देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
CICLOPIROX
PHARMA SHALOM
D01AE14
LACQUE
CICLOPIROX 80 MG/G
TOPICAL-NAIL
Not required
SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY
CICLOPIROX
CICLOPIROX
For the treatment of fungal infections of the nails.
2014-09-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed without a doctor’s prescription NAME OF THE PREPARATION AND ITS FORM: BATRAFEN NAIL LACQUER ACTIVE INGREDIENT AND ITS CONCENTRATION: Each 1 gram contains: Ciclopirox 80 mg Inactive ingredients - see section 6 - Further information. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. THIS MEDICINE IS NOT INTENDED FOR USE IN CHILDREN UNDER THE AGE OF 12; UNDER THIS AGE, REFER TO A DOCTOR. This medicine does not require a doctor’s prescription. You must always use it as described in this leaflet or in accordance with the instructions you received from the doctor or pharmacist. Consult the pharmacist if you need further information. Refer to the doctor if the symptoms of the illness worsen or are not improving after 6 months of treatment. Keep this leaflet, you may need to read it again. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the treatment of fungal infections of the fingernails and toenails. THERAPEUTIC GROUP: Antimycotic (antifungal) from the hydroxypyridone group. 2. BEFORE USING THE MEDICINE X DO NOT USE THE MEDICINE: • If you are sensitive (allergic) to the active ingredient, ciclopirox, or to any of the additional ingredients contained in the medicine (see Section 6). • If you are pregnant or breastfeeding. • In children under the age of 12. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: • In the following cases, do not use the preparation without consulting a doctor before starting treatment: If you are a diabetic patient being treated with insulin or if you have diabetic neuropathy, if you suffer or have suffered in the past from immune system suppression, for example: if you have undergone a transplant, if you are taking medicines for epilepsy, if you are using topical corticosteroids regularly (on a mon पूरा दस्तावेज़ पढ़ें
1 1. NAME OF THE MEDICINAL PRODUCT Batrafen Nail Lacquer Active substance: ciclopirox 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g medicated nail lacquer contains 80 mg ciclopirox. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Medicated nail lacquer for application to the nails. 4. CLINICAL PARICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of fungal infections of the nails 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE Batrafen Nail Laquer is applied in a thin layer every other day in the first month, at least twice weekly in the second month and once a week from the third month onwards. METHOD OF ADMINISTRATION As much as possible of the destroyed nail material should be removed before the start of treatment with Batrafen Nail Laquer, for example with scissors or with the enclosed disposable nail files. Unless directed otherwise, Batrafen Nail Laquer is applied in a thin layer to the diseased nail every other day in the first month. In this way, the nail is saturated with the active substance. In the second month of treatment, application can be reduced to at least twice weekly and to once a week from the third month of treatment onwards. Throughout the application period the entire layer of lacquer is removed once a week with alcohol swabs. During this process too, as much as possible of the affected nail material should be removed with disposable nail files. If in the meantime the layer of lacquer becomes damaged, it is sufficient to paint over the chipped areas again with Batrafen Nail Laquer. Do not use nail polish or other nail cosmetic products on the treated nails. DURATION OF ADMINISTRATION The duration of use depends on the severity of the infection, but should not exceed a treatment period of 6 months. In this period, the pathogens of the nail fungal infection are generally killed off. The doctor will decide whether it is necessary to continue treatment. PEDIATRIC PATIENTS Based on the safety profile in adults, Batrafen Nail Laquer is considered safe for use in chil पूरा दस्तावेज़ पढ़ें