Nimesil instructions for use • Price in Ukrainian pharmacies

Nimesil is a branded drug representing the group of non-steroidal anti-inflammatory drugs, which was first registered in Italy and has been used for 35 years to relieve attacks of acute pain and inflammation.

The composition of the drug includes nimesulide, which belongs to sulfonamide derivatives and has a threefold pharmacological effect:

anti-inflammatory;
painkillers;
antipyretic.

Nimesil is the first drug that selectively inhibits the activity of the enzyme cyclooxygenase-2, which is formed in an inflamed lesion after damage to an organ or tissue, which leads to a slowdown in the synthesis of prostaglandins and a decrease in inflammation, attacks of pain and a decrease in temperature.

For what diseases do you need to take nimesil?

The drug is used as prescribed by a doctor as a “second-line” medication and is added to therapy additionally when other drugs fail to relieve an attack of pain and relieve symptoms of inflammation that are caused by:

toothache;
painful menstruation and inflammation of the genital organs in women and men;
damage to joints and ligaments that occur due to injuries, dislocations, fractures, sprains;
pain in the spine and back;
degenerative changes in joints with osteoarthritis.

How to take Nimesil?

The drug is prescribed to adults and adolescents from 12 years of age, 1 sachet twice a day after meals.

The granules are dissolved in half a glass of warm water, mixed and drunk immediately, since the medicine is prepared before use.

Nimesil for toothache reduces the patient's suffering within 20 minutes, reduces temperature and reduces swelling in tissues during inflammatory diseases in the oral cavity. The drug is used to relieve the symptoms of the disease, so the patient needs to see a dentist.

Nimesil for headaches is used to relieve attacks that are caused by migraines and occur due to changes in weather conditions, fatigue or stressful situations. A single dose is enough for the patient; improvement occurs within 40 minutes and lasts 12 hours.

Nimesil in gynecology is prescribed for premenstrual syndrome, inflammation of the female organs, and endometriosis. The dosage form in powder form is absorbed and acts faster than tablets. A decrease in inflammation symptoms occurs on the second day of treatment.

Nimesil during menstruation is used on the first day of the cycle or two days before the start of menstruation and helps a woman prevent or cope with painful sensations after 25 minutes. The effect of the medicine lasts 6 hours.

Nimesil for cystitis is used in complex treatment and reduces temperature and pain during urination, reduces inflammation. The medication alleviates the symptoms of the disease in women 30 minutes after administration and lasts for seven hours.

Nimesil for osteochondrosis is the most effective drug in the fight against pain and inflammation, which is caused by depletion and deformation of articular cartilage. The medicine is used according to a standard regimen as prescribed by a doctor. The course of treatment should not exceed two weeks.

Experience of using Nimesil in the treatment of gouty arthritis

About the article

19063

Regular issues of "RMZh" No. 8 dated April 29, 2005 p. 552

Category: General articles

Authors: Yakunina I.A. , Barskova V.G. , Nasonova V.A.

For quotation:

Yakunina I.A., Barskova V.G., Nasonova V.A. Experience of using Nimesil in the treatment of gouty arthritis. RMJ. 2005;8:552.

Gout is a systemic tophi disease characterized by the deposition of monosodium urate (MSU) crystals in various tissues and the resulting inflammation in individuals with hyperuricemia caused by environmental and/or genetic factors [1].

For rheumatologists, general practitioners, and doctors of other specialties who encounter patients with gout in their work, the first task is to relieve an acute attack of arthritis. The choice of drug is based on the doctor’s personal commitment to a certain group of drugs, his awareness of the effectiveness and safety of this drug, as well as the presence of concomitant pathology in a particular patient. At the present stage, therapy with non-steroidal anti-inflammatory drugs (NSAIDs) is in first place in the treatment of both acute attacks and chronic joint damage due to gout. One of the promising areas is the use of selective COX-2 inhibitors. Since there is currently sufficient data indicating that the main therapeutic effects of NSAIDs are the result of inhibition of COX-2, and the development of adverse reactions is associated with inhibition of COX-1, therefore, the use of “classical” NSAIDs leads to the suppression of both isoforms of cyclooxygenase, which sufficient anti-inflammatory effect is associated with an increased risk of adverse reactions [2]. The most common of them are NSAID gastropathy, kidney and liver damage, arterial hypertension, and the development of peripheral edema. The experience of using COX-2 inhibitors in clinical practice indicates that the main task that was set during the development of this class of drugs - reducing gastrointestinal toxicity - was solved very successfully by choosing effective antiulcer therapy [3]. Along with damage to the gastrointestinal tract, all NSAIDs can potentially have a negative effect on kidney function and the circulatory system. The risk of cardiovascular and renal complications is especially high in older people, as well as those suffering from related concomitant diseases, which is primarily relevant for patients with gout. Only one study has been published comparing the effectiveness of the selective COX-2 inhibitor etoricoxib in gouty arthritis with indomethacin [3]. An open controlled study on the effectiveness of nimesulide (Nimesil®, Berlin-Chemie) in acute and chronic gouty arthritis was conducted at the State Institute of Rheumatology. The first stage of our study, which was mainly aimed at studying the effectiveness of the drug, showed the brilliant potential of the drug against gouty inflammation [4]. An equally important issue is the safety of therapy, for which it is necessary to take into account the characteristics of the disease as a whole. It is well known that gout is accompanied by a wide range of metabolic disorders, among which arterial hypertension, liver and kidney damage of various origins, and type 2 diabetes are in first place. Moreover, the majority of patients with gout are people of middle and older age groups, and therefore it is necessary to take into account age-related changes in internal organs and polypharmacy, which leads to an increase in the number of adverse reactions. Currently, we have accumulated experience in treating 52 patients, and in this work we included some special studies to assess the safety of Nimesil. Material and methods The study included 52 men with gout; the diagnosis met the Wallas criteria [5]. The age of the patients was 35–79 years (on average 52.4 years), the average duration of the disease was 6.7 years, with 13 patients having more than 10 years. 38 patients had acute arthritis, in 30 of them the frequency of attacks per year ranged from 1 to 4, and in 8 there was a continuously relapsing course of arthritis. 14 patients had chronic arthritis. Damage to one joint (metatarsophalangeal 1st finger) was observed in 21 patients, damage to 2–3 joints – in 24 patients, a tendency towards a polyarticular course (4–6 joints) – in 7 patients. The duration of arthritis before treatment was on average 26 days (1–150 days). In the first 10 days of arthritis, 31 patients applied, during the first month - 7 patients, 14 patients applied later (the maximum period of inflammatory phenomena was 5 months). Before Nimesil was prescribed, 26 patients were taking other NSAIDs (diclofenac, indomethacin), of which 14 were patients with chronic arthritis. Replacing one drug with another occurred only in case of ineffectiveness of the previously used drug, which was regarded as the absence or insufficient effect on the articular syndrome for at least 7 days of continuous use. In 21 patients, upon inclusion in the study, an increase in blood pressure > 140 and 90 mm Hg was detected. Doses of antihypertensive drugs remained unchanged in those patients who used this therapy. Nimesil was prescribed in a standard dose of 100 mg per day, twice a day, for 14 or 21 days. The duration of the course of treatment depended on the dynamics of clinical manifestations determined by the patient and the doctor, but always until the arthritis was completely relieved. 21 days of therapy were required for 14 patients with chronic gouty arthritis. Clinical assessment by a doctor was carried out on days 1, 5, 14 and, in the case of a 21-day course, on the last day of taking the drug. At the first stage, the effectiveness of the drug was assessed using the following indicators: 1. Joint swelling index in points (0 – no swelling, 1 – palpable swelling, 2 – visible swelling, 3 – severe swelling). 2. Hyperemia of the skin over the joint in points (0 – none, 1 – mild, weak, 2 – average, moderate, 3 – severe). 3. Joint index in points (0 – no pain, 1 – pain on palpation, which the patient talks about, 2 – pain on palpation, causing the patient to make a grimace, 3 – pain on palpation, causing the patient to withdraw the affected limb). 4. Pain at rest and with movement, assessed using a visual analogue scale (VAS) in mm. 5. Nature of pain and level of functional activity (patients filled out a modified Holes questionnaire at each visit). 6. Blood pressure level (measured manually). 7. Clinical and biochemical blood tests (performed on the first and last visit). At the second stage of the study, the safety of the drug was assessed in 20 patients, and therefore the glomerular filtration rate (GFR) was additionally studied and double 24-hour blood pressure monitoring (ABPM) was carried out - on the first and last visits. Computer processing of the results was carried out using the statistical software package Statistica, version 5. Results and discussion The main manifestation of gout is arthritis, one of the most painful among all joint diseases. In order to effectively and safely relieve joint damage, various groups of drugs are used, the main of which are NSAIDs. In this case, not only the choice of drug is important, but also the duration of therapy. Taking into account the generally accepted opinion of experts, patients were recommended to take the drug until the arthritis is completely resolved and then for several more days to prevent a rapidly developing subsequent exacerbation. In our previous open study, the decision on the timing of therapy was made only on the basis of the dynamics of the clinical manifestations of arthritis, determined jointly by the patient and the doctor, but always until it was completely relieved [4]. Interestingly, in the study on the effectiveness of etoricoxib cited above, the course of treatment for acute arthritis was 14 days, despite a pronounced effect already by the 8th day of therapy [3]. Taking into account this experience, patients were divided according to the duration of therapy depending on the clinical picture of arthritis, and a 14-day course was effective in 38 patients, and 14 patients required an extension of therapy for another week (due to persistent inflammation in the joints). After the end of the study, those factors that influenced the duration of the course of therapy were identified. It is worth dwelling on the main ones: this is the duration of the current exacerbation, which amounted to 52 days in the group of patients with a 21-day course of therapy and 10 days with a 14-day course (p As can be seen from Table 1, at the first examination all patients had almost signs of inflammation were most pronounced in all respects. Attention was drawn to the severity of hyperemia of the skin and swelling of the affected joints, as well as the severity of pain at rest and during movement. As a result of the therapy, dynamic observation showed a rapid onset of a positive effect: already on the 5th day therapy, a halving of inflammation and pain in the joints was noted. In all patients with acute arthritis by day 14, but, more importantly, in all patients with chronic arthritis, complete relief was achieved by day 21. These data indicate good effectiveness Nimesil courses in patients with different durations of arthritis, provided that all symptoms of joint inflammation are completely relieved. Table 2 reflects the dynamics of patients’ subjective assessment of pain intensity and limits of motor activity. The greatest interest is caused not only by the expressed intensity of pain (which corresponds to the classic manifestations of gouty arthritis, as one of the most painful), but also by clear evidence of what consequences arthritis leads to in the patient’s real life and how much the work capacity index decreases. Thus, the walking function was significantly limited: in most patients it was no more than 200 meters. It can be considered indicative that the decrease in participation in social life turned out to be the most significant for patients with gout, since it was in this section of the questionnaire that the highest average score was scored - 3.1, which is typical for patients with gout, since most of them remain active. life position. Changes in sleep duration, etc. were noted. Thus, the total score on the questionnaire, reflecting the patient’s subjective assessment of his condition, reached only half the capabilities of a healthy person and amounted to 49% of the ability to work. However, by the 5th day of taking Nimesil, there was a pronounced positive dynamics in the Osversti disability index, which decreased by 2 times, and at the end of therapy, regardless of its duration, all study participants were ready to return to their daily duties, without limiting the work they performed. The results of biochemical and clinical blood tests are shown in Table 3. This study is of interest in connection with the assessment of the state of liver function in patients taking Nimesil for 2–3 weeks. This cohort of patients can be considered as a group of people at high risk of developing hepatotoxic reactions, taking into account the inherent addiction of patients with gout to nutritional disorders, alcohol intake, as well as a number of metabolic disorders, which are factors that have a negative impact on the condition of the liver. The presence of initial damage to hepatocytes was confirmed by an increase in aminotransferases (ALT in 25%, AST in 15% of patients), and in some patients the ALT level was 2–2.5 times higher than normal. An increase in g-GT was observed in 50% of patients. The use of Nimesil did not lead to negative dynamics of biochemical parameters characterizing the state of hepatocytes, with the exception of 1 patient who initially had an elevated ALT level. On the contrary, a number of patients showed a decrease in the levels of ALT, AST and g-GT, which was probably the result of an explanatory conversation conducted by doctors, a transition to dietary nutrition, and a refusal to drink alcohol. Assessing renal function in patients with gout while using NSAIDs is important for several reasons. First, kidney damage is a common symptom in people with gout. The genesis of the lesion is due to a number of reasons: hyperuricemia itself and the formation of tophi, age, vascular risk factors, in particular hypertriglyceridemia and hypertension [7,8]. Secondly, the influence of “classical” NSAIDs is well known, which, when entering the body, accumulate to the greatest extent in the area of inflammation, and also obligately damage the interstitium of the kidneys, which further leads to the development of chronic renal failure and arterial hypertension, which is especially important for elderly patients , constituting the main cohort of patients with gout. Dynamic monitoring of serum creatinine and urea levels, as well as glomerular filtration rate (GFR) did not reveal significant changes in these indicators. The mean GFR levels before and after therapy were 118.2±50.0 ml/min and 141.8±98.0 ml/min, respectively. Although, when gout was combined with type 2 diabetes, 2 elderly patients showed a clinically significant, but subsequently reversible, decrease in GFR. When assessing the safety of Nimesil in patients with gouty arthritis, one of the objectives was to evaluate the effect on blood pressure. When using the manual method of measuring blood pressure at each visit, we did not notice any significant movement in the dynamics of blood pressure. The use of 24-hour blood pressure monitoring (ABPM) showed that in patients without hypertension receiving Nimesil, the change in average SBP/DBP values was unreliable and amounted to 2–5 mm Hg, variability indices (IV) changed slightly, and the 24-hour blood pressure profile significantly improved . A third of the patients had elevated blood pressure, up to a maximum of 200/130 mmHg, all of these patients received antihypertensive therapy (ACE inhibitors and b-blockers). When taking the drug for two weeks in such patients, ABPM values did not change, and in some values even decreased. SBP (by 16 mmHg) and DBP (by 8 mmHg) significantly decreased, and the circadian rhythm normalized (Fig. 1). This may be partly due to the significant reduction in pain. Tolerability of Nimesil therapy was generally good. Adverse reactions noted during therapy, requiring discontinuation of the drug, were recorded in 5 patients (in 4 of them, with a significant positive effect on joint syndrome). In 2 patients there was an increase in blood pressure. At the same time, one independently canceled the previously received antihypertensive therapy. One patient developed swelling of the face and ankles, which was not accompanied by other symptoms or changes in parameters we monitored. One patient dropped out of the study due to the development of urticaria on the 5th day of taking the drug. Only one patient experienced an exacerbation of articular syndrome: upon careful questioning, it turned out that the patient independently performed a foot massage. The drug was discontinued due to the patient's negative attitude. One patient developed pain in the epigastrium, which had previously been noted in a more severe form when taking any NSAIDs, but the patient refused to discontinue the drug due to its pronounced effectiveness; the pain was relieved by taking omeprazole. Conclusion Nimesil can be considered the drug of choice used to relieve gouty arthritis, since its tropism has been shown to suppress the activity of COX-2 on neutrophils and macrophages, which are the leading cell populations in microcrystalline inflammation. Nimesil also has an indirect effect on the activity of platelet activating factor, tumor necrosis factor-a, inhibition of phosphodiesterase IV, metalloproteinase, enzymes that play a leading role in the mechanisms of acute inflammation associated with the activation of neutrophils and phagocytes [3]. In this connection, the use of nimesulide for gouty arthritis is pathogenetically justified. The high effectiveness and good tolerability of Nimesil in the presence of concomitant pathology of various body systems seem especially important, since the combination of gout with damage to the gastrointestinal tract, liver, kidneys, arterial hypertension, type 2 diabetes can be considered obligate. This combination significantly increases the risk in patients with gout due to the negative effect of NSAIDs on the condition of the mucous membranes of various parts of the gastrointestinal tract, the development of serious hepatotoxic and nephrotoxic reactions, as well as damage to the cardiovascular system, which creates certain difficulties in selecting adequate anti-inflammatory therapy. In addition, our study showed the high effectiveness of Nimesil for relieving acute and chronic gouty inflammation, as well as the relative safety of using two- and three-week courses in patients with gout. Literature 1. Nasonova V.A., Barskova V.G. Early diagnosis and treatment of gout is a scientifically based requirement for improving the work and life prognosis of patients. Scientific and Practical Rheumatology 2004, 1, 5–7 2. Vane JR, Booting RM Mechanism of action of anti-inflammatory drags. Scand. J. Rheumatol. 1996; 102: 9. 3. Nasonov E.L. the use of non-steroidal anti-inflammatory drugs in medicine at the beginning of the 21st century. RMJ 2003, volume 11, no. 7 pp. 7–9. 4. Schumacher HR, Boice JA, Daikh DI, et al. Randomized double blind trial of etoricoxib and indomethacin in the treatment of acute gouty arthritis. BMJ 2002; J 22; 324(7352):1488–1492. 5. Barskova V.G., Yakunina I.A., Nasonova V.A. Use of nimesil for gouty arthritis. Ter archive 2003, 5 volume 75 pp. 60–64 6. Wallace SL, Robinson H, Masi AT, et al: Preliminary criteria for the classification of the acute arthritis of primary gout. Arthritis Rheum 1977; 20: 895–900 7. Bennett WM, Debroe MA. Analgesic Nephropathy - A Preventable Renal Disease. N English j med 1989; 320: 1269–1271 8. Ya TF, Berger L. Impaired Renal Function in Gout. Its Association with Hypertensive Vascular Disease and Intrinsic Renal Disease. Am. J. med. 1982; 72: 95–100. 9. Nickeleit V., Mihatsch MJ Uric Acid Nephropathy and End - Stage Renal Disease: Review of non - Disease. Nephrol. Dial. Transplant. 1997; 12: 1832–1838.

Content is licensed under a Creative Commons Attribution 4.0 International License.

Share the article on social networks

Recommend the article to your colleagues

Contraindications and side effects

Nimesil should not be prescribed for:

individual intolerance in patients to nimesulide and excipients of the drug;
stomach and duodenal ulcers;
inflammation of the digestive system and bleeding;
the occurrence of bronchospasm and runny nose while taking aspirin or other NSAIDs;
coronary artery bypass surgery that the patient underwent;
high blood pressure;
pregnancy and breastfeeding;
diabetes mellitus, which belongs to type II.

Taking the drug is prohibited for adolescents under 12 years of age and is not recommended for patients with impaired renal function, since the removal of the drug from the body can lead to a deterioration in their function.

The medicine should not be used for more than two weeks, because the drug is hepatotoxic and leads to a weakening of the protective function of the liver.

When prescribing Nimesil, side effects occur rarely and include:

increased blood pressure and increased heart rate
allergies - sweating, itching, skin rashes, dermatitis and urticaria
decreased levels of hemoglobin or platelets in the blood
malfunction of the nervous system - sleep and vision disturbances, anxiety and weakness
disorders of the digestive system - nausea, vomiting, diarrhea, bloating and exacerbation of gastritis
depression of respiratory functions - shortness of breath, increased frequency of attacks of bronchial asthma.

Nimesil granules for suspension 100 mg sachet 2 g 9 pcs ➤ instructions for use

Undesirable side effects can be minimized by using the minimum effective dose of the drug for the shortest possible short course.

Nimesil® should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since exacerbation of these diseases is possible.

The risk of gastrointestinal bleeding, ulceration or perforation of an ulcer increases with increasing doses of NSAIDs in patients with a history of ulcers, especially those complicated by bleeding or perforation, and in elderly patients, so treatment should be started at the lowest possible dose. Patients receiving drugs that reduce blood clotting or suppress platelet aggregation also increase the risk of gastrointestinal bleeding. If gastrointestinal bleeding or ulcers occur in patients taking Nimesil®, treatment with the drug should be discontinued.

Since Nimesil® is partially excreted by the kidneys, its dosage for patients with impaired renal function should be reduced depending on the level of urination.

There is evidence of rare cases of liver reactions. If signs of liver damage appear (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of liver transaminases), you should stop taking the drug and consult your doctor.

Despite the rarity of visual impairment in patients taking nimesulide concomitantly with other NSAIDs, treatment should be stopped immediately. If any visual disturbance occurs, the patient should be examined by an ophthalmologist.

The drug can cause fluid retention in tissues, so patients with high blood pressure and cardiac dysfunction should use Nimesil® with extreme caution.

In patients with renal or heart failure, Nimesil® should be used with caution, as renal function may deteriorate. If the condition worsens, treatment with Nimesil® should be discontinued.

Clinical studies and epidemiological data suggest that NSAIDs, especially at high doses and with long-term use, may lead to a small risk of myocardial infarction or stroke. There is insufficient data to exclude the risk of such events when using nimesulide.

The drug contains sucrose, this should be taken into account by patients suffering from diabetes mellitus (0.15–0.18 XE per 100 mg of the drug) and those on a low-calorie diet. Nimesil® is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose deficiency.

If signs of a cold or acute respiratory viral infection occur during treatment with Nimesil®, the drug should be discontinued.

Nimesil® should not be used simultaneously with other NSAIDs.

Nimesulide can change the properties of platelets, so caution must be exercised when using the drug in people with hemorrhagic diathesis, however, the drug does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

Elderly patients are particularly susceptible to adverse reactions to NSAIDs, incl. the risk of gastrointestinal bleeding and perforations that threaten the patient’s life, deterioration of kidney, liver and heart function. When taking Nimesil® for this category of patients, proper clinical monitoring is necessary.

The effect of the drug on the ability to drive vehicles and operate machinery. The effect of the drug Nimesil® on the ability to drive vehicles and operate machinery has not been studied, therefore, during treatment with the drug Nimesil®, care should be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Note!

The description of the drug Nimesil on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Nimesil granules d/susp. for oral administration 100 mg pack 2g N30

Registration Certificate Holder

Laboratori GUIDOTTI SpA (Italy)

Dosage form

Medicine - Nimesil® (Nimesil®)

Description

Granules for preparation of suspension for oral administration

in the form of a light yellow granular powder with an orange odor.

1 pack (2 g)

nimesulide 100 mg

Excipients

: ketomacrogol 1000, sucrose, maltodextrin, anhydrous citric acid, orange flavor.

2 g - laminated paper bags (9) - cardboard packs. 2 g - laminated paper bags (15) - cardboard packs. 2 g - laminated paper bags (30) - cardboard packs.

Indications

treatment of acute pain (back pain, lower back pain; pain syndrome in the musculoskeletal system, including injuries, sprains and dislocations of joints, tendonitis, bursitis; toothache);
symptomatic treatment of osteoarthritis with pain syndrome;
algodismenorrhea.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use.

Contraindications for use

history of hyperergic reactions, for example, bronchospasm, rhinitis, urticaria, associated with taking acetylsalicylic acid or other NSAIDs, incl. nimesulide;
history of hepatotoxic reactions to nimesulide;
concomitant (simultaneous) use of drugs with potential hepatotoxicity, for example, paracetamol or other analgesic or non-steroidal anti-inflammatory drugs;
inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase;
period after coronary artery bypass surgery;
fever in infectious and inflammatory diseases;
complete or partial combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses with intolerance to acetylsalicylic acid and other NSAIDs (including a history);
peptic ulcer of the stomach and duodenum in the acute phase, a history of ulcers, perforation or bleeding in the gastrointestinal tract;
a history of cerebrovascular hemorrhage or other bleeding, as well as diseases accompanied by bleeding;
severe blood clotting disorders;
severe heart failure;
severe renal failure (creatinine clearance <30 ml/min), confirmed hyperkalemia;
liver failure or any active liver disease;
children under 12 years of age;
pregnancy and breastfeeding;
alcoholism, drug addiction;
hypersensitivity to the components of the drug.

With caution
: severe forms of arterial hypertension, type 2 diabetes mellitus, heart failure, coronary heart disease, cerebrovascular diseases, dyslipidemia/hyperlipidemia, peripheral arterial disease, smoking, CC < 60 ml/min, anamnestic data on the presence of ulcerative lesions of the gastrointestinal tract, infections, caused by Helicobacter pylori; elderly age; long-term previous use of NSAIDs; severe somatic diseases; concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, sertraline).

The decision to prescribe Nimesil should be based on an individual risk-benefit assessment when taking the drug.

pharmachologic effect

Non-steroidal anti-inflammatory drug from the sulfonamide class. Has anti-inflammatory, analgesic and antipyretic effects. Nimesulide acts as an inhibitor of the cyclooxygenase enzyme responsible for the synthesis of prostaglandins and inhibits mainly cyclooxygenase-2.

Drug interactions

Pharmacodynamic interactions:

When used together with glucocorticosteroids, the risk of gastrointestinal ulcers or bleeding increases.

When used together with antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, the risk of gastrointestinal bleeding increases.

NSAIDs may enhance the effect of anticoagulants such as warfarin. Due to the increased risk of bleeding, this combination is not recommended and is contraindicated in patients with severe coagulation disorders. If combination therapy cannot be avoided, careful monitoring of blood clotting parameters is necessary.

Diuretics

NSAIDs may weaken the effect of diuretics.

In healthy volunteers, nimesulide temporarily reduces the excretion of sodium under the influence of furosemide, to a lesser extent the excretion of potassium, and reduces the diuretic effect itself.

The combined use of nimesulide and furosemide leads to a decrease (by approximately 20%) in the area under the congestion curve.

From the respiratory system

: infrequently - shortness of breath; very rarely - exacerbation of bronchial asthma, bronchospasm.

From the digestive system

: often - diarrhea, nausea, vomiting; infrequently - constipation, flatulence, gastritis; very rarely - abdominal pain, dyspepsia, stomatitis, tarry stools, gastrointestinal bleeding, ulcer and/or perforation of the stomach or duodenum; very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis, increased activity of liver enzymes.

From the urinary system

: rarely - dysuria, hematuria, urinary retention;
very rarely - renal failure, oliguria, interstitial nephritis. General disorders
: rarely - malaise, asthenia; very rarely - hypothermia.

Others

: rarely - hyperkalemia.

special instructions

Undesirable side effects can be minimized by using the minimum effective dose of the drug for the shortest possible short course.

Nimesil should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since exacerbation of these diseases is possible.

The risk of gastrointestinal bleeding, ulceration or perforation of an ulcer increases with increasing dose of NSAIDs in patients with a history of ulcers, especially those complicated by bleeding or perforation, and in elderly patients, so treatment should be started with the lowest possible dose. Patients receiving drugs that reduce blood clotting or inhibit platelet aggregation also have an increased risk of gastrointestinal bleeding. If gastrointestinal bleeding or ulcers occur in patients taking Nimesil, treatment with the drug should be discontinued.

Since Nimesil is partially excreted by the kidneys, its dosage for patients with impaired renal function should be reduced, depending on the level of urination.

The drug can cause fluid retention in tissues, so patients with high blood pressure and cardiac problems should use Nimesil with extreme caution.

In patients with renal or heart failure, Nimesil should be used with caution, as renal function may deteriorate. If the condition worsens, treatment with Nimesil should be stopped.

The drug contains sucrose, this should be taken into account by patients suffering from diabetes mellitus (0.15-0.18 XE per 100 mg of the drug) and those on a low-calorie diet. Nimesil is not recommended for use in patients with rare hereditary diseases of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose deficiency.

If signs of a “cold” or acute respiratory viral infection occur during treatment with Nimesil, the drug should be discontinued.

Nimesil should not be used simultaneously with other NSAIDs.

Elderly patients are especially susceptible to adverse reactions to NSAIDs, including life-threatening gastrointestinal bleeding and perforation, deterioration of renal, liver and cardiac function. When taking the drug Nimesil for this category of patients, proper clinical monitoring is necessary.

Like other drugs of the NSAID class that inhibit prostaglandin synthesis, nimesulide can adversely affect pregnancy and/or embryo development and can lead to premature closure of the ductus arteriosus, hypertension in the pulmonary artery system, impaired renal function, which can lead to renal failure with oligodyramnia, to an increased risk of bleeding, decreased uterine contractility, and the occurrence of peripheral edema. In this regard, nimesulide is contraindicated during pregnancy and lactation. The use of the drug Nimesil can negatively affect female fertility and is not recommended for women planning pregnancy. When planning a pregnancy, consultation with your doctor is necessary.

There is evidence of the occurrence in rare cases of skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) to nimesulide as well as to other NSAIDs.
At the first signs of a skin rash, damage to the mucous membranes or other signs of an allergic reaction, Nimesil should be discontinued. The effect of the drug on the ability to drive vehicles and operate machinery.
The effect of the drug Nimesil on the ability to drive vehicles and operate machinery has not been studied, therefore, during treatment with the drug Nimesil, caution should be exercised when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage conditions

Storage conditions:

List B. Store in a dry place, protected from light and out of reach of children, at a temperature not exceeding 25 °C.

Best before date

Best before date:

2 years.

Do not use after the expiration date stated on the package.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.

Like other drugs of the NSAID class that inhibit prostaglandin synthesis, nimesulide can adversely affect pregnancy and/or embryo development and can lead to premature closure of the ductus arteriosus, hypertension in the pulmonary artery system, impaired renal function, which can lead to renal failure with oligodyramnia, to an increased risk of bleeding, decreased uterine contractility, and the occurrence of peripheral edema. In this regard, the drug is contraindicated during pregnancy and breastfeeding.

Use for renal impairment

Restrictions for impaired renal function - Contraindicated.

In patients with renal failure, Nimesil should be used with caution, as renal function may deteriorate. If the condition worsens, treatment with Nimesil should be stopped. The drug is contraindicated in severe renal failure (creatinine clearance <30 ml/min).

In patients with mild to moderate forms of renal failure (creatinine clearance 30-80 ml/min), there is no need for dose adjustment.

Use for liver dysfunction

Restrictions for liver dysfunction - Contraindicated.

The drug is contraindicated in liver failure or any active liver disease.

Use in elderly patients

Restrictions for elderly patients - Use with caution.

The drug is prescribed with caution to elderly patients. Elderly patients are especially susceptible to adverse reactions to NSAIDs, including life-threatening gastrointestinal bleeding and perforation, deterioration of renal, liver and cardiac function. When taking the drug Nimesil for this category of patients, proper clinical monitoring is necessary.

When treating elderly patients, the need to adjust the daily dose is determined by the doctor based on the possibility of interaction with other drugs.

Use in children

Restrictions for children - Contraindicated.

The drug is contraindicated in children under 12 years of age.
Adolescents (ages 12 to 18 years):
Based on the pharmacokinetic profile and pharmacodynamic characteristics of nimesulide, no dose adjustment is necessary in adolescents.

Terms of sale

The drug is available with a prescription.

Contacts for inquiries

BERLIN-CHEMIE/MENARINI PHARMA GmbH (Germany)

BERLIN-CHEMIE/A.MENARINI LLC

123317 Moscow, Presnenskaya embankment. 10 Business, Block B Tel.; Fax

Experience of using Nimesil in the treatment of gouty arthritis

For what diseases do you need to take nimesil?

How to take Nimesil?

Experience of using Nimesil in the treatment of gouty arthritis

Contraindications and side effects

Nimesil should not be prescribed for:

Nimesil granules for suspension 100 mg sachet 2 g 9 pcs ➤ instructions for use

Popular questions about Nimesil:

Nimesil how to take the drug?

How to dilute Nimesil?

How to take Nimesil for toothache?

How often can you take nimesil?

Note!

Nimesil granules d/susp. for oral administration 100 mg pack 2g N30