देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
AMOROLFINE AS HYDROCHLORIDE
A.M.I. MEDICAL TECHNOLOGIES LIMITED, ISRAEL
D01AE16
LACQUER
AMOROLFINE AS HYDROCHLORIDE 5 %W/V
TOPICAL
Required
LABORATOIRES GALDERMA, FRANCE
AMOROLFINE
AMOROLFINE
Topical treatment of onycomycosis caused by dermatophytes, yeast and moulds.
2020-06-30
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only LOCERYL LACQUER TO TREAT FUNGAL NAIL INFECTIONS Active ingredient: Amorolfine hydrochloride 6.4% w/w, equivalent to Amorolfine 5% w/v. For the list of the additional ingredients, see section 6. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if you think their medical condition is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? Loceryl is intended for topical treatment of fungal infections of different types, yeasts and molds. THERAPEUTIC GROUP Antifungal for topical use. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: Do not use if you are sensitive (allergic) to the active ingredient or to any of the additional ingredients the medicine contains (for a list of the additional ingredients, see section 6). SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: • The use of Loceryl may cause allergic reactions which may be serious. If an allergic reaction appears, discontinue the use, remove the lacquer immediately with a nail varnish remover, or with the cleaning swabs in the package. Seek medical advice. Do not use the lacquer again. See also the 'Side Effects' section for details of possible symptoms of an allergic reaction. • Do not apply the lacquer on the skin around the nail. • Avoid contact with the eyes, ears and/or mucous membranes (such as the mouth, inside the nose). If the lacquer came into contact with these areas, rinse immediately with water and proceed to a doctor or an emergency room as quickly as possible. • Do not inhale the lacquer. • If you need to use organic solvents (e.g. paint thinners or white spirit) - wear suitable impermeable gloves (in order to protect the lacquer on the na पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Loceryl 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Amorolfine hydrochloride 6.4% w/w Eq. to Amorolfine base 5% w/v For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Lacquer. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of onycomycosis caused by dermatophytes, yeast and moulds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Loceryl should be applied to the affected nails once or twice a week. To apply the lacquer, the following recommendations should be carefully complied with: a) Before the first application of Loceryl, the nails should be thoroughly cleaned. Using a nail file, the affected areas of the nail (particularly the surface), are filed down as much as possible. Care must be taken not to file the periungual skin. b) The surface of the nail should then be cleansed and degreased using a cleansing swab provided, and all remaining lacquer removed. c) The lacquer is applied over the entire surface of the affected nail with the reusable applicators and the applicator cleaned before treating another nail to avoid contaminating the lacquer. The applicator must not be wiped off on the edge of the bottle. d) The applicator is cleaned with one of the swabs provided. The bottle must be kept tightly closed. The same process is repeated for each affected nail. Treatment should be continued without interruption until the nail is regenerated and the affected area is cured clinically and free of any fungus. The required duration of treatment depends essentially on intensity and localization of the infection and the growth rate of the nails. In general, it is six months for finger nails and nine to twelve months for toenails. Special instructions: • The same nail files must not be used for healthy nails. • Before each new application, the affected nail is filed if necessary, and always cleaned with the cleansing swabs to eliminate any remaining lacquer. • When working with organic solvents (thinners, white पूरा दस्तावेज़ पढ़ें