The instruction for medical use of Gervetin Torgovoye medicine a name Gervetin Mezhdunarodnoye the unlicensed name Benzydamine Dosage Form of the Pastil with taste of mint, 3 mg Structure One pastil contains active agent – benzydamine a hydrochloride of 3 mg, excipients: menthol, fragrance of oil of a peppermint 27198/14, povidone, sodium cyclomate, Mannitolum, sorbitol, starch corn prezhelatinizirovanny, silicon colloidal anhydrous, magnesium stearate, structure of a film cover: Опадрай® green 03F31219, sodium cyclomate, menthol, fragrance of oil of a peppermint 27198/14. The description of the Pastil of light green color with the possible marble drawing and light, and dark stains on a surface, round shape with a biconvex surface, with a mint smell. At a break the core from white till almost white color and a thin light green film cover is observed. Pharmacological group Dental drugs. Other drugs for treatment of diseases of an oral cavity. Benzydamine the ATX A01AD02 Code the Pharmacological Pharmacokinetics At properties topical administration drug is well absorbed through mucous membranes and gets into the inflamed fabrics. In 2 hours after resorption of the pastil containing 3 mg of benzydamine, peak concentration in plasma of-37.8 ng/ml and AUC – 367 ng/ml an hour were noted. However, these levels are not sufficient for emergence of system pharmacological effects. Excretion of drug happens generally kidneys and through intestines in the form of metabolites or products of conjugation. At topical administration of benzydamine its accumulation in the inflamed fabrics where it reaches effective concentration because of its ability to get into epithelium cells was observed. The pharmacodynamics Benzidamin is anti-inflammatory drug, belongs to group of indazol. Has the anti-inflammatory and local anesthetizing effect, possesses antiseptic action against a wide range of microorganisms. The mechanism of effect of drug is connected with stabilization of cellular membranes and inhibition of synthesis of prostaglandins. Benzydamine has antibacterial and specific antimicrobic effect due to fast penetration through membranes of microorganisms with the subsequent damage of cellular structures, disturbance of metabolic processes and lysis of a cell. Indications – for symptomatic treatment and pain relief and irritation of a mouth and throat. To Hold a route of administration and doses in a mouth before full resorption, about 1 pastil 3 times a day is recommended. Duration of treatment should not exceed 7 days. Children under 6 years This dosage form (pastils) is not applied at children up to 6 years. Children of 6-12 years it is necessary to use Drug on 1 pastil 3 times a day under observation of adults. Side effects Locally: – dryness in a mouth, feeling of numbness, burning in an oral cavity, change of taste Is rare: – allergic reactions (skin rash), photosensitivity – drowsiness, anaphylactic reactions Very seldom: – a laryngospasm, a bronchospasm – a Quincke’s disease of the Contraindication – hypersensitivity to components to drug – children’s age up to 6 years – hereditary intolerance of fructose Medicinal interactions it is not established clinically significant interaction of the drug Gervetin, a pastil with other medicines. The bronchospasm can cause the special instructions Drug in patients with bronchial asthma and bronchial asthma in the anamnesis. Such patients have to be warned about it surely. Drug is not recommended to patients with hypersensitivity to salicylic acid or other non-steroidal anti-inflammatory drugs. At a small number of patients, inflammation and a mucous oral cavity ulcers and drinks can be symptoms of serious diseases. Patients at whom symptoms of inflammation accrue or improvement within 3 days of treatment is not noted, have to see behind consultation the attending physician or the stomatologist. Pastils contain sorbite. To patients with rare hereditary intolerance of fructose, it is not necessary to take this drug. Sorbite can have moderately aperient effect. One pastil contains 0.415 mg of sorbite (1.08 kcal). Pregnancy and a lactation pregnant women and the feeding women have no data on use of benzydamine. Researches on drug discharge with breast milk were not conducted. The potential risk for the person is unknown. It is not recommended. Features of influence of medicine on ability of control of vehicles and works with potentially dangerous mechanisms Drug does not affect in the recommended dose ability to run motor transport and other activity requiring special attention. Overdose Symptoms: at children, very seldom, after oral administration of benzydamine (in a dosage approximately by 100 times exceeding its contents in pastils), such symptoms as excitement, spasms, perspiration, an ataxy, a tremor and vomiting were noted. Treatment: gastric lavage, careful observation, maintenance therapy, adequate level of hydration. A form of release and packing On 10 pastils in blister strip packaging from a film polyvinylchloride / thermoplastic elastomer / polyvinylidene chloride and aluminum foil. On the 2nd blister strip packagings together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. A period of storage 3 years not to use Storage conditions after an expiration date to Store in the dry, protected from light place at a temperature not over 25 ºС, in original packing. To store out of children’s reach! Prescription status Without prescription REPLEK FARM Ltd Producer. Skopje, Skopje, the Republic of Macedonia the Owner of the registration certificate of Spey Medical Ltd., London, Great Britain the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Cepheus Medical LLP (Tsefey Medikal), 050000, RK, Almaty, Panfilov St. 98, BC OLD SQUARE, office 807.