Ulsepan 14s 40 mg coated tablets

The instruction for medical use of ULSEPAN medicine the Trade name Ulsepan Mezhdunarodnoye the unlicensed name Pantoprazol Lekarstvennaya the Tablet form, covered with a kishechnorastvorimy cover, 40 mg Structure One tablet contains active agent – pantoprazol 40 mg (in the form of a pantoprazol of sodium of sexivihydrat of 45.10 mg), excipients: Mannitolum, calcium carbonate, krospovidon, kopovidon (kollidon VA 64), sucrose stearate, calcium stearate, structure of a film cover: Опадри® White (YS-1-7027) *, structure of a kishechnorastvorimy cover: Acryl-Eze yellow (93O92157) ** * Opadri's list of white (YS-1-7027): gipromelloza, titan dioxide (E171), triacetin, ** structure of Acryl-Eze yellow 93O92157: copolymer of methacrylic acid Type C, talc, titan dioxide (E171), triethyl citrate, silicon dioxide colloidal anhydrous, Natrii hydrocarbonas, gland (III) oxide yellow (E172), sodium lauryl sulfate. The description of the Tablet of an oval form, with a biconvex surface, covered with a kishechnorastvorimy cover of yellow color. Pharmacotherapeutic group Digestive tract and metabolism. Drugs for treatment of the diseases connected with disturbance of acidity. Antiulcerous drugs and drugs for treatment of a gastroesophageal reflux disease (gastro-oesophageal reflux disease – GORD). Protonew pump Pantoprazol inhibitors. ATX A02BC02 code Pharmacological Pharmacokinetics Absorption properties. After intake pantoprazol it is quickly and completely absorbed in a GIT. Peak plasma concentration at the level of 2.5 mkg/ml are noted in 2-3 hours. Pantoprazol in insignificant degree is exposed to effect of primary passing through a liver and its bioavailability is 70 - 80%. Absorption of a pantoprazol does not depend on meal or antacids. Distribution. The volume of distribution is about 11-23.6 l. Pantoprazol for 98% communicates proteins of plasma (albumine). Metabolism. Pantoprazol is metabolized in a liver by the system of P450 cytochrome. The main metabolic way - demethylation reactions. Removal. About 71% of the accepted dose are removed by kidneys and 18% by biliary excretion. Elimination half-life of a pantoprazol makes about 1 hour. Slightly gets through a blood-brain barrier. Ulsepan's pharmacodynamics belongs to group of antiulcerous means which action is caused by anti-secretory effect of a pantoprazol at the expense of inhibition of a proton pomp - H+-K +-ATF-azy. Being the weak basis, pantoprazol collects in tubules of covering cells, interacts with a hydrogen ion, it is transformed to sulfenamidny derivatives which form covalent bonds with SH group of a proton pomp on a surface of an apical membrane. Thereof the last phase of secretion of hydrochloric acid is blocked that leads to decrease in level of basal and stimulated secretion of acid in a stomach. Ulsepan has antibacterial activity concerning Helicobacter pylori and promotes manifestation of antikhelikobakterny effect of other drugs. Indications - a peptic ulcer of a stomach or duodenum - a reflux esophagitis - morbid hyper secretory conditions, including Zollingera-Ellison's syndrome - Helicobacter pylori eradikation (in a combination with antibacterial therapy) accept the Route of administration and Ulsepan's doses inside to food, without chewing, washing down with a glass of water. Peptic ulcer of a stomach and duodenum: appoint 40 mg/days, in certain cases, including at inefficiency of therapy, it is possible to appoint 80 mg/days. The course of treatment at exacerbation of a peptic ulcer of a duodenum makes 2-4 weeks, and a peptic ulcer of a stomach: 4-8 weeks. Gastroesophageal reflux disease, erosive and ulcer reflux esophagitis: appoint 40 mg/days. The course of therapy makes 4 weeks. If healing does not occur, then the additional 4-week course of treatment is recommended. Morbid hyper secretory conditions, including Zollingera-Ellison's syndrome: the dose is selected individually depending on the clinical indication. The recommended initial dose makes 40 mg 2 times/days. The dose can be raised to 240 mg/days, and to prolong a course of treatment up to 2 years. Eradikation Helicobacter pylori: accept 40 mg 2 times/days in a combination with antimicrobial means within 7 days and 7 more days can be continued. At patients with liver diseases the daily dose of drug should not exceed 20 mg. Side effects Determination of frequency of by-effects is carried out according to the following criteria: very often (≥ 1/10), it is frequent (≥ from 1/100 to & lt, 1/10), infrequently (≥ from 1/1000 to & lt, 1/100), is rare (≥ 1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000). Infrequently - a headache, dizziness - dryness in a mouth, nausea, vomiting, swelling, pain in an upper part of a stomach and discomfort, diarrhea, a constipation - skin rash, an itching, a dieback - an asthenia, fatigue and an indisposition - increase in activity of liver enzymes (transaminases, γ – GT) - the sleep disorder Is rare - an agranulocytosis - visual disturbances, vagueness of sight (a veil before eyes) - urticaria, a Quincke's disease - an arthralgia, myalgia - a lipidemia and increase in amount of triglycerides, cholesterol, change of body weight, disturbance of taste - fervescence, peripheral hypostases - hypersensitivity to active and to auxiliary components of drug (including anaphylactic reactions and an acute anaphylaxis) - increase in content of bilirubin - a depression (and all accompanying deteriorations) - a gynecomastia Very seldom - thrombocytopenia, a leukopenia, a pancytopenia - a disorientation (and all accompanying deteriorations) It is unknown - interstitial nephrite - Stephens-Johnson's syndrome, a Lyell's disease, an exudative mnogoformny erythema, photosensitivity - a hyponatremia, a hypomagnesiemia - hepatocellular damages, jaundice, hepatocellular insufficiency - hallucinations, confusion of consciousness (especially at the patients predisposed to these states and also deterioration in these symptoms if they existed prior to treatment) Contraindications - hypersensitivity to a pantoprazol and auxiliary components of drug - hepatitis or cirrhosis which are followed by a heavy liver failure - combined use with atazanaviry - the profound renal failures - hereditary intolerance of a galactose, deficiency of Lapp-lactase, glucose galactose malabsorption Medicinal interactions At simultaneous use of drugs which bioavailability depends from rn stomach environments (for example, ketokonazol), Ulsepan can change their absorption. Because pantoprazol it is metabolized in a liver by the fermental system of P450 cytochrome, it is impossible to exclude a possibility of medicinal interaction with the drugs which are metabolized the same fermental system. Special instructions It is necessary to be careful at use of the drug Ulsepan for patients with diabetes as stearate is a part of drug sucrose, dose adjustment of hypoglycemic means can be required. It is not appointed to the patients having rare hereditary diseases, such as intolerance of a galactose, deficiency of Lapp-lactase, glucose galactose malabsorption. Prior to therapy it is necessary to exclude a possibility of a malignant new growth of a stomach and gullet as Ulsepan's use can reduce expressiveness of symptoms and delay establishment of the correct diagnosis. The diagnosis a reflux esophagitis demands obligatory endoscopic confirmation. Patients should not accept at the same time other drugs-inhibitors of the proton pump or antagonists of H2 receptors. At use for patients with abnormal liver functions it is regularly necessary to control activity of liver enzymes in blood plasma and, at their increase to cancel Ulsepan. Lowering of acidity of a stomach increases quantity of gastric bacteria which usually are present at digestive tract. Treatment by the drugs lowering acidity leads to increase in risk of developing the gastrointestinal infections caused by such microorganisms as Salmonella, Campylobacter or C.difficie. Use in pediatrics Because of insufficient amount of data on safety and efficiency is not recommended use of drug at treatment of children and teenagers up to 18 years. Pregnancy and the period of a lactation Use of drug during pregnancy is possible if the expected advantage for mother exceeds potential risk for a fruit or the child. The lactation during drug treatment should be stopped. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Considering side effects of drug, it is necessary to be careful at control of vehicles and work with potentially dangerous mechanisms. Overdose Symptoms: overdoses are unknown. Treatment: in case of overdose with clinical signs of intoxication the symptomatic and supporting treatment is carried out. Pantoprazol is not brought at a hemodialysis. The form of release and packing On 7 tablets pack into blister strip packaging. On 2 or 4 blister strip packagings with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions in the dry, protected from light place at a temperature not above 25 °C. To store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer Uorld Meditsin Ilach Sang. ve Tidzh. A.Sh., TURKEY (Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami to the Dzhad Yole. No. 50 K. 1B Zemin 4-5-6, Istanbul) World Medicine İlaç San. ve Tic. A.Ş., TURKEY (Bağcılar İlçesi, Güneşli, Evren Mahallesi, Cami Yolu Cad. No: 50 K. 1B of Zemin 4-5-6, İstanbul). The owner of the registration certificate of UORLD MEDITSIN LIMITED, LONDON/GREAT BRITAIN Ground Floor, Gadd House, Arcadia Avenue, Finchley, London N3 2JU, United Kingdom the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers: Republic of Kazakhstan, Almaty, Turksibsky district, Suyunbaya Ave., 222 Ph. / fax: 8 (7272) 529090, www.worldmedicine.kz the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine: TROKA-S PHARMA LLP, Almaty, Suyunbaya Ave., 222 Cellular ph. +7 701 786 33 98, (24-hour access). e-mail:
To Develop pvpharma@worldmedicine.kz