Nimesulide-LF tablets 100mg №10×2

Product Description Nimesulide-lf. Forms of release Tablets. INN Nimesulide. Description: Round tablets, light yellow in color, with a smooth biconvex surface. Composition 1 tablet contains: Active substance: nimesulide – 100 mg. Excipients: microcrystalline cellulose, corn starch, sodium starch glycolate, anhydrous colloidal silicon dioxide, talc, magnesium stearate, calcium hydrogen phosphate dihydrate. Pharmacotherapeutic group Other nonsteroidal anti-inflammatory antirheumatic drugs. ATH code: M01AX17. Indications for use – treatment of acute pain; – primary dysmenorrhea. The drug can only be prescribed as a second-line therapy. The decision to prescribe a drug should be based on an assessment of the overall risk in each individual patient. Route of administration and doses In order to minimize unwanted side effects, the minimum effective dose should be taken with the shortest possible course of treatment. The maximum duration of taking nimesulide should not exceed 15 days. For oral administration. Tablets are washed down with a sufficient amount of water. Adults are prescribed 100 mg (1 tablet) 2 times a day after meals. The maximum daily dose is 200 mg. Dose adjustment of the drug in the elderly is not required. Children Children (under 12 years of age): for this category of patients, the appointment of nimesulide-containing drugs is contraindicated. Adolescents (12 to 18 years of age): based on the pharmacokinetic profile in adults and the pharmacodynamic characteristics of nimesulide, there is no need to adjust the dose in adolescents. Patients with impaired renal function Based on pharmacokinetic data, there is no need for dose adjustment in patients with mild to moderate renal insufficiency (creatinine clearance 30-80 ml / min), while in patients with severe renal insufficiency (creatinine clearance < 30 ml / min). min) the appointment of nimesulide is contraindicated. Patients with hepatic insufficiency Nimesulide is contraindicated in patients with hepatic insufficiency. Undesirable effects of therapy can be reduced by prescribing the lowest effective dose of the drug for the shortest possible time required for treatment. If you have any further questions about taking this medicine, ask your doctor. Contraindications - hypersensitivity to nimesulide or excipients in history; - hypersensitivity reactions (such as bronchospasm, rhinitis, urticaria) to acetylsalicylic acid or other NSAIDs in history; - hepatotoxic reactions to nimesulide in history; - gastric or duodenal ulcer, recurrent erosive and ulcerative lesion of the gastrointestinal tract, history of gastrointestinal or cerebral hemorrhages; - previous gastrointestinal bleeding or perforation associated with previous NSAID therapy; - severe disorders of the blood coagulation system; - severe heart failure; - severe impairment of kidney function; - violations of liver function; - children's age up to 12 years; - pregnancy; - the period of breastfeeding; - simultaneous appointment with other potentially hepatotoxic drugs; - alcoholism, drug addiction; - fever and/or flu-like symptoms. Side effect Description of the safety profile According to the results of clinical studies and epidemiological data, the use of some NSAIDs, especially in high doses for a long time, may be accompanied by a slight increase in the risk of developing pathologies caused by arterial thrombosis (for example, myocardial infarction or stroke). During treatment with NSAIDs, edema, increased blood pressure and heart failure have also been reported. With the use of NSAIDs, there is evidence of very rare cases of bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. In the treatment of NSAIDs, the most common adverse events were those of the gastrointestinal tract. Peptic ulcer, perforation, or gastrointestinal bleeding may develop, sometimes fatal, especially in elderly patients. There are reports of nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, tarry stools, vomiting of blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease after taking the drug. Rarely observed gastritis. The side effects listed below are based on data from controlled clinical trials*. The frequency of adverse reactions indicated below was determined using the following note: very often (> 1/10), often (> 1/100 – < 1/10), infrequently (> 1/1.000 – < 1/100), rarely (> 1 /10.000 – < 1/1.000), very rare (< 1/10.000), unknown (cannot be determined from the available data). Blood and lymphatic system disorders: rarely - anemia*, eosinophilia*; very rarely - thrombocytopenia, pancytopenia, purpura. Immune system disorders: rarely - hypersensitivity reaction *; very rarely - anaphylaxis. Metabolic disorders: rarely - hyperkalemia *. Mental disorders: rarely - a feeling of fear *, nervousness *, nightmares *. Nervous system disorders: infrequently - dizziness *; very rarely - headache, drowsiness, encephalopathy (Reye's syndrome). On the part of the organs of vision: rarely - blurred vision; very rarely - visual impairment. Hearing and vestibular disorders: very rarely - vertigo. Cardiac disorders: rarely - tachycardia *. Vascular disorders: infrequently - arterial hypertension *; rarely - hemorrhage *, lability of blood pressure *, "hot flashes" *. Respiratory system disorders: infrequently - shortness of breath *; very rarely - asthma, bronchospasm. Gastrointestinal disorders: often - diarrhea*, nausea*, vomiting*; infrequently - constipation *, flatulence *, gastrointestinal bleeding, ulcer and perforation of the duodenum, stomach ulcer and its perforation; very rarely - gastritis *, abdominal pain, dyspepsia, stomatitis, melena (tarry stools). On the part of the hepatobiliary system: often - an increased level of liver enzymes; very rarely - hepatitis (including transient fatal), jaundice, cholestasis. Skin and skin tissue disorders: infrequently - itching*, rash*, excessive sweating*; rarely - erythema*, dermatitis*; very rarely - urticaria *, angioedema *, swelling of the face *, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Renal and urinary tract disorders: rarely - hematuria*, dysuria*; very rarely - urinary retention *, renal failure, oliguria, interstitial nephritis. General disorders: infrequently - edema *; rarely - general malaise *, asthenia *; very rarely - hypothermia. * - frequency is based on the results of clinical trials. In the event of adverse reactions, including those not listed in this leaflet, you must stop taking the drug and consult a doctor. Overdose Symptoms of an acute overdose of NSAIDs are usually limited to the following: apathy, drowsiness, nausea, vomiting and pain in the epigastric region. With maintenance therapy, these symptoms are usually reversible. Gastrointestinal bleeding may occur. In rare cases, it is possible to increase blood pressure, acute renal failure, respiratory depression and coma. Anaphylactoid reactions have been reported with therapeutic doses of NSAIDs and with an overdose of such drugs. In case of NSAID overdose, treatment is symptomatic and supportive. There is no specific antidote. There are no data on the elimination of nimesulide by hemodialysis, however, based on the high level of plasma protein binding (up to 97.5%), it can be concluded that dialysis is ineffective in case of drug overdose. If symptoms of an overdose are present or after taking a large dose of the drug within 4 hours after ingestion, patients may be prescribed: inducing vomiting and / or taking activated charcoal (60-100 grams for adults) and / or taking an osmotic laxative. Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may be ineffective due to the high level of nimesulide binding to blood proteins. The functions of the kidneys and liver should be monitored. Precautions Unwanted side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control the symptoms of the disease. In the absence of improvement in symptoms, drug therapy should be discontinued. In elderly patients, the frequency of adverse reactions to NSAIDs is increased, especially the frequency of gastrointestinal bleeding and perforation (in some cases even fatal), as well as impaired renal, hepatic and cardiac function. Therefore, appropriate clinical observation is recommended. Liver disorders Rare cases of serious liver reactions, including very rare cases of death, have been reported associated with the use of nimesulide-containing medicinal products. Patients who experience symptoms similar to those of liver damage during treatment with nimesulide (eg, anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine) or patients whose liver function laboratory tests deviate from normal values should stop drug treatment. Re-appointment of nimesulide in such patients is contraindicated. Liver damage, in most cases reversible, has been reported after short-term exposure to the drug. During treatment with nimesulide, the patient should refrain from taking other analgesics. The concomitant use of nimesulide and other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Patients treated with nimesulide and who develop flu-like or cold-like symptoms should discontinue treatment with the drug. Gastrointestinal disorders Gastrointestinal bleeding, ulcers, and perforation of the ulcer may be life-threatening if there is a history of such problems with any NSAID during treatment (regardless of time elapsed), with or without dangerous symptoms, or a history of serious disorders of the gastrointestinal tract. The risk of gastrointestinal bleeding, ulceration or perforation of the ulcer increases with increasing dose of NSAIDs in patients with a history of ulcers, especially those complicated by hemorrhage or perforation, as well as in elderly patients. For these patients, treatment should be initiated at the lowest possible dose. For these patients, as well as patients who are taking concomitant low doses of aspirin or other drugs that increase the risk of gastrointestinal disease, combination therapy with protective agents (eg, misoprostol or proton pump inhibitors) should be considered. Patients with gastrointestinal toxicity, especially the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding). This is especially important in the early stages of treatment. Gastrointestinal bleeding, as well as the formation of ulcers or perforation, are noted for all NSAIDs at different stages of treatment, regardless of the presence of symptoms-precursors or the presence of a history of gastrointestinal pathology. With the development of gastrointestinal bleeding or manifestations, nimesulide should be discontinued. Nimesulide should be used with caution in patients with gastrointestinal disorders, including peptic ulcer, history of gastrointestinal bleeding, ulcerative colitis, and Crohn's disease. Patients taking concomitant medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin, should be advised to take the drug with caution. funds. In the event of gastrointestinal bleeding or ulcers in patients receiving nimesulide, drug 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 diseases may worsen. In patients with renal or heart failure, nimesulide should be used with caution, as the drug may impair renal function. If the condition worsens, treatment should be discontinued. Skin reactions Very rare cases of severe skin reactions to NSAIDs have been reported, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, some of which can be fatal. Patients appear to be most at risk of developing skin reactions during the initial period of therapy. Nimesulide should be discontinued at the first sign of skin rash, mucosal lesions and other signs of hypersensitivity. Renal disorders Care should be taken when prescribing the drug to patients with impaired renal or cardiac function, since the use of nimesulide may lead to deterioration of renal function. In case of deterioration, treatment should be interrupted. Influence on fertility The use of nimesulide can reduce female fertility, so it is not recommended to prescribe it to women planning a pregnancy. Discontinuation of nimesulide should be considered in women who have problems conceiving or who are undergoing infertility testing. Disorders of the cardiovascular and cerebrovascular systems the occurrence of fluid retention in the body and edema, as a reaction to the use of NSAID therapy, requires appropriate monitoring of the condition and consultation with a doctor. Clinical studies and epidemiological data suggest that some NSAIDs, especially at high doses and with long-term use, may lead to a small risk of arterial thrombotic events (eg, myocardial infarction or stroke). There are not enough data to exclude the risk of such events when using nimesulide. In patients with uncontrolled arterial hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease, nimesulide should be prescribed after a thorough evaluation of the condition. An equally thorough assessment of the condition should be performed before starting long-term treatment in patients with risk factors for the development of cardiovascular disease (for example, arterial hypertension, hyperlipidemia, diabetes mellitus, smoking). Since nimesulide can affect platelet function, it should be used with caution in patients with hemorrhagic diathesis. However, nimesulide does not replace acetylsalicylic acid in the prevention of cardiovascular disease. Use in Pediatrics The use of nimesulide in children under 12 years of age is contraindicated. Use during pregnancy and lactation Pregnancy Suppression of prostaglandin synthesis may adversely affect pregnancy and / or fetal development. Data obtained from epidemiological studies suggest that the use of drugs that inhibit prostaglandin synthesis in early pregnancy may increase the risk of spontaneous abortion, fetal heart disease and gastroschisis. The absolute risk of an abnormal cardiovascular system increased from less than 1% to about 1.5%. It is believed that the risk increases with increasing dose and duration of use. In animals, administration of a prostaglandin synthesis inhibitor resulted in increased pre- and post-implantation loss and increased fetal mortality. In addition, data were obtained that in animals treated with a prostaglandin synthesis inhibitor during organogenesis, the incidence of various fetal malformations, including those of the cardiovascular system, increased. Do not take nimesulide during the first and second trimester of pregnancy unless absolutely necessary. In the case of the use of the drug by women trying to become pregnant, or in the first and second trimester of pregnancy, the lowest possible dose and the shortest possible duration of treatment should be chosen. In the third trimester of pregnancy, all prostaglandin synthesis inhibitors: 1) can lead to the development of the fetus: - pneumocardial toxic damage (with premature closure of the arterial ducts and hypertension in the pulmonary artery system); - renal dysfunction, which can progress to renal failure with the development of oligohydramnios; 2) in the mother and fetus at the end of pregnancy, it is possible: - an increase in bleeding time, an antiaggregatory effect, which can occur even when using very low doses of the drug; - suppression of the contractile activity of the uterus, which can lead to a delay or lengthening of the period of childbirth. Therefore, nimesulide is contraindicated in the third trimester of pregnancy. Breast-feeding At the moment, it is not known whether nimesulide is excreted in breast milk. Nimesulide is contraindicated for use in nursing mothers. Fertility Like other NSAIDs, drugs containing nimesulide are not recommended for women planning pregnancy. Influence on the ability to drive a car or other mechanisms Studies on the effect of a nimesulide-containing drug on the ability to drive vehicles and drive machines and mechanisms have not been conducted. Despite this, patients experiencing headache, dizziness or drowsiness after taking nimesulide should not drive a vehicle, machines or mechanisms. Interactions with other medicinesAlways tell your doctor what medicines you are taking or have recently taken, even if they are over-the-counter medicines. Pharmacodynamic interactions Other non-steroidal anti-inflammatory drugs (NSAIDs) The combined use of drugs containing nimesulide and other NSAIDs, including acetylsalicylic acid in anti-inflammatory doses (> 1 g once or > 3 g as a total daily dose), is not recommended. Corticosteroids: Increase the risk of gastrointestinal ulcers or bleeding. Anticoagulants: NSAIDs may increase the effect of anticoagulants such as warfarin or acetylsalicylic acid. Due to the increased risk of bleeding, this combination is not recommended and contraindicated in patients with severe coagulation disorders. If combination therapy still cannot be avoided, careful monitoring of blood coagulation parameters should be carried out. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): Increase the risk of gastrointestinal bleeding. Diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), type 2 angiotensin receptor antagonists (AIIA): NSAIDs may reduce the effectiveness of diuretics and other antihypertensive drugs. In some patients with impaired renal function (for example, in patients with dehydration or in elderly patients), the co-administration of ACE inhibitors or angiotensin II antagonists, as well as substances that suppress the cyclooxygenase system, can cause a further decrease in kidney function up to acute renal failure, which is usually reversible. This interaction should be taken into account in patients taking nimesulide in conjunction with ACE inhibitors or AHAs. Therefore, when prescribing this combination of drugs, care should be taken, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of combination therapy and periodically thereafter. Pharmacokinetic interactions: effects of nimesulide on the pharmacokinetics of other drugs Furosemide: in healthy volunteers, nimesulide temporarily reduced the effect of furosemide on sodium excretion, to a lesser extent, on potassium excretion, and reduced the diuretic response. Co-administration of nimesulide and furosemide leads to a decrease (approximately 20%) in the area under the concentration-time curve (AUC) and a decrease in the cumulative excretion of furosemide without changing the renal clearance of furosemide. The co-administration of furosemide and drugs containing nimesulide requires caution in patients with impaired renal or cardiac function. Lithium: There is evidence that NSAIDs reduce the clearance of lithium, resulting in increased plasma lithium levels and lithium toxicity. When prescribing nimesulide to patients receiving therapy with lithium drugs, frequent monitoring of plasma lithium levels should be carried out. In vivo studies have been conducted to identify possible pharmacokinetic interactions with glibenclamide, theophylline, warfarin, digoxin, cimetidine, and antacid drugs (eg, a combination of aluminum and magnesium hydroxide). No clinically significant interactions were observed. Nimesulide inhibits the activity of the CYP2C9 enzyme. While taking drugs that are substrates of this enzyme with nimesulide, the concentration of these drugs in plasma may increase. When prescribing nimesulide less than 24 hours before or less than 24 hours after taking methotrexate, care must be taken, since in such cases the plasma level of methotrexate and, accordingly, the toxic effects of this drug may increase. In connection with the action on renal prostaglandins, inhibitors of prostaglandin synthesis, which include nimesulide, may increase the nephrotoxicity of cyclosporins. Pharmacokinetic interactions: effects of other drugs on the pharmacokinetics of nimesulide In vitro studies have shown that nimesulide is displaced from the binding sites by tolbutamide, salicylic acid and valproic acid. Despite the fact that these interactions were determined in blood plasma, these effects were not observed during the clinical use of the drug. 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 3 years. Do not use after the expiry date stated on the package. Packing: 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. Terms of releaseBy prescription. Buy Nimesulide-LF tablets 100mg No. 10×2 Price for Nimesulide-LF tablets 100mg No. 10×2