Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
TERBINAFINE AS HYDROCHLORIDE
GSK CONSUMER HEALTHCARE, ISRAEL LTD
D01AE
SOLUTION
TERBINAFINE AS HYDROCHLORIDE 10 MG/G
TOPICAL
Not required
GSK CONSUMER HEALTHCARE SCHWEIZ AG, SWITZERLAND
OTHER ANTIFUNGALS FOR TOPICAL USE
For the treatment of athlete's foot.
2022-09-30
_ _ PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor's prescription LAMISIL ONCE SOLUTION 10MG/G ACTIVE INGREDIENT: TERBINAFINE HYDROCHLORIDE 10 MG/G INACTIVE INGREDIENTS AND ALLERGENS IN THE PREPARATION - SEE SECTION 6 AND SECTION 2 UNDER THE TITLE “IMPORTANT INFORMATION ABOUT SOME INGREDIENTS OF THE MEDICINE”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. Use the preparation according to the instructions in the dosage section of this leaflet. Consult the pharmacist if you need more information. Refer to the doctor if the symptoms of the disease do not improve after 7 days. 1. WHAT IS THE MEDICINE INTENDED FOR? Treatment of athlete’s foot. THERAPEUTIC CLASS: Anti-fungal for external use. The preparation kills the fungi that cause athlete’s foot. 2. BEFORE USING THE MEDICINE X DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient terbinafine hydrochloride or to any one of the other components the medicine contains (see section 6) ! SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE: • Do not use this product after the expiry date stated on the package. • Do not use this product if the tube seal is damaged or if the packaging does not appear intact. • DO NOT USE THIS MEDICINE IN CHILDREN AND ADOLESCENTS UNDER THE AGE OF 15. • TELL THE DOCTOR OR PHARMACIST IF YOU ARE PREGNANT OR PLANNING TO BECOME PREGNANT. • THIS MEDICINE IS NOT SUITABLE FOR: o Long term treatment of fungal infection of the soles of the feet and heels with thick edges and/or peeling skin o Treatment of fungal nail infection (fungus inside or under the nail) with discoloration of the nail and change in nail texture (thickening or peeling) Tell the doctor or pharmacist if you think you may have these conditions, because you may need another preparation. ONLY USE LAMISIL Citiți documentul complet
Page 1 PRODUCT INFORMATION 1. NAME OF THE PRODUCT LAMISIL ONCE 2. Active ingredient Terbinafine hydrochloride 10mg/g Chemical structure: 3. PHARMACEUTICAL FORM Topical solution. 4. THERAPEUTIC INDICATIONS Treatment for athlete's foot. 5. DESCRIPTION Lamisil once also contains, as excipients, Ethyl alcohol 96% (v/v), acrylates/octylacrylamide copolymer (e.g. Dermacryl 79), medium chain triglycerides, hydroxypropylcellulose(e.g. Klucel MF) ,. 6. PHARMACOLOGY 6.1. PHARMACODYNAMICS Pharmacotherapeutic group: Antifungal for topical use (ATC code D01A E15). Terbinafine is an allylamine with antifungal activity mainly against dermatophytes. Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P450 system. Terbinafine does not influence the metabolism of hormones or other drugs. Page 2 A phase III, randomized, double-blind, placebo-controlled clinical trial has been conducted to investigate the efficacy and safety of Lamisil Once in patients aged 12 years and over with tinea pedis. In this study, 273 patients which were treated with a single application of Lamisil Once (190 patients) or vehicle (83 patients) according to the directions for use were analysed for the efficacy. The primary efficacy variable was the number of patients ‘effectively treated’ (negative microscopy, negative culture, total clinical signs and symptoms score 2 using a scoring scale of 0-3 for each individual sign/symptom, with no individual sign/symptom for pustules, incrustation, vesiculation and an individual score ≤1 for erythema, desquamation, pruritus,) 6 weeks after treatment. Secondary efficacy parameters included negative culture, negative microscopy, negative mycology (both negative microscopy and negative culture), clinical cure (tota Citiți documentul complet