Movalis tablets 15mg №10×2

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Movalis tabl 15mg in bl. No. 10×2
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Pastel yellow, round tablets with a snap-tab groove, one side is convex, with beveled edges, marked with the company logo, the other side is marked with a code and has a break line dividing the surface in half. The main active ingredient Meloxicam Release form Tablets Dosage 7.5 mg or 15.0 mg Pharmacological properties The anti-inflammatory activity of meloxicam has been proven in classical models of inflammation. As with other NSAIDs, the exact mechanism of action remains unknown. However, there is at least one common mechanism of action common to all NSAIDs (including meloxicam): inhibition of the biosynthesis of prostaglandins known as inflammatory mediators. Pharmacokinetics Absorption Meloxicam is well absorbed from the gastrointestinal tract, which is reflected in its high absolute bioavailability (about 90% after oral administration). After a single application of meloxicam, the average maximum plasma concentrations are reached within 5-6 hours after taking solid oral dosage forms (capsules and tablets). With repeated use, the equilibrium state of pharmacokinetics was achieved within 3-5 days. The appointment of a single daily dose provides plasma concentrations of the drug with a relatively small peak fluctuation in the range of 0.4-1.0 μg / ml for a dosage of 7.5 mg and 0.8-2.0 μg / ml for a dosage of 15 mg (respectively Cmin and Cmax in the equilibrium state). The average maximum concentrations of meloxicam in blood plasma in an equilibrium state were reached within 5-6 hours. The degree of absorption of meloxicam after oral administration did not depend on food intake or the use of inorganic antacids. Distribution Meloxicam binds well to plasma proteins, mainly to albumin (99%). Meloxicam penetrates into the synovial fluid, reaching concentrations corresponding to approximately 50% of the plasma concentration. The volume of distribution after multiple oral doses of meloxicam (7.5 to 15 mg) is about 16 L with intersubject variation in the range of 11-32%. Biotransformation Meloxicam is extensively metabolized in the liver. Four different pharmacodynamically inactive metabolites of meloxicam have been identified in urine. The main metabolite 5′-carboxymeloxicam (60% of the administered dose) is formed by oxidation of the intermediate metabolite 5′-hydroxymethylmeloxicam, which is also excreted, but to a lesser extent (9% of the administered dose). In vitro studies have shown that CYP 2C9 plays an important role in this metabolic transformation, and the CYP 3A4 isoenzyme is of additional importance. The activity of peroxidase in the patient’s body probably causes the appearance of two other metabolites, which account for 16% and 4%, respectively, of the administered dose. Withdrawal Meloxicam is excreted mainly in the form of metabolites equally with feces and urine. Less than 5% of the daily dose is excreted unchanged in the feces; in the urine, unchanged, the drug is found only in trace amounts. The mean half-life of meloxicam varies from 13 to 25 hours after oral, intramuscular and intravenous administration. The total plasma clearance is about 7-12 ml/min. after a single oral dose. Linearity/Nonlinearity Linearity of meloxicam pharmacokinetics has been demonstrated with oral or intramuscular therapeutic doses ranging from 7.5 to 15 mg. Special groups of patients Patients with hepatic / renal insufficiency Hepatic insufficiency and moderate renal insufficiency do not significantly affect the pharmacokinetics of meloxicam. In patients with moderate renal impairment, a higher total clearance of the drug was observed. In patients with end-stage renal disease, a decrease in plasma protein binding was observed. In end-stage renal disease, an increase in the volume of distribution may lead to higher concentrations of free meloxicam, so in such patients the daily dose should not exceed 7.5 mg. Elderly patients Pharmacokinetic parameters for elderly male patients were similar to pharmacokinetic parameters for younger male patients. In elderly female patients, a higher AUC value and a longer half-life were observed compared with young patients of both sexes. In elderly patients, the average plasma clearance during the equilibrium state of pharmacokinetics is slightly lower than in young patients. Indications for use Short-term symptomatic therapy of exacerbation of osteoarthritis. Long-term symptomatic therapy of rheumatoid arthritis or ankylosing spondylitis. Dosage and administration Dosage The daily dose of the drug is taken once. Minimizing the risk of developing adverse effects is possible by using the minimum effective dose for the shortest period of time necessary to control symptoms. The need for therapy and the patient’s response to therapy should be periodically assessed, especially in patients with osteoarthritis. Exacerbations of osteoarthritis: 7.5 mg / day (one 7.5 mg tablet or half a 15 mg tablet). If necessary, in the absence of improvement, the dose may be increased to 15 mg / day (two 7.5 mg tablets or 1 15 mg tablet). Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (two 7.5 mg tablets or 1 15 mg tablet). Depending on the severity of the response to therapy, the dosage may be reduced to 7.5 mg / day (one 7.5 mg tablet or half a 15 mg tablet). Do not exceed 15 mg/day. Special patient groups Elderly patients and patients at increased risk of adverse reactions The recommended dose for long-term treatment of elderly patients with rheumatoid arthritis or ankylosing spondylitis is 7.5 mg per day. Patients with an increased risk of developing adverse reactions should begin treatment with a dosage of 7.5 mg per day. Impaired renal function In patients with severe renal insufficiency on dialysis, the dose should not exceed 7.5 mg per day. Dose reduction is not required in patients with mild to moderate renal impairment (i.e., in patients with creatinine clearance greater than 25 ml/min.). Impaired liver function In patients with mild to moderate hepatic impairment, dose reduction is not required. Children and adolescents MOVALIS tablets are contraindicated in children and adolescents under 16 years of age. Method of application For oral administration. MOVALIS tablets 7.5 mg or 15 mg are taken with food, drinking water or other liquid. Use during pregnancy and lactation Pregnancy Suppression of prostaglandin synthesis may have an undesirable effect on pregnancy and fetal development. Data from epidemiological studies indicate an increased risk of spontaneous abortions, heart defects and gastroschisis in the fetus after the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of developing CVD increased from less than 1% to about 1.5%. This risk increases with increasing dose and duration of therapy. In animal studies, it has been shown that the administration of a prostaglandin synthesis inhibitor leads to an increase in pre- and post-implantation losses and feto-embryonic mortality. In addition, in animals treated with a prostaglandin synthesis inhibitor during organogenesis, an increase in the number of cases of various malformations, including those of the cardiovascular system, was registered. The use of meloxicam during the first and second trimesters of pregnancy is not recommended unless absolutely necessary. When meloxicam is used by a woman planning a pregnancy, or during the first and second trimester of pregnancy, the dose of the drug should be the smallest, and the duration of treatment should be as short as possible. In the III trimester of pregnancy, the use of any prostaglandin synthesis inhibitors can lead to the following disorders: in the fetus: due to toxic effects on the cardiopulmonary system: premature closure of the arterial duct and the development of pulmonary hypertension; kidney dysfunction with further development of renal failure with oligohydroamniosis. in mother and newborn when used at the end of pregnancy: an increase in the duration of bleeding is possible, and the antiaggregatory effect can develop even at a low dosage; decrease in uterine contractility, and, as a result, an increase in the duration of labor. Therefore, meloxicam is contraindicated in the third trimester of pregnancy. Breastfeeding period Despite the lack of data on the experience with the use of meloxicam, it is known that NSAIDs pass into breast milk. Therefore, these medicines are not recommended during breastfeeding. Fertility The use of meloxicam, as well as other drugs that block cyclooxygenase/prostaglandin synthesis, can affect fertility, so this drug is not recommended for women planning pregnancy. In case of violation of the ability to conceive in women or an examination for infertility, it is necessary to consider the abolition of meloxicam. Precautions Undesirable effects can be minimized by administering the lowest effective dose necessary to control symptoms for the shortest period of time. In case of insufficient therapeutic effect, the recommended maximum daily dose should not be exceeded and / or an additional NSAID should be prescribed, because. this can lead to increased toxicity in the absence of therapeutic benefits. The simultaneous administration of meloxicam with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Meloxicam is not suitable for the relief of acute pain. In the absence of clinical improvement after several days of taking the drug, it is recommended to re-evaluate the prescribed treatment. Patients with a history of esophagitis, gastritis, and/or peptic ulcer should be ascertained to be cured before prescribing meloxicam. Careful monitoring of these patients receiving meloxicam is necessary in order to timely detect a relapse of the disease. Effects on the gastrointestinal tract As with other NSAIDs, potentially fatal gastrointestinal bleeding, ulceration or perforation may occur at any time during treatment with or without prior symptoms or a history of serious gastrointestinal disease. The risk of gastrointestinal bleeding, ulceration or perforation is higher with an increase in the dose of NSAIDs in patients with a history of ulcer, especially complicated by bleeding or perforation, and in elderly patients. In such patients, treatment should be initiated at the lowest effective dose. For such patients, combination therapy with protective medicinal products (such as misoprostol or proton pump inhibitors) should be considered, as well as for patients who require concomitant use of a low dose of acetylsalicylic acid or other drugs that increase the risk of gastrointestinal damage. Patients with a history of gastrointestinal toxicity, especially elderly patients, should report all unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial stages of treatment. Patients taking drugs that may increase the risk of ulcers or bleeding, such as heparin, prescribed both for radical treatment and in geriatric practice, anticoagulants such as warfarin, or other non-steroidal anti-inflammatory drugs, including acetylsalicylic acid in a single dose? 500 mg or in the total daily dose? 3 g, the simultaneous use of meloxicam is not recommended. With the development of gastrointestinal bleeding or ulcers in patients using meloxicam, treatment should be discontinued. NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), as these conditions may worsen. Influence on the cardiovascular system In patients with arterial hypertension and / or with a history of mild to moderate congestive heart failure, careful monitoring is recommended, since fluid retention and edema have been reported during NSAID therapy. Patients with risk factors are recommended clinical monitoring of blood pressure at the beginning of therapy, especially at the beginning of the course of treatment with meloxicam. Data from clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and with long-term treatment), incl. meloxicam may be associated with a slight increased risk of vascular thrombotic events (eg, myocardial infarction or stroke). There are insufficient data to rule out such a risk for meloxicam. Patients with uncontrolled hypertension, congestive heart failure, established coronary artery disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with meloxicam after careful assessment of their condition. Such an assessment is necessary before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, smokers). Skin reactions Serious life-threatening skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with meloxicam. Patients should be aware of symptoms and signs and carefully monitored for skin reactions. The highest risk of developing Stevens-Johnson syndrome and toxic epidermal necrolysis was observed during the first weeks of treatment. Meloxicam should be discontinued at the first symptoms or signs of Stevens-Johnson syndrome or toxic epidermal necrolysis (eg, progressive skin rash, often blistering, or mucosal lesions). The best outcome in the treatment of Stevens-Johnson syndrome and toxic epidermal necrolysis was observed with early diagnosis and immediate withdrawal of the suspect drug. Early drug withdrawal was associated with a better prognosis. If Stevens-Johnson syndrome or toxic epidermal necrolysis develops while taking it, then meloxicam should not be re-administered to this patient in the future. Hepatic and renal function tests As with most NSAIDs, an increase in serum transaminases, an increase in serum bilirubin or other liver function tests, as well as an increase in creatinine and blood urea levels and other laboratory abnormalities have been rarely recorded. In most cases, the violations were temporary and unexpressed. The development of a pronounced deviation of indicators from the norm or their persistence requires the cessation of the introduction of meloxicam and an appropriate examination. Functional renal failure NSAIDs, by inhibiting the vasodilating action of renal prostaglandins, can cause functional renal failure as a result of a decrease in glomerular filtration. This response is dose-dependent. It is recommended to carefully monitor diuresis and renal function at the beginning of treatment or after increasing the dose in patients with the following risk factors: advanced age; concomitant therapy with ACE inhibitors, angiotensin II antagonists, sartans, diuretics; hypovolemia (regardless of cause); congestive heart failure; kidney failure; nephrotic syndrome; lupus nephropathy; severe liver dysfunction (serum albumin < 25 g/l or Child-Pugh score ? 10). In rare cases, NSAIDs can cause interstitial nephritis, glomerulonephritis, medullary necrosis of the kidney, or nephrotic syndrome. The dose of meloxicam in patients with end-stage renal disease on hemodialysis should not exceed 7.5 mg. Dose reduction is not required in patients with mild to moderate renal impairment (i.e., in patients with creatinine clearance greater than 25 ml/min.). Sodium, Potassium and Water Retention The use of NSAIDs can lead to retention of sodium, potassium and water and may affect the natriuretic effect of diuretics. In addition, it is possible to reduce the antihypertensive effect of antihypertensive drugs. As a result, predisposed patients may develop or increase edema, symptoms of heart failure or hypertension. Clinical observation is recommended for these patients. Hyperkalemia The risk of developing hyperkalemia is increased in patients with diabetes mellitus or in concomitant therapy with drugs that increase the level of potassium in the blood. In such cases, it is necessary to regularly monitor the level of potassium in the blood. Combination with pemetrexed Patients with mild to moderate renal impairment receiving pemetrexed should not take meloxicam for at least 5 days prior to pemetrexed administration, on the day of administration, and for 2 days after pemetrexed administration. Other Warnings and Precautions Elderly, debilitated and malnourished patients are more susceptible to adverse reactions and therefore require careful monitoring. As with other NSAIDs, special care must be taken when prescribing the drug to elderly patients who often have impaired renal, hepatic and cardiac functions. Elderly patients also have an increased incidence of adverse reactions with NSAIDs, especially gastrointestinal bleeding and gastrointestinal perforation, which can be fatal. Meloxicam, like other N6Cs, may mask the symptoms of an infectious disease. The use of meloxicam may reduce fertility in women and, accordingly, is not recommended for women planning a pregnancy. In case of violation of the ability to conceive in women or an examination for infertility, it is necessary to consider the abolition of meloxicam. MOVALIS tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interactions with other drugs Risk of hyperkalemia Some drugs or therapeutic groups may contribute to the development of hyperkalemia: potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim. The development of hyperkalemia may depend on the presence of risk factors. The risk of developing hyperkalemia increases with the simultaneous use of the above drugs and meloxicam. Contraindications The drug is contraindicated in the following cases: hypersensitivity to meloxicam or any excipient; third trimester of pregnancy; children and adolescents under the age of 16; hypersensitivity to substances with a similar effect, for example, NSAIDs, acetylsalicylic acid. Meloxicam should not be prescribed to patients who have experienced symptoms of bronchial asthma, nasal polyps, angioedema or urticaria after administration of acetylsalicylic acid or other NSAIDs; history of gastrointestinal bleeding or perforation of the gastrointestinal tract associated with previous NSAID therapy; active phase or recurrent ulcer/bleeding of the gastrointestinal tract (two or more separate episodes in which the presence of an ulcer or bleeding is confirmed); severe liver dysfunction; severe renal failure without dialysis; gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders in history; severe heart failure. Composition 1 tablet contains: Active substance: meloxicam 7.5 mg or 15.0 mg. Excipients: sodium citrate, lactose monohydrate, microcrystalline cellulose, povidone K 25, colloidal anhydrous silicon dioxide, crospovidone, magnesium stearate. Overdose Symptoms Symptoms of acute overdose of NSAIDs are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with maintenance therapy. Gastrointestinal bleeding may occur. Severe poisoning may be accompanied by arterial hypertension, acute renal failure, liver dysfunction, respiratory depression, coma, convulsions, cardiovascular failure and cardiac arrest. With the therapeutic use of NSAIDs, anaphylactoid reactions have been reported, which can also be observed in overdose. Treatment In case of an overdose of NSAIDs, patients are recommended symptomatic and supportive therapy. A clinical study showed an acceleration of the elimination of meloxicam with oral administration of 4 g of cholestyramine 3 times / day. Side effects Clinical trial data and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with a slight increase in the risk of vascular thrombotic events (such as myocardial infarction or stroke). When using NSAIDs, edema, arterial hypertension and heart failure were observed. Most side effects were observed from the gastrointestinal tract. Perhaps the development of ulcers, perforations or gastrointestinal bleeding, including fatal, especially in elderly patients. After application, cases of nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, vomiting of blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported. Gastritis was observed with less frequency. Severe adverse skin reactions have been reported: Stevens-Johnson syndrome and toxic epidermal necrolysis. The frequency of the following adverse reactions is based on the received relevant reports of adverse events registered in 27 clinical studies with a duration of treatment of at least 14 days. The information is based on clinical studies involving 15197 patients taking meloxicam at a daily dose of 7.5 or 15 mg in the form of tablets or capsules for up to one year. Also included are adverse reactions received in the post-marketing period. Criteria for assessing the incidence of adverse drug reactions: very often (? 1/10); often (? 1/100, < 1/10); infrequently (? 1/1000, < 1/100); rarely (? 1/10000, < 1/1000); very rarely (< 1/10000); unknown (cannot be determined from the available data). On the part of the blood and lymphatic system Uncommon: anemia. Rarely: abnormal blood test values (including changes in the number of leukocytes), leukopenia, thrombocytopenia. Very rare cases of agranulocytosis have been reported. On the part of the immune system Infrequently: allergic reactions, excluding anaphylactic and anaphylactoid ones. Not known: anaphylactic reactions, anaphylactoid reactions. On the part of the psyche Rarely: mood changes, nightmares. Not known: confusion, disorientation. From the side of the nervous system Often: headache. Uncommon: dizziness, drowsiness. On the part of the organ of vision Rarely: impaired visual function, including blurred vision, conjunctivitis. On the part of the organ of hearing and labyrinth disorders Infrequently: dizziness. Rare: ringing in the ears. From the side of the heart Rarely: palpitations. Heart failure associated with the use of NSAIDs has been reported. From the side of the vessels Infrequently: increased blood pressure, hot flashes. Respiratory, thoracic and mediastinal disorders Rare: asthma in patients allergic to acetylsalicylic acid and other NSAIDs. From the gastrointestinal tract Very often: gastrointestinal disorders such as dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea. Infrequently: hidden or macroscopically visible gastrointestinal bleeding, stomatitis, gastritis, belching. Rare: colitis, gastroduodenal ulcer, esophagitis. Very rare: perforation of the gastrointestinal tract. Not known: pancreatitis. Gastrointestinal bleeding, ulcers, or perforation can be severe and potentially fatal, especially in elderly patients. On the part of the liver and biliary tract Infrequently: a violation of liver function tests (for example, an increase in transaminases or bilirubin). Very rare: hepatitis. From the skin and subcutaneous tissue Uncommon: angioedema, itching, rash. Rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria. Very rare: bullous dermatitis, erythema multiforme. Not known: photosensitivity. From the urinary system Infrequently: sodium and water retention, hyperkalemia, changes in laboratory tests of kidney function (increased creatinine and / or urea in the blood serum). Very rare: acute renal failure, particularly in patients with risk factors. General disorders and reactions at the injection site Uncommon: edema, including swelling of the lower extremities. Selected Serious and/or Common Adverse Reactions Very rare cases of agranulocytosis have been reported in patients treated with meloxicam and other potentially myelotoxic drugs. Adverse reactions not associated with the use of the drug, but which are generally characteristic of other compounds of this class Organic kidney damage, which probably leads to acute renal failure: very rare cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome and papillary necrosis. Storage conditionsStore at a temperature not exceeding 25°C. Keep out of the reach of children. 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