Nimefast pills 100mg №10×2

Name Nimefast tabl. The main active ingredient Nimesulide Release form Tablets Dosage 100 mg Indications for use Treatment of acute pain; primary dysmenorrhea. Nimesulide can only be prescribed as a second-line therapy. The decision to prescribe nimesulide should be based on an overall risk assessment for each patient. Route of administration and doses In order to minimize unwanted side effects, the minimum effective dose should be taken with the shortest duration of treatment. The maximum duration of treatment with nimesulide is 15 days. Adult patients: 1 tablet (100 mg nimesulide) twice a day after meals. Elderly patients In the treatment of elderly patients, there is no need to reduce the daily dose. Children and adolescents 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, do not need to adjust the dose 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 Nimefast is contraindicated. Patients with hepatic impairment Nimefast is contraindicated in patients with hepatic impairment. Undesirable effects of therapy can be reduced by prescribing the lowest effective dose of the drug for the shortest possible time required to treat the relevant disease. Use during pregnancy and lactation Not recommended for use during pregnancy. The use of nimesulide can impair female fertility and is not recommended for women who are planning a pregnancy, as well as those who have difficulty in pregnancy or are undergoing examination for infertility. Like other NSAIDs known to inhibit prostaglandin synthesis, nimesulide can cause premature closure of the ductus arteriosus, pulmonary hypertension, oliguria, oligoamnios, an increased risk of bleeding, weakness in labor and the development of peripheral edema. There have been isolated cases of renal failure in children of women taking nimesulide in late pregnancy. Application during lactation Penetrates into breast milk, therefore, its use during lactation is not recommended. The ability to influence the reaction rate when driving motor transport or operating other mechanisms text Precautions Undesirable side effects can be minimized by using the smallest 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. Elderly patients Elderly patients have an increased incidence of adverse reactions to non-steroidal anti-inflammatory drugs, especially gastrointestinal bleeding and perforation (in some cases even fatal), as well as renal, hepatic and cardiac dysfunction. Therefore, appropriate clinical observation is recommended. Rare cases of serious liver reactions, including very rare cases of death associated with the use of nimesulide-containing drugs, have been reported. Patients who experience symptoms similar to those of liver damage during treatment with Nimefast (eg, anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine) or patients in whom laboratory tests of liver function deviate from normal values should discontinue 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 Nimefast, the patient should refrain from taking long-term analgesics. The concomitant use of Nimefast 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, ulceration, and ulcer perforation may be life-threatening if there is a history of such problems with any NSAIDs during treatment (regardless of time elapsed), with or without the presence of dangerous symptoms, or the presence of 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 non-steroidal anti-inflammatory drug, in patients with a history of ulcers, especially those complicated by hemorrhage or perforation, and in elderly patients. For these patients, treatment should be initiated at the lowest possible dose. For these patients, as well as patients 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 precursor symptoms or a history of gastrointestinal pathology. With the development of gastrointestinal bleeding or ulceration, 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. If gastrointestinal bleeding or ulcers occur in patients receiving Nimefast, treatment with the drug 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. Nimefast should be used with caution in patients with renal or cardiac insufficiency 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 non-steroidal anti-inflammatory drugs 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. Nimefast should be discontinued at the first sign of skin rash, mucosal lesions and other signs of hypersensitivity. Renal disorders It is necessary to prescribe the drug with caution in 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. In women who have problems conceiving or who are being examined for infertility, the possibility of discontinuing nimesulide should be considered. Cardiovascular and cerebrovascular disorders Patients with arterial hypertension and / or mild / moderate acute heart failure in history, as well as patients with the occurrence of fluid retention in the body and edema as a reaction to the use of NSAID therapy, require appropriate monitoring of the condition and consultation with a physician . Clinical studies and epidemiological data suggest that some non-steroidal anti-inflammatory drugs, 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, Nimefast does not replace acetylsalicylic acid in the prevention of cardiovascular disease. Influence on the ability to drive vehicles and control mechanisms Patients who experience dizziness or drowsiness should refrain from driving a car and working with mechanisms that require increased concentration and precise coordination of movements when using Nimefast. Interaction with other drugs Pharmacodynamic interactions: Other non-steroidal anti-inflammatory drugs (NSAIDs) The combined use of drugs containing nimesulide and other non-steroidal anti-inflammatory drugs, including acetylsalicylic acid in anti-inflammatory doses (? 1 g once or ? 3 g as a total daily dose), 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 is 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), angiotensin type 2 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 Nimefast together with ACE inhibitors or APAs. 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 Nimefast to patients receiving lithium therapy, 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 antacids (eg, a combination of aluminum and magnesium hydroxide). No clinically significant interactions were observed. Nimesulide inhibits the activity of the CYP2C9 enzyme. When taking drugs that are substrates of this enzyme with Nimefast, 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, prostaglandin synthetase inhibitors, such as 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. Contraindications known hypersensitivity to nimesulide or to one of the excipients of the drug; past hyperergic reactions (for example, bronchospasm, rhinitis, urticaria) in connection with the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs; past hepatoxic reactions to nimesulide; concomitant use of other substances with potential hepatotoxicity; alcoholism, drug addiction; previous gastrointestinal bleeding or perforation associated with previous NSAID therapy; gastric or duodenal ulcer in the acute phase, a history of ulcers, perforation or bleeding in the gastrointestinal tract; a history of cerebrovascular bleeding or other hemorrhages, as well as diseases accompanied by bleeding; severe blood clotting disorders; severe heart failure; severe renal failure; liver failure; patients with cold or flu symptoms; age up to 12 years; the appointment of the drug is contraindicated in the third trimester of pregnancy and during lactation. Composition Each tablet contains: active substance: nimesulide 100 mg; excipients: microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, povidone, lactose monohydrate. Overdose Symptoms of 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 overdose of NSAIDs, 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 an overdose of the drug. In the presence of overdose symptoms 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 drug binding to blood proteins. The functions of the kidneys and liver should be monitored. Side effectsAccording to the results of clinical studies and epidemiological data, the use of some NSAIDs, especially at high doses and 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, blood vomiting, 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 obtained from controlled clinical trials* (approximately 7800 patients) and from post-marketing studies. The frequency of cases is classified as follows: very often (? 1/10); often (? 1/100, < 1/10), sometimes (? 1/1,000, < 1/100); rare (? 1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated cases. Circulatory and lymphatic system disorders: Rare - Anemia*, Eosinophilia* Very rare - Thrombocytopenia, Pancytopenia, Purpura Immune system disorders: Rare - Hypersensitivity* Very rare - Anaphylaxis Metabolic and nutritional disorders: Rare - Hyperkalemia * Psychiatric disorders: Rarely - Fear*, Nervousness*, Nightmarish dreams* Nervous system disorders: Sometimes - Dizziness* Very rare - Headache, Drowsiness, Encephalopathy (Reye's syndrome) Visual disturbances: Rare - Blurred vision* Very rare - Visual impairment Hearing and labyrinth disorders Very rare - Vertigo Heart disease: Rare - Tachycardia* Vascular disorders: Uncommon - Hypertension* Rare - Hemorrhage*, Blood pressure lability*, Hot flashes* Respiratory tract disorders: Uncommon - Shortness of breath * Very rare - Asthma, Bronchospasm Gastrointestinal disorders: Often - Diarrhea*, Nausea, *Vomiting* Sometimes - Constipation*, Flatulence*, Gastrointestinal bleeding, ulcer and perforation 12-p. intestines, gastric ulcer and perforation Very rare - Gastritis*, Abdominal pain, Dyspepsia, Stomatitis, Tar-like stools Liver and biliary system disorders: Common - Elevated liver enzymes Very rare - Hepatitis, Fulminant hepatitis (including fatal outcomes), Jaundice, Cholestasis Pathology of the skin and subcutaneous tissue: Sometimes - Itching*, Rash*, Increased sweating* Rarely - Erythema*, Dermatitis* Very rarely - Urticaria, Angioedema, Facial edema, Erythema polyforme, Stevens-Johnson Syndrome, Toxic epidermal necrolysis Renal and urinary disorders: Rare - Dysuria*, Hematuria* Very rare - Urinary retention, *Renal failure, Oliguria, Interstitial nephritis General disorders and local drug reactions: Uncommon - Edema* Rare - Malaise*, Asthenia* Very rare - Hypothermia *frequency based on results of clinical trials Storage conditionsStore away from light and moisture at temperatures not higher than 25 °C. 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