The instruction for medical use of GODEKS® medicine the Trade name of Godeks® the International unlicensed name Is not present the Dosage form of the Structure One Capsule Capsule contains active agents: carnitine orotat (including acids of orotovy 73.8 mg and carnitine of 76.2 mg) 150 mg, anti-toxic fraction of extract of a liver (including cyanocobalamine of 0.125 mg) 12.5 mg, pyridoxine hydrochloride of 25 mg, cyanocobalamine of 0.125 mg, adenine hydrochloride of 2.5 mg, Riboflavinum of 0.5 mg, biphenyl dimethyl dicarboxylate of 25 mg, excipients: lactose anhydrous, cellulose microcrystalline, silicon dioxide, magnesium stearate, structure of the capsule: body: gelatin, aerosil (silicon dioxide), titan dioxide (E 171), ferrous oxide black (E 172), quinolinic yellow (E104), ponso 4R (E124) lid: gelatin, aerosil (silicon dioxide), titan dioxide (E 171), ferrous oxide black (E 172), quinolinic yellow (E104), ponso 4R (E124). The description Solid gelatin capsules with the body and a lid of red-brown color with marking of GODEX and CELLTRION, contents of capsules − the yellowy-brown granulated powder. Pharmacological group Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of a liver. The ATX A05BA code the Pharmacological Pharmacokinetics Later properties of intake a complex of active agents is released in a duodenum. Absorption of water-soluble vitamins of group B (cyanocobalamine, Riboflavinum, a pyridoxine), a carnitine of the orotat, anti-toxic fraction of a liver, hydrochloride adenine, bifenildimetit dicarboxylate occurs throughout a small intestine. Deposition of cyanocobalamine happens in kidneys, an intestines wall, mainly in a liver, is brought out of a liver with bile in intestines where it is repeatedly soaked up. Distribution of Riboflavinum in an organism unevenly: the greatest number is found in a myocardium, a liver, kidneys. The pyridoxine is metabolized in a liver with formation pharmacological of active metabolites (pyridoxal phosphate, piridoksaminofosfat), distributed in muscles, a liver, the central nervous system. Elimination is carried out mainly by kidneys. Effect of the drug Godeks® is cumulative action of its components therefore carrying out kinetic researches is not possible. Everything together components cannot be tracked by means of markers or bioresearches. A pharmacodynamics of Godeks®-drug for treatment of diseases of a liver and biliary tract. Stimulates metabolism of fats – the components – oxidizing process of free fatty acids in mitochondrions of hepatocytes, biosynthetic process, prevents hepatocyte necrosis, normalizes process of proliferation of hepatocytes, a hepatoenzymatic system and restores normal hepatic function. A carnitine orotat (DAN-221) – the active organic compound containing a carnitine and orotovy acid. The carnitine promotes splitting of fatty long-chain acids and substitution of the fatty acid metabolic shunt carbohydrate, increases secretion and activity of digestive enzymes, improves digestion of food. Main functions of a carnitine of the orotat: prevention of necrosis of hepatocytes, strengthening of cellular regeneration and proliferation of hepatocytes, stimulation of metabolism of fats, restoration and stimulation of biosynthesis of proteins and lipoproteids. Biphenyl dimethyl dicarboxylate – a synthetic analog of a skhizandrin With, one of the components received from fruits of a magnolia vine Chinese. It is effective in treatment and protection of a liver due to increase in synthesis of P450 2B cytochrome that leads to strengthening of detoksitsiruyushchy function of a liver due to acceleration of metabolism of toxic substances with the subsequent biotrasformation and their removal from an organism. Possesses a wide range of pharmacological activity: stimulates the central nervous system, renders anti-inflammatory, antioxidant, antimicrobial, antifungal and antineoplastic action. The anti-toxic fraction of extract of a liver is the cleaned antitoxic extract from a liver of cattle, representing a complex of the amino acids participating in process of binding and removal of toxins and renders disintoxication effect. Presence of adenine of the hydrochloride which is a component of coenzymes, nucleic acids provides regulation of processes of a hemopoiesis. Group B vitamins (cyanocobalamine, Riboflavinum, a pyridoxine) – regulate oxidation-reduction processes, take part in protein, fat and carbohydrate metabolism, participate in exchange of tryptophane, methionine, cysteine, glutaminic acid and other amino acids. The pyridoxine contributes to normalization of lipidic exchange. Cyanocobalamine participates in transmethylation process, hydrogen transfer, formation of methionine, nucleic acids, sincaline, creatine. Riboflavinum directly participates in processes of tissue respiration, many biochemical reactions and regulation of biosynthesis of protein. The drug Godeks® increases secretory function of a stomach, improves a zhelchevydeleniye, facilitates absorption of carbohydrates in a small intestine, is necessary for maintenance of normal intestinal microflora. Promotes improvement of glikogenofiksiruyushchy, synthetic, anti-toxic function of a liver, increases sensitivity of hepatic cells to effect of insulin, promotes an insulin inkretion. Indications as a part of complex therapy at: acute, chronic hepatitises cirrhosis of fat dystrophy of a liver of a drug disease of a liver of an alcoholic liver disease the Route of administration and doses of Godex is appointed inside by the adult on 2 capsules 2-3 times a day, irrespective of meal. The maximum single dose 2 capsules, the maximum daily dose makes 6 capsules. Duration of treatment depends on a course of a basic disease, and is defined in each case individually. Side effects – skin rash, an itching, a small tortoiseshell, a Quincke’s edema – abdominal pain, nausea, vomiting, diarrhea, a constipation, passing jaundice – a headache, dizziness, hyperphrenia of the Contraindication – individual intolerance of components of drug – children’s and teenage age up to 18 years – pregnancy and the period of a lactation – a nephrolithiasis – an erythremia, a hyperglobulia, a thrombembolia – exacerbation of a peptic ulcer of a stomach and duodenum Medicinal interactions B6 Vitamin weakens action of a levodopa, prevents or reduces toxic manifestations which are observed at use of an isoniazid and other antitubercular drugs. PASK, Cimetidinum, calcium drugs, ethanol reduce B12 vitamin absorption. Riboflavinum is incompatible with streptomycin and reduces efficiency of antibacterial drugs (Oxytetracyclinum, doxycycline, erythromycin, tetracycline and lincomycin). Tricyclic antidepressants, imiprimin and amitriptyline, inhibit Riboflavinum metabolism, especially in heart tissues. Special instructions It is necessary to observe special measures of precaution at a severe form of chronic hepatitis, a severe form of cirrhosis. In case of appearance of jaundice it is necessary to stop administration of drug for some time, additional therapy can be necessary. During administration of drug of Godeks® the purpose of the polyvitaminic complexes containing group B vitamins is not recommended. Administration of drug can lead to the false positive urobilinigen test with use of reagent of Ehrlich. It is recommended to exclude alcohol intake during the Godeks® drug treatment. It is necessary to use with care at patients with ulcer of stomach and duodenum in the anamnesis, in a serious illness of heart and kidneys, in the presence of new growths. There can seldom be skin rash, an itching or erubescence, in this case it is necessary to stop administration of drug, antihistaminic therapy can be required. As drug contains lactose as excipient, it should not be applied at patients with a lactose intolerance, a galactosemia or a sprue of glucose galactose. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms driving and other potentially dangerous mechanisms as drug does not cause decrease in concentration of attention is possible. Overdose Symptoms: nausea, vomiting, diarrhea, strengthening of side effects. At prolonged use in high doses the development of peripheral neuropathy is possible. Treatment: intake of activated carbon, osmotic laxatives. A form of release and packing On 10 capsules in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished. On 3, 5 or 10 blister strip packagings together with the instruction for medical use in the state and Russian languages in a pack from cardboard. To Store storage conditions in the dry, protected from light place, at a temperature not over 250C. To store out of children’s reach! A period of storage 4 years not to use drug after the expiration date specified on packing. Prescription status According to the prescription the Producer Celltrion Pharm. Inc., Korea. 588-2, Sakok-ri, Eewol-myun, Chinchun-gun, Chungcheongbuk-do, Korea. Packer of Abdi Ibrahim Global Pharm LLP Republic of Kazakhstan, Almaty Region, Iliysky area, Industrial zone 282 ph.: +7 (727) 232-44-85 The owner of the registration certificate of Abdi Ibrahim Global Pharm LLP, the Republic of Kazakhstan the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Abdi Ibrahim Global Pharm LLP, the Republic of Kazakhstan, the Almaty Region, the Iliysky area, Industrial zone 282, ph.: +7 (727) 232-44-85
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