देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Terbinafine hydrochloride
Ratiopharm UK Ltd
D01AE15
Terbinafine hydrochloride
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100200
PACKAGE LEAFLET: INFORMATION FOR THE USER ATHLETE FOOT CREAM 1% TERBINAFINE HYDROCHLORIDE 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 you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET: 1. What Athlete Foot Cream is and what it is used for 2. What you need to know before you use Athlete Foot Cream 3. How to use Athlete Foot Cream 4. Possible side effects 5. How to store Athlete Foot Cream 6. Contents of the pack and other information 1. WHAT ATHLETE FOOT CREAM IS AND WHAT IT IS USED FOR Athlete Foot Cream is an anti-fungal preparation. It kills fungi, which cause skin infections. Athlete Foot Cream is used for the local treatment of fungal infections of the skin such as Athlete’s foot and Jock itch (an infection in the groin area, characterised by red ring like areas, sometimes with small blisters, and itching). FOR EXTERNAL USE ONLY. FUNGAL INFECTIONS CAN DEVELOP IN THE FOLLOWING AREAS OF THE BODY: Fungal infection of the foot (Athlete’s foot) appears on the feet, mainly between the toes. It can spread to the soles, edges or the instep of the feet. It may affect one or both feet. The most common symptoms can be inflammation, cracking or scaling of the skin, unpleasant itching. In more severe cases, small weeping blisters, peeling skin and painful, deep cracks can appear A superficial fungal infection of the skin can appear anywhere on the body surface. As the fungus grows, it spreads out in a circle, leaving normal looking skin in the middle. This makes it look like a ring. At the edge of the ring, the पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Athlete Foot Cream 1% 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 10 mg terbinafine hydrochloride (equivalent to 8.89 mg terbinafine) in 1 g cream. Excipient(s) with known effect: Each 1 g cream contains 10 mg benzyl alcohol, 40 mg cetyl alcohol and 40 mg cetostearyl alcohol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream White or almost white cream, with slight almond odour 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of tinea pedis (Athlete’s foot) and tinea cruris (jock itch) caused by _ Trichophyton_ (e.g. _ T. rubrum_, _ T. mentagrophytes)_ and _ Epidermophyton _ _floccosum_. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Athlete Foot Cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of Athlete Foot Cream. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly. The likely durations of treatment are as follows: Tinea cruris: 1 to 2 weeks Tinea pedis: 1 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, the diagnosis should be verified. _Paediatric population_ The experience with topical terbinafine in children aged 16 and under is still limited and its use cannot therefore be recommended. _Elderly _ There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients. Method of administration Via the topical route. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Athlete Foot Cream is for external use only. Contact with the eyes should be avoided. If it gets into the eyes accidentally, the eyes should be washed with plenty of water and the patient should tu पूरा दस्तावेज़ पढ़ें