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De-Nol 112s 120 mg coated tablets




The instruction for medical use of medicine of De-Nol the Trade name of De-Nol the International unlicensed name Is not present the Dosage form of the Tablet, coated, 120 mg Structure One tablet contains active agent: bismuth a trikaliya dicitrate of 304.6 mg, in terms of bismuth mg Bi2O3 120 oxide excipients: starch corn, K30 povidone, potassium polyacrylate, macrogoal 6000, magnesium stearate structure of a cover: opadr of OY-S-7366 (gipromelloza of 5 MPas · with, a macrogoal 6000) the Description Round biconvex tablets, coated cream-white color, with the inscription gbr 152 which is squeezed out on one party and the graphic drawing in the form of a square with the faltering parties and the rounded-off corners which is squeezed out on another, flavourless or with a light smell of ammonia. Pharmacotherapeutic group Other antiulcerous drugs and drugs for treatment of a gastroesophageal reflux (GORD). Bismuth trikaliya dicitrate. The ATX A02BX05 code the Pharmacological Pharmacokinetics Absorption properties of De-Nol is a surface-active agent, is insignificant small amounts of bismuth, bismuth subcitrate derivatives, are absorbed during treatment (less than 0.2% of a dose). Distribution Bismuth is mainly postponed in kidneys, other bodies also contain bismuth traces. De-Nol’s biotransformation is postponed in a stomach in insoluble complex compounds of bismuth, it is possible in bismuth oxychloride and bismuth citrate. Discharge the Main part of the bismuth accepted inside is removed with a stake. The clearance of urine at a small amount of the absorbed bismuth is about 50 ml/min. However, the most part of the absorbed bismuth is removed during the half-life period which is 5-11 days. De-Nol’s pharmacodynamics – antiulcerous means with bactericidal activity concerning Helicobacter pylori. Possesses also anti-inflammatory and knitting action. In acidic environment of a stomach insoluble oxychloride of bismuth and citrate are besieged, chelate connections with proteinaceous substrate in the form of a protective film on a surface of ulcers and erosion are formed. Increasing synthesis of prostaglandins E, myxopoiesis and secretion of a hydrocarbonate, stimulates activity of cytoprotective mechanisms, increases resistance of a mucous membrane of digestive tract to influence of pepsin, hydrochloric acid, enzymes and salts of bile acids. Leads to accumulation of an epidermal growth factor in a defect zone. Reduces activity of pepsin and a pepsinogen. Indications – a peptic ulcer of a stomach and duodenum – chronic gastritis also gastroduodenit in an aggravation phase, including the Route of administration associated with Helicobacter pylori and doses Inside. By adult De-Nol appoint on 1 tablet 4 times a day in 30 minutes prior to meal and to night or 2 tablets 2 times a day in 30 min. prior to meal. Maximum single dose of 240 mg, maximum daily 480 mg. A pill should be taken in 30 min. prior to food and to wash down with a small amount of water. Duration of a course of treatment is 4-8 weeks. Within the next 8 weeks it is not necessary to use the drugs containing bismuth. For an eradikation of Helicobacter pylori De-Nol’s use in a combination with other antibacterial agents having antikhelikobakterny activity and inhibitors of a proton pomp, a so-called kvadroterapiya is reasonable. Side effects Very often (≥ 1/10) – coloring a calla in dark color owing to formation of bismuth sulfide, however it it is possible to distinguish easily from a melena Infrequently (≥ 1/1000, & lt, 1/100) – nausea, vomiting, a constipation, diarrhea, – allergic reactions: moderate allergic skin reactions Very seldom (& lt, 1/10000), it is unknown – anaphylactic reactions of the Contraindication – hypersensitivity to any component of drug – a heavy renal failure – pregnancy and the period of a lactation Medicinal interactions Within half an hour after De-Nol’s reception is not recommended use in other medicines and also meal and liquids, in particular, of antacids, milk, fruit and fruit juice. It is connected with the fact that they at a concomitant use inside can influence De-Nol’s efficiency.-Nol reduces tetracycline absorption. Special instructions Long reception of compounds of bismuth in high doses is not recommended as there were cases of development of reversible encephalopathy. Risk of developing reversible encephalopathy, is minimum, at the condition of application of drug-Nol in the recommended doses. It is not recommended to use drug in a combination with others vismutsoderzhashchy medicinal sredstvamy. At use-Nola coloring a calla in dark color owing to formation of bismuth sulfide is possible. Darkening of language is sometimes noted. It is not recommended to children up to 18 years. It is not recommended during therapy alcohol intake. The feature of influence on ability to manage transporty means and potentially dangerous mechanisms does not influence. Overdose Symptoms: dyspepsia, rash, inflammation of mucous membranes of a mouth, characteristic darkening in the form of blue lines on gums, a renal failure. Treatment: drug withdrawal, gastric lavage, intake of activated carbon, salt depletive. Control of function of kidneys, concentration of bismuth in blood and urine is shown. Further carry out symptomatic therapy. In a renal failure, followed by the high level of bismuth in blood plasma, it is possible to enter kompleksoobrazovatel – dimercaptoamber and dimercaptopropane – sulfonic acids. In a heavy renal failure the hemodialysis is shown. The form of release and packing On 8 tablets place in blister strip packaging from the aluminum foil laminated. On 7 or 14 packs together with the instruction for medical use in the state and Russian languages place in a pack cardboard. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! 4 years not to apply a period of storage after the expiry date specified on packing. Prescription status Without prescription the Name and the country of the Astellas Pharma manufacturing organization Europe B.V., Silviusveg 62, 2333 VE, Leiden, the Netherlands the Name and the country of the Astellas Pharma organization packer Europe B.V., Silviusveg 62, 2333 VE, Leiden, the Netherlands the Name and the country of the owner of the registration certificate Astellas of Pharm B.V. Europe, Silviusveg 62, 2333 VE, Leiden, Netherlands the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of the products (goods) responsible for post-registration observation of safety of medicine: Representation Astellas of Pharm B.V. Europe in PK 050059, Republic of Kazakhstan, Almaty, Al-Farabi Ave. 15, BC Nurly Tau, body 4B, office No. 20

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