Movalis 15 mg (20 tablets)

The instruction for medical use of MOVALIS® medicine Trade name МОВАЛИС® the International unlicensed name Meloksikam Lekarstvennaya a form of the Tablet of 7.5 mg and 15 mg One tablet contains Structure: active agent: to meloksika of 7.5 or 15 mg, excipients: sodium citrate dihydrate, lactoses monohydrate, cellulose microcrystalline, K25 povidone, silicon dioxide colloidal anhydrous, krospovidon, magnesium stearate. The description Round tablets from pale yellow till citreous color. One party convex with slanted edge and the engraved logo of the BI company, on other party on diameter is put risk on both sides of which it is engraved: 59D for tablets of 7.5 mg and 77C for tablets of 15 mg. Pharmacotherapeutic group Non-steroidal anti-inflammatory drugs. Oksikama. The ATX M01AC06 code Pharmacological action Pharmacokinetics Meloksikam is well soaked up from digestive tract, the absolute bioavailability at intake is nearly 90%. At single dose of drug in the form of tablets the average maximum concentration in blood plasma is reached within 5-6 hour. At repeated use the steady condition of pharmacokinetics is reached from 3 to 5 days in time. The concomitant use of food or inorganic antiacid agents does not influence drug absorption. Meloksikam intensively contacts proteins of plasma, especially albumine (99%). Gets into synovial fluid where concentration makes him about 50% of concentration in plasma. Distribution volume low also averages 11 l, at the same time coefficient of variation is from 7 to 20%. Distribution volume after multiple dose on average is 16 l, at the same time coefficient of variation lies in the range from 11 up to 32%. Biotransformation. Meloksikam is exposed to considerable biotransformation in a liver. In urine four various metabolites of a meloksikam which had no pharmakodinamichesky activity are revealed. The main metabolite (5 '-karboksimeloksikam (60% of dose size)) is formed by oxidation of an intermediate metabolite (5 '-hydroksimetilmeloksikama (9% of a dose). The activity of peroxidase takes part in formation of two other metabolites making 16% and 4% of a drug dose probably. Removal. Meloksikam is mainly brought equally with a stake and through kidneys, in not changed look – less than 5% of a daily dose with a stake, in urine in not changed look only traces of an initial form of drug are found. Elimination half-life varies from 13 to 25 hours after reception. The general plasma clearance is 7-12 ml/min. after reception of a single dose. Pharmacokinetics at special groups of patients the Renal and liver failure the Liver failure and also a renal failure from easy to moderate severity of significant effect on pharmacokinetics of a meloksikam do not render. At patients with a moderate renal failure the general clearance is higher. At patients with a terminal renal failure the increase in volume of distribution can lead to increase in concentration of a free meloksikam due to decrease in linking of drug with proteins. Elderly people Elderly men have the pharmacokinetic parameters similar to parameters of young men. Elderly women have higher AUC values and longer elimination half-life in comparison with young patients of both sexes. The average plasma clearance in an equilibrium state at elderly people is lower in comparison with persons of young age. MOVALIS pharmacodynamics – non-steroidal anti-inflammatory drug (NPVP), belongs to derivatives of enolovy acid and has the anti-inflammatory, anesthetizing and febrifugal effect. The significant anti-inflammatory action of a meloksikam is established at all stages of inflammatory process. The mechanism of action of a meloksikam consists in its ability to inhibit synthesis of prostaglandins (inflammation mediators). Thanks to mainly selection inhibition of cyclooxygenase-2 (TsOG-2) in comparison with cyclooxygenase-1 (TsOG-1), to meloksika inhibits synthesis of prostaglandins in the place of inflammation in bólshey degrees, than in a mucous membrane of a stomach or kidneys. The selectivity of a meloksikam in relation to TsOG-2 is confirmed by in Vivo and ex vivo. Meloksikam dozozavisimo inhibits TsOG-2 more actively, having the greater inhibiting influence on the products of E2 prostaglandin stimulated by lipopolysaccharide (the reaction controlled by TsOG-2) than on products of the thromboxane participating in fibrillation process (the reaction controlled by TsOG-1). Thereby it is proved what to meloksika in the recommended doses does not influence aggregation of thrombocytes and a bleeding time. Indications Symptomatic therapy: - a pain syndrome in an osteoarthritis (arthrosis, degenerative diseases of joints) - a pseudorheumatism - an ankylosing spondylarthritis the Route of administration and doses It is necessary to reduce duration of treatment and the minimum daily dose whenever possible in order to avoid development of the undesirable phenomena connected with duration of treatment and increase in a dose. The daily dose should be accepted once. The recommended daily dose of the drug MOVALIS used in the form of different dosage forms should not exceed 15 mg. Pain syndrome of 7.5 mg/days. If necessary a dose it is possible in an osteoarthritis: to increase up to 15 mg/days. Rheumatoid 15 mg/days. Depending on therapeutic arthritis: reaction can reduce a dose to 7.5 mg/days. Ankylosing 15 mg/days. Depending on therapeutic a spondylarthritis: reaction can reduce a dose to 7.5 mg/days. Special groups of patients At patients with the increased risk of development of undesirable reactions, for example, gastrointestinal diseases or risk factors of developing cardiovascular diseases, treatment it is necessary to begin 7.5 mg/days in a dose. At insignificant or moderate depression of function of kidneys (the clearance of creatinine is reduced no more than by 25 ml/min. from norm) the dose decline is not required. To patients with heavy renal failures, not being on a hemodialysis, MOVALIS is contraindicated (see the section Contraindications). At the patients with an end-stage of a renal failure who are on a hemodialysis, the dose of drug MOVALIS should not exceed 7.5 mg. Children's age from 12 to 18 years: the maximum daily dose makes 0.25 mg/kg and should not exceed 15 mg. A pill should be taken at meal time, washing down with water or other liquid. Side effects the Undesirable phenomena are given below with use of the following classification: very often ≥ 1/10, it is frequent ≥1/100 to & lt, 1/10, is not frequent ≥1/1000 to & lt, 1/100, is rare ≥1/10000 to & lt, 1/1000, also lt, 10000 is very rare, it is not known – cannot be defined from available data. Disturbances from blood and lymphatic systems Infrequently: - anemia Seldom: - change of the general blood test (including change of a leukocytic formula), a leukopenia, thrombocytopenia - a cytopenia (at simultaneous use of potentially myelotoxic medicines, in particular a methotrexate) Disturbances from the immune system Infrequently: - other reactions of immediate hypersensitivity it is rare: - anaphylactic reactions, anaphylactoid reactions of Disturbance of mentality Seldom: - change of mood Is unknown: - confusion of consciousness, disturbance of orientation of Disturbance from nervous system It is frequent: - a headache It is unknown: - dizziness - drowsiness of Disturbance from organs of sight Seldom: - conjunctivitis, disorder of vision, including. illegibility of sight of Narusheniya from organs of hearing and balance Infrequently: - dizziness Is rare: - sonitus of Narusheniya from a cardiovascular system Seldom: - heartbeat Infrequently: - increase in arterial blood pressure, feeling of rush of blood to the person Narusheniya from the respiratory system, bodies of a thorax and mediastinum is rare: - acute development of bronchial asthma (at patients with an allergy to acetylsalicylic acid or other NPVP) Narusheniya from a GIT Often: - abdominal pain, dyspepsia, diarrhea, nausea, vomiting Infrequently: - the concealed or obvious gastrointestinal hemorrhage, gastritis - a constipation, a meteorism, an eructation, stomatitis Seldom: - gastroduodenal ulcer, colitis, esophagitis Very seldom: - perforation of digestive tract (the lethal outcome is possible) Narusheniya from a gepatobiliarny system Infrequently: - passing changes of indicators of function of a liver (for example, increase in activity of transaminases or bilirubin) It is very rare: - the hepatitis Disturbance from integuments Infrequently: - itching, angioedema Seldom: - toxic epidermal necrolysis, Stephens-Johnson's syndrome, small tortoiseshell Very seldom: - bullous dermatitis, a multiformny erythema, rash It is unknown: - photosensitization Renal failure and disorders of urination Infrequently: - changes of indicators of function of kidneys (increase in level of creatinine and/or urea in blood serum) It is very rare: - an acute renal failure - difficulty at urination, a sharp ischuria of Narusheniya from a reproductive system: It is unknown: - female infertility, an ovulation delay the General disorders and disturbances in the injection site: - Contraindication hypostasis - hypersensitivity to a meloksikam or any other component of drug - with symptoms of asthma, nasal polyps, a Quincke's disease or small tortoiseshell when sharing acetylsalicylic acid or other NPVP in the anamnesis - perioperatsionny pain in the field of installation of a transplant for shunting of a coronary artery (TSKA) - erosive and ulcer changes mucous a stomach and duodenum/perforation in an aggravation phase - recently postponed acute inflammatory bowel diseases (nonspecific ulcer colitis in an aggravation phase, Crohn's disease) - a heavy liver failure - a heavy renal failure (if the hemodialysis is not carried out) - ulcer gastrointestinal bleeding, recently postponed cerebrovascular bleeding or other hemorrhagic diseases - dekompensirovanny heart failure - pregnancy, breastfeeding - children's age up to 12 years in case of existence at the patient of the rare hereditary diseases incompatible with any of drug ingredients, use of drug MOVALIS is also contraindicated (see the section Special Instructions). Medicinal interactions - Other inhibitors of synthesis of prostanglandin (ISP), including glucocorticosteroids or salicylates (acetylsalicylic acid): co-administration of ISP is not recommended as synergy interaction can increase risk of developing gastrointestinal bleeding or an ulceration. - Oral anticoagulants, heparin, trombolitik: increase risk of developing bleeding. If it is impossible to avoid joint prescribing of drugs, it is necessary to control carefully effect of anticoagulants on coagulation. - Antiagreganta and selective serotonin reuptake inhibitors (SSRI): increase risk of developing bleeding because of depression of function of thrombocytes. - Lithium: it was reported that NPVP increase lithium level in blood plasma. Co-administration is not recommended. If it is impossible to avoid combined use of drugs, it is necessary to control lithium level in plasma at the beginning and at the end of treatment and also after change of a dose of drug MOVALIS. - Methotrexate: NPVP reduce canalicular secretion of a methotrexate, thereby increasing concentration of a methotrexate in plasma. For this reason for the patients accepting a methotrexate in high doses (more than 15 mg/week), the accompanying use of NPVP is not recommended. The risk of interaction of NPVP and methotrexate should be considered also at the patients accepting a methotrexate in low doses, especially at patients with renal failures. In case of need the combined treatment it is necessary to control the general blood test and function of kidneys. It is necessary to show care at joint reception of NPVP and methotrexate within 3 days when methotrexate level in plasma can increase and lead to strengthening of toxicity. - Contraception: there are messages that NPVP reduce efficiency of intrauterine contraceptives. - Diuretics: at treatment of NPVP, patients have a high risk of developing an acute renal failure with dehydration. The patients accepting MOVALIS in combination with diuretics have to receive enough liquid, it is necessary to check function of kidneys before therapy by drug MOVALIS. - Antihypertensive drugs (for example, beta-blockers, inhibitors of angiotensin-converting enzyme
, vazodilatator, diuretics): during treatment of NPVP the decrease in efficiency of antihypertensive drugs owing to blocking of prostaglandins-vazodilatatorov was noted. - Combined use of NPVP and antagonists of receptors of angiotensin II (also as well as APF inhibitors) enhances effect of decrease in glomerular filtration. At patients with a renal failure it can lead to development of an acute renal failure - Holestiramin connects to meloksika in digestive tract that leads to the accelerated removal of drug from an organism. - Cyclosporines: NPVP can increase indirectly through renal prostaglandins nephrotoxicity of cyclosporines. During joint prescribing of these drugs it is necessary to exercise control of function of kidneys. - Pemetreksed: For the accompanying use of a meloksikam with pemetreksedy at patients with clearance of creatinine from 45 to 79 ml/min. the reception of a meloksikam should be suspended in 5 days prior to reception, in day of reception and in 2 days after reception of a pemetreksed. If the combination of a meloksikam with pemetreksedy is necessary, patients should be controlled carefully, especially regarding myelosuppression and gastrointestinal undesirable reactions. Patients with clearance of creatinine have lower than 45 ml/min. the accompanying use of a meloksikam with pemetreksedy is not recommended. - Meloksikam is almost completely brought due to metabolism in a liver which approximately on two thirds is mediated by enzymes of P450 cytochrome (CYP) (the main way of CYP 2C9 and a minor way of CYP 3A4) and to one third - other ways, for example, by peroksidazny oxidation. It is necessary to consider a possibility of the pharmacokinetic interactions at simultaneous introduction of a meloksikam and drugs which are obviously inhibiting or the metabolized CYP 2C9 and/or CYP 3A4. The interaction mediated by CYP 2C9 can be expected in a combination with such medicines as oral anti-diabetic drugs (sulphonylurea derivatives, nateglinid), this interaction can lead to increase in level of these drugs and a meloksikama in plasma. The patients accepting to meloksika and drugs of sulphonylurea or nateglinid should be controlled carefully regarding a hypoglycemia. No pharmacokinetic medicinal interactions were revealed at co-administration of a meloksikam and antacids, Cimetidinum, digoxin, furosemide. Special instructions At treatment meloksikamy there is a high risk of developing life-threatening gastrointestinal bleeding, an ulceration or perforation as with existence of alarming symptoms or serious gastrointestinal violations in the anamnesis, and without them. Consequences of such disturbances, as a rule, are more serious at elderly people. It is necessary to show care at treatment of patients with gastrointestinal diseases in the anamnesis. It is necessary to control patients with gastrointestinal symptoms. MOVALIS should be cancelled when developing a round ulcer or gastrointestinal bleeding. It is necessary to show care to patients, receiving treatment by anticoagulants. Due to the use of drug MOVALIS it was occasionally reported about serious skin reactions (some of which were led to death), including exfoliative dermatitis, Stephens-Johnson's syndrome and a toksiko-epidermal necrolysis. The highest risk of development of these reactions at patients, apparently, takes place at the beginning of therapy, in most cases the beginning of skin reactions is shown within the first month of treatment. Administration of drug should be stopped at emergence of the first symptoms of skin rash, defeats mucous or any other sign of hypersensitivity. NPVP can increase risk of developing serious cardiovascular trombotichesky diseases, a myocardial infarction and to Ince
of the t, it is possible from the death. Such risk increases at prolonged use of drug. Patients with cardiovascular diseases or risk factors of cardiovascular diseases are more subject to risk. NPVP inhibit synthesis of prostaglandins in kidneys which play a supporting role in maintenance of a blood-groove in kidneys. With the lowered renal blood-groove and volume of blood the introduction of NPVP can cause the expressed renal decompensation in patients, at the termination of therapy of NPVP the function of kidneys is usually restored to initial level. Elderly people, patients with dehydration, with stagnant cardiovascular insufficiency, cirrhosis, a nephrotic syndrome and the profound renal failure, the patients receiving the accompanying treatment using diuretics, APF inhibitors or antagonists of a receptor of angiotensin II or the patients who transferred extensive surgery which led to a hypovolemia are subject to the greatest risk. At such patients in an initiation of treatment it is necessary to control carefully functions of kidneys, including diuresis volume. In rare instances NPVP can cause interstitial nephrite, a glomerulonephritis, medullary necrosis of kidneys or a nephrotic syndrome. Perhaps slight taking place increase of level of transaminases in serum of blood or other parameters of function of a liver, in particular the level of transaminases in blood serum. In most cases these effects represented the slight taking place increase of parameters above normal values. If such changes are significant or resistant, administration of drug of MOVALIS it is necessary to stop and perform necessary examination of the patient with the subsequent observation. For patients with clinically stable cirrhosis the dose decline is not required. The weakened patients can worse transfer side effects, in this case careful control is necessary. It is necessary to show care at treatment of elderly patients who more likely suffer from a renal failure, a liver or heart. NPVP can cause a delay of sodium, potassium and water and to prevent natriuretic effect of diuretics that can lead to strengthening or sharpening of cardiovascular insufficiency or hypertensia. For patients of risk group the clinical monitoring is recommended. Meloksikam, as well as any other NPVP, can mask symptoms of the basic infectious disease. MOVALIS of 7.5 mg contains 47 mg of lactose in the maximum daily dose. To patients with rare hereditary intolerance of a galactose, for example, a galactosemia, administration of drug is contraindicated. MOVALIS of 15 mg contains 20 mg of lactose in the maximum daily dose. To patients with rare hereditary intolerance of a galactose, for example, a galactosemia, administration of drug is contraindicated. Fertility, pregnancy and period of a lactation Fertility. Use of a meloksikam, as well as any drug inhibiting synthesis of cyclooxygenases / prostaglandins can affect reproductive ability and is not recommended to the women planning pregnancy. Cancellation of reception of a meloksikam is recommended to the women having difficulties with conception or undergoing inspection in connection with infertility. Pregnancy. MOVALIS is contraindicated during pregnancy. The inhibition of synthesis of prostaglandins can negatively affect pregnancy and/or development of an embryo and fruit. Data of epidemiological researches indicate the increased risk of an abortion, heart diseases and a gastroshizis after intake of inhibitors of synthesis of prostaglandins in the early stages of pregnancy. During the third trimester of pregnancy all inhibitors of synthesis of prostaglandins can subject a fruit: - to cardiopulmonary toxicity (with premature closing of a botallov of a channel and pulmonary hypertensia), - to a renal failure which can progress to a renal failure with an oligoamnios, Mother and a fruit at the end of pregnancy: - to possible increase in a bleeding time, effect of anti-aggregation which can arise even at very low doses, - to the suppression of reductions of a uterus leading to a delay or increase in a duration of delivery, the lactation Period. MOVALIS is contraindicated to the women nursing. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. Researches of influence on ability to drive the car and to use mechanisms were not conducted. Nevertheless, patients should be informed on possible manifestation of undesirable effects, such as disorder of vision, including illegibility of sight, dizziness, drowsiness, other disturbances of the central nervous system. In case of any of the specified side effects the patients have to avoid control of vehicles and refuse work with potentially dangerous mechanisms. Overdose Symptoms: nausea, vomiting, abdominal pain, strengthening of other side effects of drug. Treatment: symptomatic. Specific antidote is unknown. During clinical trials it was shown what holestiramin accelerates removal of a meloksikam. A form of release and packing On 10 tablets in blister strip packaging (blister) from polyvinylchloride and aluminum foil. On 1 or 2 planimetric packs together with the instruction for use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature not above 25 °C. To store out of children's reach! 3 years not to use a period of storage after the expiry date specified on packing. Prescription status According to the prescription the Name and the country of the owner of the registration certificate of Boehringer Ingelcheim International GmbH, Germany the Producer Boehringer A.E. Ingelheim Ellas, Greece the Address of the organization accepting claims from consumers on quality of products in the territory of the Republic of Kazakhstan Representation Boehringer Ingelcheim of Pharm Hess mbkh in RKAdres: Almaty, 050008, the ave of Abay, the Innova Tower 52business-center, the 7th etazhtet: +7 (727) 250 00 77, fax: +7 (727) 244 51 77 e-mail-mail
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