For instructions for use, see section 4.2. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER Recordati Ireland Limited. Raheens East, Ringaskiddy, CO. Cork, Ireland 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10. DATE OF REVISION OF THE TEXT MM/YYYY Gynaecological Fenticonazole – September 2016 6 .