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Ursosan® forte 30s 500 mg film-coated tablets




The instruction for medical use of FORTE URSOSAN® medicine Trade name УРСОСАН® FORTE the International unlicensed name Ursodezoksikholiyevaya acid the Dosage form of the Tablet, film coated, 500 mg Structure One tablet contains active agent – acid of ursodezoksikholevy 500 mg excipients (kernel): starch corn, starch corn prezhelatinizirovanny, sodium carboxymethylstarch (type A), silicon dioxide colloidal, magnesium stearate. excipients (cover): opadray white (03B28796): a gipromelloza 6, the titan dioxide (E 171), a macrogoal 400, the water purified. The description of the Tablet of oblong shape, film coated almost white color from dividing cross risky. Tablet length – 17 mm. Pharmacotherapeutic group Digestive tract and metabolism. Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of biliary tract. Bile acids and their derivatives. Ursodezoksikholevy acid. The ATX A05AA02 code the Pharmacological Pharmacokinetics At properties oral administration of ursodezoksikholevy acid (UDHK) comes fast full absorption in a small intestine due to passive diffusion, and in an ileal gut by means of active transport. Absorption speed, as a rule, is 60 – 80%. UDHK in 96 – 98% is connected with proteins of plasma, is effectively released in a liver and removed with bile in the form of conjugates of glycine and taurine. In intestines a part of conjugates dekonjyugirutsya and there occurs repeated absorption. Conjugates can also degidroksilirovatsya on litokholichesky acid which part is soaked up, sulphated in a liver and is removed in bilious ways. At systematic reception, ursodezoksikholevy acid becomes the main bile acid of blood serum (48% of the general contents of bile acids) that leads to reduction of absorption of toxic bile acids and receipt them in a liver. The therapeutic effect of drug depends on concentration of UDHK in bile. Biological elimination half-life of ursodezoksikholevy acid makes 3 – 5, 5 – 8 days. The pharmacodynamics of Ursodezoksikholevaya acid (UDHK) is bile acid and in a human body is developed by a natural way in small amounts (no more than 5%). Reduces synthesis of cholesterol in a liver and concentration of cholesterol in bile, increases solubility of cholesterol in a bile-excreting system, stimulates education and removal of bile. UDHK reduces bile saturation cholesterol due to oppression of its absorption in intestines, first of all, due to dispersion of cholesterol and formation of a liquid crystal phase, reduces the litogenny index of bile. Dissolution of cholesteric gallstones and prevention of formation of new concrements is result. Having high polar properties, UDHK forms the non-toxic mixed micelles with non-polar (toxic) bile acids that reduces ability of the gastric reflyuktat to damage cellular membranes in cholestatic diseases of a liver, biliary a reflux gastritis and a reflux esophagitis. Besides, UDHK forms the double molecules capable to be included cellular membranes of hepatocytes, holangiotsit and epithelial cells of digestive tract, stabilizes and protects them from the damaging effect of salts of toxic bile acids. Reducing concentration of toxic bile acids and stimulating the cholepoiesis rich with bicarbonates, UDHK effectively promotes permission of an intra hepatic cholestasia. Competitively reduces absorption of lipophilic bile acids in intestines, raises their fractional turn at enterogepatichesky circulation, induces a cholepoiesis, stimulates a passage of bile and removal of toxic bile acids through intestines. Causes strengthening of gastric and pancreatic secretion, enhances activity of a lipase, has hypoglycemic effect. Immunomodulatory action is caused by oppression of an expression of HLA of antigens on membranes of hepatocytes and holangiotsit, normalization of natural killerny lymphocyte activity, formation of interleukin-2, reduction of quantity of eosinophils, suppression of immunocompetent immunoglobulins (Ig), first of all – IgM, regulation of apoptosis of hepatocytes and epithelial cells of digestive tract. Authentically delays progressing of fibrosis at patients with primary biliary cirrhosis, mucoviscidosis, alcoholic and not alcoholic steatogepatit, reduces risk of developing a varicosity of a gullet. Cystous fibrosis – children’s population. The long-term experience of treatment of children’s patients with the cystous fibrosis connected with gepatobiliarny diseases (CFAHD) using UDHK numbering up to 10 years and more is available. There are data that therapy using UDHK can reduce proliferation in bile ducts, stop progressing of histologic changes and even to eliminate gepatobiliarny changes at the early stage CFAHD. Therapy by means of UDHK should be begun after diagnosis of CFAHD for optimization of efficiency of treatment as soon as possible. Indications – Dissolution of cholesteric gallstones in a gall bladder. Gallstones should not be represented on x-rays as shadows, and their diameter should not exceed 15 mm. The functional capacity of a gall bladder has to be kept even in the presence of gallstones. – Symptomatic treatment of the primary biliary cholangitis (PBC) on condition of absence of dekompensirovanny cirrhosis. Children’s population – Gepatobiliarny disturbance in cystous fibrosis (mucoviscidosis) at children from 6 to 18 years. A route of administration and doses УРСОСАН® FORTE a pill needs to be taken inside in time or after a meal, without chewing, washing down with enough water. For providing the recommended dosage the tablet should be halved, breaking after risk. The segments broken incorrectly should not be used. When keeping a segment in an oral cavity the bitter taste is felt. УРСОСАН® FORTE has no age restrictions in use, however children under 6 years are not recommended to use drug in this dosage form. To apply regularly. Calculation of daily quantity of tablets depending on the body weight of the patient and the recommended drug dose on 1 kg of body weight, mg/kg/days For dissolution of cholesteric gallstones the average daily dose of drug makes 10 mg/kg (to 12-15 mg/kg). The body weight, kg More than 100 2 ½ table the Daily dose of drug take Quantity of the pill UrsosanForte of 500 mg Up to 60 1 61 – 80 1 ½ table 81-100 2 once for the night. A course of treatment from 6 to 24 months depending on the size and structure of gallstones. It is recommended to carry out the subsequent holetsistogramma or ultrasonography at an interval of 6 months to disappearance of gallstones and it is necessary to check whether there was no calcification of stones. Treatment should be continued until 2 consecutive holetsistogramma and/or ultrasonography with an interval of 4-12 weeks do not show absence of gallstones. In case stones in a gall bladder do not decrease in the amount of later 12 months of treatment, drug should be cancelled. For prevention of repeated formation of stones the use of drug within several months after dissolution of stones is recommended. For prevention of a repeated cholelithiasis after cholecystectomia appoint 250 mg (½ tablets) 2 times a day within several months. Symptomatic treatment of the primary biliary cholangitis (PBC) the Daily dose depends on body weight and fluctuates from 1 ½ up to 3 ½ tablets (14 ± 2 mg of UDHK on 1 kg of body weight). Within the first three months of treatment it is necessary to distribute reception УРСОСАН® FORTE of a tablet during the day. At improvement of values of hepatic tests the daily dose can be accepted once a day in the evening. The body weight (kg) the Daily dose (body weight mg/kg) to Ursosan Forta of 500 mg, a tablet, coated First 3 months Further morning a lunch evening in the evening (once a day) 47-62 12 – 16 ½ ½ ½ 1 ½ 63-78 13 – 16 ½ ½ 1 2 79-93 13 – 16 ½ 1 1 2 ½ 94-109 14 – 16 1 1 1 3 over 110 1 1 1 ½ 3½ At PBH URSOSAN® FORTE it is possible to take a pill during the unlimited span. In case of deterioration in clinical symptoms in an initiation of treatment (strengthening of an itching) the treatment should be continued, accepting ½ tablets URSOSAN® FORTE daily, further it is necessary to raise gradually a dosage (increasing a daily dose weekly by ½ tablets) until again the recommended dosing mode is not reached. Children’s population (6-18 years) Gepatobiliarny disturbance in cystous fibrosis (mucoviscidosis) Children with cystous fibrosis aged from 6 up to 18 years: 20 mg/kg/day in 2-3 divided doses, with further increase in a dose up to 30 mg/kg/day if necessary. The body weight (kg) the Daily dose (body weight mg/kg) of Ursosan® to Forta of 500 mg, a tablet, coated morning a lunch evening 20 – 29 17 – 25 ½ – ½ 30 – 39 19 – 25 ½ ½ ½ 40 – 49 20 – 25 ½ ½ 1 50 – 59 21 – 25 ½ 1 1 60 – 69 22 – 25 1 1 1 70 – 79 22 – 25 1 1 1½ 80 – 89 22 – 25 1 1½ 1½ 90 – 99 23 – 25 1½ 1½ 1½ 100 – 109 23 – 25 1½ 1½ 2 over 110 1 ½ 2 2 Side effects the Frequency of occurrence of side effects (quantity cases/number of observations) is presented in the form of the following gradation: very often (≥1/10), it is frequent (≥1/100 to & lt, 1/10), infrequently (≥1/1000 to & lt, 1/100), is rare (≥1/10000 to & lt, 1/1000), is very rare (& lt, 1/10,000), it is unknown – frequency cannot be counted according to available data. From digestive tract In clinical trials against the background of treatment the tablets URSOSAN® FORTE often observed diarrhea or a pastelike chair. At treatment of primary biliary cirrhosis the severe pain in an upper part of a stomach was very seldom noted. From a liver and biliary tract Against the background of treatment the tablets URSOSAN® FORTE seldom or never observed calcination of gallstones. At treatment of primary biliary cirrhosis at late stages the cirrhosis decompensation which regressed after the treatment termination was seldom or never noted. From skin and hypodermic fabrics a small tortoiseshell Seldom or never can be observed. Contraindications – hypersensitivity to bile acids or any excipient which is a part of drug – acute inflammatory diseases of a gall bladder or bile ducts – impassability of bile ducts (impassability of the general bile duct or vesical bile duct) – frequent attacks of bilious gripes – X-ray contrast calciphied gallstones – disturbances of sokratitelny ability of a gall bladder – children’s age up to 6 years Children’s population – the portoenterostomiya which did not result in successful result or if the sufficient channel of bile at children with an atresia of bile ducts Medicinal interactions УРСОСАН® FORTE was not restored it is not necessary to appoint along with holestiraminy, holestipoly or the antacids containing aluminum hydroxide and/or smectite (aluminum oxide) as these drugs knit UDHK in intestines and, therefore, suppress its absorption and efficiency. It is necessary to take these drugs not earlier, than in 2 hours prior to, or 2 hours after reception of the tablets URSOSAN® FORTE. Reception УРСОСАН® FORTE of a tablet can influence absorption of cyclosporine from intestines that demands carrying out monitoring of concentration of cyclosporine in blood plasma, and if necessary – corrections of its mode of dosing. In some cases reception УРСОСАН® FORTE of tablets can reduce absorbability of ciprofloxacin. Simultaneous use УРСОСАН® FORTE (500 mg/day) and rosuvastatin (20 mg/day) brought in easy degree to the increased level of presence of rosuvastatin at plasma. Clinical relevance of this interaction including concerning other statines, it is unknown. There are data that UDHK reduces peak concentration in plasma (Cmax) and the area under pharmaceutical akinetic the curve (AUC) antagonist of calcium of a nitrendipin that demands carrying out monitoring of concentration of a nitrendipin. It is not excluded need of increase in a dose of a nitrendipin. Data that interaction of UDHK and dapsone leads to decrease in effect of the last Imeetsya. These observations, can testify to UDHK potential to induction of tsitokhromny P450 3A enzymes. However, induction was not observed during the careful research of interaction of UDHK with budesonidy, known as tsitokhromny P450 3A substrate. Some medicines, such as estrogen, progestogens (oral contraceptives), Neomycinum, Clofibratum, can increase a cholelithiasis, rendering thereby opposite effect of ability of ursodezoksikholevy acid to dissolve cholesteric bilious concrements. Special indications of the Tablet URSOSAN® FORTE should be accepted under observation of the doctor. Within the first three months of treatment the doctor has to check indicators of function of a liver of nuclear heating plant (SGOT), ALT (SGPT) and GGT (y-GT) each 4 weeks and, subsequently, each 3 months. Along with what it will allow to reveal in the mass of the patients undergoing treatment the persons reacting and not reacting to treatment it will also allow to reveal at an early stage potential injury of a liver, in particular, at patients with primary biliary cholangitis in a progressive stage. When using for dissolution of cholesteric gallstones: For treatment progress assessment and also for early detection of any calcification of gallstones, depending on the stone size, it is necessary to visualize a gall bladder (oral cholecystography) – a general view and occlusion in a standing position and lying on spin (check by means of ultrasonography) 6-10 months later after an initiation of treatment. If the gall bladder cannot be visualized on the x-ray or in calciphied gallstones, disturbances of sokratitelny ability of a gall bladder or frequent episodes of biliary gripes it is not necessary to apply УРСОСАН® FORTE. When using for treatment of a late stage of primary biliary cholangitis. The cirrhosis decompensation with partial regression after the treatment termination was seldom or never observed. At patients with PBC in rare instances in an initiation of treatment the deterioration in clinical symptoms can take place, i.e. the itching can be aggravated. In that case it is necessary to lower a dosage to 250 mg a day and gradually to increase it to the recommended dose specified in the section Route of Administration and Doses. In case of diarrhea, the dose should be reduced, and in cases of not stopping diarrhea the treatment should be stopped. Additional information for special groups of patients Long-term therapy by high doses УРСОСАН® FORTE (28 – 30 mg/kg/day) at patients with primary sklerotiziruyushchy cholangitis (use of off-label) was connected with higher frequency of manifestation of undesirable heavy medicinal reactions. Pregnancy and the period of a lactation Data on influence on birth rate after treatment by the tablets URSOSAN® FORTE are absent. Data on use of ursodezoksikholevy acid for pregnant patients are absent, or are limited. There are data on existence of teratogenic action during an early phase of pregnancy. Use of UDHK during pregnancy is possible only if the expected advantage for mother exceeds potential risk of development of side effects at a fruit or the newborn (adequate and strictly controlled researches of use of ursodezoksikholevy acid for pregnant women were not conducted). Women of childbearing age have to take the drug, only against the background of use of reliable means of contraception. It is recommended to use non-hormonal methods of contraception, or with the low content of estrogen. At the patients accepting УРСОСАН® FORTE in tablets of 500 mg for dissolution of gallstones it is necessary to use non-hormonal methods of contraception as hormonal contraceptives can promote formation of stones. The possibility of pregnancy, has to be excluded prior to treatment. According to several confirmed cases, concentration of ursodezoksikholevy acid in milk of the feeding women is small, emergence of undesirable reactions at children against the background of feeding by a breast is improbable. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms does not influence. Overdose Symptoms: diarrhea. In this case it is necessary to reduce a dose and if the diarrhea (diarrhea) does not disappear, to stop treatment. Other symptoms of overdose Malov
royatna as absorption of ursodezoksikholevy acid decreases with increase in a dose and, therefore, is more allocated with a stake. Treatment: symptomatic with compensation of loss of volume of liquid and electrolytic balance. The form of release and packing On 10 tablets place in blister strip packagings from a film of polyvinylchloride / polyvinylidene chloride and aluminum foil. On 1, 2, 3, 5, 6, 9 or 10 planimetric packs together with the instruction for medical use in the state and Russian languages place in a cardboard pack. Storage conditions In original packing at a temperature not higher than 25 wasps. To store out of children’s reach! 4 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer / Holder of the registration certificate of the Prague PRO.MED.TsS and. the lake of Telchsk 377/1, Mikhle 140 00 Prague 4 Czech Republic 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 and responsible for post-registration observation of safety of medicine: PROM. MEDIK.KAZ LLP city of Almaty, District of Nauryzbaysky, Mikrorayon Rakhat, Asanbay Askarov Street, 21/1, settlement 1 and, phone number 2608936, email:
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