Melbek tablets 15mg №10×2

Name:
Melbek tabl 15mg in bl. in pack. No. 10×2 Main active ingredient Meloxicam Release form tablet Composition 1 tablet contains: meloxicam 7.5 mg (or 15 mg). Excipients: crospovidone (Kollidon Cl), povidone (PVP K30, polyvinylpyrrolidone), microcrystalline cellulose PH 102, sodium citrate, anhydrous lactose, anhydrous colloidal silicon (Aerosil 200), magnesium stearate.
Description:
Tablets 7.5 mg: light yellow round tablets with a score line on one side. Tablets 15 mg: light yellow round tablets with a cross line on one side. Dosage 7.5 mg or 15 mg Indications for use Short-term symptomatic therapy of exacerbation of osteoarthritis. Long-term symptomatic therapy of rheumatoid arthritis or ankylosing spondylitis. Contraindications Hypersensitivity to meloxicam or any of the excipients, as well as other non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin. Patients who develop asthma symptoms, nasal polyps, Quincke’s edema or urticaria after taking aspirin or other NSAIDs should not take meloxicam; history of gastrointestinal bleeding or perforation in connection with previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs); acute or previous stomach ulcer or gastrointestinal bleeding (at least 2 episodes of confirmed ulcer or bleeding); gastrointestinal bleeding, history of cerebrovascular bleeding or other conditions with an increased risk of bleeding; nonspecific inflammatory bowel disease in the acute phase (Crohn’s disease, ulcerative colitis); severe liver failure; patients with severe renal insufficiency who are not on hemodialysis; severe heart failure; contraindicated for the treatment of intraoperative pain in coronary artery bypass grafting (CABG); the period of pregnancy and breastfeeding; children and teenagers under the age of 16. Use during pregnancy and lactation Melbek is contraindicated during pregnancy. Suppression of prostaglandin synthesis can 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. In the III trimester of pregnancy, the use of any prostaglandin synthesis inhibitors can lead to the following fetal developmental disorders: premature closure of the arterial duct and pulmonary hypertension due to toxic effects on the cardiopulmonary system; kidney dysfunction, with the further development of renal failure with oligohydroamniosis. In the mother during childbirth, the duration of bleeding may increase (and the antiplatelet effect may develop even at a low dosage) and the contractility of the uterus may decrease, and, as a result, the duration of labor may increase. Despite the lack of data on the experience of using the drug Melbek, it is known that NSAIDs penetrate into breast milk. Therefore, these drugs are contraindicated during lactation. 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. Influence on the ability to drive a car and mechanisms Studies to evaluate the effect of the drug on the ability to drive a car and mechanisms have not been conducted. However, patients should be warned that adverse reactions such as visual disturbances, dizziness, drowsiness and other disorders of the central nervous system may occur. Patients with the above symptoms should refrain from performing potentially hazardous activities such as driving or operating machinery. Dosing and Administration The daily dose should be taken once with food, drinking water or other liquid. Adverse reactions may be reduced by administration of the lowest effective dose for the shortest time necessary to control symptoms. The need for taking the drug and the effectiveness of treatment should be periodically monitored, especially in patients with osteoarthritis. Osteoarthritis in the acute stage: a daily dose of 7.5 mg (one 7.5 mg tablet or half a 15 mg tablet). If there is no effect, the dose may be increased to 15 mg per day (two 7.5 mg tablets or one 15 mg tablet). Rheumatoid arthritis, ankylosing spondylitis: 15 mg daily dose (two 7.5 mg tablets or one 15 mg tablet). (See section “Use in certain categories of patients” below). Depending on the clinical effect, the dose may be reduced to 7.5 mg per day (one 7.5 mg tablet or half a 15 mg tablet). The daily dose of meloxicam 15 mg should not be exceeded. Application in certain categories of patients In elderly patients and patients with an increased risk of adverse reactions: in elderly patients, the recommended dose for long-term treatment of rheumatoid arthritis or Bechterew’s disease is 7.5 mg per day. Patients at increased risk of developing adverse reactions should also start treatment with 7.5 mg of meloxicam per day. Use in patients with renal insufficiency: in patients with severe renal insufficiency on hemodialysis, the daily dose of meloxicam 7.5 mg should not be exceeded. In patients with mild to moderate renal insufficiency (creatinine clearance more than 25 ml / min), a dose reduction is not required (see section “Precautions”). Use in patients with hepatic insufficiency: in patients with mild and moderate hepatic insufficiency, dose reduction is not required (see section “Precautions”). Use in children: Melbek tablets are contraindicated in children and adolescents under 16 years of age. Side effects Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with an increased risk of arterial thrombosis (eg, myocardial infarction or stroke). There have been reports of the development of heart failure, edema, arterial hypertension associated with the use of NSAIDs. The most common adverse reactions are gastrointestinal disorders. Complications of peptic ulcer may develop: perforation or gastrointestinal bleeding, sometimes fatal, especially in the elderly. It was reported about the development of nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, vomiting with blood, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn’s disease, gastritis. Adverse reactions are presented by frequency of occurrence according to the following scale: very often (?1/10), often (?1/100 to <1/10), infrequently (?1/1000 to <1/100), rarely (?1 /10,000 to <1/1,000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data). Blood and lymphatic system disorders Uncommon: anemia. Rarely: a change in the blood count (including a change in the leukocyte formula), leukopenia, thrombocytopenia. In rare cases, agranulocytosis. Immune system disorders Uncommon: allergic reactions. Not known: anaphylactic reactions, anaphylactoid reactions, anaphylactic shock. Psychiatric disorders Rare: mood disorders, nightmares. Not known: confusion, disorientation. Nervous system disorders Common: headache. Uncommon: dizziness, drowsiness. On the part of the organ of vision Rarely: visual disturbances, including blurred vision, conjunctivitis. Hearing disorders and labyrinth disorders Uncommon: dizziness. Rare: ringing in the ears. Cardiac disorders Uncommon: palpitations. Cases of heart failure associated with the use of NSAIDs have been reported. Vascular disorders Infrequently: increased blood pressure, sensation of "hot flashes". Respiratory, thoracic and mediastinal disorders Rare: bronchial asthma in patients with allergic reactions to acetylsalicylic acid or other NSAIDs. Gastrointestinal disorders Very common: 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 perforations can be severe and potentially fatal, especially in elderly patients. Liver and biliary tract disorders Uncommon: Liver dysfunction (eg, elevated transaminases or bilirubin). Very rare: hepatitis. Skin and subcutaneous tissue disorders Uncommon: Quincke's edema, itching, rash. Rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria. Very rare: bullous dermatitis, erythema multiforme. Not known: photosensitivity reactions. Renal and urinary tract disorders Uncommon: sodium and water retention, hyperkalemia, impaired renal function (increased serum creatinine and/or urea levels). Very rare: acute renal failure, especially in patients with risk factors. Patients with kidney disease have an increased risk of developing acute renal failure, cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome and papillary necrosis have been reported. Other disorders Uncommon: edema, including edema of the lower extremities. Overdose In acute overdose of NSAIDs, the following symptoms may occur, which are usually reversible with maintenance therapy: weakness, drowsiness, nausea, vomiting and epigastric pain. Gastrointestinal bleeding may develop. Severe intoxication can lead to hypertension, acute renal failure, liver failure, respiratory depression, coma, convulsions, and cardiovascular failure. As well as when taking NSAIDs in therapeutic doses, with their overdose, there may be anaphylactoid reactions. Treatment is symptomatic. The antidote is not known, in case of an overdose of the drug, general maintenance therapy should be carried out. Clinical studies have shown that cholestyramine accelerates the elimination of meloxicam. Interaction with other drugs Other prostaglandin synthesis inhibitors, including glucocorticoids and salicylates (acetylsalicylic acid): the simultaneous use of prostaglandin synthesis inhibitors increases the risk of gastrointestinal ulcers and gastrointestinal bleeding due to synergistic action. The combined use of meloxicam and NSAIDs is not recommended. Co-administration with acetylsalicylic acid prescribed in anti-inflammatory doses (? 500 mg single dose or ? 3 g total daily dose) is not recommended. Oral anticoagulants, antiplatelet agents, systemic heparin, thrombolytic agents and selective serotonin reuptake inhibitors: increased risk of bleeding. The simultaneous use of NSAIDs and oral anticoagulants or heparin is not recommended for elderly patients. If it is impossible to avoid the simultaneous use of these drugs, careful monitoring of the effect of anticoagulants is necessary: careful monitoring of INR (international normalized ratio) is required. Lithium: NSAIDs increase the concentration of lithium in the blood plasma by reducing the renal excretion of lithium. The concentration of lithium in plasma can reach toxic values. The combined use of lithium and NSAIDs is not recommended. If such combination therapy is necessary, the plasma lithium concentration should be monitored at the beginning of treatment, when selecting a dose and canceling meloxicam. Methotrexate: NSAIDs may reduce tubular secretion of methotrexate and thus increase the plasma concentration of methotrexate. In this regard, patients receiving high doses of methotrexate (more than 15 mg per week), the simultaneous use of NSAIDs is not recommended. The risk of interaction with the simultaneous use of methotrexate and NSAIDs is also possible in patients receiving low doses of methotrexate, especially in patients with impaired renal function. If combination therapy is necessary, the blood count and kidney function should be monitored. Care must be taken if NSAIDs and methotrexate are used simultaneously for 3 days, because. plasma methotrexate concentration may increase and, as a result, toxic effects may occur. The simultaneous use of meloxicam did not affect the pharmacokinetics of methotrexate at a dose of 15 mg per week, however, it should be taken into account that the hematological toxicity of methotrexate increases with the simultaneous use of NSAIDs. Contraception: A decrease in the effectiveness of intrauterine contraceptive devices has been previously reported with the use of NSAIDs, but this information requires further confirmation. Diuretics: The use of NSAIDs increases the risk of acute renal failure in dehydrated patients. In patients taking Melbek and diuretics, adequate hydration should be maintained. Before starting treatment, a study of kidney function is necessary. Antihypertensive agents (eg, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, vasodilators, diuretics): NSAIDs reduce the effect of antihypertensive agents by inhibiting prostaglandins, which have vasodilatory properties. The combined use of NSAIDs and angiotensin II receptor antagonists and ACE inhibitors enhances the effect of reducing glomerular filtration. In some patients with impaired renal function (eg, patients with dehydration or elderly patients with impaired renal function), the concomitant use of an ACE inhibitor or an angiotensin II antagonist and cyclooxygenase inhibitors may lead to further deterioration of renal function, including the possibility of developing acute renal failure, such as reversible rule. This combination should be administered with caution, especially in elderly patients. Adequate hydration of the patient and monitoring of renal function after initiation of concomitant therapy and periodically during treatment are recommended. Cholestyramine, by binding to meloxicam in the gastrointestinal tract, leads to its faster elimination. This interaction is of clinical importance. NSAIDs, by acting on renal prostaglandins, may increase the nephrotoxicity of cyclosporine and tacrolimus. In the case of combination therapy, renal function should be monitored, especially in elderly patients. With the simultaneous use of meloxicam and antacids, cimetidine, digoxin, no significant pharmacokinetic interactions were identified. The possibility of interaction with oral antidiabetic agents cannot be ruled out. 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. Deferasirox: Concomitant use of meloxicam and deferasirox may increase the risk of gastrointestinal side effects. In this regard, these drugs should be taken simultaneously with caution. Pemetrexed: If meloxicam and pemetrexed are to be taken concomitantly 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 within 2 days of pemetrexed administration. 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, consequently, an increase in its side effects. Thus, concomitant use of meloxicam 15 mg and pemetrexed with normal renal function (creatinine clearance ?80 ml/min.) should be done with caution. Precautions: Adverse reactions may be reduced by administering the lowest effective dose for the shortest time necessary to control symptoms. In case of insufficient therapeutic effect, the maximum recommended daily dose (15 mg) should not be exceeded. The concomitant use of other NSAIDs should be avoided, as the risk of toxicity may increase without improving the effectiveness of treatment. The use of meloxicam in combination with other NSAIDs, including selective cyclooxygenase-2 inhibitors, is not recommended. Meloxicam is not recommended for patients requiring acute pain relief. If there is no improvement after several days of taking meloxicam, treatment should be reconsidered. Before starting treatment with meloxicam, it is necessary to clarify the history, whether the patient has previously had esophagitis, gastritis, peptic ulcer of the stomach or duodenum, and whether these conditions have been completely cured. In connection with the possible occurrence of relapse, patients with past diseases should be under constant supervision while taking meloxicam. Gastrointestinal tract: As with other NSAIDs, potentially life-threatening gastrointestinal bleeding, ulceration, or perforation may occur during treatment at any time with or without warning symptoms, regardless of the patient's history of serious gastrointestinal intestinal diseases. The above complications are usually more serious in older patients. The risk of gastrointestinal bleeding, ulcers, or perforation is higher with increasing doses of NSAIDs, in patients with a history of ulcers or bleeding, and in elderly patients. These patients should start treatment at the lowest effective dose. As with other NSAIDs, special precautions should be taken when treating patients who have or have had gastrointestinal disease. Patients who present with gastrointestinal symptoms should be monitored closely. If an ulcerative lesion of the gastrointestinal tract or gastrointestinal bleeding occurs, Melbek must be canceled. For elderly patients, as well as for patients receiving low doses of aspirin or other drugs that may increase the risk of gastrointestinal disorders, combination therapy (eg, misoprostol or proton pump inhibitors) should be considered. Patients with gastrointestinal toxicity, especially the elderly, should report the development of any unusual abdominal symptoms, especially in the early stages of treatment. Use with caution in patients receiving drugs that may increase the risk of ulceration or bleeding (elderly patients, patients receiving therapeutic doses of heparin, anticoagulants (eg, warfarin), or other NSAIDs, including acetylsalicylic acid, prescribed in anti-inflammatory doses (in Cardiovascular and cerebrovascular effects: Patients with arterial hypertension and/or mild to moderate heart failure should be monitored during treatment with NSAIDs due to possible fluid retention and increased edema. recommended in patients at risk of elevated blood pressure before and during treatment with meloxicam.Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and with long-term treatment) leads to a small increase in the risk of arterial thrombosis (for example, myocardial infarction or stroke, up to death). This risk is not excluded for meloxicam. Patients with cardiovascular disease or those with factors predisposing to the development of cardiovascular disease are at higher risk. In patients with uncontrolled arterial hypertension, congestive heart failure, coronary heart disease, peripheral arterial disease and / or cerebrovascular disease, meloxicam should be prescribed only after assessing the benefit / risk ratio. The same analysis should be carried out before starting long-term therapy in patients with risk factors for the development of cardiovascular diseases (for example, arterial hypertension, hyperlipidemia, diabetes mellitus, smoking). Impaired liver function: with the use of the drug Melbek (as with most other NSAIDs), episodic increases in serum transaminases or other indicators of liver function have been reported. In most cases, this increase was small and transient. If the identified changes are significant or do not decrease over time, Melbek should be canceled and the identified laboratory changes should be monitored. Impaired renal function: with the use of the drug Melbek (as with most other NSAIDs), episodic increases in serum creatinine or urea or other indicators of liver function have been reported. In most cases, this increase was small and transient. If the identified changes are significant or do not decrease over time, Melbek should be canceled and the identified laboratory changes should be monitored. In rare cases, NSAIDs can cause interstitial nephritis, glomerulonephritis, medullary renal necrosis, or nephrotic syndrome. In patients with end-stage renal disease who are on hemodialysis, the dose of Melbek should not exceed 7.5 mg. Dose reduction is not required for patients with minimal or moderate renal impairment (i.e., if creatinine clearance is greater than 25 ml/min). NSAIDs inhibit the synthesis of prostaglandins in the kidneys, which are involved in maintaining renal perfusion. The use of NSAIDs in patients with reduced renal blood flow or reduced circulating blood volume may lead to decompensation of renal failure. After discontinuation of NSAIDs, renal function usually returns to baseline. Elderly patients, patients with dehydration, congestive heart failure, severe liver failure, cirrhosis of the liver, nephrotic syndrome, lupus nephropathy, or other severe diseases are most at risk of developing this reaction. kidneys; patients simultaneously taking diuretics, ACE inhibitors, angiotensin II receptor antagonists, as well as patients who have undergone major surgical interventions leading to hypovolemia. In such patients, diuresis and renal function should be carefully monitored at the beginning of therapy. The use of NSAIDs can lead to retention of sodium, potassium and water, affect the natriuretic effect of diuretics. As a result, predisposed patients may experience increased signs of heart failure or hypertension. Clinical monitoring is recommended for these patients. Potassium levels should be monitored in patients with diabetes mellitus and in patients taking medications that may affect blood potassium levels. Debilitated or debilitated patients may be less able to tolerate adverse reactions, so such patients should be closely monitored. As with other NSAIDs, caution should be exercised in the treatment of elderly patients who are more likely to have impaired renal, hepatic, and cardiac function. Meloxicam, like other NSAIDs, may mask the symptoms of an infectious disease. The medicinal product contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Melbeck tablets. Potentially life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with meloxicam. Initially, a rash appears all over the body in the form of red round spots, often in the center with a blister. Additional signs: ulcers in the mouth, throat, nose, genitals, conjunctivitis (red, swollen eyes). Very often, a life-threatening skin rash is accompanied by flu-like symptoms. The rash can progress, often becoming confluent, accompanied by detachment of the epidermis. The highest risk of developing severe skin reactions during the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while taking meloxicam. you should never restart the use of this drug. If you develop a rash or other skin symptoms, stop using meloxicam, contact your doctor immediately and tell him what medications you are taking. 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 conducting research on infertility, it is necessary to consider the abolition of meloxicam. 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. Storage conditions Store at a temperature not exceeding 25 ° C in the original package. Buy Melbek tablets 15 mg No. 10x2 Price for Melbek tablets 15 mg No. 10x2