Therapeutic Indications: AMOROLFINE is treatment for nail mycosis (fungal infections) on at least 2 nails on adults. A mycosis is when the colour of the nail changes (white, yellow or brown) and the nail thickens. If the damage is limited to the upper part of the nail, follow the advice of your pharmacist. If the infection is more serious, consult your doctor. Contraindications: Do not use AMOROLFINE BGR: · If you are allergic (very sensitive) to the active ingredients or one of its components · If you are under 18 years of age. Special warnings and side effects: Be careful when using AMOROLFINE BGR. Avoid contact with eyes, skin and mucous membranes. Consult your doctor: - if you are diabetic, - if you are being treated for a disease of the immune system (disease decreasing the body’s defences), - if you have poor circulation in the hands and feet, - if you nail is damaged or infected In this case your doctor can add an oral treatment. - do not apply the varnish onto a normal nail or normal nail varnish onto infected nails. This product contains ethanol (alcohol). Using this too often or not in the right way can cause irritation and the nail to dry out. Interaction with other drugs: Talk to your doctor or pharmacist if you take or have recently taken any other drug, including any non-prescription drugs. Pregnancy and breast feeding: No effect of amorolfine is expected during pregnancy and lactation due to negligible systemic exposure (passage of drug in the blood). Amorolfine can be used during pregnancy and breast-feeding. Consult your doctor or pharmacist before taking any drugs. Dosage: Treat your nails as explained below. NAILS SHOULD BE TREATED ONCE PER WEEK. This application should be continued until the total regrowth of the healthy nail; is about 6 months for fingernails and 9 to 12 months for toenails. Nails grow slowly, it takes 2-3 months to see an improvement. It is important to use the varnish until the infection has completely disappeared and the nail has properly grown back. If you do not see an improvement after 3 months, consult your doctor. How to use:: Each of the following steps need to be followed. For packaging without accessories: Step 1: preparing the nail Get rid of any existing varnish from your nail. File the surface of your nail, particularly in the infected part. WARNING: do not use the same file for non-infected nails. Be careful that no one else uses your files. Step 2: cleaning the nail Use a dressing or tissue damp with solvant to clean the nail. Keep it to clean the spatula later. Step 3: treating the nail Put one of the spatulas in the bottle of varnish. Do not dab any varnish on the bottle edge. Apply the varnish on the surface of the nail. Leave to dry for 3 minutes. After application: It is important to clean the spatula with a dressing or cotton pad with a solvent after each application. A spatula can be used several times as long as it is cleaned after each use to avoid contamination. Use the dressing or cotton pad with solvent to clean the spatula. Do not touch the treated nails with the dressing. If you have put varnish on the outside of the cap, it is important to remove it using a compress or a cloth impregnated with solvent. Close the bottle. After each use it is important to wash your hands. However, when applied on the fingernails, it is necessary to wait for the complete drying of the varnish. Before using the bottle the next time, remove residual varnish coats, file the nail again. Re-clean with a compress or cotton pad with solvent and re-apply the varnish as explained above, - Once dry, the varnish is water and soap resistant so you can wash your hands and feet as normal. - Wear gloves to protect your hands when suing other solvents. - It is important to use the varnish until the infection has completely disappeared and the nail has properly grown back. For fingernails it can take 6 months and for toenails 9-12 months. You will see the infected nail disappear. - Do not use false nails during this treatment. For packaging with accessories: Step 1: preparing the nail Get rid of any existing varnish from your nail. File the surface of your nail, particularly in the infected part. WARNING: do not use the same file for non-infected nails. Be careful that no one else uses your files. Step 2: cleaning the nail Use one of the wipes provided to clean the nail. Keep it to clean the spatula later. Step 3: treating the nail Put one of the spatulas in the bottle of varnish. Do not dab any varnish on the bottle edge. Apply the varnish on the surface of the nail. Leave to dry for 3 minutes. After application: Clean the spatula with the wipe after each use. A spatula can be used several times as long as it is cleaned after each use to avoid contamination. Use the wipe that you have already used to clean the spatula. Do not touch the treated nails with the wipe. If you have put varnish on the outside of the cap, it is important to remove it using a wipe provided. Close the bottle. After each use it is important to wash your hands. However, when applied on the fingernails, it is necessary to wait for the complete drying of the varnish. Before using the bottle the next time, remove residual varnish coats, file the nail again. Re-clean with the wipe with solvent and re-apply the varnish as explained above - Once dry, the varnish is water and soap resistant so you can wash your hands and feet as normal. - Wear gloves to protect your hands when suing other solvents. - It is important to use the varnish until the infection has completely disappeared and the nail has properly grown back. For fingernails it can take 6 months and for toenails 9-12 months. You will see the infected nail disappear. - Do not use false nails during this treatment. Important · If you get AMOROLFINE BGR 5% varnish in the eyes or ears, wash immediately with water and contact your doctor, pharmacist or nearest hospital immediately. · Avoid contact of the varnish with the mucous membranes (eg the mouth or nostrils). Do not inhale the varnish. · If you, or someone else, accidentally swallows varnish, contact your doctor, pharmacist or nearest hospital immediately. Side effects: Like all drugs AMOROLFINE BGR 5% can cause side effects (this will not affect everyone). Side effects are rare. There have been reported cases of nail abnormalities (discoloured nail, fragile nail or brittle nail) and cases of skin burning sensation and contact allergies. However, these abnormalities may be directly related to nail disease. Composition : Active Ingredient: Amorolfine hydrochloride: 5.574 g Quantity of amorolfine: 5.000 g Per 100ml. Other ingredients: Methacrylic acid copolymer (EUDRAGIT RL100), triacetin, butyl acetate, ethyl acetate, absolute ethanol