Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Terbinafine hydrochloride
Karo Healthcare UK Ltd
D01AE15
Terbinafine hydrochloride
10mg/1gram
Spray
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100200; GTIN: 5012131742501
Lamisil AT 1% Spray Terbinafine Hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Lamisil AT 1% Spray carefully to get the best results from it. – Please keep this leaflet. You may need to read it again. – Ask your pharmacist if you need more information or advice. – You must contact a doctor if your symptoms worsen or do not improve after 7 days. – If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Lamisil AT 1% Spray is and what it is used for 2. Before you use Lamisil AT 1% Spray 3. How to use Lamisil AT 1% Spray 4. Possible side effects 5. How to store Lamisil AT 1% Spray 6. Further information 1. WHAT LAMISIL AT 1% SPRAY IS AND WHAT IT IS USED FOR Lamisil AT 1% Spray contains the active ingredient terbinafine which is an antifungal used to treat skin problems caused by fungi in: • Athlete’s foot (tinea pedis) - Athlete’s foot appears only on the feet (usually both, but not always), where it often appears in between the toes. It can also appear on the instep, soles, or other areas of the feet. The most common type of athlete’s foot causes cracking or scaling of the skin, but you may also have mild swelling, blisters, or weeping ulcers. Lamisil AT 1% Spray is recommended for athlete’s foot when it occurs between the toes. If you have a fungal nail infection (fungus inside and under the nail) with discolouration of the nails and changes in nail texture (thick or flaky), you should consult your doctor because Lamisil AT 1% Spray is not appropriate for this type of infection. • Dhobie itch/jock itch (tinea cruris) - Dhobie itch appears in the groin and inner thigh area, usually on both sides but often with one side more than the other, where it can spread further between the legs to the buttocks, or up towards the stomach. Dhobie itch looks like a clearl Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamisil AT 1% Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 10mg terbinafine hydrochloride per 1g spray solution Excipients with known effect Each gram of spray contains 250 mg ethanol and 50 mg propylene glycol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous spray, solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of tinea pedis (athlete’s foot) and tinea cruris (dhobie (jock) itch) caused by _Trichophyton_ (e.g. _T. rubrum, T. mentagrophytes, T. _ _verrucosum, T. violaceum_) and _Epidermophyton floccosum_. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Lamisil AT 1% Spray is applied once daily, for one week. DURATION AND FREQUENCY OF TREATMENT: Interdigital type tinea pedis, and tinea cruris: Once a day for one week. Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, a physician should be consulted. DOSING IN SPECIAL POPULATIONS: Paediatric population Not to be used in children under 16 years of age. Experience with Lamisil AT 1% Spray in children is limited and its use cannot, therefore, be recommended. Elderly patients There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients. METHOD OF ADMINISTRATION For cutaneous use. Cleanse and dry the affected areas thoroughly before applying Lamisil AT 1% Spray from a distance of 5 to 10 cm. A sufficient amount of spray solution should be applied to wet the treatment area(s) thoroughly, and to cover the affected skin and surrounding area. 4.3 CONTRAINDICATIONS Known hypersensitivity to terbinafine or any of the excipients contained in the spray solution (see section 6.1 List of excipients). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Lamisil AT 1% Spray should be used with caution in patients with les Olvassa el a teljes dokumentumot