2 x NIMESIL 2G X 30 SACHETS 100 MG — MADE IN GERMANY — FREE SHIPPING

Preparation:

Instructions For the use of medicine NIMESIL

Ingredients:  Active ingredients: Nimesulide - 1 single use packet of 2 g granules contains nimesulide 100 mg Inactive ingredients: macrogol cetostearyl ether, sucrose, maltodextrin, citric acid anhydrous, orange flavoring.

Medication form:  granules for oral suspension. Physical and chemical properties: light yellow granular powder  with orange scent, white or light yellow solution after partial dissolution

Pharmaceutical group: non-selective nonsteroidal anti-inflammatory drug

Pharmaceutical properties. Pharmacodynamics: Nimesil is a nonsteroidal anti-inflammatory drug (NSAID) with pain medication and fever reducing properties. Medical actions of Nimesil are provided by its interaction with arachidonic acid cascade and reduces bio-syntheses though cyclooxygenase inhibition.  Pharmacokinetics: Nimesil is absorbed rapidly following oral administration reaching peak concentration in plasma within 2-3 hours. Near 97.5% of nimesil binds to plasma proteins. Nimesil metabolizes rapidly by liver due to cytochrome  isopherment  P450. Paridroxide is the main metabolite has the pharmacologic activity as well. Elimination half-life  is between 3.2 and 6 hours. Approximately 50% of nimesulide is excreted through urine. Nearly 29 % is metabolized and excreted through feces. Only 1-3% is excreted unchanged.  Pharmacokinetics in elderly patients does not change.

Clinical characteristics. Use: approved indications are the treatment of acute pain, the symptomatic treatment of osteoarthritis, and primary dysmenorrhea.  Nimesulide should only be used as a secondary drug. All risks should be taken into consideration before taking nimesil.

Do not use if the following conditions are present: hyperergic reactions in the anamnesis, for example, bronchospasm, rhinitis, urticaria associated with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), incl. nimesulide; hepatotoxic reactions to nimesulide in the anamnesis; concomitant (simultaneous) administration of drugs with potential hepatotoxicity, for example, paracetamol or other analgesic or non-steroidal anti-inflammatory drugs; inflammatory bowel disease (Crohn's disease, ulcerative colitis) during the exacerbation phase; period after aortocoronary shunting; 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 in the anamnesis); peptic ulcer of the stomach and duodenum in the phase of exacerbation, the presence of an ulcer in an anamnesis, perforation or bleeding in the gastrointestinal tract; the presence in the anamnesis of cerebrovascular vascular bleeding or other bleeding, as well as diseases accompanied by bleeding; severe blood clotting disorders; severe heart failure; severe renal failure (QC <30 ml / min), confirmed hyperkalemia; hepatic insufficiency or any active liver disease; children's age till 12 years; pregnancy and the period of breastfeeding; alcoholism (simultaneous reception with alcohol is prohibited because of the risk of bleeding from the digestive tract), drug dependence; hypersensitivity to the components of the drug.

Drug interaction: Pharmaceutical interactions: When combined with glucocorticosteroids, the risk of a gastrointestinal ulcer or bleeding increases. When combined with antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs), for example, Fluoxetine increases the risk of gastrointestinal bleeding.

NSAIDs can enhance the action of anticoagulants, such as warfarin. Because of the increased risk of bleeding, this combination is not recommended and is contraindicated in patients with severe coagulation disorders. If combined therapy can still be avoided, careful monitoring of blood coagulation should be carried out. Diuretics.  NSAIDs may reduce the effect of diuretics. In healthy volunteers, nimesulide temporarily reduces the excretion of sodium by furosemide, to a lesser extent - the excretion of potassium, and reduces the actual diuretic effect. The simultaneous administration of Nimesil and Furosemide results in a reduction (approximately 20%) of the area under the concentration-time curve (AUC) and a decrease in cumulative furosemide excretion without altering the renal clearance of furosemide. Co-administration of furosemide and nimesulide requires caution in patients with impaired renal and cardiac function. ACE inhibitors and angiotensin 2 receptor antagonists NSAIDs can reduce the effect of antihypertensive drugs. In patients with mild to moderate renal failure (CK 30-80 ml / min), concomitant administration of ACE inhibitors, angiotensin-2 receptor antagonists, or agents that inhibit the system of cycloxygenase (NSAIDs, antiplatelet agents) may further impair kidney function and cause acute renal failure , which, as a rule, is reversible. These interactions should be considered in patients taking Nimesil in combination with ACE inhibitors or angiotensin II receptor antagonists. Therefore, joint administration of these drugs should be administered with caution, especially for elderly patients.Patients should receive a sufficient amount of fluid, and renal function should be carefully monitored after the initiation of co-therapy.

Pharmacokinetic interactions with other drugs

There is evidence that NSAIDs reduce the clearance of lithium, which leads to an increase in the concentration of lithium in blood plasma and its toxicity. When nimesulide is prescribed, patients receiving lithium therapy should be monitored regularly for plasma lithium concentrations. Clinically significant interactions with glibenclamide, theophylline, digoxin, cimetidine and antacid preparations (for example, a combination of aluminum and magnesium hydroxides) were not observed. When nimesulide is prescribed less than 24 hours before or after taking methotrexate, care should be taken, as in such cases the plasma Methotrexate level and, accordingly, the toxic effects of this drug may increase. In connection with the effect on renal prostaglandins, inhibitors of prostaglandin synthetases, to which nimesulide belongs, may increase the nephrotoxicity of cyclosporins.

Interaction of other drugs with nimesulide 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 application of the drug.

Specific application: Nimesil should be used with caution in patients with gastrointestinal diseases in history (ulcerative colitis, Crohn's disease), since it is possible aggravation of these diseases. The risk of gastrointestinal bleeding,ulcer or perforation of the ulcer increases with an increase in the dose of NSAIDs in patients with a history of an ulcer, especially complicated by bleeding or perforation, as well as in elderly patients, so treatment should be started with the lowest possible dose. Patients receiving medications that reduce blood clotting or suppress platelet aggregation also increase the risk of gastrointestinal bleeding. In case of gastrointestinal bleeding or ulcers in patients taking Nimesil, treatment with the drug should be discontinued. Since Nimesil is partially excreted by the kidneys, dosage for patients with impaired renal function should be reduced, depending on the level of urination.

There are data on the occurrence of rare cases of reactions from the liver. If there are signs of liver damage (itchy skin, yellowing of the skin, nausea, vomiting, abdominal pain, darkening of the urine, increased activity of "liver" transaminases), stop taking the drug and consult a doctor.

Despite the rarity of visual impairment in patients taking nimesulide concomitantly with other NSAIDs, treatment should be stopped immediately.If any visual impairment occurs, the patient should be examined by an oculist. The drug can cause fluid retention in the tissues, so patients with high blood pressure and with cardiac abnormalities Nimesil should be used with extreme caution.

In patients with renal or heart failure, Nimesil should be used with caution, since kidney function may worsen. In case of deterioration, treatment with Nimesil must be discontinued.

Clinical studies and epidemiological data suggest that NSAIDs, especially in high doses and with prolonged use, can lead to an insignificant risk of myocardial infarction or stroke. To exclude the risk of such events occurring when nimesulide is used, data is insufficient.

The composition of the drug includes sucrose, this should be taken into account in patients with diabetes mellitus (0.15-0.18 XE per 100 mg of the drug) and those who observe a low-calorie diet. Nimesil is not recommended for patients with rare hereditary diseases of intolerance to fructose, malabsorption of glucose-galactose or insufficiency of sucrose-isomaltose.

If there are signs of "cold" or acute respiratory viral infection in the process of treatment with Nimesil, the drug should be stopped.  Do not use Nimesil concomitantly with other NSAIDs.

Nimesulide can change the properties of platelets, so care must be taken when using the drug in people with hemorrhagic diathesis, but the drug does not replace the preventive effect of Acetylsalicylic acid in cardiovascular diseases. Elderly patients are particularly prone to adverse reactions to NSAIDs, including the occurrence of gastrointestinal bleeding and perforations, which threaten the patient's life, impair the function of the kidneys, liver and heart. When Nimesil is taken for this category of patients, proper clinical control is necessary. Like other NSAID products that inhibit the synthesis of prostaglandins, nimesulide can adversely affect the course of pregnancy and / or embryo development and can lead to premature closure of the arterial duct, pulmonary arterial hypertension, impaired renal function, which can pass into renal failure with oligodioremia, to increase the risk of bleeding, reduce the contractility of the uterus, the occurrence of peripheral edema. In this regard, nimesulide is contraindicated in pregnancy and lactation. The use of Nimesil can negatively affect female fertility and is not recommended for women planning a pregnancy. When planning pregnancy, consultation with the doctor is necessary. Simultaneous intake of Nimesil with alcohol is prohibited because of the risk of developing bleeding from the gastrointestinal tract. There are reports of the occurrence in rare cases of skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) on nimesulide as well as other NSAIDs. At the first signs of skin rashes, lesions of mucous membranes or other signs of an allergic reaction, the drug Nimesil should be stopped.

Usage during pregnancy and lactation:

Like other classes of NSAID drugs that inhibit prostaglandin synthesis, Nimesil may adversely affect the course of pregnancy and / or embryo development, and may result in the premature closure of the ductus arteriosus, hypertension in the pulmonary artery, renal dysfunction, which may progress to renal failure with oligodiramniey to increase the risk of bleeding, reduction in uterine contractility, peripheral edema. In this regard, the drug is contraindicated in pregnancy and during breastfeeding.

Usage while driving and operating machinery: The influence of Nimesil on the ability to drive vehicles and operate machinery has not been studied, therefore, during the period of treatment with Nimesil, caution should be exercised when driving vehicles and practicing potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Usage and Dosage: For oral administering dissolve  1 packet (100 mg of nimesulide) in a glass of water , take after meal 2 times a day. The prepared solution is not subject to storage. Nimesil is used only for the treatment of patients older than 12 years. Adolescents (aged 12 to 18 years): based on the pharmacokinetic profile and pharmacodynamic characteristics of nimesulide, there is no need to adjust the dose in adolescents. Elderly patients: in the treatment of elderly patients, the need to adjust the daily dose is determined by the physician based on the possibility of interaction with other medicines. The maximum duration of treatment with nimesulide is 15 days.

Children: do not use for children under 12 years.

 Overdose: Symptoms: apathy, drowsiness, nausea, vomiting, pain in the epigastric region. With maintenance therapy of gastropathy, these symptoms are usually reversible. There may be a gastrointestinal bleeding. In rare cases, it is possible to raise blood pressure, acute renal failure, respiratory depression and coma, anaphylactoid reactions.

Treatment: symptomatic. There is no specific antidote. In case an overdose has occurred within the last 4 hours, induction of vomiting and / or the administration of activated charcoal (from 60 to 100 g per adult) and / or osmotic laxative. Forced diuresis, hemodialysis - ineffective because of the high connection of the drug with proteins (up to 97.5%). The control of kidney and liver function is shown.

Side effects:  The frequency is classified according to the headings, depending on the occurrence of the case: very often (> 10), often (> 100 - <10); infrequently (> 1000- <100), rarely (> 10000- <1000), very rarely (<10000).

Disorders from the blood and lymphatic systems: rarely - anemia, eosinophilia, hemorrhages; very rarely - thrombocytopenia, pancytopenia, purpura thrombocytopenic. Allergic reactions: infrequently - itching, rash, excessive sweating; rarely - hypersensitivity reactions, erythema, dermatitis; very rarely - anaphylactoid reactions, urticaria, angioedema, erythema polyforma, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome). Disorders from the side of the central nervous system: infrequently - dizziness; rarely - a sense of fear, nervousness, nightmarish dreams; very rarely - headache, drowsiness, encephalopathy (Reye syndrome). Impaired sensory organs: rarely - blurred vision. Disorders from the CCC: infrequently - arterial hypertension, tachycardia, lability of blood pressure, hot flashes. Disturbances from the respiratory system: infrequent - dyspnea; very rarely - exacerbation of bronchial asthma, bronchospasm. Disorders from the digestive tract: often - diarrhea, nausea, vomiting; infrequently - constipation, flatulence, gastritis; very rarely - abdominal pain, dyspepsia, stomatitis, tarry stool, gastrointestinal bleeding, ulcer and / or perforation of the stomach or duodenum. Disturbances from the liver and bile excretory system: very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis, increased activity of hepatic enzymes. Disorders from the kidneys and urinary system: rarely - dysuria, hematuria, urinary retention; very rarely - renal failure, oliguria, interstitial nephritis. Common disorders: rarely - malaise, asthenia; very rarely - hypothermia. Other: rarely - hyperkalemia. Shelf life: 3 years.

Storage: Store medicines in original package at room temperature. Keep medicines away from children and pets. Do not use the product after expiration date indicated on the package.

Packaging: 9, or 15 or 30 single use packets 2 g granules in a cardboard box

Manufactured for Laboratory GUIDOTTI S.p.a. Address: Via Livorneze, 897 56122 La Vettoia (Piza), Italy Manufacturer:  Fine Foods & Pharmaceuticals N.T.M. S.P.AAddress: Via Grignano, 43-24041 Brembate (BG), Italy