NEMULEX GRANULES FOR SUSPENSION 100MG/2G BAGS

Release form

Granules for the preparation of suspensions for oral administration.

Packaging

30 bags.

Mechanism of action

Nemulex has anti-inflammatory, analgesic, antipyretic, antiaggregatory effect.

Indications

• rheumatoid arthritis;
• osteoarthritis;
• arthritis of various etiologies;
• arthralgia;
• myalgia;
• postoperative and post-traumatic pains;
• bursitis;
• tendonitis;
• algomenorrhea;
• toothache and headache.
• The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use; the progression of the disease is not affected.

Contraindications

• hypersensitivity;
• complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to Acetylsalicylic acid (ASA) and other NSAIDs (including a history of);
• erosive and ulcerative lesions of the mucous membrane of the stomach and duodenum;
• active Gastrointestinal bleeding;
• bleeding, incl. cerebrovascular;
• inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute phase;
• hemophilia and other bleeding disorders;
• decompensated chronic heart failure (CHF);
• liver failure or any active liver disease;
• hepatotoxic reactions with the use of Nimesulide in history;
• alcoholism;
• addiction;
• severe chronic renal failure (CRF) (creatinine Cl
• progressive kidney disease;
• confirmed hyperkalemia;
• the period after coronary artery bypass surgery;
• simultaneous reception of other hepatotoxic drugs;
• children up to 12 years;
• pregnancy;
• breastfeeding period.
• Carefully: Coronary artery disease, cerebrovascular diseases, CHF, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, renal failure (Cl creatinine 30-60 ml / min), anamnestic data on the development of gastrointestinal ulcers, infectionHelicobacter pylori, old age, long-term use of NSAIDs, severe somatic diseases, simultaneous administration of anticoagulants (including warfarin), antiplatelet agents (including ASA, clopidogrel), oral GCS, SSRIs (including citalopram, Fluoxetine, paroxetine, sertraline).

Use during pregnancy and lactation

CATEGORY OF ACTION ON THE FRUIT. C (The study of reproduction in animals revealed an adverse effect on the fetus, and adequate and well-controlled studies in pregnant women have not been carried out, but the potential benefits associated with the use of drugs in pregnant women may justify its use, despite the possible risk.)

Special notes

To reduce the risk of side effects, it is necessary to use the drug Nemux in the minimum effective dose of the shortest duration. If the patient’s condition does not improve, treatment should be stopped. It is necessary to stop taking the drug in case of fever or the development of flu-like symptoms on the background of his reception.
When patients taking Nimesulide, symptoms that indicate liver damage (for example, anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine), or increased hepatic transaminases, should be discontinued. It is not recommended to prescribe Nimesulide in such patients in the future. Gastrointestinal bleeding or an ulcer / perforation of the stomach or duodenum may develop at any time with the use of the drug, which may not be accompanied by clinically pronounced symptoms (including pain syndrome). If gastrointestinal bleeding or ulceration occurs, the drug should be withdrawn.
In case of deterioration of renal function, the drug Nemulex should be withdrawn. If the drug is used for more than 2 weeks, monitoring of liver function indicators is necessary. In patients with cirrhosis of the liver or with renal insufficiency with hypoalbuminemia or hyperbilirubinemia, the binding of nimesulide is reduced. Elderly patients most often develop side effects while taking the drug, including gastrointestinal bleeding, perforation, impaired function of the heart, kidneys and liver. Therefore, regular clinical monitoring of the patient’s condition is recommended.The use of nimesulide may adversely affect female fertility and is not recommended for women planning a pregnancy. If during the use of the drug Nemulex, undesirable phenomena arise from the central nervous system and sensory organs, it is necessary to refrain from driving by motor transport and engaging in activities that require an increased concentration of attention and quickness of psychomotor reactions.

Composition

Active substance: 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 flavoring - 20 mg.

Dosage and administration

Inside. The content of 1 sachet of Nemulex granulate is dissolved in 80-100 ml of water. The recommended dose for adults and adolescents aged 12–18 years is 100 mg (1 sachet of Nemuleks), 2 times a day after meals. The maximum daily dose for adults and adolescents aged 12-18 years is 200 mg. No dose reduction is required for elderly patients. Patients with chronic renal failure require a reduction in the daily dose to 100 mg.
The minimum effective dose of Nemulex should be administered for as short a period as possible in order to minimize the risk of adverse reactions.
The maximum duration of the drug Nemulex should not exceed 15 days.

Side effects

Allergic reactions: hypersensitivity reactions, anaphylactoid reactions.
From the side of the central nervous system: dizziness, fear, nervousness, nightmares, headache, drowsiness, encephalopathy (Reye's syndrome).
On the part of the skin: itching, skin rash, increased sweating, erythema, dermatitis, urticaria, angioedema, swelling of the face, erythema multiforme exudative, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
On the side of the urinary system: edema, dysuria, hematuria, urinary retention, hyperkalemia, renal failure, oliguria, interstitial nephritis.
On the part of the gastrointestinal tract: diarrhea, nausea, vomiting, constipation, flatulence, gastritis, abdominal pain, stomatitis, tarry stools, gastrointestinal bleeding, ulcers and / or perforation of the stomach or duodenum.
On the part of the liver and biliary system: an increase in "liver" transaminases, hepatitis, fulminant hepatitis, jaundice, cholestasis.
From the side of blood-forming organs: anemia, eosinophilia, thrombocytopenia, pancytopenia, purpura, lengthening of the bleeding time.
On the part of the respiratory system: shortness of breath, exacerbation of bronchial asthma, bronchospasm. From the senses: blurred vision.
Since the cardiovascular system: arterial hypertension, tachycardia, hemorrhage, "hot flashes".
Others: general weakness, hypothermia.

Drug interaction

There is evidence that nimesulide can reduce the bioavailability of Furosemide, to compete in the binding of plasma proteins with fenofibrate, salicylic acid, tolbutamide. Nimesulide can replace salicylic acid and furosemide (but not warfarin) in plasma proteins. It has no effect on drugs that affect blood glucose concentration and glucose tolerance in diabetic patients treated with various drugs containing sulfonylureas.
It is not recommended to take nimesulide simultaneously with diuretics, which have a damaging effect on renal hemodynamics. Physiological concentrations of unsaturated fatty acids do not affect the binding of nimesulide to serum albumin. At therapeutic concentrations, the binding of nimesulide was not affected by Warfarin, furosemide, glibenclamide, digitoxin. In the presence of nimesulide, the free fractions of Methotrexate can significantly increase.
Taking nimesulide in therapeutic doses orally for a short period does not change the serum profile of Digoxin in patients with mild heart failure. The concentration of lithium in the plasma increases while taking drugs of lithium and nimesulide. Nimesulide may enhance the effect of cyclosporine on the kidneys. The use of Nemulex with glucocorticosteroids, serotonin reuptake inhibitors increases the risk of developing gastrointestinal bleeding.

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 Nimesulide. Patients admitted to the hospital with symptoms of an overdose of the drug (within 4 hours after taking it or after taking a high dose) recommended gastric lavage, taking Activated carbon (60-100 mg for adults) and / or osmotic type laxatives. Requires regular monitoring of liver and kidney function.
There is no data on the possibility of removing nimesulide using hemodialysis.
Formed diuresis, hemodialysis are ineffective due to the high association of the drug with proteins.

Storage conditions

B. List: In a dry, the dark place at a temperature of no higher than 25 ° C.