⚠️ Warnings
Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see DOSAGE AND ADMINISTRATION and gastrointestinal and cardiovascular risks below). If treatment is not effective, therapy should be discontinued. Concomitant use of nimesulide with other NSAIDs, including selective COX-2 inhibitors, should be avoided. During therapy with Nimesil, patients should be advised to refrain from using other analgesics. Nimesil contains sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicinal product. During treatment with nimesulide, concomitant use of hepatotoxic drugs and alcohol consumption should be avoided. The use of NSAIDs may mask fever associated with an underlying bacterial infection. Effects on the liver. Serious hepatic reactions associated with the use of nimesulide have been rarely reported, including very rare fatal cases (see ADVERSE REACTIONS). Patients who develop symptoms suggestive of liver injury during nimesulide treatment, such as anorexia, nausea, vomiting, abdominal pain, fatigue, or dark urine, or patients whose liver function test results deviate from normal values, should discontinue therapy. Such patients should not be re-administered nimesulide. Liver injury, in most cases reversible, has been reported after short-term exposure to the medicinal product. Patients taking nimesulide who develop fever and/or flu-like symptoms should discontinue treatment. Effects on the gastrointestinal tract. Gastrointestinal bleeding, ulceration, or perforation (with or without warning symptoms or a history of serious GI events), which may be fatal, has been reported at any time during treatment with all NSAIDs. The risk of gastrointestinal bleeding, ulceration, or perforation increases with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated by hemorrhage or perforation (see CONTRAINDICATIONS), and in elderly patients. Such patients should start treatment at the lowest possible dose. For these patients, as well as for those requiring concomitant use of low-dose acetylsalicylic acid or other agents that increase the risk of gastrointestinal complications, combination therapy with protective agents such as misoprostol or proton pump inhibitors should be considered (see below and INTERACTIONS). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment. Gastrointestinal bleeding, ulceration, or perforation may occur at any time during treatment, with or without warning symptoms or a history of GI events. If gastrointestinal bleeding or ulceration occurs, nimesulide should be discontinued. Nimesulide should be used with caution in patients with gastrointestinal disorders, including a history of peptic ulcer, gastrointestinal bleeding, ulcerative colitis, or Crohn's disease (see ADVERSE REACTIONS). Patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents such as acetylsalicylic acid, should be informed of the need to exercise caution. If patients receiving nimesulide develop gastrointestinal bleeding or ulceration, treatment should be discontinued. NSAIDs should be prescribed with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as exacerbation may occur (see ADVERSE REACTIONS). Concomitant use of nimesulide with other medicinal products, such as oral contraceptives, anticoagulants, and antiplatelet agents, may cause exacerbation of Crohn's disease and other gastrointestinal disorders. Effects on the cardiovascular and cerebrovascular systems. Patients with a history of hypertension and/or mild to moderate congestive heart failure require appropriate monitoring and medical consultation, as fluid retention and edema have been reported in association with NSAID therapy. Clinical studies and epidemiological data suggest that the use of certain NSAIDs, particularly at high doses and with prolonged treatment, may be associated with a small increased risk of arterial thrombotic events, such as myocardial infarction or stroke. There are insufficient data to exclude such a risk with nimesulide. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with nimesulide only after careful assessment. Similar assessment should be performed before initiating long-term treatment of patients with risk factors for cardiovascular disease, such as hypertension, hyperlipidemia, diabetes mellitus, or smoking. Since nimesulide may affect platelet function, it should be used with caution in patients with hemorrhagic diathesis (see also CONTRAINDICATIONS). However, Nimesil cannot replace acetylsalicylic acid for cardiovascular prophylaxis. Effects on the kidneys. Caution is advised in patients with renal impairment or heart failure, as the use of nimesulide may lead to deterioration of renal function. In such cases, treatment should be discontinued (see also INTERACTIONS). Elderly patients. Elderly patients may have an increased frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which in some cases may be fatal (see ADVERSE REACTIONS), as well as impairment of renal, cardiac, and hepatic function; therefore, appropriate clinical monitoring is recommended. Skin reactions. Very rarely, serious skin reactions, some of which are life-threatening, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with NSAIDs (see ADVERSE REACTIONS). Patients appear to be at highest risk for these reactions early in the course of treatment; in most cases, reactions occur within the first month of therapy. Nimesulide should be discontinued at the first appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity. Cases of fixed drug eruption (FDE) have been reported with the use of nimesulide. Nimesulide should not be re-administered to patients with a history of nimesulide-related FDE (see ADVERSE REACTIONS). Effects on fertility. The use of Nimesil may impair female fertility and is not recommended in women planning pregnancy. Women who have difficulty conceiving, or who are undergoing investigation for infertility, should consider discontinuing Nimesil (see Use during pregnancy or breastfeeding). Use during pregnancy or breastfeeding. Pregnancy. The use of nimesulide is contraindicated in the third trimester of pregnancy (see CONTRAINDICATIONS). Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Data from epidemiological studies suggest that in early pregnancy, the use of prostaglandin synthesis inhibitors may increase the risk of miscarriage, cardiac malformations, and gastroschisis in the fetus. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. The risk is believed to increase with increasing dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor led to increased pre- and post-implantation losses and increased embryo/fetal mortality. In addition, increased incidences of various malformations, including cardiovascular, were reported in animals receiving a prostaglandin synthesis inhibitor during organogenesis. Use of nimesulide from the 20th week of pregnancy may cause oligohydramnios due to fetal renal dysfunction. This may be observed shortly after initiation of treatment and is usually reversible upon discontinuation. In addition, cases of fetal ductal constriction have been reported following use during the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Therefore, during the first and second trimesters of pregnancy, nimesulide should not be used unless strictly necessary. If nimesulide is used by women attempting to conceive, or during the first and second trimesters of pregnancy, the lowest possible dose and shortest possible duration of treatment should be used. Antenatal monitoring for oligohydramnios and fetal ductal constriction should be considered following nimesulide exposure for several days from gestational week 20 onwards. Nimesulide should be discontinued in pregnant women if oligohydramnios or fetal ductal constriction is detected. In the third trimester of pregnancy, all prostaglandin synthesis inhibitors may cause: in the fetus: • pneumocardiac toxic effects (premature constriction/closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction, which may progress to renal failure with oligohydramnios (see above); in the mother at the end of pregnancy and in the neonate: • prolonged bleeding time, an anti-aggregation effect that may occur even at very low doses; • inhibition of uterine contractions, resulting in delayed or prolonged labor. Breastfeeding. It is not known whether nimesulide is excreted in human breast milk. Nimesulide is contraindicated during breastfeeding (see CONTRAINDICATIONS and Preclinical safety data). Fertility. As with other NSAIDs, nimesulide-containing medicinal products are not recommended for women attempting to conceive (see SPECIAL PRECAUTIONS). Women who have difficulty conceiving or who are undergoing investigation for infertility should discontinue nimesulide. If pregnancy is established during nimesulide use, the physician should be informed. Children. Nimesil is contraindicated in children under 12 years of age. Ability to drive and use machines. No studies on the effects of nimesulide-containing medicinal products on the ability to drive or operate machinery have been conducted; however, patients who experience dizziness, vertigo, or drowsiness after taking nimesulide should refrain from driving or operating machinery.
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