Name:
Meloxicam-lf
Description:
Tablets of light yellow or yellow color, flat-cylindrical shape, with a chamfer and a risk mark. Marbling is allowed on the surface of the tablets. The main active ingredient Meloxicam Release form tablets 10 tablets in a blister pack made of PVC film and aluminum foil. One or two blister packs together with instructions for medical use in a cardboard pack. Dosage 7.5 mg Pharmacodynamics Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family with anti-inflammatory, analgesic and antipyretic 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. PharmacokineticsAbsorption 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 (tablets, capsules). 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 meloxicam 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 at equilibrium). 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 the synovial fluid, reaching concentrations corresponding to approximately 50% of the plasma concentration. The volume of distribution after taking several oral doses of meloxicam (from 7.5 mg to 15 mg) is about 16 liters with a coefficient of inter-individual variation in the range of 11-32%. Metabolism 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 meloxicam 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 administration. Linearity/Nonlinearity Linearity in the pharmacokinetics of meloxicam has been demonstrated with oral or intramuscular therapeutic doses ranging from 7.5 mg 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 insufficiency, a higher total clearance of meloxicam 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 these 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. Method of administration and doses For oral administration. The score on the tablets is intended solely to facilitate taking one tablet (by breaking the tablet into two halves), and not to divide the tablet into two doses. The daily dose of meloxicam is taken once with a meal, washed down with water or other liquid. The likelihood of adverse effects can be minimized by using the lowest effective dose of the drug 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. Exacerbation of osteoarthritis: 7.5 mg / day (one tablet of 7.5 mg). If necessary, in the absence of improvement, the dose may be increased to 15 mg / day (two 7.5 mg tablets or one 15 mg tablet). Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (two 7.5 mg tablets or one 15 mg tablet). Depending on the severity of the response to therapy, the dosage may be reduced to 7.5 mg / day (one tablet of 7.5 mg). 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. Patients with 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). Patients with hepatic impairment No dose reduction is required in patients with mild to moderate hepatic impairment. Children and adolescents The drug Meloxicam-LF is contraindicated in children and adolescents under 16 years of age 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 malformations of the cardiovascular system increased from less than 1% to 1.5%. This risk increases with increasing dose and duration of therapy. An animal study has shown that the administration of a prostaglandin synthesis inhibitor results in increased pre- and post-implantation losses and feto-fetal 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 lowest and the duration of treatment 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 the mother and newborn when used at the end of pregnancy: an increase in the duration of bleeding is possible, and the antiplatelet effect may 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 conducting an examination for infertility, it is necessary to consider the abolition of meloxicam. However, based on the pharmacodynamic profile and observed adverse reactions, meloxicam does not or does not significantly affect this activity. However, patients who have experienced visual impairment, including blurred vision, dizziness, drowsiness, vertigo, or other central nervous system disorders, are advised to refrain from driving or operating machinery. Undesirable effects can be minimized by administering the lowest effective dose needed 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. If there is no clinical improvement after a few 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, ulcers, 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. Should be used with caution in patients taking concomitant drugs that may increase the risk of ulcer 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 anti-inflammatory doses (≥ 500 mg single dose or ≥ 3 g total daily dose). 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 observed 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. Research 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 (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, blood urea 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: Old age; Concomitant therapy with ACE inhibitors, angiotensin II antagonists, sartans, diuretics; Hypovolemia (regardless of cause); Heart failure; kidney failure; nephrotic syndrome; Lupus nephropathy; Severe hepatic impairment (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. Co-administration 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 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 function. 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 NSAIDs, 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 during the examination for infertility, it is necessary to consider the abolition of meloxicam. The medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interactions with other drugsDrug interaction studies have only been performed in adults. 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. Pharmacodynamic interactions Other NSAIDs and acetylsalicylic acid Simultaneous use with other NSAIDs, including acetylsalicylic acid in anti-inflammatory doses (≥ 500 mg once or ≥ 3 g per day) is not recommended. Corticosteroids (eg, glucocorticoids) When used simultaneously with corticoids, caution should be exercised due to an increased risk of bleeding or perforation of the gastrointestinal tract. Anticoagulants or heparin Significantly increased risk of bleeding due to inhibition of platelet function and damage to the lining of the stomach and duodenum. NSAIDs may enhance the effects of anticoagulants such as warfarin. The simultaneous use of NSAIDs and anticoagulants or heparin at therapeutic doses or in geriatrics is not recommended. In other cases, heparin is prescribed with caution due to an increased risk of bleeding. If necessary, the appointment of this combination is recommended careful monitoring of INR. Thrombolytics and antiplatelet drugs Increased risk of bleeding due to inhibition of platelet function and damage to the gastric and duodenal mucosa. Selective serotonin reuptake inhibitors (SSRIs) Increased risk of gastrointestinal bleeding. Diuretics, ACE inhibitors and angiotensin receptor antagonists NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (eg, dehydration or elderly patients with impaired renal function), the concomitant use of an ACE inhibitor or angiotensin II receptor antagonist and drugs that block cyclooxygenase may lead to further deterioration of kidney function, up to the development of acute renal failure. insufficiency, which is usually reversible. Thus, this combination should be used with caution, especially in the elderly. In patients, it is necessary to exclude possible dehydration (including latent), to monitor renal function after initiation and periodically during combination therapy. Other antihypertensive drugs (eg, β-blockers) The antihypertensive effect of β-blockers may be reduced by inhibiting the synthesis of prostaglandins with a vasodilating effect. Calcineurin inhibitors (eg, cyclosporine, tacrolimus) Due to the effect of NSAIDs on the synthesis of renal prostaglandins, the nephrotoxicity of calcineurin inhibitors may increase. When conducting this combination therapy, it is necessary to monitor renal function, especially in elderly patients. Deferasirox Concomitant use of meloxicam and deferasirox may increase the risk of gastrointestinal side effects. In this regard, these drugs should be taken at the same time with caution. Pharmacokinetic interactions: effect of meloxicam on the pharmacokinetics of other medicinal products Lithium It has been reported that NSAIDs can increase the concentration of lithium in the blood plasma (by reducing the renal excretion of lithium), which can reach toxic values. Simultaneous use of lithium and NSAIDs is not recommended. If combination therapy is necessary, plasma lithium levels should be carefully monitored at the start of treatment, when adjusting the dose, and when discontinuing treatment with meloxicam. Methotrexate NSAIDs can reduce the tubular secretion of methotrexate, thereby increasing its plasma concentration. For this reason, the simultaneous use of NSAIDs by patients taking a high dose of methotrexate (more than 15 mg / week) is not recommended. The risk of interaction between NSAIDs and methotrexate should also be considered in patients taking low doses of methotrexate, especially in patients with impaired renal function. If combined treatment is required, it is necessary to monitor blood counts and kidney function. Caution should be exercised if NSAIDs and methotrexate are taken for more than 3 days, since it is possible to increase the plasma level of methotrexate and, accordingly, its toxicity. Although the pharmacokinetics of methotrexate (15 mg/week) did not change with concomitant treatment with meloxicam, it should be considered that the hematological toxicity of methotrexate may increase with the treatment of NSAIDs. Pemetrexed If meloxicam and pemetrexed are to be co-administered in patients with mild to moderate renal impairment (creatinine clearance 45-79 ml/min), meloxicam should not be taken for at least 5 days prior to pemetrexed administration, on the day of administration, and for 2 days after administration of pemetrexed. If the combination of meloxicam and pemetrexed is necessary, careful monitoring of the patient is recommended, especially due to myelosuppression and gastrointestinal side effects. In patients with severe renal insufficiency (creatinine clearance < 45 ml / min), the simultaneous use of meloxicam and pemetrexed is not recommended. In patients with normal renal function (creatinine clearance ≥ 80 ml / min), the use of meloxicam at a dose of 15 mg may lead to a decrease in the clearance of pemetrexed and, therefore, an increase in its side effects. Thus, concomitant use of meloxicam 15 mg and pemetrexed in patients with normal renal function (creatinine clearance ≥ 80 ml/min) should be done with caution. Pharmacokinetic interactions: influence of other medicinal products on meloxicam pharmacokinetics This interaction is clinically significant. There were no clinically significant pharmacokinetic interactions when taken simultaneously with antacids, cimetidine and digoxin. Pharmacokinetic interactions: effects of co-administration of meloxicam and other medicinal products on pharmacokinetics Oral antidiabetic agents (sulfonylurea derivatives, nateglinide) Meloxicam is almost completely eliminated by hepatic metabolism, with approximately two-thirds being eliminated indirectly by cytochrome (CYP) enzymes P450 (CYP 2C9 is the main route of elimination and CYP 3A4, an accessory excretion pathway), and one third through other pathways, such as peroxidase oxidation. When meloxicam is taken concomitantly with medicinal products that inhibit or are metabolized by CYP 2C9 and/or CYP 3A4, the possibility of a pharmacokinetic interaction should be taken into account. When taken simultaneously with drugs such as oral antidiabetic agents (sulfonylurea derivatives, nateglinide), an interaction mediated by CYP 2C9 can be expected, which can lead to an increase in plasma concentrations of these drugs and meloxicam. Patients concomitantly receiving meloxicam and sulfonylurea derivatives or nateglinide should be closely monitored for signs of hypoglycemia. ContraindicationsThird trimester of pregnancy. Children and teenagers under the age of 16. Hypersensitivity reactions to meloxicam or any auxiliary component, or hypersensitivity to substances with a similar effect, for example, NSAIDs, acetylsalicylic acid. Meloxicam should not be administered 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. History of gastrointestinal bleeding, cerebrovascular bleeding, or other bleeding disorders. Severe heart failure. Composition Each tablet contains: active substance: meloxicam - 7.5 mg or 15 mg; excipients: magnesium stearate, sodium citrate, povidone, crospovidone, anhydrous colloidal silicon dioxide, microcrystalline cellulose, lactose monohydrate. Overdose Symptoms of acute NSAID overdose 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. In case of an overdose of NSAIDs, patients are recommended symptomatic and supportive therapy. Studies have shown an acceleration of the elimination of meloxicam with oral administration of 4 g of cholestyramine 3 times a day. Side effects Research 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 mg or 15 mg in the form of tablets and 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 (≥1/10,000, <1/1000); very rarely (<1/10,000); unknown (frequency cannot be estimated from the available data). On the part of the blood and lymphatic system: infrequently - anemia; rarely - deviations of blood test parameters from the norm (including a change in the number of leukocytes), leukopenia, thrombocytopenia. Very rare cases of agranulocytosis have been reported. From the immune system: infrequently - allergic reactions, excluding anaphylactic and anaphylactoid ones; unknown - anaphylactic reactions, anaphylactoid reactions. On the part of the psyche: rarely - mood changes, nightmares; unknown - confusion, disorientation. From the nervous system: often - headache; infrequently - dizziness, drowsiness. On the part of the organ of vision: rarely - a violation of the function of vision, including blurred vision, conjunctivitis. On the part of the organ of hearing and labyrinth disorders: infrequently - dizziness; rarely - 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. On the part of the respiratory system, chest organs and mediastinum: rarely - asthma in patients allergic to acetylsalicylic acid and other NSAIDs. From the gastrointestinal tract: very often - dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; infrequently - latent or macroscopically visible gastrointestinal bleeding, stomatitis, gastritis, constipation, belching; rarely - colitis, gastroduodenal ulcer, esophagitis; very rarely - perforation of the gastrointestinal tract, unknown - pancreatitis. Gastrointestinal bleeding, ulcers, or perforation can be severe and potentially fatal, especially in elderly patients. From the side of the liver and biliary tract: infrequently - a violation of liver function indicators (for example, an increase in transaminases or bilirubin); very rarely - hepatitis. From the skin and subcutaneous tissue: infrequently - angioedema, itching, rash; rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria; very rarely - bullous dermatitis, erythema multiforme; unknown - photosensitivity. From the urinary system: infrequently - sodium and water retention, hyperkalemia, changes in laboratory tests of kidney function (increased creatinine and / or serum urea); very rarely - acute renal failure, in particular in patients with risk factors. From the reproductive system and mammary glands: unknown - female infertility, delayed ovulation. General disorders and reaction at the injection site: infrequently - 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 medicinal products. 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 have been reported and papillary necrosis. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiration date indicated on the package. Buy Meloxicam-LF tablets 7.5 mg No. 10x2 Price for Meloxicam-LF tablets 7.5 mg No. 10x2
INN | MELOXICAM |
---|---|
The code | 130 804 |
Barcode | 4 812 608 007 901 |
Active substance | Meloxicam |
Manufacturer | Lekpharm SOOO, Belarus |
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