Azelik 5g of 15% gel for topical application

The instruction for medical use of Azelik Torgovoye medicine the name Azelik Mezhdunarodnoye the unlicensed name Azelaic acid the Dosage form Gel for external use Structure of 100 g of gel is contained: active agent - azelaic acid in terms of 100% substance – 15.00 g, excipients: benzoic acid, metilpirrolidon, squalane, propylene glycol, dinatrium edetat, sodium hydroxide, dimetikon, a macrogoal tsetostearat, carbomer an interpolimer (type A), the water purified. The description Gel of white or almost white color, is allowed existence of a slight specific smell. Pharmacotherapeutic group Drugs for treatment of acne rash. Other drugs for topical treatment of acne rash. Azelaic acid. The ATX D10AX03 code the Pharmacological Pharmacokinetics Later properties of drawing on skin gets into epidermis and a derma, 3.6% of the general dose are absorbed in a system blood stream. A part of the soaked-up acid is removed by kidneys in not changed look, a part – in the form of the dicarboxylic acids (C7, C5) which are formed as a result of beta oxidation. The pharmacodynamics Has bacteriostatic activity concerning Propionibacterium acne and Staphylococcus epidermidis, reduces production of the fatty acids promoting developing of an acne. Reduces formation of comedones. Influencing process of keratinization of cells of epidermis, suppresses growth and activity of the abnormal melanocytes causing a melazma type hyperpegmentation. Has antiacne, depigmenting effect. Indications - Acne rash (acne vulgaris). Route of administration and doses Outwardly. Gel should be applied on previously carefully washed up (water or cleaned with the soft cleaning cosmetic) and the dried-up face skin. Gel is applied with a thin layer on affected areas of skin of 2 times/days (in the morning and in the evening) and slightly rubbed. About 2.5 cm of gel are enough for all surface of a face. At patients with eels ordinary (acne vulgaris) the significant improvement usually is observed in 4 weeks. For obtaining the best results the use of drug should be continued within several months. At patients with sensitive skin to apply only once in day. Side effects Very often (≥1/10) - burning, an itching and hyperaemia on the site of application of drug (by results of clinical trials) is frequent (≥1/100 & lt, 1/10) - peeling of skin, pain, dryness, coloring change, irritation on the site of application of drug Infrequently (≥1/1000 & lt, 1/100) - seborrhea, an acne, a skin depigmentation - paresthesias, dermatitis, discomfort and hypostasis on the site of application of drug Seldom (≥1/10000 &, 1/1000) - a cheilitis - bubbles, ulcers, eczema, feeling of warmth on the site of application of drug - reactions of hypersensitivity - rash (in the course of post-marketing observations) the Description of separate side reactions the Local irritation of skin usually passes lt in treatment process. With an unknown frequency, noted in the course of post-registration use of drug: - a Quincke's disease, contact dermatitis, an eye swelled and faces (can arise because of hypersensitivity) - rash - urticaria - deterioration in bronchial asthma of the Contraindication - hypersensitivity to drug components Medicinal interactions Can be applied in combination with other medicines to therapy of acne rash. Special instructions It is necessary to avoid hit of drug in eyes and also on mucous membranes of a nose, lips and a mouth. In cases of severe irritation of skin in the first weeks of treatment gel it is possible to apply 1 times/days, short-term drug withdrawal is also possible. After disappearance of symptoms of irritation of skin it is necessary to resume regular use of drug in the recommended dose. During treatment it is necessary to protect skin from all range of sunlight. Pregnancy and the period of a lactation Adequate and controlled researches at topical administration of azelaic acid at women during pregnancy were not conducted. It is necessary to be careful at Azelik's appointment to pregnant women. It is unknown whether azelaic acid with breast milk in the researches in Vivo is emitted. Nevertheless, penetration of drug into breast milk is possible. However it is not expected that penetration of azelaic acid promotes a significant change in its basal level in breast milk as azelaic acid does not concentrate in breast milk and less than 4% of the azelaic acid applied outwardly are absorbed systemically, without increasing its endogenous influence above physiological level. Nevertheless, the feeding women should be careful when prescribing drug. Use in pediatrics Drug is appointed to children 12 years are more senior. Dose adjustment of drug is not required from teenagers of 12-18 years. Safety and efficiency of drug at children are younger than 12 years is not established. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Use of drug does not affect ability to run motor transport and potentially dangerous mechanisms. Overdose Now cases of overdose of drug are not described. A form of release and packing Gel for external use of 15%. On 5, 15 or 30 g in a tuba aluminum. Each tuba together with the instruction for use in a pack from cardboard. To Store storage conditions at a temperature not above 25 °C. Not to freeze. To store out of children's reach. Period of storage 2 years. Not to apply after an expiration date. Prescription status Without prescription. Name and country of the manufacturing organization Joint-stock company 'Chemical and pharmaceutical plant 'AKRIKHIN' (JSC AKRIKHIN), Russia 142450, Moscow region, Noginsk district. Old Kupavna, Kirov St., 29. Phone number / fax: +7 (495) 702-95-03. The name and the country of the owner of the registration certificate of JSC Khimpharm, the Republic of Kazakhstan the Name and the country of the organization packer Joint-stock company 'Chemical and pharmaceutical plant 'AKRIKHIN' (JSC AKRIKHIN), Russia the Address of the organization in the territory of the Republic of Kazakhstan the accepting claim (offer) from consumers on quality of medicine and responsible for post-registration observation of safety of medicine of JSC Khimpharm, Shymkent, Republic of Kazakhstan, Rashidov St., 81