Pharmacy No. 84. Delivery of medicines to your home and office.

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Nemulex gran d/susp i.n. approx 100 mg 2 g pack/pack card x10

NEMULEX

Representative office: PharmFirma SOTEX CJSC ATX code: M01AX17 Registration certificate holder: PharmFirma SOTEX CJSC produced by SC ROMPHARM Company, SRL nimesulide

Release form, composition and packaging Granules for the preparation of a suspension for oral administration are yellowish in color, the prepared suspension is light yellow in color.

1 pack nimesulide 100 mg

Excipients: macrogol cetostearate (Cremophor A25) - 100 mg, anhydrous citric acid -19 mg, colloidal silicon dioxide (Aerosil) - 40 mg, sucrose - 1721 mg, orange flavor - 20 mg.

Clinical and pharmacological group: NSAIDs. Selective COX-2 inhibitor Registration No.: • granules for preparation. susp. for oral administration 100 mg: sachets of 2, 4, 6, 10, 20 or 30 - LSR-006686/10, 07/15/10. Validity period of reg. beat is not limited. ——————————————————————————— Description of the drug NEMULEX is based on the officially approved instructions for use of the drug NEMULEX for specialists and approved by the manufacturer for the 2013 edition of the year. ——————————————————————————— Pharmacological action | Pharmacokinetics | Indications | Dosage regimen | Side effect | Contraindications | Pregnancy and lactation | Special instructions | Overdose | Drug interactions | Terms of release from pharmacies | Storage conditions and expiration dates ——————————————————————————— Pharmacological action

NSAIDs. It has anti-inflammatory, analgesic, antipyretic and antiplatelet effects. Unlike other NSAIDs, it selectively suppresses COX-2, inhibits the synthesis of prostaglandins at the site of inflammation, and has a less pronounced inhibitory effect on COX-1 (less likely to cause side effects associated with inhibition of prostaglandin synthesis in healthy tissues).

Pharmacokinetics Absorption Absorption when taken orally is high. Eating reduces the rate of absorption without affecting its extent. Tmax in blood plasma - 1.5-2.5 hours. Cmax in blood plasma - 3.5-6.5 mg/l. Distribution: Binding to plasma proteins - 95%, to erythrocytes - 2%, to lipoproteins - 1%, to acidic alpha1-glycoprotein 1%. Changing the dose does not affect the degree of binding. Vd - 0.19-0.35 l/kg. Penetrates well into the acidic environment of the inflammation site (40%) and synovial fluid (43%). Easily penetrates histohematic barriers. Metabolism Metabolized in the liver by tissue monooxygenases. The main metabolite, 4-hydroxynimesulide (25%), has similar pharmacological activity, but due to a decrease in molecular size, it is able to quickly diffuse through the hydrophobic COX-2 channel to the active binding site of the methyl group. 4-hydroxynimesulide is a water-soluble compound, the elimination of which does not require glutathione and phase II metabolic conjugation reactions (including sulfation, glucuronidation). 4-hydroxynimesulide undergoes enterohepatic recirculation. Excretion T1/2 of nimesulide is 1.56-4.95 hours, 4-hydroxynimesulide is 2.89-4.78 hours. 4-hydroxynimesulide is excreted by the kidneys (65%) and bile (35%).

Indications for use of the drug NEMULEX: rheumatoid arthritis, osteoarthritis, arthritis of various etiologies, arthralgia, myalgia, postoperative and post-traumatic pain, bursitis, tendinitis, algodismenorrhea, toothache, headache.

The drug is intended for symptomatic therapy, reduces pain and inflammation at the time of use, and does not affect the progression of the disease.

Dosage regimen The drug is taken orally. The contents of 1 sachet of granulate are dissolved in 80-100 ml of water. The recommended dose for adults and adolescents aged 12-18 years is 100 mg (1 sachet) 2 after meals. The maximum daily dose for adults and adolescents aged 12-18 years is 200 mg. Elderly patients do not require dose reduction. Patients with chronic renal failure require a reduction in the daily dose to 100 mg. To minimize the risk of adverse reactions, the drug should be prescribed at the minimum effective dose for the shortest possible period of time. The maximum duration of taking the drug is 15 days.

Side effects From the digestive system: diarrhea, nausea, vomiting, constipation, flatulence, gastritis, abdominal pain, stomatitis, tarry stools, gastrointestinal bleeding, ulcer and/or perforation of the stomach or duodenum, increased “liver” transaminases, hepatitis , fulminant hepatitis, jaundice, cholestasis. Allergic reactions: hypersensitivity reactions, urticaria, angioedema, facial swelling, anaphylactoid reactions. From the side of the central nervous system: dizziness, feeling of fear, nervousness, nightmares, headache, drowsiness, encephalopathy (Reye's syndrome). From the skin: itching, skin rash, increased sweating, erythema, dermatitis, erythema multiforme exudative, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome). From the urinary system: edema, dysuria, hematuria, urinary retention, hyperkalemia, renal failure, oliguria, interstitial nephritis. From the hematopoietic system: anemia, eosinophilia, thrombocytopenia, pancytopenia, purpura, prolongation of bleeding time. From the respiratory system: shortness of breath, exacerbation of bronchial asthma, bronchospasm. From the senses: blurred vision. From the cardiovascular system: arterial hypertension, tachycardia, hemorrhages, hot flashes. Other: general weakness, hypothermia.

Contraindications to the use of the drug NEMULEX - complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history), - erosive and ulcerative lesions of the mucous membrane of the stomach and duodenum, - active gastrointestinal bleeding, - cerebrovascular or other bleeding, - inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the acute phase, - hemophilia and other bleeding disorders, - decompensated chronic heart failure, - liver failure or any active liver disease, - hepatotoxic reactions when using nimesulide in the anamnesis, - alcoholism, - drug addiction, - severe chronic renal failure (CC < 30 ml/min), - progressive kidney diseases, - confirmed hyperkalemia, - the period after coronary artery bypass surgery, - simultaneous use of other hepatotoxic medications, - children under 12 years of age, - pregnancy, - breastfeeding, - hypersensitivity to the components of the drug.

The drug should be used with caution in patients with coronary artery disease, cerebrovascular diseases, chronic heart failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, renal failure (creatinine clearance less than 60 ml/min), with a history of development of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection, severe somatic diseases with long-term use of NSAIDs, while taking anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), oral corticosteroids, selective serotonin reuptake inhibitors (including including citalopram, fluoxetine, paroxetine, sertraline), in elderly patients.

Use of the drug NEMULEX during pregnancy and breastfeeding Use during pregnancy and lactation (breastfeeding) is contraindicated. The use of nimesulide may adversely affect female fertility and is not recommended for women planning pregnancy.

Use for impaired renal function Use is contraindicated in severe chronic renal failure (creatinine clearance <30 ml/min).

Special instructions To reduce the risk of side effects, it is necessary to use the drug in the minimum effective dose for the shortest duration. If the patient's condition does not improve, treatment should be stopped. It is necessary to stop taking the drug if the temperature rises or flu-like symptoms develop while taking it. If patients taking Nemulex develop symptoms indicating liver damage (for example, anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine), or increased liver transaminases, the drug should be discontinued. Such patients are not recommended to be prescribed Nemulex in the future. Gastrointestinal bleeding or ulcer/perforation of the stomach or duodenum can develop at any time while using the drug and is not accompanied by clinically significant symptoms (including pain). If gastrointestinal bleeding or ulcers occur, the drug should be discontinued. If renal function deteriorates, the drug should be discontinued. If the drug is used for more than 2 weeks, monitoring of liver function indicators is necessary. In patients with liver cirrhosis or renal failure with hypoalbuminemia or hyperbilirubinemia, nimesulide binding is reduced. Elderly patients most often develop side effects when taking the drug, incl. gastrointestinal bleeding, perforation, dysfunction of the heart, kidneys and liver. Therefore, regular clinical monitoring of the patient’s condition is recommended. Effect on the ability to drive vehicles and operate machinery If, when using the drug, adverse events from the central nervous system and sensory organs occur, then patients should refrain from driving vehicles and engaging in activities that require increased concentration and speed of psychomotor reactions.

Overdose Symptoms: nausea, vomiting, drowsiness, apathy, gastrointestinal bleeding, increased blood pressure, acute renal failure, respiratory depression. Treatment: Symptomatic and supportive treatment is recommended. There is no specific antidote. Patients admitted to the hospital with symptoms of a drug overdose (within 4 hours after taking it or after taking a high dose) are recommended to lavage the stomach, take activated charcoal (adults - 60-100 mg) and/or an osmotic laxative. Regular monitoring of liver and kidney function is necessary. There is no data on the possibility of removing nimesulide using hemodialysis. Forced diuresis and hemodialysis are ineffective due to the high degree of binding of the drug to proteins.

Drug interactions There is evidence that nimesulide can reduce the bioavailability of furosemide and compete for binding to plasma proteins of fenofibrate, salicylic acid, and tolbutamides. Nemulex can replace salicylic acid and furosemide (but not warfarin) in plasma proteins. In the presence of Nemulex, free fractions of methotrexate may increase significantly. Physiological concentrations of unsaturated fatty acids do not affect the binding of nimesulide to serum albumin. At therapeutic concentrations, the binding of Nemulex was not affected by warfarin, furosemide, glibenclamide, or digitoxin. Taking Nemulex in therapeutic doses orally for a short period does not change the serum digoxin profile in patients with mild heart failure. Plasma lithium concentrations increase when lithium and Nemulex are taken simultaneously. Nemulex has no effect on drugs that affect blood glucose concentrations and glucose tolerance in patients with diabetes mellitus treated with sulfonylurea derivatives. It is not recommended to take Nemulex simultaneously with diuretics, which have a damaging effect on renal hemodynamics. Nemulex may enhance the effect of cyclosporine on the kidneys. When Nemulex is used simultaneously with GCS and serotonin reuptake inhibitors, the risk of gastrointestinal bleeding increases.

Conditions for dispensing from pharmacies The drug is dispensed with a prescription.

Conditions and periods of storage The drug should be stored out of the reach of children, in a dry place, protected from light, at a temperature not exceeding 25°C. Shelf life: 4 years.