Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Terbinafine hydrochloride
McDermott Laboratories Ltd., T/A Gerard Laboratories
D01BA; D01BA02
Terbinafine hydrochloride
250 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Antifungals for systemic use; terbinafine
Marketed
2005-06-17
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NAILDERM 250 MG TABLETS terbinafine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 only. 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 Nailderm is and what it is used for 2. What you need to know before you take Nailderm 3. How to take Nailderm 4. Possible side effects 5. How to store Nailderm 6. Contents of the pack and other information. 1. WHAT NAILDERM IS AND WHAT IT IS USED FOR Nailderm contains a medicine called terbinafine as terbinafine hydrochloride, which belongs to a group of medicines called antifungals. It is used in adults and older people to treat a number of fungal infections of the skin and nails such as athlete’s foot, groin infections, ringworm and also onychomycosis (a fungal infection of the nails). It kills the fungus and stops it growing. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAILDERM DO NOT TAKE NAILDERM: if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6). if you have severe kidney problems. if you have or had liver problems. if you are breastfeeding. if you are pregnant or trying to become pregnant. Do not take Nailderm if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Nailderm. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Nailderm: if you have or have experienced patches of red/silver skin (psoriasis), or facial rash, joint pain, muscle disorder, fever (cutaneous and systemic lupus erythematosus read_full_document
Health Products Regulatory Authority 15 July 2022 CRN00CQGN Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nailderm 250 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains terbinafine hydrochloride, equivalent to 250 mg terbinafine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, round, biconvex tablet with TF scoreline 250 on one side and G on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fungal infections of the skin caused by Trichophyton (e.g. _T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum_) _Microsporum canis _and _Epidermophyton floccosum. _ _ _ Oral Terbinafine tablets are indicated in the treatment of ringworm (tinea corporis, tinea cruris and tinea pedis where oral therapy is considered appropriate due to the site, severity or extent of the infection. The treatment of onychomycosis (terbinafine-sensitive fungal infection of the nails) caused by dermatophyte fungi. N.B. Orally administered terbinafine tablets are not effective against Pityriasis versicolor. Consideration should be given to official guidance on the appropriate use of antifungal agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ 250 mg once daily. The duration of treatment is varies according to the indication and the degree of severity of the infection. _Skin infections_ The likely durations of treatment are as follows: Tinea pedis (interdigital, plantar/moccasin-type): 2 to 6 weeks Tinea corporis: 4 weeks Tinea cruris : 2 to 4 weeks _Onychomycosis_ The duration of treatment for most patients is between 6 weeks and 3 months. Treatment periods of less than 3 months can be anticipated in patients with fingernail infections, toenail infection other than of the big toe, or patiens of younger age. In the treatment of toenail infection, 3 months is usually sufficient although a few patients m read_full_document