País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Terbinafine hydrochloride
Dowelhurst Ltd
D01AE15
Terbinafine hydrochloride
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100200
IN THIS LEAFLET: 1. What Terbinafine cream is and what it is used for 2. Before you use Terbinafine cream 3. How to use Terbinafine cream 4. Possible side effects 5. How to store Terbinafine cream 6. Further information 1. WHAT TERBINAFINE CREAM IS AND WHAT IT IS USED FOR Terbinafine cream belongs to a group of medicines called antifungals which are used to treat fungal infections, especially of the skin. It can be used in the treatment of infections, such as Athlete’s foot, ringworm, itchy rash of the groin and fungal infections of the skinfolds (intertrigo). 2. BEFORE YOU USE TERBINAFINE CREAM DO NOT USE TERBINAFINE CREAM IF: • you are allergic (hypersensitive) to terbinafine hydrochloride or any of the other ingredients of the cream (listed in Section 6 Further Information) • you are under 16 years of age • you are breast-feeding. PREGNANCY AND BREAST-FEEDING If you are pregnant or trying for a baby, tell your doctor before using the cream. If you have already informed your doctor, follow his/her instructions carefully. Do not use Terbinafine cream if you are breastfeeding. DRIVING AND USING MACHINES Using Terbinafine cream does not affect your ability to drive or use machinery. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF TERBINAFINE CREAM. The cream contains cetyl alcohol and steryl alcohol, which may cause local skin reactions (e.g. contact dermatitis). 3. HOW TO USE TERBINAFINE CREAM TAKE SPECIAL CARE WITH TERBINAFINE CREAM AS: • your Terbinafine cream is for external use only and should not be put in the mouth or swallowed. If swallowed accidentally, seek medical advice immediately and take this leaflet with you. • you must keep the cream away from your eyes. If the cream gets in your eyes wipe the cream from around the eye and then rinse with clean water. Seek medical advice immediately. Before use, invert the cap over the end of the tube and press to pierce the tube seal. ADULTS INCLUDING THE ELDERLY Your doctor will tell you how much cream to use and how long to use it for. Always Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Terbinafine Hydrochloride 1% Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Terbinafine hydrochloride 1% w/w For the fill list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. White homogenous cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fungal infection of the skin caused by _Trichophyton _ _(e.g. _ _T.rubrum, _ _T. _ _mentagrophytes, _ _T. _ _verrucosum, _ _T. _ _violaceum), _ _Microsporum _ _canis _ _and _ _Epidermophyton floccosum. _ Yeast infections of the skin, principally those caused by the genus _Candida (e.g. C. _ _albicans). _ Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as _Malassezia furfur)._ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Terbinafine Hydrochloride 1% Cream can be applied once or twice daily DURATION AND FREQUENCY OF TREATMENT: The likely durations of each treatment are as follows: • Tinea corporis , cruris: 1 to 2 weeks • Tinea pedis: 1 week • Cutaneous candidosis: 2 weeks • Pityriasis versicolor: 2 weeks 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. DOSING IN SPECIAL POPULATIONS: PAEDIATRIC POPULATION The experience with topical Terbinafine Hydrochloride 1% Cream in children is still limited and its use cannot therefore be recommended. ELDERLY PATIENTS: There is no evidence to suggest that elderly patients require different dosage or experience side-effects different to those of younger patients. Method of administration For cutaneous use. Cleanse and dry the affected areas thoroughly before application of Terbinafine Hydrochloride 1% Cream. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a Llegiu el document complet