Lamikon 1% 15g cream for external use

The instruction for medical use of LAMIKON® medicine the Trade name of Lamikon® the International unlicensed name Terbinafin Lekarstvennaya a form Cream of 1% 15 g Structure of 1 g of drug contain active agent – a terbinafin a hydrochloride in terms of 100% anhydrous substance - 0.01 g excipients - phenylethyl alcohol, paraffin white soft, oil mineral (liquid paraffin), cetostearyl alcohol, polyethyleneglycol (macrogoal) the 20th cetostearyl ether, propylene glycol, half-oxameasures 407, sodium hydroxide, water purified. The description Cream of white or almost white color with a specific smell. Pharmacotherapeutic group Drugs for treatment of diseases of skin. Antifungal drugs for treatment of diseases of skin. Antifungal drugs for topical administration. Other antifungal drugs for topical administration. Terbinafin. The ATX D01A E15 code the Pharmacological Pharmacokinetics At properties topical administration in the form of cream of a terbinafin a hydrochloride very restrictedly is soaked up in a system blood stream (less than 5% of the applied dose) therefore its systemic action is minimum. Terbinafina a hydrochloride quickly gets into a thermal layer of skin and collects in a lipophilic corneal layer (including sebaceous glands and hair follicles). Differs expressed epidermo- and an onikhotropnost. At topical administration of a terbinafin the hydrochloride quickly begins to work, shows efficiency at short-term treatment (7 days). The concentration of a terbinafin of a hydrochloride necessary for fungicide effect of drug is present at a corneal layer of epidermis within 7 days after the treatment termination. The pharmacodynamics Terbinafin is antifungal drug of a broad spectrum of activity, to allylamine derivatives. Terbinafin specifically oppresses an early stage of biosynthesis of sterols in a cellular membrane of a mushroom by skvalenepoksidaza enzyme inhibition. It results in deficiency of ergosterol and to intracellular accumulation of squalene, causing death of a cell of a mushroom. Enzyme of a skvalenepoksidaz does not belong to the system of P450 cytochrome, thus, terbinafin does not affect the system of P450 cytochrome at the person and, respectively, metabolism of hormones or other medicines. Terbinafin has fungicide effect (causes death of a cell of a mushroom) concerning the following species of mushrooms: - dermatophytes, such as Trichophyton (T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum), Microsporum canis, Epidermophyton floccosum) - Pityrosporum orbiculare (known just as Malassezia furfur) - mold mushrooms - certain dimorphous mushrooms Terbinafin is active rather barmy mushrooms (generally the sorts Candida), depending on their look, can be fungicidal or fungistatic. Ламикон® cream has the anti-inflammatory, antipruritic, epithelizing effect. Indications – the fungal infections of skin caused by such dermatophytes as Trichophyton (for example, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum, for example, dermatofitiya of feet, an inguinal dermatofitiya (an itching of the jockey), a trunk dermatofitiya (cutting deprive), – the skin candidiasis caused by sort Candida fungi, usually Candida albicans, – multi-colored deprive (Pityriasis versicolor), the caused Pityrosporum orbiculare (it is also known as Malassezia furfur). The route of administration and doses to Adults and children are more senior than 12 years Lamikon® Cream to apply to skin 1 or 2 times a day depending on a disease. Before putting cream it is necessary to clean and dry affected areas carefully. To apply cream a thin layer to the affected skin and adjacent sites, slightly rubbing. In the infections which are followed by an intertrigo (under mammary glands, in an interdigital zone, inguinal area and between buttocks), sites of application can be covered with a gauze, especially for the night. Duration and frequency of treatment. Duration of treatment depends on weight of a course of the disease: – interdigital dermatofitiya of feet, inguinal dermatofitiya and dermatofitiya of a trunk: 1 time a day within 1 week, – squamous giperkeratoticheskaya a dermatofitiya of feet (mokasinovy foot): 2 times a day within 2 weeks, – skin candidiasis: 1-2 times a day within 1 week, – multi-colored deprive: 1-2 times a day within 2 weeks. For patients of advanced age the dose adjustment is not necessary. Relief of symptoms usually happens over several days. Irregular use or the premature termination of treatment can lead to a recurrence. In the absence of signs of improvement of a state after 2 weeks of treatment it is necessary to see a doctor. Side effects Local manifestations, such as itching, peeling or burning of skin, pain and irritation in the site of application, pigmentation disturbance, an erythema, crusting and others can be observed in the site of application. These insignificant manifestations should be distinguished from reactions of hypersensitivity, including rash about which it is reported in isolated cases and which demand the treatment termination. At accidental contact with eyes of a terbinafin the hydrochloride can cause irritation of eyes. In rare instances the masked fungal infection can become aggravated. Side reactions are classified by the systems of bodies (according to MedDRA) and by emergence frequency: very often (≥1/10), it is frequent (≥1/100 and & lt, 1/10), is rare (≥1/1000 and & lt, 1/100), is rare (≥1/10000 and & lt, 1/1000) and is very rare (& lt, 1/10000). Possible side effects: From the immune system Infrequently: reactions of hypersensitivity. Very seldom: small tortoiseshell. From organs of sight Seldom: irritation of eyes. From skin and connective tissues Often: peeling of skin, itching. Infrequently: injury of skin, crusting, damage of skin, pigmentation disturbance, erythema, burning sensation of skin. Seldom: feeling of xeroderma, contact dermatitis, eczema. Frequency is unknown: rash. The general disturbances and reactions in the site of application Infrequently: pain, pain in the site of application, irritation in the site of application. Seldom: aggravation of symptoms. Contraindications – hypersensitivity to a terbinafin or other components of drug, – children's age up to 12 years. Medicinal interactions are not established. Special instructions With care: liver and/or renal failure, alcoholism, oppression of a marrowy hemopoiesis, tumor, metabolism disease, occlusal diseases of vessels of extremities. Reduction of expressiveness of clinical manifestations is usually noted in the first days of treatment. Cream is intended only for external use. It is necessary to avoid contact of cream with eyes. At accidental hit of cream in eyes they need to be washed with flowing water carefully. Ламикон®крем, contains cetostearyl alcohol which can cause local irritation of skin (for example, contact dermatitis). For prevention of a reinfitsirovaniye mycoses of skin it is necessary to follow such rules: to daily change linen as existence of a fungus on clothes which were in contact with the infected surfaces of skin is possible, to avoid wearing too close or badly passing air clothes, to carefully dry up affected areas of skin after washing, to daily use a clean individual towel. In mycosis of feet it is impossible to go barefoot. In addition to external treatment of 1 times a day it is recommended to process Lamikon® spray socks or footwear inside. Use in pediatrics the Experience of use of drug to children up to 12 years is limited therefore this age category of patients should not use drug. Use during pregnancy and a lactation is not recommended use during the period pregnancy and lactations. About cases of congenital anomalies at the person at use of a terbinafin it was not reported. However, as clinical experience of use of a terbinafin for pregnant women is limited, use of external forms of drug during pregnancy is possible only according to strict indications. Features of influence of drug on ability to run transport and potentially dangerous mechanisms Drug does not affect ability to run the vehicle or potentially dangerous mechanisms. The overdose Low system absorption of a terbinafin at topical administration causes extremely low probability of overdose. It is possible to compare accidental ingestion of contents of two tubas of 30 g (which contain 300 mg of a terbinafin of a hydrochloride) to reception of 1 tablet Lamikona® on 250 mg (a dosage form for oral administration). At accidental ingestion of bigger amount of cream the side effects have to be similar to that at overdose of the tablets Lamikon® (a headache, nausea, pain in epigastric area and dizziness). Treatment of overdose at accidental ingestion consists active ingredient, first of all, by intake of activated carbon and performing symptomatic therapy at a distance if necessary. A form of release and packing On 15 g in tubas aluminum. Each tuba together with the instruction for medical use in the state and Russian languages is placed in a pack. To Store storage conditions in original packing at a temperature not higher than 25 wasps. Freezing of drug is not allowed. To store out of children's reach. A period of storage 3 years not to use drug after the expiration date specified on packing. Prescription status Without prescription PJSC Pharmak Producer, Ukraine, 04080, Kiev, st. of Frunze, 74. The holder of the registration certificate of PJSC Pharmak, Ukraine the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan accepting claims from consumers on quality of products (goods) and responsible for post-registration observation of safety of medicine Representative office of PJSC Pharmak in the Republic of Kazakhstan the Republic of Kazakhstan, Almaty, index 050012, Amangelda St. 59 'A' Business center 'Shartas', the 9th floor. Ph. +7 (727) 267 64 63, fax +7 (727) 267 63 73, e-mail address:
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