Country: Malta
Language: English
Source: Medicines Authority
ISOCONAZOLE NITRATE
LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark
D01AC05
ISOCONAZOLE NITRATE 10 mg/g
CREAM
ISOCONAZOLE NITRATE 10 mg/g
OTC
ANTIFUNGALS FOR DERMATOLOGICAL USE
Withdrawn
2007-05-15
PL02402001 PACKAGE LEAFLET: INFORMATION FOR THE USER TRAVOGEN - CREAM Isoconazole nitrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • 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. • You must talk to your doctor if you do not feel better or if you feel worse after 4 weeks. A medical prescription is required for the treatment of fungal disease in the genital region. For this reason, the following also applies: • 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. WHAT IS IN THIS LEAFLET: 1. WHAT TRAVOGEN CREAM IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRAVOGEN CREAM 3. HOW TO USE TRAVOGEN CREAM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TRAVOGEN CREAM 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TRAVOGEN CREAM IS AND WHAT IT IS USED FOR Travogen is a medicine used to treat superficial fungal diseases of the skin, such as those between the toes, on the hands, in the groin, for the treatment of fungal diseases in the genital region and erythrasma (inflammation of the skin due to a specific group of bacteria). You must talk to your doctor if you do not feel better or if you feel worse after 4 weeks. A medical prescription is required for the treatment of fungal disease in the genital region. Travogen is effective against all major types of fungus that occur on human skin. PL02402001 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRAVOGEN CREAM DO NOT USE TRAVOGEN CREAM - if you are allergic to isoconazole nitrate or any of Read the complete document
SPC02402001 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TRAVOGEN - CREAM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g cream contains 10 mg isoconazole nitrate. (Equivalent to 1% (w/w) isoconazole nitrate.) 1 cm Travogen cream contains 2 mg isoconazole nitrate Excipient with known effect: 50 mg/g cetostearyl alcohol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream White to slightly yellowish transparent cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Superficial fungal infections of the skin, such as tinea pedum et manuum, tinea inguinalis, of the genital region and erythrasma. A medical prescription is required when the product is used in the genital region. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Cutaneous use. Posology Travogen cream should be applied once daily on the affected portions of the skin. A general rule that applies to all fungal infections is that topical treatment must be performed over a period of 2-3 weeks, and in cases of persistent infection (especially when the interdigital spaces are affected), even for 4 weeks. Depending on the symptoms, topical treatment may be used for longer periods of time. To avoid renewed infection, the treatment should be continued for at least 2 weeks after clinical healing. Paediatric population Data on a limited number of infants, toddlers, children and adolescents indicate no negative effects with the use of Travogen cream. Currently available data are described in section 5.1; however, no dosage recommendation can be given. SPC02402001 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE When using Travogen cream on the face, it should be ensured that the cream does not come into contact with the eyes. The physician should provide the patient with information on hygienic measures during use. If Travogen cream is used in the genital region, the components liquid paraf Read the complete document