Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Amorolfine
Chanelle Medical
D01AE16
Amorolfine
5 percent weight/volume
Medicated nail lacquer
Product subject to prescription which may be renewed (B)
amorolfine
Not marketed
2013-06-21
Page1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER AMOROLFINE 5% W/V MEDICATED NAIL LACQUER amorolfine (as hydrochloride) 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. 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 Amorolfine Lacquer is and what it is used for 2. What you need to know before you use Amorolfine Lacquer 3. How to use Amorolfine Lacquer 4. Possible side effects 5. How to store Amorolfine Lacquer 6. Contents of the pack and other information 1. WHAT AMOROLFINE LACQUER IS AND WHAT IT IS USED FOR Amorolfine Lacquer is used to treat fungal infections of the nails. Amorolfine Lacquer contains the active ingredient amorolfine (as the hydrochloride) which belongs to a group of medicines known as anti fungals. It kills a wide variety of fungi that can cause nail infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMOROLFINE LACQUER DO NOT USE AMOROLFINE LACQUER IF YOU ARE: Allergic (hypersensitive) to amorolfine or any of the other ingredients of Amorolfine Lacquer. Please check by reading the list of ingredients in section 6. If you answer yes, you must inform your doctor before starting treatment. Please seek immediate medical attention if you experience symptoms of an allergic reaction. Signs or symptoms of a severe allergic reaction may include a rash, with or without itching, swelling of the face, eyelids or lips and difficulty in breathing. WARNINGS AND PRECAUTIONS: This medicine can cause allergic reactions, some can be serious. If this happens, stop applying the product, immediately remove the product with a n read_full_document
Health Products Regulatory Authority 01 April 2019 CRN008P19 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amorolfine 5% w/v medicated nail lacquer 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml contains 50mg amorolfine (as hydrochloride). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated nail lacquer. A clear, colourless to almost colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Onychomycoses caused by dermatophytes, yeasts and moulds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The nail lacquer should be applied to the affected finger or toe nails once weekly. The patient should apply the nail lacquer as follows: 1. Before the first application of Amorolfine 5% w/v Medicated Nail Lacquer, it is essential that the affected areas of nail (particularly the nail surfaces) should be filed down as thoroughly as possible using the nail file supplied. The surface of the nail should then be cleansed and degreased using an alcohol cleaning pad. Before repeat application of Amorolfine 5% w/v Medicated Nail Lacquer the affected nails should be filed down again as required, following cleansing with a cleaning pad to remove any remaining lacquer. _Caution: _Nail files used for affected nails must not be used for healthy nails. 2. With one of the reusable spatulas supplied, apply the nail lacquer to the entire surface of the affected nails. Allow the nail lacquer to dry for 3-5 minutes. After use, clean the spatula with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed. For each nail to be treated, dip the spatula into the nail lacquer without wiping off any of the lacquer on the bottle neck. The required duration of treatment depends essentially on intensity and localisation of the infection. In general, it is six months (finger nails) and nine to twelve months (toe nails). Elderly There are no specific dosage recommendations for use in elderly patients. Children There are no specific dosage recommendations for read_full_document