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Zulbeks 14s 20 mg coated tablets




The instruction for medical use of ZULBEKS® medicine Trade name ЗУЛЬБЕКС® the International unlicensed name Rabeprazol Lekarstvennaya the Tablet form, covered with a kishechnorastvorimy cover, 10 mg and 20 mg Structure One tablet contains active agent – rabeprazol sodium of 10.0 mg (it is equivalent to a rabeprazol of 9.420 mg) or 20.0 mg (it is equivalent to a rabeprazol of 18.850 mg), excipients: Mannitolum, magnesium oxide easy, hydroxypropyl cellulose, hydroxypropyl cellulose with low extent of substitution, magnesium stearate, structure of a cover: ethyl cellulose, magnesium oxide easy, gipromelloza phthalate, diacetylized monoglycerides, talc, titan dioxide (E 171), ferrous oxide red (E 172), ferrous oxide yellow (E 172). The description of the Tablet of round shape, with a biconvex surface, covered plenoch-ache a cover of salmoncolored color, with a facet (for a dosage of 10 mg). Tablets of round shape, with a biconvex surface, film coated light – brownish-yellow color (for a dosage of 20 mg). Pharmacotherapeutic group Antiulcerous drugs and drugs for treatment of a gastroesophageal reflux. Inhibitors of the protonew pump. The code of automatic telephone exchange A02BC04 the Pharmacological Pharmacokinetics ЗУЛЬБЕКС® properties represents the tablets of a rabeprazol of sodium covered kishechnorastvorimy (steady in a stomach) a cover. Such form is caused by instability of a rabeprazol in acidic environment. Therefore absorption of a rabeprazol begins in intestines. Neither food, nor time of administration of drug influence absorption of a rabeprazol of sodium. There are no clinically significant interactions with food. Fast absorption, the maximum plasma concentration of a rabeprazol are reached approximately in 3.5 hours after reception of a dose of 20 mg. The maximum plasma concentration of a rabeprazol (Cmax) and the area under a curve concentration time (AUC) have linear character in the range of doses from 10 mg to 40 mg. The absolute bioavailability of orally accepted dose of 20 mg (in comparison with intravenous administration) is about 52%, more due to presistemny metabolism. Time of semi-removal from plasma is about one hour (from 0.7 to 1.5 hours), and the general clearance – 283 ± 98 ml/min. rabeprazol contacts proteins of plasma approximately for 97%. Metabolism and removal Rabeprazol of sodium, as well as other representatives of a class of inhibitors of a proton pomp, is metabolized in a liver with participation of P450 (CYP450) cytochrome. Rabeprazol of sodium is metabolized by isoenzymes of CYP450 (CYP2C19 and CYP3A4). Rabeprazol in the expected plasma concentration does not suppress and does not stimulate CYP3A4. The main metabolites found in plasma are monothioester (M1) and carboxyl acid (M6), and sulfonic (M2), desmetil-monothioester (M4) and a conjugate decide on merkapturinovy acid (M5) in smaller quantities. Only a desmetilovy metabolite (M3obladayet small anti-secretory activity, but it is not defined in plasma. After single oral administration of 20 mg, not changed drug in urine is not found. About 90% of the accepted dose are removed with urine in the form of two metabolites: a conjugate with merkapturinovy acid (M5) and carboxyl acid (M6), and in the form of two unknown metabolites. The rest of the administered drug is removed by excrements. Paule Taking into account adjustments for growth and body weight did not reveal sexual differences in pharmacokinetic parameters of a rabeprazol in a dose of 20 mg. Patients with a stable final stage of the renal failure demanding a hemodialysis (clearance of  creatinine of 5 ml/min. / 1.73 sq.m) distribution of a rabeprazol had very similar to distribution renal failure at healthy volunteers. AUC and Cmax at such patients was about 35% lower than the corresponding indicators at healthy volunteers. The average time of semi-removal of a rabeprazol was 0.82 hours at healthy volunteers, 0.95 hours at patients against the background of a hemodialysis and 3.6 hours – after a hemodialysis. The clearance of drug at patients with diseases of the kidneys demanding the supporting hemodialysis was approximately twice more, than at healthy volunteers. An abnormal liver function After single introduction of 20 mg of a rabeprazol to patients with chronic lungs or moderate diseases of a liver AUC increased twice, and by 2-3 times time of semi-removal of a rabeprazol in comparison with healthy volunteers increased. However after daily reception of a dose in 20 mg within 7 days AUC increased only by 1.5 times, and Cmax – only by 1.2 times. Time of semi-removal of a rabeprazol at patients with diseases of a liver was 12.3 hours in comparison with 2.1 hours at healthy volunteers at clinically comparable pharmakodinamichesky answer (control of pH of a stomach). Elderly At elderly the removal of a rabeprazol is a little reduced. After reception within 7 days of a rabeprazol of sodium in a daily dose of 20 mg AUC increased approximately twice, and Cmax increased by 60%, t½ was increased by 30% in comparison with healthy young volunteers. However signs of accumulation of a rabeprazol are not revealed. Polymorphism of CYP2C19 After reception within 7 days of an oral dose of a rabeprazol of 20 mg at people with the slowed-down CYP2C19 – metabolism of AUC and t½ were approximately in 1.9 and 1.6 times above the corresponding parameters at persons with active metabolism while Cmax increased only by 40%. Pharmacodynamics ЗУЛЬБЕКС® belongs to a class of anti-secretory drugs, the replaced benzimidazoles which suppress gastric secretion by N+/K+-ATF-azy enzyme inhibition (proton pomp). The effect of drug depends on a dose and leads to suppression of basal and stimulated secretion of hydrochloric acid in a stomach, irrespective of the stimulating factors. Being the weak basis, ЗУЛЬБЕКС® it is quickly soaked up in all dosages and collects in acidic environment of covering cells of a stomach. ЗУЛЬБЕКС® it is converted into a sulfenamidny form by a protonization and then interacts with available molecules of cysteine of a proton pomp. After oral administration ЗУЛЬБЕКС® in a dosage of 20 mg the anti-secretory effect beginswithin 1 hour, reaching a maximum in 2-4 hours. Suppression by basal and stimulated food of secretion of hydrochloric acid in a stomach in 23 hours after reception of the first dose of a rabeprazol of sodium makes 69% and 82%, respectively, and lasts till 48 o’clock. The inhibiting effect of a rabeprazol of sodium concerning secretion of hydrochloric acid at reception of repeated doses increases a little, reaching an equilibrium state in 3 days. After drug withdrawal the secretory activity of a stomach is restored in 2-3 days. Influence on serumal gastrin At long reception (up to 43 months) ЗУЛЬБЕКС® in a dose of 10 mg or 20 mg once a day gastrin levels in serum increase in the first 2 – 8 weeks of reception, reflecting overwhelming action on acid secretion, and then remain stable at therapy continuation. Indicators of concentration of gastrin returned to reference values usually within 1-2 weeks after therapy cancellation. Biopsy samples from the antral part and a greater cul-de-sac accepting rabeprazol on an extent up to 8 weeks and 36 months of therapy did not reveal changes in the ECL cellular and histologic building, gastritis degree, frequency of development of atrophic gastritis, an intestinal metaplasia or prevalence of infection of H. pylori. Other effects System effects of a rabeprazol of sodium concerning central nervous system, cardiovascular and respiratory systems are not revealed today. Oral administration ЗУЛЬБЕКС® in a dose of 20 mg within 2 weeks, does not influence function of a thyroid gland, carbohydrate metabolism or the circulating levels of parathormone, cortisol, estrogen, testosterone, prolactin, cholecystokinin, secretin, a glucagon, follicle-stimulating hormone (FSG), lyuteniziruyushchy hormone (LH), renin, Aldosteronum or somatotropic hormone. ЗУЛЬБЕКС® does not enter clinically significant interactions with amoxicillin and has no negative impact on plasma concentration of amoxicillin or a klaritromitsin at simultaneous use of these drugs for an eradikation of H. pylori from upper parts of digestive tract. Indications – a peptic ulcer of a stomach or duodenum in an aggravation stage – a gastroesophageal reflux disease (GERD): an erosive reflux an esophagitis, symptomatic treatment of GERD (i.e. NERB – not erosive reflux disease) – Zollingera-Elison’s syndrome or other states which are characterized by pathological hypersecretion – Helicobacter pylori eradikation at patients with a peptic ulcer of a stomach or chronic gastritis in a combination with the antibacterial drugs Route of administration and doses of the Tablet ZULBEKS® needs to be poglatyvat entirely, they cannot be chewed or broken. Adult, elderly the Peptic ulcer of a stomach or a 12-perstny gut in an aggravation stage: the recommended dose ЗУЛЬБЕКС® makes 20 mg once a day, in the morning. At most of patients the active ulcer of a 12-perstny gut heals within four weeks. However 4 more weeks for full healing of an ulcer can be required by some patients. Active benign stomach ulcer at most of patients heals within six weeks. However at a small amount of patients for full healing six more weeks can be required. Erosive and ulcer or gastroesophageal reflux disease (GERD): the recommended dose ЗУЛЬБЕКС® for intake at this state makes 20 mg once a day, for from four to eight weeks. Long therapy of a gastroesophageal reflux disease (maintenance therapy of GERD): At long therapy maintenance dose ЗУЛЬБЕКС® in a dose of 20 mg or 10 mg once a day, depending on the response of the patient to treatment can be applied. Symptomatic therapy of a gastroesophageal reflux disease from moderated to heavy degree (symptomatic GERD): Once a day patients have 10 mg without esophagitis. If in 4 weeks it is not possible to achieve control of symptoms, it is necessary to perform additional examination of the patient. After improvement of a state the further control of symptoms can be exercised reception of 10 mg once a day on demand. Zollingera-Ellison’s syndrome or other states which are characterized by pathological hypersecretion: the recommended starting dose for adults makes 60 mg once a day. It is possible to increase a dose to 120 mg / in day depending on individual needs of the patient. It is possible to appoint a daily dose to 100 mg with the single mode of reception. The dose of 120 mg can demand multiple reception, on 60 mg two times a day. Therapy is carried out until there are corresponding clinical indications. Eradikation H. pylori: The patients infected with H. pylori have to undergo eradikatsionny therapy. The following combinations of drugs by a course in 7 days are recommended. ЗУЛЬБЕКС® in a dosage of 20 mg two times a day + klaritromitsin 500 mg two times a day and amoxicillin of 1 g two times a day. If schemes of an eradikation demand administration of drugs once a day, the pill ZULBEKS® needs to be taken in the morning, before a breakfast and though neither time of day, nor food affect activity of a rabeprazol of sodium, such mode of administration of drug promotes the best commitment to treatment. The abnormal liver function or kidneys with diseases of a liver or kidneys of dose adjustment is not required From patients. Side effects Often (³1/100 to & lt, 1/10): insomnia a headache, dizziness cough, pharyngitis, rhinitis diarrhea, vomiting, nausea, an abdominal pain, constipations, a meteorism nonspecific pain, a dorsodynia an asthenia, a grippopodobny disease Infrequently (³1/1.000 to & lt, 1/100): nervousness drowsiness bronchitis, sinusitis dyspepsia, dryness in a mouth, an eructation rash, an erythema myalgia, spasms in legs, an arthralgia of an infection of an uric path a stethalgia, a fever, temperature increase increase in activity of enzymes of a liver Is rare: (³1/10000 to & lt, 1/1000): – a neutropenia, a leukopenia, thrombocytopenia, a leukocytosis – hypersensitivity reactions (face edema, hypotension, short wind), the erythema, bullous reactions usually disappearing after drug withdrawal anorexia a visual disturbance depression gastritis, stomatitis, change of taste hepatitis, jaundice, hepatic encephalopathy at patients with cirrhosis of naggers, perspiration interstitial nephrite increase in weight is Very rare (& lt, 1/10000): – the multiformny erythema, the toksiko-epidermal necrosis (TEN), Stephen-Johnson Chastot’s syndrome is not known (it cannot be established on the available data): the hyponatremia confusion of consciousness peripheral hypostases the Contraindication gynecomastia – hypersensitivity to a rabeprazol or excipients of drug – pregnancy and the period of a lactation – children’s and teenage age up to 18 years (safety and efficiency are not established) Medicinal interactions Rabeprazol of sodium causes permanent and long suppression of secretion of acid in a stomach. There can be an interaction with drugs which absorption depends on the pH level. Simultaneous use of a rabeprazol of sodium with ketokonazoly or itrakonazoly can lead to significant decrease in their antifungal concentration in plasma. Therefore observation with possible need of change of doses at co-administration of Zulbeksa® and these drugs can be required by certain patients. In clinical trials the antacids were applied along with rabeprazoly. And in a special research on medicinal interaction interactions between rabeprazoly and liquid antacids were not revealed. The concomitant use healthy volunteers of an atazanavir of 300 mg / ritonavira 10 mg and omeprazolum (40 mg once a day) or an atazanavira of 400 mg and a lanzoprazol (60 mg once a day) was followed by significant reduction of action of an atazanavir. Absorption of an atazanavir depends on the pH level. Though special researches were not conducted, but similar results are possible also for other inhibitors of a proton pomp. Therefore inhibitors of a proton pomp, including rabeprazol, should not be applied along with atazanoviry. The special instructions Reduction of Expressiveness of Symptoms against the background of therapy rabeprazoly does not exclude existence of malignant new growths in a stomach or a gullet therefore before therapy of Zulbeksom® it is necessary to perform examination for the purpose of an exception of oncological processes. The patients receiving long therapy by drug (especially more than one year) have to undergo regular inspection. It is impossible to exclude risk of cross-reactions with other inhibitors of a proton pomp or with the replaced petrolimidazoles. Patients need to be warned that the tablets Zulbeks® need to be poglatyvat entirely, they cannot be chewed or broken. Зульбекс® children since experience of use of drug in this group of patients is absent are not recommended to appoint. There are messages from post-marketing use of a rabeprazol about development of dyscrasias of blood in (cases of thrombocytopenia and a neutropenia). In most cases, when it was not succeeded to find out the alternative reasons of these states, they did not give complications and passed after cancellation of a rabeprazol. In clinical trials and during post-marketing use the change of activity of enzymes of a liver is noted. In most cases, when it was not succeeded to find out the alternative reasons of these states, they did not give complications and passed after cancellation of a rabeprazol. In a research at patients with slight or moderate abnormal liver functions the vital issues connected with safety of use of drug in comparison with control group of the healthy patients corresponding on gender and age were not noted. Due to the lack of clinical data on use of a rabeprazol for patients with heavy abnormal liver functions, such patients are recommended to be careful at the first purpose of Zulbeksa®. The concomitant use of an atazanavir and Zulbeksa® is not recommended to Feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms was not reported About influence, but considering possible side effects – a headache, dizziness, it is necessary to be careful when working, demanding concentration of attention. Overdose Symptoms: are unknown. Most established accepted amount of drug did not exceed 60 mg two times a day or 160 mg once a day. Effects were minimum significant, corresponded izvest
to ohm to a profile of undesirable reactions which took place independently without any additional medical intervention. Treatment: if necessary – symptomatic treatment and the general supporting actions. There is no specific antidote. Rabeprazol of sodium actively contacts proteins therefore it cannot be removed by dialysis. The form of release and packing On 14 or 15 tablets place in blister strip packaging from a film three-layer (the focused polyamide/aluminium/polyvinylchloride) and aluminum foil. On 1 or 2 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions in original packing at a temperature not over 30 ºС, in the place protected from light. To store out of children’s reach! 2 years not to use a period of storage after a period of storage. Prescription status According to the prescription the Producer of KRK, of. The place is new, Slovenia Shmaryeshka 6, 8501 the place, Slovenia the Name and the country of the owner of the registration certificate of KRK, of Is new, the Place Is new, Slovenia

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