Nimesulide (Tablets, Granules, Gel) Instructions for Use

Instructions
Dosage forms

ATC Code

M01AX17 (Nimesulide)

Active Substance

Nimesulide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

NSAID. Selective COX-2 inhibitor

Pharmacotherapeutic Group

Anti-inflammatory and antirheumatic drugs; non-steroidal anti-inflammatory and antirheumatic drugs; other non-steroidal anti-inflammatory and antirheumatic drugs

Pharmacological Action

NSAID from the sulfonanilide class, a selective competitive reversible inhibitor of COX-2. It has anti-inflammatory, analgesic, and antipyretic effects. It has a less pronounced inhibitory effect on COX-1.

It reduces the concentration of short-lived prostaglandin H₂, a substrate for kinin-stimulated synthesis of prostaglandin E₂, at the site of inflammation and in the ascending pathways of pain impulse transmission in the spinal cord. The reduction in the concentration of prostaglandin E₂ (a mediator of inflammation and pain) decreases the activation of EP-type prostanoid receptors, which is manifested by analgesic and anti-inflammatory effects.

Pharmacokinetics

After oral administration, Nimesulide is well absorbed from the gastrointestinal tract. C_max in blood plasma is reached on average after 2-3 hours and is 3-4 mg/L. AUC is 20-35 mg×h/L. Plasma protein binding is 97.5%. After a single oral dose of 100 mg, Nimesulide is present in the tissues of the female genital organs at a concentration of 40% of the plasma concentration. It is metabolized in the liver with the participation of the CYP2C9 isoenzyme. The main metabolite is the pharmacologically active parahydroxy derivative of nimesulide – hydroxynimesulide, which is found exclusively as a glucuronate. Nimesulide is eliminated from the body mainly in the urine (about 50% of the administered dose), and about 29% is excreted in the feces as metabolites. T_1/2 is 3.2-6 hours.

Indications

Acute pain (back pain, lower back pain; pain syndrome in the musculoskeletal system, including bruises, sprains, and dislocations of joints; tendinitis, bursitis; toothache); symptomatic treatment of osteoarthritis (osteoarthritis) with pain syndrome; primary dysmenorrhea.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
K08.8	Other specified disorders of teeth and supporting structures (including toothache)
M05	Seropositive rheumatoid arthritis
M13.9	Arthritis, unspecified
M15	Polyosteoarthritis
M19.9	Unspecified arthrosis
M25.5	Pain in joint
M42	Spinal osteochondrosis
M54	Dorsalgia
M54.1	Radiculopathy
M54.3	Sciatica
M54.4	Lumbago with sciatica
M65	Synovitis and tenosynovitis
M70	Soft tissue disorders related to use, overuse, and pressure
M71	Other bursopathies
M79.0	Unspecified rheumatism
M79.1	Myalgia
N94.4	Primary dysmenorrhea
R52.0	Acute pain
R52.2	Other chronic pain
T14.0	Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.3	Dislocation, sprain and strain of joint and ligament of unspecified body region

ICD-11 code	Indication
8B93.Z	Radiculopathy, unspecified
8E4A.1	Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
DA0A.Z	Diseases of teeth and supporting structures, unspecified
EH92	Dermatoses provoked by friction or mechanical impact
EH92.1	Blister due to friction
FA05	Polyosteoarthritis
FA0Z	Osteoarthritis, unspecified
FA20.0	Seropositive rheumatoid arthritis
FA27.2	Palindromic rheumatism
FA2Z	Inflammatory arthropathies, unspecified
FA85.Z	Defects of vertebral end-plates, unspecified
FB40.Z	Tenosynovitis, unspecified
FB50.1	Bursitis associated with use, overuse or pressure
FB50.Z	Bursitis, unspecified
FB51.3	Fibroblastic rheumatism
FB56	Specified soft tissue diseases, not elsewhere classified
FB56.2	Myalgia
GA34.3	Dysmenorrhea
LA30.5Z	Anomalies of tooth resorption or loss, unspecified
ME82	Pain in joint
ME84.20	Lumbago with sciatica
ME84.3	Sciatica
ME84.Z	Back pain, unspecified
MG30.Z	Chronic pain syndrome, unspecified
MG31.Z	Acute pain, unspecified
ND56.0	Superficial injury of unspecified body region
ND56.3	Dislocation, sprain or strain of unspecified body region

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Orally.

The contents of 1 sachet of granules 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 times/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 should be prescribed for the shortest possible duration to minimize the risk of adverse reactions. The maximum duration of drug use should not exceed 15 days.

Granules

Orally 100 mg 2 times/day, after meals.

Gel

Apply externally, apply to the affected area 3-4 times/day.

Should not be used for more than 10 days without consulting a doctor.

Adverse Reactions

From the hematopoietic system rarely – anemia, eosinophilia, hemorrhages; very rarely – thrombocytopenia, pancytopenia, thrombocytopenic purpura.

From the immune system rarely – hypersensitivity reactions; very rarely – anaphylactoid reactions, urticaria, angioneurotic edema.

From the skin and subcutaneous tissues infrequently – itching, skin rash, increased sweating; rarely – erythema, dermatitis; very rarely – urticaria, facial edema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome).

From the nervous system: infrequently – dizziness; very rarely – headache, drowsiness, encephalopathy (Reye’s syndrome).

Mental disorders rarely – feeling of fear, nervousness, nightmares.

From the organ of vision rarely – blurred vision; very rarely – visual impairment.

From the organ of hearing and labyrinthine disorders very rarely – vertigo.

From the cardiovascular system infrequently – increased blood pressure; rarely – tachycardia, blood pressure lability, flushing, palpitations.

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, gastrointestinal bleeding, ulcer and/or perforation of the stomach or duodenum; very rarely – abdominal pain, dyspepsia, stomatitis, tarry stools.

From the liver and biliary tract often – increased activity of “liver” enzymes; very rarely – hepatitis, fulminant hepatitis (including fatal outcomes), jaundice, cholestasis.

From the urinary system rarely – dysuria, hematuria, urinary retention; very rarely – renal failure, oliguria, interstitial nephritis.

From metabolism rarely – hyperkalemia; infrequently – peripheral edema; very rarely – hypothermia.

Other: rarely – malaise, asthenia.

Contraindications

Hypersensitivity to nimesulide; hyperergic reactions in history (bronchospasm, rhinitis, urticaria) associated with the use of acetylsalicylic acid or other NSAIDs, including nimesulide; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or sinusitis with intolerance to acetylsalicylic acid and other NSAIDs (including in history); history of hepatotoxic reactions to Nimesulide; simultaneous use with other drugs with potential hepatotoxicity (e.g., other NSAIDs); chronic inflammatory bowel diseases (Crohn’s disease, ulcerative colitis) in the acute phase; period after coronary artery bypass surgery; febrile syndrome in colds and acute respiratory viral infections; suspicion of acute surgical pathology; peptic ulcer of the stomach or duodenum in the acute phase; erosive and ulcerative lesions of the gastrointestinal tract; history of perforations or gastrointestinal bleeding; history of cerebrovascular bleeding or other diseases accompanied by increased bleeding; severe blood clotting disorders; severe heart failure; severe renal failure (creatinine clearance <30 ml/min), confirmed hyperkalemia; children under 12 years of age (for suspension - children under 2 years of age); pregnancy, breastfeeding period; alcoholism, drug dependence; hepatic insufficiency, active liver disease.

With caution

Arterial hypertension, diabetes mellitus, compensated heart failure, coronary artery disease, cerebrovascular diseases, dyslipidemia/hyperlipidemia, peripheral arterial diseases, hemorrhagic diathesis, smoking, creatinine clearance 30-60 ml/min.

History of ulcerative lesions of the gastrointestinal tract; history of Helicobacter pylori infection; elderly age; long-term prior use of NSAIDs; severe somatic diseases.

Simultaneous use with the following drugs: anticoagulants (e.g., warfarin), antiplatelet agents (e.g., acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (e.g., prednisolone), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline).

Use in Pregnancy and Lactation

Nimesulide is contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in moderate and severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in renal failure (creatinine clearance less than 30 ml/min).

Pediatric Use

When used in pediatrics, dosage forms intended for children should be used.

Geriatric Use

With external use, medical supervision of the condition of elderly patients with impaired renal function, liver function, and congestive heart failure is required.

Special Precautions

If symptoms similar to signs of liver damage appear (anorexia, itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of liver transaminases), the use of nimesulide should be stopped immediately and a doctor should be consulted. Repeated use of nimesulide in such patients is contraindicated.

Liver reactions are reported, which are reversible in most cases, with short-term use of nimesulide.

During the use of nimesulide, the patient should refrain from taking other analgesics, including NSAIDs (including selective COX-2 inhibitors).

Use with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn’s disease), as exacerbation of these diseases is possible. The risk of gastrointestinal bleeding, peptic ulcer/perforation of the stomach or duodenum increases in patients with a history of ulcerative lesions of the gastrointestinal tract (ulcerative colitis, Crohn’s disease), as well as in elderly patients, with an increase in the dose of NSAIDs, so treatment should be started with the lowest possible dose. Such patients, as well as patients who require simultaneous use of low doses of acetylsalicylic acid or other agents that increase the risk of gastrointestinal complications, are recommended to additionally prescribe gastroprotective agents (misoprostol or proton pump inhibitors). Patients with a history of gastrointestinal diseases, especially elderly patients, should inform the doctor about any newly emerging gastrointestinal symptoms (especially symptoms that may indicate possible gastrointestinal bleeding).

In case of gastrointestinal bleeding or ulcerative lesions of the gastrointestinal tract in patients taking Nimesulide, it should be discontinued.

Given reports of visual impairment in patients taking other NSAIDs, if any visual disturbance occurs, the use of nimesulide should be stopped immediately and an ophthalmological examination should be performed.

Nimesulide may cause fluid retention, so it should be used with particular caution in patients with arterial hypertension, renal and/or heart failure. If the condition worsens, treatment with nimesulide must be discontinued.

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

If signs of a cold or acute respiratory viral infection appear during the use of nimesulide, it should be discontinued immediately.

Nimesulide may alter platelet properties, so caution should be exercised when using it in persons with hemorrhagic diathesis; however, Nimesulide does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

Elderly patients are particularly susceptible to adverse reactions to NSAIDs, including the risk of gastrointestinal bleeding and perforations, which are life-threatening, and decreased renal, liver, and heart function. When taking nimesulide for this category of patients, proper clinical monitoring is necessary.

At the first appearance of skin rash, damage to mucous membranes, or other signs of an allergic reaction, nimesulide should be discontinued immediately.

Effect on ability to drive vehicles and operate machinery

During the use of nimesulide, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Glucocorticosteroids increase the risk of gastrointestinal ulcers or bleeding.

Antiplatelet agents and selective serotonin reuptake inhibitors, for example, fluoxetine, increase the risk of gastrointestinal bleeding.

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

NSAIDs can reduce the effect of diuretics. In healthy volunteers, Nimesulide temporarily reduces sodium excretion under the influence of furosemide, to a lesser extent – potassium excretion, and reduces the diuretic effect itself.
Simultaneous use of nimesulide and furosemide leads to a decrease (approximately by 20%) in AUC and a decrease in the cumulative excretion of furosemide without changing the renal clearance of furosemide. Simultaneous use of furosemide and nimesulide requires caution in patients with renal or heart failure.

NSAIDs can reduce the effect of antihypertensive drugs. In patients with mild to moderate renal failure (creatinine clearance 30-80 ml/min), with simultaneous use of ACE inhibitors, angiotensin II receptor antagonists, and agents that suppress the COX system (NSAIDs, antiplatelet agents), further deterioration of renal function and the occurrence of acute renal failure, which is usually reversible, are possible. These interactions should be considered in patients taking Nimesulide in combination with ACE inhibitors or angiotensin II receptor antagonists. Therefore, simultaneous use of these drugs should be carried out with caution, especially in elderly patients. Patients should receive sufficient fluids, and renal function should be carefully monitored after starting simultaneous use.

Theoretically, a decrease in the effectiveness of mifepristone and prostaglandin analogs is possible when used simultaneously with NSAIDs (including acetylsalicylic acid) due to the antiprostaglandin effect of the latter. Limited data show that the use of NSAIDs on the day of prostaglandin analog use does not adversely affect the effect of mifepristone or prostaglandin analog on cervical dilation, uterine contractility, and does not reduce the clinical efficacy of medical termination of pregnancy.

There is evidence that NSAIDs reduce the clearance of lithium, leading to an increase in plasma lithium concentration and its toxicity. When using nimesulide in patients on lithium therapy, regular monitoring of plasma lithium concentration should be carried out.

Nimesulide inhibits the activity of the CYP2C9 isoenzyme. When used simultaneously with nimesulide, drugs that are substrates of this enzyme may have increased plasma concentrations.

When using nimesulide less than 24 hours before or after using methotrexate, caution is required, as in such cases the plasma concentration of methotrexate and, accordingly, toxic effects may increase.

Due to the effect on renal prostaglandins, prostaglandin synthetase inhibitors, which include Nimesulide, may increase the nephrotoxicity of cyclosporine.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Nimesulide [Repliekpharm, AD (Macedonia)]
Tablets 100 mg: 1000 pcs.

Marketing Authorization Holder

Repliekpharm, AD (Macedonia)

Dosage Form

Nimesulide

Tablets 100 mg: 1000 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Nimesulide	100 mg

1000 pcs. – polyethylene bags (1) – polyethylene containers.

Nimesulide [Repliekpharm, AD (Macedonia)]
Tablets 100 mg: 20 pcs.

Marketing Authorization Holder

Repliekpharm, AD (Macedonia)

Labeled By

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Nimesulide	100 mg

10 pcs. – contour cell blisters (2) – cardboard packs.

Nimesulide [Avva Rus, JSC (Russia)]
Granules for oral suspension 100 mg/sachet: 2 g sachets 10, 20 or 30 pcs.

Marketing Authorization Holder

Avva Rus, JSC (Russia)

Dosage Form

Nimesulide

Granules for oral suspension 100 mg/sachet: 2 g sachets 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Granules for oral suspension preparation mixture of powder and granules from almost white to light yellow with an orange odor; color heterogeneity is allowed; the prepared suspension is from white to light yellow with an orange odor.

	1 sachet
Nimesulide	100 mg

Excipients: orange flavor – 42 mg, citric acid – 30 mg, maltodextrin – 15 mg, macrogol cetostearyl ether – 8 mg, sucrose up to a mass of 2000 mg.

2 g – multilayer sachets (10) – cardboard packs.
2 g – multilayer sachets (20) – cardboard packs.
2 g – multilayer sachets (30) – cardboard packs.

Nimesulide [Avva Rus, JSC (Russia)]
Granules for oral suspension 100 mg: 2 g sachets 4, 5, 6, 7, 8, 10, 20 or 30 pcs.

Marketing Authorization Holder

Avva Rus, JSC (Russia)

Dosage Form

Nimesulide

Granules for oral suspension 100 mg: 2 g sachets 4, 5, 6, 7, 8, 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

	1 sachet
Nimesulide	100 mg

Excipients: orange flavor – 42 mg, citric acid – 30 mg, maltodextrin – 15 mg, macrogol cetostearyl ether – 8 mg, sucrose – up to a mass of 2000 mg.

2 g – sachets (4) – cardboard pack.
2 g – sachets (5) – cardboard pack.
2 g – sachets (6) – cardboard pack.
2 g – sachets (7) – cardboard pack.
2 g – sachets (8) – cardboard pack.
2 g – sachets (10) – cardboard pack.
2 g – sachets (20) – cardboard pack.
2 g – sachets (30) – cardboard pack.

Nimesulide [Avva Rus, JSC (Russia)]
Tablets 100 mg: 10, 20 or 30 pcs.

Marketing Authorization Holder

Avva Rus, JSC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow or yellow, round, biconvex.

	1 tab.
Nimesulide	100 mg

Excipients: calcium hydrogen phosphate dihydrate – 75 mg, corn starch – 54 mg, microcrystalline cellulose 101 – 40 mg, sodium carboxymethyl starch (type A) – 35 mg, magnesium stearate – 3 mg, colloidal silicon dioxide – 2 mg, talc – 1 mg.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.

Nimesulide [Avva Rus, JSC (Russia)]
Granules for oral suspension preparation 100 mg/pkg.: 2 g packets 10, 20 or 30 pcs.

Marketing Authorization Holder

Avva Rus, JSC (Russia)

Dosage Form

Nimesulide

Granules for oral suspension preparation 100 mg/pkg.: 2 g packets 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Granules for oral suspension preparation in the form of a mixture of powder and granules from almost white to light yellow with an orange odor; color heterogeneity is allowed; the prepared suspension is from white to light yellow with an orange odor.

	1 sachet
Nimesulide (calculated as 100% substance)	100 mg

Excipients: orange flavor – 42 mg, citric acid – 30 mg, maltodextrin – 15 mg, macrogol cetostearyl ether – 8 mg, sucrose – up to a mass of 2000 mg.

2 g – single-use multilayer packaging material sachets (10) – cardboard packs.
2 g – single-use multilayer packaging material sachets (20) – cardboard packs.
2 g – single-use multilayer packaging material sachets (30) – cardboard packs.

Nimesulide [Alliancepharma, LLC (Russia)]
Tablets 100 mg: 10, 20, 30, 50, or 100 pcs.

Marketing Authorization Holder

Alliancepharma, LLC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 20, 30, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow, round, biconvex, the presence of yellow inclusions is allowed.

	1 tab.
Nimesulide	100 mg

Excipients: lactose monohydrate – 118.6 mg, sodium carboxymethyl starch – 28 mg, povidone K25 – 16 mg, magnesium stearate – 3.2 mg, microcrystalline cellulose – 52.2 mg, colloidal silicon dioxide – 2 mg.

20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters (100) – group packaging (for hospitals).
10 pcs. – contour cell blisters (300) – group packaging (for hospitals).
10 pcs. – contour cell blisters (500) – group packaging (for hospitals).

Nimesulide [Artelar, LLC (Russia)]
Tablets 100 mg: 10, 20 or 30 pcs.

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow or yellow, round, biconvex.

	1 tab.
Nimesulide	100 mg

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
15 pcs. – contour cell blisters (1) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (3) – cardboard packs.

Nimesulide [Artelar, LLC (Russia)]
Granules for oral suspension 100 mg: 2 g sachets 4, 5, 6, 7, 8, 10, 20 or 30 pcs.

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Form

Nimesulide

Granules for oral suspension 100 mg: 2 g sachets 4, 5, 6, 7, 8, 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Granules for oral suspension preparation in the form of a mixture of powder and granules from almost white to light yellow, with an orange odor; color heterogeneity is allowed; the prepared suspension is from white to light yellow, with an orange odor.

	1 sachet
Nimesulide (calculated as 100% substance)	100 mg

Excipients: orange flavor – 42 mg, citric acid – 30 mg, maltodextrin – 15 mg, macrogol cetostearyl ether – 8 mg, sucrose – up to a mass of 2000 mg.

2 g – single-use sachets (4) – cardboard packs.
2 g – single-use sachets (5) – cardboard packs.
2 g – single-use sachets (6) – cardboard packs.
2 g – single-use sachets (7) – cardboard packs.
2 g – single-use sachets (8) – cardboard packs.
2 g – single-use sachets (10) – cardboard packs.
2 g – single-use sachets (20) – cardboard packs.
2 g – single-use sachets (30) – cardboard packs.

Nimesulide [Atoll LLC (Russia)]
Gel for external use 1%: 10 g, 20 g, or 30 g tubes

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Nimesulide

Gel for external use 1%: 10 g, 20 g, or 30 g tubes

Dosage Form, Packaging, and Composition

Gel for external use light yellow or yellow, transparent, with a specific odor.

	100 g
Nimesulide (calculated as 100% dry substance)	1 g

Excipients: macrogol-400 – 31.55 g, methylpyrrolidone – 25 g, isopropanol – 10 g, propylene glycol – 10 g, carbomer – 1.2 g, lavender oil – 0.25 g, trometamol – 0.09 g, purified water – up to 100 g.

Note. If necessary to achieve the optimal pH of the gel, the trometamol content may be adjusted within the range from 0.02 g to 0.15 g per 100 g.

10 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Nimesulide [Atoll LLC (Russia)]
Tablets 100 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 160, 180, 200, 240 or 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Ozon Pharm, LLC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 160, 180, 200, 240 or 300 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow, round, biconvex; the presence of yellow inclusions is allowed.

	1 tab.
Nimesulide	100 mg

Excipients: lactose monohydrate (milk sugar) – 115 mg, microcrystalline cellulose (MCC-101) – 52.2 mg, sodium carboxymethyl starch – 28 mg, povidone-K25 – 16 mg, magnesium stearate – 3.2 mg, colloidal silicon dioxide – 2 mg, water – 3.6 mg.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
20 pcs. – contour cell blisters (1) – cardboard packs.
20 pcs. – contour cell blisters (2) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
20 pcs. – contour cell blisters (4) – cardboard packs.
20 pcs. – contour cell blisters (5) – cardboard packs.
20 pcs. – contour cell blisters (6) – cardboard packs.
20 pcs. – contour cell blisters (8) – cardboard packs.
20 pcs. – contour cell blisters (10) – cardboard packs.
30 pcs. – contour cell blisters (1) – cardboard packs.
30 pcs. – contour cell blisters (2) – cardboard packs.
30 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – contour cell blisters (4) – cardboard packs.
30 pcs. – contour cell blisters (5) – cardboard packs.
30 pcs. – contour cell blisters (6) – cardboard packs.
30 pcs. – contour cell blisters (8) – cardboard packs.
30 pcs. – contour cell blisters (10) – cardboard packs.

Nimesulide [Beryozovsky Pharmaceutical Plant, CJSC (Russia)]
Tablets 100 mg: 10, 20, 30 or 100 pcs.

Marketing Authorization Holder

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 20, 30 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Nimesulide	100 mg

10 pcs. – contour cell blisters (aluminum/PVC) (1) – cardboard packs.
10 pcs. – contour cell blisters (aluminum/PVC) (2) – cardboard packs.
10 pcs. – contour cell blisters (aluminum/PVC) (3) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Nimesulide [Biocom, JSC (Russia)]
Tablets 100 mg: 10, 20, 30, 40, 50, 60 or 100 pcs.

Marketing Authorization Holder

Biocom, JSC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 20, 30, 40, 50, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow to yellow, round, biconvex, the presence of inclusions from white to yellow, marbling is allowed.

	1 tab.
Nimesulide	100 mg

Excipients: lactose monohydrate – 135.7 mg, potato starch – 30 mg, microcrystalline cellulose 101 – 34.1 mg, povidone K30 – 8 mg, croscarmellose sodium – 22 mg, colloidal silicon dioxide (aerosil) – 3.4 mg, docusate sodium – 1.7 mg, polysorbate 80 – 1 mg, magnesium stearate – 4.1 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

Nimesulide [Bright Way, LLC (Russia)]
Tablets 100 mg: 10, 14, 15, 20, 28, 30, 40, 42, 50, 56, 60, 70 or 84 pcs.

Marketing Authorization Holder

Bright Way, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 14, 15, 20, 28, 30, 40, 42, 50, 56, 60, 70 or 84 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow or yellow in color, round, biconvex; the presence of yellow specks is allowed.

	1 tab.
Nimesulide	100 mg

Excipients: lactose monohydrate (milk sugar), sodium carboxymethyl starch, povidone K17, magnesium stearate, microcrystalline cellulose type 102, colloidal silicon dioxide (aerosil), water.

Nimesulide [Izvarino Pharma LLC (Russia)]
Tablets 100 mg: 10, 20, 30, 40, 50, 60 or 100 pcs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 20, 30, 40, 50, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow to yellow in color, round, biconvex in shape, with a score on one side and an embossed symbol ” f ” on the other side.

	1 tab.
Nimesulide	100 mg

Excipients: microcrystalline cellulose, corn starch, sodium starch glycolate (type A), copovidone, polyethylene glycol, polysorbate 80, magnesium stearate, colloidal silicon dioxide.

Nimesulide [Lekpharm, SOOO (Republic of Belarus)]
Tablets 100 mg: 10, 20 or 30 pcs.

Marketing Authorization Holder

Lekpharm, SOOO (Republic of Belarus)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow in color, round, with a smooth biconvex surface.

	1 tab.
Nimesulide	100 mg

Excipients: microcrystalline cellulose (102) – 53.95 mg, corn starch – 31 mg, sodium starch glycolate (type A) – 37.2 mg, colloidal silicon dioxide – 3.1 mg, talc – 3.1 mg, magnesium stearate – 3.1 mg, calcium hydrogen phosphate dihydrate – to obtain a tablet with a mass of 310 mg.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.

Nimesulide [Marbiopharm, JSC (Russia)]
Tablets 100 mg: 20 or 30 pcs.

Marketing Authorization Holder

Marbiopharm, JSC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow in color, round, flat-cylindrical, with a bevel and a score.

	1 tab.
Nimesulide	100 mg

Excipients: lactose monohydrate, calcium hydrogen phosphate dihydrate – 75 mg, corn starch – 54 mg, microcrystalline cellulose 101 – 40 mg, sodium carboxymethyl starch – 35 mg, magnesium stearate – 3 mg, colloidal silicon dioxide (aerosil) – 2 mg, talc – 1 mg.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.

Nimesulide [MK Development LLC (Russia)]
Granules for oral suspension preparation 100 mg: 2 g packets 10 or 30 pcs.

Marketing Authorization Holder

MK Development LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Form

Nimesulide

Granules for oral suspension preparation 100 mg: 2 g packets 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Granules for preparation of oral suspension in the form of a mixture of powder and granules from almost white to light yellow in color with an orange odor; color heterogeneity is allowed; the prepared suspension is from white to light yellow in color with an orange odor.

	1 sachet
Nimesulide	100 mg

Excipients: orange flavor – 42 mg, citric acid – 30 mg, maltodextrin – 15 mg, macrogol cetostearyl ether – 8 mg, sucrose – to a mass of 2000 mg.

2 g – sachet (10) – cardboard pack.
2 g – sachet (30) – cardboard pack.

Nimesulide [Patent-Pharm, JSC (Russia)]
Gel for external use 1%: 15 g, 20 g, 25 g, or 30 g tubes

Marketing Authorization Holder

Patent-Pharm, JSC (Russia)

Manufactured By

Murom Instrument-Making Plant, JSC (Russia)

Dosage Form

Nimesulide

Gel for external use 1%: 15 g, 20 g, 25 g, or 30 g tubes

Dosage Form, Packaging, and Composition

Gel for external use from light yellow to yellow in color, transparent, homogeneous, with a specific odor; the presence of air bubbles is allowed.

	100 g
Nimesulide	1 g

Excipients: methylpyrrolidone – 25 g, propylene glycol – 10 g, macrogol 400 – 30 g, isopropanol – 10 g, carbomer 940 – 2 g, butylated hydroxytoluene – 0.02 g, potassium dihydrogen phosphate – 0.02 g, methylparaben – 0.02 g, purified water – up to 100 g.

15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Nimesulide [Promomed Rus LLC (Russia)]
Gel for external use 1%: 20 g, 25 g, 30 g, 50 g, 75 g, or 100 g tubes 1 or 2 pcs., 25 g jar

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Nimesulide

Gel for external use 1%: 20 g, 25 g, 30 g, 50 g, 75 g, or 100 g tubes 1 or 2 pcs., 25 g jar

Dosage Form, Packaging, and Composition

Gel for external use yellowish in color, homogeneous, translucent, with a characteristic odor.

	1 g
Nimesulide	10 mg

Excipients: hydroxypropyl cellulose – 16.8 mg, carbomer – 6 mg, ethanol (ethyl alcohol) 95% – 665.7 mg, triacetin – 70.5 mg, dimethylacetamide – 148 mg, concentrated phosphoric acid – 2.5 mg, lavender oil – 1.5 mg, purified water – up to 1 g.

20 g – tubes (1) – cardboard packs.
20 g – tubes (2) – cardboard packs.
25 g – tubes (1) – cardboard packs.
25 g – tubes (2) – cardboard packs.
30 g – tubes (1) – cardboard packs.
30 g – tubes (2) – cardboard packs.
50 g – tubes (1) – cardboard packs.
50 g – tubes (2) – cardboard packs.
75 g – tubes (1) – cardboard packs.
75 g – tubes (2) – cardboard packs.
100 g – tubes (1) – cardboard packs.
100 g – tubes (2) – cardboard packs.
25 g – dark glass jars (1) – cardboard packs.

Nimesulide [Salvus, LLC (Russia)]
Tablets 100 mg: 10, 20, 30, 40, 50, or 60 pcs.

Marketing Authorization Holder

Salvus, LLC (Russia)

Manufactured By

Rubicon, LLC (Republic of Belarus)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow in color, round, biconvex; the presence of yellow specks is allowed.

	1 tab.
Nimesulide	100 mg

Excipients: lactose monohydrate – 115 mg, microcrystalline cellulose (type 101) – 52.2 mg, sodium carboxymethyl starch (type A) – 28 mg, povidone K25 – 16 mg, magnesium stearate – 3.2 mg, colloidal silicon dioxide – 2 mg, purified water – 3.6 mg.

Nimesulide [Tula Pharmaceutical Factory, LLC (Russia)]
Gel for external use 1%: 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 100 g, 150 g, or 200 g tubes

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Nimesulide

Gel for external use 1%: 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 100 g, 150 g, or 200 g tubes

Dosage Form, Packaging, and Composition

Gel for external use transparent, from light yellow to yellow in color, free from foreign particles.

	1 g
Nimesulide	10 mg

Excipients: N-methyl-2-pyrrolidone – 250 mg, propylene glycol – 100 mg, macrogol 400 – 315.5 mg, isopropanol – 100 mg, purified water – 200 mg, carbomer 940 – 20 mg, butylated hydroxyanisole – 0.2 mg, thiomersal – 0.1 mg, potassium dihydrogen phosphate – 0.2 mg, flavor (Narcissus-938) – 4 mg.

20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
35 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.
70 g – aluminum tubes (1) – cardboard packs.
80 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
150 g – aluminum tubes (1) – cardboard packs.
200 g – aluminum tubes (1) – cardboard packs.

Nimesulide [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Gel for external use 1%: 25 g or 30 g jars; 25 g, 30 g, 40 g, 50 g, or 60 g tubes

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Nimesulide

Gel for external use 1%: 25 g or 30 g jars; 25 g, 30 g, 40 g, 50 g, or 60 g tubes

Dosage Form, Packaging, and Composition

Gel for external use homogeneous transparent, light yellow or yellow in color with a specific odor.

	100 g
Nimesulide	1 g

Excipients: macrogol 400 – 31.55 g, methylpyrrolidone – 25 g, isopropanol – 10 mg, propylene glycol – 10 mg, carbomer – 1.2 g, lavender oil – 0.25 g, trometamol – 0.09 g, purified water – up to 100 g.

25 g – dark glass jars (1) – cardboard packs.
30 g – dark glass jars (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.

Nimesulide [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Granules for oral suspension preparation 100 mg/pkg.: 2 g packets 10, 20 or 30 pcs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Nimesulide

Granules for oral suspension preparation 100 mg/pkg.: 2 g packets 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Granules for preparation of oral suspension in the form of a mixture of powder and granules of round and irregular shape from light yellow to yellow in color, with an orange odor.

	1 sachet
Nimesulide	100 mg

Excipients: sucrose – 1807 mg, macrogol glyceryl hydroxystearate – 8 mg, citric acid – 30 mg, maltodextrin – 15 mg, orange flavor – 40 mg.

2 g – sachets (10) – cardboard packs.
2 g – sachets (20) – cardboard packs.
2 g – sachets (30) – cardboard packs.

Nimesulide [Formula-FR, LLC (Russia)]
Tablets 100 mg: 10, 20 or 30 pcs.

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow or yellow in color, round, biconvex.

	1 tab.
Nimesulide	100 mg

Excipients: calcium hydrogen phosphate dihydrate – 75 mg, corn starch – 54 mg, microcrystalline cellulose 101 – 40 mg, sodium carboxymethyl starch type A – 35 mg, magnesium stearate – 3 mg, colloidal silicon dioxide – 2 mg, talc – 1 mg.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.

Nimesulide [Formula-FR, LLC (Russia)]
Granules for oral suspension 100 mg: 2 g sachets 4, 5, 6, 7, 8, 10, 20 or 30 pcs.

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Form

Nimesulide

Granules for oral suspension 100 mg: 2 g sachets 4, 5, 6, 7, 8, 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

	1 sachet
Nimesulide (calculated as 100% substance)	100 mg

Excipients: orange flavor – 42 mg, citric acid – 30 mg, maltodextrin – 15 mg, macrogol cetostearyl ether – 8 mg, sucrose – up to a mass of 2000 mg.

Nimesulide [YUGPHARM, LLC (Russia)]
Gel for external use 1%

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Form

Nimesulide

Gel for external use 1%

Dosage Form, Packaging, and Composition

Gel for external use transparent, homogeneous, from light yellow to yellow in color with a specific odor.

	1 g
Nimesulide	10 mg

Excipients: methylpyrrolidone, propylene glycol, macrogol-400, isopropanol, carbomer, lavender oil, trometamol, purified water.

15 g – aluminum tubes (1) – cardboard packs (1).
20 g – aluminum tubes (1) – cardboard packs (1).
30 g – aluminum tubes (1) – cardboard packs (1).
50 g – aluminum tubes (1) – cardboard packs (1).
100 g – aluminum tubes (1) – cardboard packs (1).

Nimesulide [YUGPHARM, LLC (Russia)]
Tablets 100 mg: 10, 20, 30, 40 or 50 pcs.

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Form

Nimesulide

Tablets 100 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets light yellow in color, round, biconvex; the presence of yellow inclusions is allowed.

	1 tab.
Nimesulide	100 mg

Excipients: lactose monohydrate – 115 mg, microcrystalline cellulose – 52.2 mg, sodium carboxymethyl starch (type A) – 28 mg, povidone K-25 – 16 mg, magnesium stearate – 3.2 mg, colloidal silicon dioxide – 2 mg, purified water – 3.6 mg.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.

Nimesulide [YUGPHARM, LLC (Russia)]
Granules for oral suspension preparation 100 mg: 2 g packets 5, 9, 10, 15, 20 or 30 pcs.

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Form

Nimesulide

Granules for oral suspension preparation 100 mg: 2 g packets 5, 9, 10, 15, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Granules for the preparation of an oral suspension in the form of a mixture of powder and granules from almost white to light yellow in color with a specific odor; color heterogeneity is allowed; the prepared suspension is from white to light yellow in color with a specific odor.

	1 sachet
Nimesulide	100 mg

Excipients: sucrose – 1805 mg, macrogol cetostearyl ether – 8 mg, anhydrous citric acid – 30 mg, maltodextrin – 15 mg, orange flavor – 42 mg.

2 g – sachets (5) – cardboard pack.
2 g – sachets (9) – cardboard pack.
2 g – sachets (10) – cardboard pack.
2 g – sachets (15) – cardboard pack.
2 g – sachets (20) – cardboard pack.
2 g – sachets (30) – cardboard pack.

Nimesulide forte [Beryozovsky Pharmaceutical Plant, CJSC (Russia)]
Gel for external use 2%: 50 g tube

Marketing Authorization Holder

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

Manufactured By

Repliek Farm Ltd. Skopje (Republic of North Macedonia)

Packaging and Quality Control Release

Beryozovsky Pharmaceutical Plant, CJSC (Russia)

Dosage Form

Nimesulide forte

Gel for external use 2%: 50 g tube

Dosage Form, Packaging, and Composition

Gel for external use homogeneous, yellowish-white in color.

	100 g
Nimesulide	2 g

Excipients: diethylene glycol monoethyl ether – 15 g, propylene glycol – 5 g, methylparaben – 0.2 g, propylparaben – 0.02 g, edetic acid (ethylenediaminetetraacetic acid) – 0.1 g, caprylcaproyl macrogol-8 glycerides (caprylcaproyl polyoxyl-8 glycerides, caprylcaproyl macrogol glycerides) – 2 g, carbomer – 1 g, glycerol – 5 g, liquid paraffin – 5 g, PEG/PPG-20/6 dimethicone – 1 g, triethanolamine (trolamine) – 0.5 g, purified water – 63.18 g.

50 g – aluminum tubes (1) – cardboard packs.

Nimesulide-Akrikhin [Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)]
Gel for external use 1%: 20 g or 50 g tubes

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Nimesulide-Akrikhin

Gel for external use 1%: 20 g or 50 g tubes

Dosage Form, Packaging, and Composition

Gel for external use light yellow or yellow in color, transparent or almost transparent; the presence of a specific odor and air bubbles is allowed.

	100 g
Nimesulide	1 g

Excipients: methylpyrrolidone, isopropanol, propylene glycol, carbomer 940 (carbopol 980), macrogol 400, lavender oil, trometamol, purified water.

20 g – aluminum tubes (1) with a cap – cardboard packs.
50 g – aluminum tubes (1) with a cap – cardboard packs.

Nimesulide-Incampharm^® [Incampharm, LLC (Russia)]
Gel for external use 1%: 20 g, 25 g, 30 g, 50 g, 75 g, or 100 g tubes; 25 g, 30 g, or 50 g jars.

Marketing Authorization Holder

Incampharm, LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Nimesulide-Incampharm^®

Gel for external use 1%: 20 g, 25 g, 30 g, 50 g, 75 g, or 100 g tubes; 25 g, 30 g, or 50 g jars.

Dosage Form, Packaging, and Composition

Gel for external use yellowish in color, semi-transparent, homogeneous.

	100 g
Nimesulide	1 g

Excipients: hypromellose, carbomer, ethanol (ethyl alcohol) 95%, purified water, triacetin, dimethylacetamide, concentrated phosphoric acid, lavender oil.

20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
25 g – glass jars (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
30 g – glass jars (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
50 g – glass jars (1) – cardboard packs.
75 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.

Nimesulide-Vertex [Vertex, JSC (Russia)]
Gel for external use 1%: tubes 20 g, 30 g, 50 g, or 100 g

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Nimesulide-Vertex

Gel for external use 1%: tubes 20 g, 30 g, 50 g, or 100 g

Dosage Form, Packaging, and Composition

Gel for external use1% light yellow in color, homogeneous, semi-transparent.

	1 g
Nimesulide	10 mg

Excipients: ethanol 95% (ethyl alcohol 95%) – 667 mg, dimethylacetamide – 150 mg, triacetin – 70 mg, hypromellose (hydroxypropyl cellulose) – 16.67 mg, carbomer – 5 mg, concentrated phosphoric acid (phosphoric acid, orthophosphoric acid) – 4.37 mg, purified water – up to 1 g.

20 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.