Lomexin 1000 mg fenticonazole antifungal 2 soft vaginal capsules

Lomexin contains the active ingredient fenticonazole nitrate. It belongs to a group of medicines called 'gynecological antimicrobials and antiseptics'. Lomexin is used to treat infections of the mucous membranes of the genital organs caused by a fungus called Candida such as: inflammation of the vulva and vagina (vulvovaginitis), inflammation of the cervix (affected), increased vaginal discharge due to infections (infectious fluor). Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment. Warnings: The use, especially if prolonged, of medicines for local use (topical use) can cause allergic reactions (sensitization phenomena). In this case, stop the treatment and consult your doctor who will recommend an appropriate therapy. Soft vaginal capsules or vaginal cream should not be used with barrier contraceptives. How to use: Always use this medicine exactly as stated on the package leaflet or the instructions of your doctor or pharmacist. The recommended dose is 1 soft vaginal capsule of 200 mg in the evening before bedtime, for three days, depending on the judgment of the doctor; The soft vaginal capsules are inserted deeply into the vagina (up to the level of the fornixes). Composition: The active ingredient is fenticonazole nitrate. 1 capsule contains 200 mg of fenticonazole nitrate. - The other ingredients are triglycerides of saturated fatty acids, anhydrous colloidal silica. Constituents of the shell: gelatin, glycerin, titanium dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate. Format: The contents of the package are 6 capsules
Lomexin 200 mg soft vaginal capsules Read all of this leaflet carefully before using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to. Keep this leaflet. You may need to read it again. If you would like more information or advice, please ask your pharmacist. If you get any of the side effects, including effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Contact your doctor if you do not notice any improvement or if you notice a worsening of your symptoms after a short period of treatment. Contents of this leaflet: 1. What Lomexin is and what it is used for 2. What you need to know before you use Lomexin 3. How to use Lomexin 4. Possible side effects 5. How to store Lomexin 6. Contents of the pack and other information 1. What what Lomexin is and what it is used for Lomexin contains the active substance fenticonazole nitrate. It belongs to a group of medicines called 'gynecological antimicrobials and antiseptics'. Lomexin is used to treat infections of the mucous membranes of the genital organs caused by a fungus called Candida such as: inflammation of the vulva and vagina (vulvovaginitis) inflammation of the cervix of the uterus (affected) increased vaginal discharge due to infections (fluor infectious). Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment. 2. What you need to know before you use Lomexin Do not use Lomexin if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6) if you are pregnant (see section “Pregnancy and breast-feeding”). Warnings and precautions Talk to your doctor or pharmacist before using Lomexin. The use, especially if prolonged, of medicines for local use (topical use) can cause allergic reactions (sensitization phenomena). In this case, stop the treatment and consult your doctor who will recommend an appropriate therapy. Soft vaginal capsules or vaginal cream should not be used with barrier contraceptives (see section “Other medicines and Lomexin”). At the time of introduction into the vagina you may experience a modest burning sensation that disappears quickly. Other medicines and Lomexin Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. The fatty excipients and oils contained in vaginal soft capsules or vaginal cream can damage latex contraceptives (see section “Warnings and precautions”). Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. The use of Lomexin is not recommended during pregnancy, although vaginal absorption of fenticonazole is rather poor. Driving and using machines Lomexin does not affect the ability to drive or use machines. Lomexin vaginal soft capsules contain: sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. They can cause allergic reactions (even delayed). 3. How to use Lomexin Always use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Lomexin vaginal soft capsules The recommended dose is: - 1 vaginal soft capsule of 200 mg in the evening before bedtime, for three days, depending on the judgment of the doctor; If you use more Lomexin than you should In case of accidental ingestion / overdose of Lomexin, notify your doctor immediately or go to the nearest hospital. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you forget to use Lomexin Do not use a double dose to make up for a forgotten dose. If you stop taking Lomexin If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. When used as recommended, Lomexin is only poorly absorbed and no undesirable effects affecting the whole body (systemic effects) are expected. Prolonged use of medicinal products for local use (topical use) can cause sensitization phenomena (see section “Warnings and precautions”). The following side effects have been observed with Lomexin: Very rare (may affect up to 1 in 10,000 people) • vulvovaginal burning sensation • redness of the skin (erythema) • itching • skin rash (rash). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Lomexin This medicinal product does not require any special storage conditions. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month. Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment. 6. Contents of the pack and other information What Lomexin contains. Lomexin 200 mg soft vaginal capsules The active substance is fenticonazole nitrate. 1 capsule contains 200 mg of fenticonazole nitrate. The other ingredients are triglycerides of saturated fatty acids, anhydrous colloidal silica. Constituents of the shell: gelatin, glycerin, titanium dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate. What Lomexin looks like and contents of the pack Lomexin comes in the form of: 200 mg soft vaginal capsules. The contents of the pack are 6 capsules Marketing authorization holder and manufacturer Marketing authorization holder RECORDATI Industria Chimica e Farmaceutica SpA - via M. Civitali, 1 - 20148 Milano. Dealer for sale: INNOVA PHARMA SpA - Milan. Manufacturer Lomexin vaginal cream RECORDATI Chemical Industry and Pharmaceutical SpA - via M. Civitali, 1 - Milan. Lomexin vaginal solution COC Farmaceutici Srl - via Modena, 15 - Sant'Agata Bolognese (BO) Lomexin vaginal soft capsules CATALENT ITALY SpA - via Nettunense Km 20,100 - Aprilia (LT). This leaflet was last revised in MM / YYYY