Instruction for use: Nemulex

Active substance Nimesulide

ATX code M01AX17 Nimesulide

Pharmacological group

Other non-narcotic analgesics, including non-steroidal and other anti-inflammatory drugs

Nosological classification (ICD-10)

K08.8.0 * Painful toothache

Dentinal pain, Dentinal pains, Pain pulpitis, Anesthesia in dentistry, Pain syndromes in dental practice, Pain after removal of tartar, Pain when extracting a tooth, Toothache, Pain after dental interventions

M13.9 Arthritis, unspecified

Arthritis,Purulent arthritis (non-infectious), acute Arthritis,Pain in acute inflammatory diseases of the musculoskeletal system,Pain in chronic inflammatory diseases of the musculoskeletal system,The pain in osteoarthritis, Inflammation in osteoarthritis, Inflammatory arthropathy, Inflammatory and degenerative joint diseases, Inflammatory disease of the musculoskeletal system, Inflammatory joint disease, Inflammatory diseases of the musculoskeletal system, destructive arthritis, The disease of the musculoskeletal system, Diseases of the musculoskeletal system, Diseases of the musculoskeletal system and connective tissue, Infections musculoskeletal system, monoartrit, Non-infectious arthritis, rheumatic arthritis, Osteoarthritis, Acute inflammation of the musculoskeletal tissue, Acute inflammatory diseases of the musculoskeletal system, Acute inflammatory condition of the musculoskeletal system, Acute arthritis, Acute osteoarthritis, Post-traumatic osteoarthritis, Reactive arthritis, Chronic inflammatory diseases of the joints, Chronic arthritis, Chronic inflammatory arthritis, Chronic inflammation of the inner layer of the joint capsule, Chronic inflammation of the joint capsule,Chronic inflammatory disease of the joints, Exudative arthritis

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

M25.5 Pain in the joint

Arthralgia, Pain syndrome in musculo-articular diseases, Pain syndrome in osteoarthritis, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the joints, Soreness of the joints, Soreness of joints in severe physical exertion, Painful inflammatory joint damage, Painful conditions of the musculoskeletal system, Painful joint conditions, Painful traumatic affection of joints, Pain in the musculoskeletal system, Pain in Shoulder Joints, Pain in the joints, Joint pain, Joint pain with injuries, Musculoskeletal pain, Pain with osteoarthritis, Pain in the pathology of the joints, Pain in rheumatoid arthritis, Pain in chronic degenerative bone diseases, Pain in chronic degenerative joint diseases, Bone-joint pain, Joint pain, Arthritic pain of rheumatic origin, Articular pain syndrome, Joint pain, Rheumatic pain, Rheumatic pains

M54.5 Pain below the back

Pain in the lower back, Lumbar pain, Lumbalia, Painful conditions of the spinal column, Back pain, Lower Back Pain Syndrome

M54.9 Dorsalgia, unspecified

Pain syndrome with radiculitis, Pain syndrome in the back,Pain with radiculitis, Degenerative changes in the spine, Degenerative and dystrophic disease of the spine and joints, Degenerative disease of the spine, Osteoarthrosis of the spine, Painful lesions of the spine

M71 Other bursopathies

Bursitis, Bursopathy, Diseases of soft tissues, Osteoarthritis in musculo-articular diseases, Inflammatory disease of soft tissues, Subacute bursitis

M77.9 Other unspecified

Capsule, Periarthritis, Tendonitis, Tendopathy, Periarthropathy

M79.1 Myalgia

Myofascial pain syndromes ,Pain syndrome in musculo-articular diseases, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the muscles, Tenderness of muscles, Muscular soreness in severe physical exertion, Painful conditions of the musculoskeletal system, Pain in the musculoskeletal system, Pain in the muscles, Pain at rest, Muscle aches, Muscle pain, Musculoskeletal pain, Myalgia, Muscle pain, Muscle pain at rest, Muscle pain, Muscular pain of non-rheumatic origin, Muscle pain of rheumatic origin, Acute muscle pain, Rheumatic pain, Rheumatic pains, Myofascial syndrome, Fibromyalgia

M89.9 Disease of bone, unspecified

Local osteopathy, Disturbance of bone mineralization processes, Osteopenia, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the musculoskeletal system, Infection of bones, Ossalgia, Pain in chronic degenerative bone diseases

N94.6 Dysmenorrhea Unspecified

Pain during menstruation, Functional disorders of the menstrual cycle, Menstrual cramps, Emmeniopathy, Pain during menstruation, Painful menstrual irregularities, algomenorrhea, algomenoreya, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Disalgomenoreya, dysmenorrhea, Dysmenorrhea (essential) (Exfoliative), menstrual disorder, menstruation painful, metrorrhagia, Violation of the menstrual cycle, Menstrual irregularities, Prolaktinzavisimoe menstrual disorders, Prolaktinzavisimoe menstrual dysfunction, Pain spasm of smooth muscles of internal organs, Spasmodic dysmenorrhea, Primary disalgomenoreya

R52.0 Acute pain

Acute pain syndrome, Acute pain syndrome with osteoarthritis, Acute pain syndrome of traumatic origin, Severe pain of a neurogenic nature, Severe pain, Pain syndrome at delivery

R52.9 Unspecified Pain

Pain after cholecystectomy, Pain shooting, Non-malignant pain, Obstetric and gynecological pain, Pain syndrome, Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain of inflammatory genesis, Pain than cancer genesis, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after injuries, Pain after the removal of hemorrhoids, Pain at the non-rheumatic inflammation of nature, Pain in inflammatory lesions of the peripheral nervous system, Pain in diabetic neuropathy, Pain in acute inflammatory diseases of the musculoskeletal system, Pain when the tendon pathology, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Pain in trauma syndrome, Pain with injuries and after surgical interventions, Pain in chronic inflammatory diseases of the musculoskeletal system, Pain with duodenal ulcer, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, pain, Pain during menstruation, pain syndromes, painful condition, Painful foot fatigue, Sore gums when wearing dentures, Soreness of the cranial nerves exit points, Painful menstrual irregularities, Painful dressings, Painful muscle spasm, Painful teeth growth, Melosalgia, Pain in the area of the surgical wound, Pain in the postoperative period, Pain in the body, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain after surgery, The pains of the flu, Pain in diabetic polyneuropathy, Pain for burns, Pain during sexual intercourse, Pain during diagnostic procedures, Pain during therapeutic procedures, for colds Pain, Pain in sinusitis, Pain in trauma, Pain traumatic, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, Pain after surgery, postoperative Pain, Pain postoperative and posttraumatic, posttraumatic pain, Pain when swallowing, Pain in infectious and inflammatory diseases of the upper respiratory tract, The pain of burns, The pain in traumatic muscle injury, Pain in trauma, The pain of tooth extraction, The pain of traumatic origin, Pain caused by spasm of smooth muscles, Expressed pain syndrome, Expressed pain syndrome, traumatic origin, Postoperative pain, Post-traumatic pain, Post-traumatic pain syndrome, Torpid pain, Traumatic pain, Traumatic pain, Mild pain, Moderately severe pain, Moderate pain, Polyarthralgia with polymyositis

R68.8.0 * Inflammatory syndrome

Painful syndrome of inflammatory genesis, Pain syndrome with inflammation of non-rheumatic nature, Pain syndrome with inflammatory lesions of the peripheral nervous system, Painful inflammation of the shoulder joint, Painful inflammation after trauma or surgery, Painful inflammation after surgery, Painful hemorrhoids, Inflammation of the tympanic membrane, Inflammation of the larynx, Inflammation of the gums, Inflammation of cellulose, Inflammation of lymph nodes, Tonsillitis, Inflammation of muscles, Inflammation of soft tissues, Inflammation of the mouth, Inflammation after surgery and trauma, Inflammation after orthopedic surgery, Inflammation after trauma, Inflammation in rheumatoid arthritis, Inflammation of the middle ear, Inflammatory gum disease, Inflammatory diseases of the eyelids, Inflammatory eye diseases, Inflammatory swelling of soft tissues, Inflammatory processes, Inflammatory processes after surgical interventions, Inflammatory process, Inflammatory Syndrome, Inflammatory syndrome of non-rheumatic origin, Inflammatory syndrome after surgery, Purulent infections, Infringements of function of a liver of an inflammatory etiology, Acute inflammation of the musculoskeletal tissue, Pre-inflammatory soft tissue inflammation

T03.9 Multiple dislocations, sprains and injuries of capsular-ligamentous apparatus of joints, unspecified

Dislocation, Dislocations, Distortion

T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of the joint of the unspecified area of the body

Painful stretching of muscles, Pain and inflammation in tension, Dislocation of dislocation, Degenerative changes in the ligamentous apparatus, Edema due to sprains and bruises, Edema after interventions for sprains, Damage and rupture of ligaments, The musculoskeletal system is damaged, Damage to ligaments, Damage to the joints, Ligament ruptures, Tendon tendons,Ruptures of the tendons of muscles,Stretching, Crick, Stretching of the muscle, Sprain, Tension of the tendons, Extensions,Stretch muscles, Sprains, Tension of the tendons, Injury of the musculoskeletal system, Injuries to the joints, Injuries of capsule-articular tissues, Injuries of the osteoarticular system, Injuries to ligamentsInjuries to the joints, Joint wounds, Stretching of the ligamentous apparatus, Habitual stretching and tearing

T14.9 Injury unspecified

Pain syndrome after trauma, Pain syndrome with injuries, Pain syndrome with trauma and after surgery, Pain in case of injury, Pain of a traumatic nature, Joint pain with injuries, Postoperative and post-traumatic pain, Pain in case of injury, Pain of a traumatic origin, Severe pain syndrome of traumatic origin, Deep tissue damage, Deep scratches on the trunk, Closed injury, Minor Household Injuries, Minor skin damage, Violations of the integrity of soft tissues, Uncomplicated trauma, Extensive traumatic injury, Acute pain syndrome of traumatic origin, Edema with trauma, Postponed sports injuries, Post-traumatic pain, Soft tissue injuries, Joint wounds, Sports injuries, Injury, Traumatic pain, Traumatic pains, Traumatic infiltrate,Injuries to sports

Composition

Granules for the preparation of a suspension for oral administration 1 pack.

active substance:

nimesulide 100 mg

auxiliary substances: Macrogol cetostearate (Cremophor A25) - 100 mg; citric acid anhydrous - 19 mg; silicon dioxide colloid (aerosil) - 40 mg; sucrose 1721 mg; orange flavoring - 20 mg

Description of dosage form

Granules: yellowish in color.

The resulting suspension is a light yellow color.

pharmachologic effect

Pharmacological action - anti-inflammatory, antipyretic, antiaggregational, analgesic.

Pharmacodynamics

NSAIDs from the class of sulfonamides. Has anti-inflammatory, analgesic and antipyretic effect. Unlike nonselective NSAIDs, nimesulide mainly inhibits COX-2, inhibits the synthesis of PG in the inflammatory focus; has a less pronounced inhibitory effect on COX-1.

Pharmacokinetics

Nimesulide is well absorbed from the digestive tract. Cmax in the blood plasma after oral administration of a single dose of nimesulide, 100 mg, is achieved on average 2-3 hours and is 3-4 mg / l.

AUC-20 · 35 mg h / l.

Connection with blood plasma proteins - up to 97.5%.

Metabolised in the liver with the cytochrome P450 isoenzyme CYP2C9. The main metabolite is the pharmacologically active parahydroxy derivative of nimesulide - hydroxynimidesulide, which is found exclusively in the form of glucuronate.

Nimesulide is excreted from the body mainly with urine (about 50% of the dose taken), in the metabolized form with feces about 29% is excreted. T1 / 2 is 3.2 to 6 hours.

The pharmacokinetic profile of nimesulide in elderly patients and patients with mild to moderate renal insufficiency does not change with single and multiple / repeated doses.

In a study in patients with mild to moderate renal insufficiency (Cl creatinine 30-80 ml / min), Cmax nimesulide and its main metabolite were not higher than in healthy volunteers. AUC and T1 / 2 were 50% higher, but were within the values observed in healthy volunteers against the background of nimesulide. Repeated use did not result in the cumulation of nimesulide.

Indications

acute pain (pain in the back, lower back, pain in the musculoskeletal system, including bruises, sprains and joints, tendonitis, bursitis, toothache);

symptomatic treatment of osteoarthritis (osteoarthritis) with pain syndrome;

primary algodismenorea.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use; Nimesulide is recommended for therapy as a second-line drug.

Contraindications

hypersensitivity to nimesulide or other components of the drug;

hyperergic reactions in the anamnesis (bronchospasm, rhinitis, urticaria) associated with the use of acetylsalicylic acid or other NSAIDs, incl. nimesulide;

complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses with intolerance to acetylsalicylic acid and other NSAIDs (including in the anamnesis);

hepatotoxic reactions to nimesulide (in anamnesis);

simultaneous use with other drugs with potential hepatotoxicity (eg other NSAIDs);

chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis) in the phase of exacerbation;

period after aortocoronary shunting;

febrile syndrome for colds and acute respiratory viral infections;

suspected acute surgical pathology;

peptic ulcer of the stomach or duodenum in the phase of exacerbation, erosive-ulcerative gastrointestinal lesions, perforations or gastrointestinal hemorrhages in the anamnesis;

cerebrovascular hemorrhages in the anamnesis or other diseases, accompanied by increased bleeding;

severe blood clotting disorders;

severe heart failure;

severe renal failure (Cl creatinine <30 ml / min), confirmed hyperkalemia;

hepatic insufficiency or any active liver disease;

hereditary intolerance to fructose, a deficiency of sucrose-isomaltase and a glucose-galactose malabsorption syndrome;

alcoholism, drug dependence;

pregnancy;

the period of breastfeeding;

children under 12 years.

With caution: arterial hypertension; diabetes; compensated heart failure; cardiac ischemia; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diseases of peripheral arteries; hemorrhagic diathesis; smoking; Cl creatinine 30-60 ml / min, peptic ulcer of the gastrointestinal tract in the anamnesis; an infection caused by Helicobacter pylori in the anamnesis; elderly age; prolonged previous use of NSAIDs; severe physical illness; simultaneous use with the following drugs: anticoagulants (eg warfarin), antiaggregants (eg acetylsalicylic acid, clopidogrel), oral GCS (eg prednisolone), SSRIs (eg citalopram, fluoxetine, paroxetine, sertraline).

pregnancy and lactation

Like other drugs from the class of NSAIDs that inhibit the synthesis of PG, nimesulide can adversely affect the course of pregnancy and / or embryo development and lead to premature closure of the arterial duct, hypertension in the fetal pulmonary artery system, impaired renal function that can translate into renal failure with oligouria in the fetus, an increased risk of bleeding, a decrease in contractility of the uterus, the emergence of peripheral edema in the mother.

Data from epidemiological studies indicate a possible increase in the risk of spontaneous abortion, the risk of heart disease and gastroschisis in the use of early-stage drugs that block the synthesis of PG. The absolute risk of developing an abnormality of the CCC increases from about 1 to 1.5%. It is believed that the risk increases with increasing dose and duration of use.

Data on the penetration of nimesulide in breast milk is not available.

The use of NEMULEX® during pregnancy and during breastfeeding is contraindicated.

The use of nimesulide may adversely affect female fertility and is not recommended for women planning a pregnancy. When planning pregnancy, consultation with the doctor is necessary.

Side effects

Frequency of development of side effects: often (1-10%); infrequently (0.1-1%); rarely (0.01-0.1%); very rarely (less than 0.01%); frequency is unknown (can not be estimated based on available data).

On the part of the blood and lymphatic system: rarely - anemia, eosinophilia, hemorrhages; very rarely - thrombocytopenia, pancytopenia, purpura thrombocytopenic.

From the immune system: rarely - hypersensitivity reactions; very rarely anaphylactoid reactions.

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

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

Disorders of the psyche: rarely - a sense of fear, nervousness, nightmarish dreams.

From the side of the organ of vision: rarely - blurred vision; very rarely - impaired vision.

From the side of the hearing organ and labyrinthine disturbances: very rarely - vertigo.

From the CCC: infrequent - increased blood pressure; rarely - tachycardia, lability of blood pressure, flushing of blood to the skin of the face, a feeling of palpitations.

From the respiratory system: infrequently - shortness of breath; very rarely - exacerbation of bronchial asthma, bronchospasm.

From the digestive tract: often - diarrhea, nausea, vomiting; infrequent - 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 lethal outcomes), jaundice, cholestasis.

From the side of the kidneys and urinary tract: rarely - dysuria, hematuria, urinary retention; very rarely - renal failure, oliguria, interstitial nephritis.

From the side of water-electrolyte metabolism: rarely - hyperkalemia.

Other: infrequent peripheral edema; rarely - malaise, asthenia; very rarely - hypothermia.

Interaction

SCS increases the risk of gastrointestinal ulcers or bleeding.

Antiplatelet agents and SSRIs, such as fluoxetine, increase 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.

NSAIDs can 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. Simultaneous use of nimesulide and furosemide results in a decrease (approximately 20%) in AUC and a decrease in cumulative furosemide excretion without altering the renal clearance of furosemide.

The 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 and moderate renal insufficiency (Cl creatinine 30-80 ml / min), concomitant use of ACE inhibitors, APA II and COX-suppressing agents (NSAIDs, antiaggregants), further deterioration of renal function and the occurrence of acute renal failure , which, as a rule, is reversible. These interactions should be considered in patients taking nimesulide in combination with ACE inhibitors or ARA II. Therefore, the simultaneous use of these drugs should be carried out with caution, especially in elderly patients. Patients should receive a sufficient amount of fluid, and renal function should be carefully monitored after the onset of simultaneous use.

Theoretically, it is possible to reduce the effectiveness of mifepristone and PG analogues when used simultaneously with NSAIDs (including acetylsalicylic acid) due to the anti-prostaglandin effect of the latter. Limited data show that the use of NSAIDs on the day of the use of the PG analog does not adversely affect the effect of mifepristone or an analogue of PG on cervical dilatation, uterine contractility and does not reduce the clinical effectiveness of drug abortion.

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 using nimesulide in patients who are on therapy with lithium drugs, regular monitoring of the concentration of lithium in blood plasma should be carried out.

Clinically significant interactions with glibenclamide, theophylline, digoxin, cimetidine and antacid preparations (for example, a combination of aluminum and magnesium hydroxides) were not observed.

Nimesulide inhibits the activity of the isoenzyme CYP2C9. With simultaneous use with nimesulid drugs, which are substrates of this enzyme, the concentration of the latter in the plasma can increase.

Caution is required when administering nimesulide less than 24 hours before or after using methotrexate. in such cases, the concentration of methotrexate in the plasma and, accordingly, the toxic effects of this drug may increase.

In connection with the effect on renal PG, inhibitors synthetase PG, incl. nimesulide, may increase the nephrotoxicity of cyclosporins.

Dosing and Administration

Inside. Content 1 pack. dissolved in 100 ml of warm water. The suspension is used immediately after preparation.

Adults and children over 12 years: 1 pack. 2 times a day, after meals.

Elderly patients: in the treatment of elderly patients, the need for correction of the daily dose is determined by the doctor based on the possibility of interaction with other medicinal products.

Patients with renal insufficiency: in patients with mild and moderate renal insufficiency (Cl creatinine 30-60 ml / min), dose adjustment is not required, while for patients with severe renal insufficiency (Cl creatinine <30 ml / min), NEMULEX ® is contraindicated.

Patients with hepatic insufficiency: the use of NEMULEX® in patients with hepatic insufficiency is contraindicated.

To reduce the likelihood of side effects, it is recommended to take the minimum effective dose for the shortest possible time.

The maximum daily dose for adults and children over 12 years is 200 mg.

The maximum duration of treatment is 15 days.

Overdose

Symptoms: apathy, drowsiness, nausea, vomiting, pain in the epigastric region. These symptoms are usually reversible in symptomatic and maintenance therapy. Possible an increase in blood pressure, the occurrence of gastrointestinal bleeding, acute renal failure, respiratory depression, coma, anaphylactoid reactions ..

Treatment: symptomatic and supportive therapy. There is no specific antidote. In case an overdose has occurred within the last 4 hours, induction of emesis and / or administration of activated charcoal (60 to 100 g for an adult) and / or osmotic laxative is necessary. Forced diuresis, hemodialysis, hemoperfusion, alkalinization of urine are ineffective because of the high degree of binding of nimesulide to plasma proteins (up to 97.5%). It is necessary to monitor the status of kidney and liver function.

special instructions

Unwanted side effects can be minimized when the drug is used in the minimum effective dose with the minimum duration of application necessary to relieve the pain syndrome.

There are data on very rare cases of serious reactions from the liver, incl. cases of lethal outcome associated with the use of nimesulide-containing drugs. If symptoms similar to those of liver damage (anorexia, skin itching, yellowing of the skin, nausea, vomiting, abdominal pain, darkening of the urine, increased activity of liver transaminases), immediately stop using NEMULEX® and consult a doctor.

Repeated use of NEMULEX® in such patients is contraindicated.

It is reported on the reactions of the liver, which in most cases are reversible, with short-term use of the drug.

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

The drug NEMULEX® should be used with caution in patients with gastrointestinal ailments in history (ulcerative colitis, Crohn's disease), as possible exacerbation of these diseases.

The risk of gastrointestinal bleeding, peptic ulcer / perforation of the stomach or duodenum is increased in patients with an ulcerative lesion of the gastrointestinal tract (ulcerative colitis, Crohn's disease) in the anamnesis, 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 the simultaneous use of low doses of acetylsalicylic acid or other agents that increase the risk of complications from the gastrointestinal tract, it is recommended to additionally appoint a method of gastroprotective agents (misoprostol or proton pump blockers). Patients with a history of gastrointestinal disease, especially elderly patients, should inform the physician about the newly emerging symptoms of the gastrointestinal tract (especially the symptoms that may indicate possible gastrointestinal bleeding).

NEMULEX® should be administered with caution to patients taking drugs that increase the risk of ulceration or bleeding (oral corticosteroids, anticoagulants, eg warfarin, SSRIs or antiplatelet agents, eg acetylsalicylic acid).

In case of gastrointestinal bleeding or ulcerative lesions of the gastrointestinal tract in patients taking NEMULEX®, treatment with the drug should be stopped immediately.

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

Nimesulide can cause fluid retention, so in patients with hypertension, renal and / or heart failure, NEMULEX® should be used with extreme caution. In case of worsening, treatment should be stopped.

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.

Patients with hypertension, renal and / or heart failure, coronary heart disease, peripheral arterial disease and / or cerebrovascular disease, risk factors for cardiovascular disease (eg, hyperlipidemia, diabetes, smokers) should be given NEMULX® with a particular caution. In case of worsening, treatment with NEMULEX® should be stopped.

The composition of the drug includes sucrose, this should be taken into account for patients suffering from diabetes (0.15 XE in one sachet), and for those who observe a low-calorie diet. The drug NEMULEX® is not recommended for patients with fructose intolerance, sucrose-isomaltase deficiency or glucose galactose malabsorption syndrome.

If there are signs of a cold or SARS in the process of using NEMULEX®, the drug should be stopped.

Nimesulide can alter 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 susceptible to adverse reactions to NSAIDs, incl. the occurrence of gastrointestinal bleeding and perforations, which threaten the patient's life, reduce the functions of the kidneys, liver and heart. When taking NEMULEX® for this category of patients, proper clinical control is necessary.

There are data on the occurrence of rare cases of skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) when taking NSAIDs, incl. and nimesulide. At the first manifestations of skin rashes, lesions of mucous membranes or other signs of an allergic reaction, the taking of NEMULEX® should be stopped immediately

Influence on the ability to drive vehicles and mechanisms. The influence of NEMULEX® on the ability to drive vehicles and mechanisms has not been studied, therefore, during the period of application of NEMULEX®, caution should be exercised when driving vehicles and engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Form of issue

Granules for the preparation of a suspension for oral administration, 100 mg. 2 grams of granules in single or double laminated bags of three-layer (PE, aluminum, paper) or four-layer (paper, PE, aluminum, PE) foil. By 2, 4, 6, 10, 20 or 30 packs. in a pack of cardboard.

Conditions of leave from pharmacies

On prescription.

Storage conditions

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

Keep out of the reach of children.

Shelf life

4 years.

Do not use after the expiry date printed on the package.