Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Fenticonazole nitrate
Recordati Industria Chimica e Farmaceutica SpA
G01AF; G01AF12
Fenticonazole nitrate
600 milligram(s)
Vaginal capsule, soft
Product subject to prescription which may be renewed (B)
Imidazole derivatives; fenticonazole
Not marketed
1992-02-24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GYNOXIN 200 MG VAGINAL CAPSULES GYNOXIN 600 MG VAGINAL CAPSULES Fenticonazole nitrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Gynoxin is and what it is used for 2. What you need to know before you use Gynoxin 3. How to use Gynoxin 4. Possible side effects 5. How to store Gynoxin 6. Contents of the pack and other information 1. WHAT GYNOXIN IS AND WHAT IT IS USED FOR Gynoxin contains fenticonazole nitrate. Fenticonazole is an antifungal agent. It slows the growth of some types of fungi and kills some. It is particularly good at killing Candia albicans. Candida is the organism that causes thrush. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GYNOXIN DO NOT USE GYNOXIN: - if you are allergic to fenticonazole or any of the other ingredients of this medicine (listed in section 6). - Gynoxin 600 mg vaginal capsules contains soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist if: - You are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”). - You are using a “barrier” method of contraception made of latex (see section “Other medicines and Gynoxin”). Consequently, you should use alternative precautions while using this product. - You are using spermicides, intravaginal douches or other vaginal products (see section “Other medicines and Gynoxin”). - You experience any irritation or sensitivity to the product. - Your s Leggi il documento completo
Health Products Regulatory Authority 23 September 2020 CRN009277 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gynoxin 600 mg Vaginal Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vaginal capsule contains 600 mg of the active ingredient fenticonazole nitrate. Excipients with known effect: ethyl parahydroxybenzoate sodium (E215) 1 mg per vaginal capsule, and sodium propyl parahydroxybenzoate (E217) 0.5 mg per vaginal capsule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal capsule, soft. (Vaginal capsule) Ivory white, opaque, soft gelatin capsules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the topical treatment of vulvo vaginal infections due to superficial dermatophytes of _C. albicans_, sensitive to the drug. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage One 200 mg vaginal capsule at bedtime for 3 days or one 600 mg vaginal capsule at bedtime once only. If necessary treatment may be repeated after 3 days. Administration Intravaginal, inserted deeply into vagina. Paediatric population The safety and efficacy of Gynoxin in children under 16 years have not been established. No data are available. The dose recommendation for children aged 16 years or above is the same as for adults. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Gynoxin 600 mg vaginal capsule contains soya lecithin. This medicinal product should not be used in patients allergic to peanut or soya. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Some excipients of the vaginal capsules (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 exposur Leggi il documento completo