Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amorolfine hydrochloride
A A H Pharmaceuticals Ltd
D01AE16
Amorolfine hydrochloride
50mg/1ml
Medicated nail lacquer
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100200; GTIN: 5025903009962 5025903015352
4 COLOUR: CMYK PACKAGE LEAFLET: INFORMATION FOR THE USER AMOROLFINE 5% W/V MEDICATED NAIL LACQUER 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 a doctor if your symptoms worsen or do not improve within 3 months. WHAT IS IN THIS LEAFLET: 1. What Amorolfine 5% w/v is and what it is used for 2. What you need to know before you use Amorolfine 5% w/v 3. How to use Amorolfine 5% w/v 4. Possible side effects 5. How to store Amorolfine 5% w/v 6. Contents of the pack and other information 1. WHAT AMOROLFINE 5% W/V IS AND WHAT IT IS USED FOR Amorolfine 5% w/v is used to treat: • Fungal infections of the nails without involvement of the nail root (nail matrix) • Fungal infections affecting up to 2 nails and affecting the upper half or sides of the nail (as shown in the first picture below). If the infection appears to be more like pictures 2 or 3, you should consult your doctor. • The active substance in Amorolfine 5% w/v is amorolfine (as the hydrochloride) which belongs to a group of medicines known as antifungals. • Amorolfine 5% w/v kills a wide variety of fungi that can cause nail infections. A fungal nail infection is likely to result in discoloured (white, yellow or brown), thick or brittle nails, although their appearance can vary considerably as the following pictures show: Picture 1 Picture 2 Picture 3 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AMOROLFINE 5% W/V DO NOT USE AMOROLFINE 5% W/V IF YOU ARE: • Allergic to amorolfine or any of the other ingredients of this medicine (listed in section 6). • Under the age of 18. Warning and precaut Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amorolfine 5% Medicated nail lacquer 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amorolfine contains 5% w/v amorolfine in the form of hydrochloride. 1 ml solution contains 55.74 mg amorolfine hydrochloride (equivalent to 50 mg amorolfine). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated nail lacquer. Clear, colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of mild cases of distal and lateral subungual onychomycoses caused by dermatophytes, yeasts and moulds; treatment is limited to 2 nails. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ADULTS AND ELDERLY _ 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, 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, 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 applicators supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. After use, clean the applicator with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed. For each nail to be treated, dip the applicator into the nail lacquer without wiping off any of the lacquer on the bottle neck. Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required frequency and duration of treatment depends essentially on intensity and localisation of the infection. In general, i Read the complete document