Land: Ísrael
Tungumál: enska
Heimild: Ministry of Health
BUTENAFINE HYDROCHLORIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
D01AE23
CREAM
BUTENAFINE HYDROCHLORIDE 1 %
DERMAL
Required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
BUTENAFINE
BUTENAFINE
Interdigital tinea pedis, tinea coporis, tinea cruris . (Treatment in tinea coporis and tinea cruris is limited to up to 4 weeks).
2023-04-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only MENTAX CREAM The cream contains Butenafine Hydrochloride at a concentration of 1%. Inactive ingredients: see section 6 in this leaflet. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. THIS LEAFLET CONTAINS CONCISE INFORMATION ABOUT THE MEDICINE. Keep this leaflet. You may want to read it again. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you only, to treat your ailment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. THIS MEDICINE IS NOT INTENDED FOR INFANTS AND CHILDREN BELOW THE AGE OF 12. 1. WHAT IS THE MEDICINE INTENDED FOR? An antifungal preparation for interdigital tinea pedis (athlete's foot), tinea corporis (ringworm) and tinea cruris (jock itch). Use of this preparation for ringworm and jock itch is for a period of up to 4 weeks. THERAPEUTIC GROUP: Antifungal. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are sensitive (allergic) to butenafine hydrochloride or to any of the other ingredients in Mentax Cream (see section 6 in this leaflet). Special attention and caution are required if you are sensitive to allylamine antifungals, as you may also be sensitive to Mentax Cream. DRUG INTERACTIONS IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER MEDICINES, INCLUDING NON-PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, tell the doctor or pharmacist. IF YOU ARE PREGNANT OR BREASTFEEDING, consult the doctor before using Mentax Cream. In any case, breastfeeding women must abstain from applying the preparation to the breast area. 3. HOW SHOULD YOU USE THE MEDICINE? • Always use according to the doctor's instructions. • Check with the doctor or pharmacist if you are uncertain. • The dosage and treatment regimen will be determined by the doctor only. The usual dosage is generally: For treatment o Lestu allt skjalið
1 Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Mentax ® Cream Butenafine hydrochloride 1% w/w Rx Only 2.THERAPUETIC INDICATIONS Interdigital tinea pedis, tinea corporis , tinea cruris . (Treatment in tinea corporis and tinea cruris is limited to up to 4 weeks). 3.DESCRIPTION Mentax Cream, contains the synthetic antifungal agent, butenafine hydrochloride 1%. Butenafine is a member of the class of antifungal compounds known as benzylamines which are structurally related to the allylamines. Butenafine HCl is designated chemically as _N_ -4- _tert_ -butylbenzyl- _N_ -methyl-1- naphthalenemethylamine hydrochloride. The compound has the empirical formula C 23 H 27 N•HCl, a molecular weight of 353.93, and the following structural formula: Butenafine HCl is a white, odorless, crystalline powder. It is freely soluble in methanol, ethanol, and chloroform, and slightly soluble in water. Each gram of Mentax Cream, contains 10 mg of butenafine HCl in a white cream base of purified water, propylene glycol dicaprilate, glycerin, cetyl alcohol, glyceryl monostearate, white soft parafin, stearic acid, polyoxyethylene cetyl ether, diethanolamine, and sodium benzoate. 4. CLINICAL PHARMACOLOGY Pharmacokinetics In one study conducted in healthy subjects for 14 days, 6 grams of Mentax Cream, was applied once daily to the dorsal skin (3,000 cm 2 ) of 7 subjects, and 20 grams of the cream was applied once daily to the arms, trunk and groin areas (10,000 cm 2 ) of another 12 subjects. After 14 days of topical applications, the 6-gram dose group yielded a mean peak plasma butenafine HCl concentration, Cmax, of 1.4 ± 0.8 ng/mL, occurring at a mean time to the peak plasma concentration, Tmax, of 15 ± 8 hours, and a mean area under the plasma concentration-time curve, AUC 0-24 hrs of 23.9 ± 11.3 ng-hr/mL. For the 20-gram dose group, the mean Cmax was 5.0 ± 2.0 ng/mL, 2 occurring at a mean Tmax of 6 ± 6 hours, and the mean AUC 0-24 hrs was 87.8 ± 45.3 ng-hr/mL. A biphasic decline of plasma butenafine HCl concen Lestu allt skjalið