Active substance: nimesulide 100 mg.
Excipients: calcium hydrogen phosphate 75 mg, microcrystalline cellulose (type 114) 40 mg, corn starch 54 mg, sodium carboxymethyl starch 35 mg, magnesium stearate 3 mg, colloidal silicon dioxide 2 mg, talc 1 mg.

Description
White with a yellowish tint, round biconvex tablets with a smooth surface.

Pharmacodynamics. Non-steroidal anti-inflammatory drug (NSAID) from the sulfonanilide class. It is a selective competitive inhibitor of cyclooxygenase-2 (COX-2), inhibits the synthesis of prostaglandins at the site of inflammation. The inhibitory effect on COX-1 is less pronounced (less likely to cause side effects associated with inhibition of prostaglandin synthesis in healthy tissues). It has anti-inflammatory, analgesic and pronounced antipyretic effects.

Pharmacokinetics. Absorption when taken orally is high (food intake reduces the rate of absorption without affecting its degree). Time to reach maximum concentration (TCmax) - 1.5-2.5 hours. Communication with plasma proteins - 95%, with erythrocytes - 2%, with lipoproteins - 1%, with acidic alpha1-glycoproteins - 1%. Changing the dose does not affect the degree of binding. The maximum concentration value (Cmax) is 3.5-6.5 mg/l. Volume of distribution - 0.19-0.35 l/kg. Penetrates into the tissues of the female genital organs, where after a single dose its concentration is about 40% of the concentration in plasma. Penetrates well into the acidic environment of the inflammation site (40%) and synovial fluid (43%). Easily penetrates histohematic barriers.
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 conjugation reactions of phase II metabolism (sulfation, glucuronidation, etc.). The half-life (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%), is subject to enterohepatic recycling.
In patients with renal failure (creatinine clearance 1.8-4.8 l/h or 30-80 ml/min), as well as in children and the elderly, the pharmacokinetic profile of nimesulide does not change significantly.

Directions for use and dosage:

Features of application:

Side effects:

Interaction with other drugs:

Contraindications:

Overdose:

Storage conditions:

List B. In a dry place, protected from light, at a temperature not exceeding 25 °C. Keep out of the reach of children! Shelf life: 3 years. Do not use after the expiration date stated on the packaging.

Vacation conditions:

On prescription

Package:

Tablets 100 mg.
1, 2 or 10 PVC/aluminum blisters of 10 tablets, along with instructions for use, are packed in a cardboard box.

Nise (tablets, gel, suspension) – instructions for use, analogues, reviews, price

Thank you

Nise is a non-narcotic anesthetic And antipyretic drug from the group of non-steroidal anti-inflammatory drugs (NSAIDs). Nise is used as a symptomatic drug as part of complex therapy for various conditions and diseases accompanied by elevated body temperature, pain and inflammation. The main areas of application of Nise are the treatment of osteoarthritis and osteoarthritis, as well as the relief of pain of various etiologies and localizations (for example, injuries, toothache, menstrual pain, diseases of the ear, nose and throat, etc.) and the reduction of body temperature during infections.

Names, varieties and forms of release

• Tablets for oral administration;
• Dispersible tablets (soluble in a small amount of water) for oral administration;
• Suspension for oral administration;
• Gel for external use.

Tablets for oral administration are simply called tablets or "Nise 100", and various terms are often used to refer to the suspension, such as syrup, solution and others, which are united by the fact that they imply a liquid dosage form intended for oral administration. The suspension is also called “Nise for children”, since this particular form of the drug is approved for use in children from 2 years of age. Dispersible tablets are sometimes called soluble tablets because they are intended to be taken orally after first dissolving in a small amount of water. These tablets differ from the usual ones in a lower dosage of the active substance, as well as a minimal risk of irritation of the gastric mucosa.

Gel for external use is often mistakenly called ointment. However, since Nise is not available in this dosage form, when people say “Nise ointment,” they mean the gel.

Nise - composition

• Tablets for oral administration – 100 mg of nimesulide per tablet;
• Dispersible tablets – 50 mg of nimesulide per tablet;
• Suspension – 50 mg of nimesulide per 5 ml of solution;
• Gel – 1% (10 mg nimesulide per 1 g).

Therapeutic effect

• Analgesic effect (analgesic);
• Antipyretic effect (reduces body temperature);
• Anti-inflammatory effect.

Nise, by blocking the work of cyclooxygenase, prevents the formation of leukotrienes and prostaglandins, which, in turn, stops the active course of the inflammatory process. Since the inflammatory process is minimized, the associated pain, heat, swelling and redness are relieved. The functioning of the affected organ is also facilitated.

Since Nise has a nonspecific effect, it is capable of providing a therapeutic effect in the inflammatory process, regardless of the location and nature of the cause that caused it. That is why Nise is able to relieve pain during menstruation, joint diseases, injuries, neuralgia, headaches, toothaches, etc. The drug also perfectly reduces body temperature during a viral or bacterial infection, and also reduces the severity of any inflammatory process, regardless of what exactly it is caused by (for example, infection, autoimmune disease, injury, etc.).

In terms of the severity of the anti-inflammatory effect, Nise is superior to Indomethacin, Diclofenac, Ibuprofen and Piroxicam. The analgesic effect of Nise is the same as that of Ibuprofen, but less pronounced compared to Indomethacin. The antipyretic effect of Nise is more powerful than that of Indomethacin, Ibuprofen, Aspirin and Paracetamol.

Since Nise can exert its effects locally and systemically, it is used in various dosage forms depending on the location of the inflammatory process and pain. For example, when pain and inflammation are localized in internal organs and mucous membranes, it is necessary to take Nise orally so that the drug can reach all affected cells and tissues through the bloodstream. And if the pain is localized in the muscles or skin, you can not take Nise orally, but apply it externally, directly to the affected area, so that the active substances penetrate to the source of inflammation through the skin structures. Often, to enhance the therapeutic effect, the drug is simultaneously taken orally and applied externally, especially for chronic joint diseases.

In addition to the antipyretic, anti-inflammatory and analgesic effects, Nise has a number of other, less significant and less pronounced effects. Thus, the drug reduces the ability of platelets to stick together (aggregate) and form blood clots by suppressing platelet activity factor.

Nise - indications for use

Tablets, dispersible tablets and Nise suspension

• Rheumatoid arthritis;
• Joint damage due to rheumatism;
• Periods of exacerbation of gout;
• Psoriatic arthritis;
• Ankylosing spondylitis;
• Osteochondrosis;
• Radiculitis;
• Sciatica;
• Lumbago;
• Osteoarthritis;
• Arthritis of any cause;
• Joint pain (arthralgia);
• Muscle pain (myalgia);
• Inflammation of ligaments and tendons (tendonitis, tendovaginitis, etc.);
• Bursitis;
• Traumatic inflammation of the soft tissues of the musculoskeletal system (for example, after bruises, ruptures and sprains, etc.);
• Pain of various origins and localization (menstrual, dental, joint, headache, pain after surgery, with gynecological and ENT diseases, etc.);
• Increased body temperature of any origin.

• Increased body temperature due to any disease, including after vaccination;
• Inflammatory process of the ENT organs and respiratory tract during viral or bacterial infections;
• Relief of pain after operations, injuries, soft tissue injuries, etc.

Nise gel (ointment)

• Inflammatory or degenerative diseases of bones, joints, ligaments, muscles and tendons, such as gout, rheumatism, arthritis, osteoarthritis, osteochondrosis, radiculitis, lumbago, bursitis, tendinitis, sciatica, etc.;
• Muscle pain of any origin;
• Traumatic inflammation of the musculoskeletal system (for example, bruises, tears or sprains of muscles, ligaments, etc.).

Instructions for use

Nise tablets - instructions for use

Nise tablets can be given to children from 12 years of age.

Nise is given to children over 12 years of age in the same dosages as adults. Elderly people over the age of 65 should also take Nise in standard, unreduced dosages. In case of renal failure with creatinine clearance determined by the Rehberg test of at least 30 ml/min, there is also no need to reduce the dosage of the drug. If creatinine clearance is below 30 ml/min, then Nise cannot be used in any dosage.

To relieve pain, relieve fever or reduce the severity of inflammation, it is recommended to take Nise 1 tablet (100 mg) twice a day. It is advisable to take the tablets at regular intervals, for example every 12 hours. If necessary, you can increase the number of tablets to 4 tablets per day, which can be taken at intervals of at least 6 hours. The maximum permissible daily dosage of Nise is 400 mg, exceeding which can provoke an overdose.

The duration of taking Nise is determined by the speed of healing and reduction in the severity of painful symptoms. That is, in each specific case, the duration of the course of therapy is determined individually and can range from several days to several weeks.

Instructions for use of Nise dispersible tablets

Before taking, one tablet is dissolved in a teaspoon of water. If you need to take two tablets at once, it is optimal to dissolve them both in a tablespoon of water. In general, to calculate the required amount of water, you can use the following ratio - one tablet per 5 ml of water (1 teaspoon).

Dissolved tablets are taken without additional water or any other drinks. If a person has a desire to wash away the feeling and taste of tablets from the oral mucosa, then they can take a large sip of clean water.

Dispersible tablets can be given to children from three years of age.

To relieve pain, fever and inflammation in various diseases, adults and adolescents over 12 years of age should take Nise 100 mg (2 dispersible tablets) twice a day. If necessary, you can increase the frequency of taking tablets up to 4 times a day, keeping at least 6-hour intervals between them. The maximum permissible daily dosage of Nise for adults and children over 12 years of age is 400 mg.

In elderly people over 65 years of age and with renal failure with a creatinine clearance of at least 30 ml/min, Nise is used in normal dosages, which do not need to be reduced. In case of renal failure with creatinine clearance below 30 ml/min, Nise cannot be used in principle.

For children aged 3 – 12 years, the daily dosage of Nise is calculated individually according to body weight, based on the ratio of 3 – 5 mg per 1 kg of weight. For example, a child weighing 20 kg should take Nise at a dosage of 3 * 20 = 60 mg and 5 * 20 = 120 mg, that is, 60 – 120 mg per day. The daily dosage calculated in this way is divided into 2 - 3 equal parts for administration 2 - 3 times a day at approximately equal intervals. The maximum permissible daily dosage of Nise is 5 mg per 1 kg of child’s body weight. If the child’s weight is more than 40 kg, but he is under 12 years old, then he is given Nise in an adult dosage of 100 mg twice a day.

The duration of use of Nise is determined individually depending on the speed of disappearance of symptoms.

Instructions for use of Nise suspension

Before use, shake the bottle with the suspension so that its contents become homogeneous, then pour the required amount into a measuring cup or syringe and drink. If necessary, you can wash down the suspension with a small amount of water.
Nise in the form of a suspension can be used for children from two months in the following dosages:

• Children aged 2 months - 2 years - the dosage of the suspension is calculated individually according to body weight, based on the ratio of 1.5 mg per 1 kg of weight. That is, a child weighing 10 kg needs 1.5 * 10 = 15 mg of Nise per day. The calculated daily amount of the drug is divided into 2 - 3 equal parts and given to the child 2 - 3 times a day. In our example, 15 mg/3 = 5 mg, that is, the child needs to be given a Nise suspension of 5 mg (which corresponds to 0.5 ml or 13 drops) three times a day;
• Children aged 2 – 5 years – take 2.5 ml of suspension 2 – 3 times a day;
• Children 5 – 12 years old – take 5 ml of suspension 2 – 3 times a day;
• Children over 12 years old - take the drug in an adult dosage in any dosage form, that is, 100 mg 2 times a day, which corresponds to 10 ml of suspension, 1 regular tablet or 2 dispersible tablets.

The duration of taking Nise suspension is different and depends on the speed of normalization of the person’s condition and the disappearance of symptoms. For acute conditions, it is recommended to use Nise for no more than 5–10 days.

Gel (ointment) Nise - instructions for use

For a one-time application, squeeze out approximately 3 cm of gel from the tube and, without rubbing, distribute it evenly over the affected surface. Then leave for 1 - 2 minutes so that the composition is absorbed into the skin. After this, you can apply a regular gauze bandage to the damaged area or leave it uncovered. Airtight dressings should not be applied over the gel.

The gel is applied to the skin 3 – 4 times a day. It is not recommended to apply the gel more than 4 times a day, as this may cause the development of side effects. The maximum allowable amount of gel that can be used during the day is 30 g, which corresponds to 1.5 tubes of 20 g.

The duration of use of the gel is determined individually depending on the speed of disappearance of unpleasant symptoms. It is not recommended to use Nise gel for more than 10 days in a row without consulting a doctor.

When rubbing the gel into the surface of the skin, a burn may occur, which will go away on its own within a few days. If irritation appears in the area where the gel is applied, you should stop using Nise.

Capsaicin, which is part of the gel, can provoke a burning sensation and redness of the skin in the area of ​​application. In rare cases, the burning sensation does not disappear, but turns into increased sensitivity of this area of ​​the skin. These effects are a normal skin reaction to the gel and do not require discontinuation of the drug.

When using the gel, it is necessary to avoid contact with the eyes, as well as the mucous membranes of the nose, mouth and other organs. After using the drug, close the tube tightly and wash your hands with soap.

special instructions

Nise should also be used with caution by people suffering from cardiovascular diseases, dehydration, asthenia, metabolic disorders and diseases of the digestive tract.

Since Nise can reduce blood clotting, it should be used with caution by people prone to bleeding, taking anticoagulants and suffering from hemorrhagic diathesis. If these conditions are present, blood clotting parameters (platelet count, fibrinogen, APTT, PTI, INR, TV, etc.) should be monitored during the entire course of using Nise.

In order to reduce the risk of side effects, it is necessary to use Nise in the minimum effective dosage. If a person’s condition does not improve within 2–3 days while using Nise, then you should stop taking the drug and consult a doctor.

If, while taking Nise tablets or suspension, a person experiences nausea, anorexia, vomiting, abdominal pain, dark urine, yellowing of the skin, increased activity of AST and ALT, as well as fatigue, then you should immediately stop using the drug and consult a doctor, since these symptoms indicate the development of liver damage. In the future, a person who experiences similar symptoms should not take Nise or any other medications containing nimesulide.

Impact on the ability to operate machinery

Overdose

• Apathy;
• Drowsiness;
• Nausea;
• Increased pressure;
• Impaired kidney function (swelling, urinary retention, increased concentration of urea, creatinine in the blood, etc.);
• Irritation of the digestive tract;
• Gastrointestinal bleeding;
• Respiratory depression;

Interaction with other drugs

Nise for children

• Children under 3 years old - only Nise suspension can be given;
• Children 3 – 12 years old – you can give dispersible tablets or Nise suspension;
• Children over 12 years old - Nise can be given in any form.

• Children aged 2 months - 2 years - the dosage of the suspension is calculated individually according to body weight, based on the ratio of 1.5 mg per 1 kg of weight. The calculated daily amount of the drug is divided into 2 - 3 equal parts and given to the child 2 - 3 times a day;
• Children aged 2 – 5 years – take 2.5 ml of suspension 2 – 3 times a day. The dosage of dispersible tablets is calculated individually according to the ratio of 3 – 5 mg per 1 kg of weight;
• Children 5 – 12 years old – take 5 ml of suspension or 1 dispersible tablet 2 – 3 times a day;
• Children over 12 years old - take the drug in an adult dosage in any dosage form, that is, 100 mg (10 ml suspension, 1 regular tablet or 2 dispersible tablets) 2 times a day.

Use during pregnancy and breastfeeding

Nise for pain, including dental

Nise by temperature

Alcohol compatibility

Side effects of Nise

• Skin rash ;
• Bronchospasm;

• Dizziness;
• Feeling of fear;
• Nightmares;
• Drowsiness;
• Reye's syndrome.

• Rash;
• Dermatitis;
• Hives;
• Swelling;
• Exudative erythema multiforme;
• Lyell's syndrome;
• Stevens-Johnson syndrome.

• Edema;
• Urinary retention;
• Increased potassium concentration in the blood;
• Kidney failure;
• Decreased amount of urine;
• Interstitial nephritis.

• Nausea;
• Vomit;
• Abdominal pain;
• Tarry stools;
• Bleeding from the gastrointestinal tract;
• Stomach or intestinal ulcer.

• Increased activity of AST and ALT;
• Hepatitis;

*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)

Registration number:

P No. 12824/03 - 040411

Trade name of the drug: Nise ®

International nonproprietary name of the drug: nimesulide.

Dosage form:

Compound

Each tablet contains:
Active substance: nimesulide 100 mg.
Excipients: calcium hydrogen phosphate 75 mg, cellulose
microcrystalline (type 114) 40 mg, corn starch 54 mg, sodium carboxymethyl starch 35 mg, magnesium stearate 3 mg, colloidal silicon dioxide 2 mg, talc 1 mg.

Description

White with a yellowish tint, round biconvex tablets with a smooth surface.

Pharmacotherapeutic group:

CodeATX:M01AX17.

Pharmacological properties

Pharmacodynamics

Non-steroidal anti-inflammatory drug (NSAID) from the sulfonanilide class. It is a selective competitive inhibitor of cyclooxygenase-2 (COX-2), inhibits the synthesis of prostaglandins at the site of inflammation. The inhibitory effect on COX-1 is less pronounced (less likely to cause side effects associated with inhibition of prostaglandin synthesis in healthy tissues). It has anti-inflammatory, analgesic and pronounced antipyretic effects.

Pharmacokinetics

Absorption when taken orally is high (food intake reduces the rate of absorption without affecting its degree). Time to reach maximum concentration (T max) - 1.5-2.5 hours. Communication with plasma proteins - 95%, with erythrocytes - 2%, with lipoproteins - 1%, with acidic alpha glycoproteins - 1%. Changing the dose does not affect the degree of binding. The maximum concentration value (Cmax) is 3.5-6.5 mg/l. Volume of distribution - 0.19-0.35 l/kg. Penetrates into the tissues of the female genital organs, where after a single dose its concentration is about 40% of the concentration in plasma. Penetrates well into the acidic environment of the inflammation site (40%) and synovial fluid (43%). Easily penetrates histohematic barriers.

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 (sulfation, glucuronidation, etc.).

The half-life (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%), is subject to enterohepatic recycling.

In patients with renal failure (creatinine clearance 1.8-4.8 l/h or 30-80 ml/min), as well as in children and the elderly, the pharmacokinetic profile of nimesulide does not change significantly.

Indications for use

Rheumatoid arthritis;
- articular syndrome during exacerbation of gout;
- psoriatic arthritis;
- ankylosing spondylitis;
- osteochondrosis with radicular syndrome;
- osteoarthritis;
- myalgia of rheumatic and non-rheumatic origin;
- inflammation of ligaments, tendons, bursitis, including post-traumatic inflammation
soft tissues;
- pain syndrome of various origins (including in the postoperative period, with
injuries, algodismenorrhea, toothache, headache, arthralgia, lumbar ischalgia).

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

Contraindications

Hypersensitivity to the active substance or auxiliary components; 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 changes in the mucous membrane of the stomach and duodenum (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 heart failure; liver failure or any active liver disease; anamnestic data on the development of hepatotoxic reactions when using nimesulide preparations; concomitant use of potentially hepatotoxic substances; alcoholism, drug addiction; severe renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease, confirmed hyperkalemia; period after coronary artery bypass surgery; pregnancy, lactation period; children under 12 years of age (for this dosage form, see section “Special instructions”).

Carefully

Coronary heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 ml/min. Anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of infection Helicobacter pylori, old age, long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).

Directions for use and doses

The minimum effective dose should be used for the shortest possible short course. The tablets are taken with enough water, preferably after meals. Adults and children over 12 years of age, take 1 tablet orally 2 times a day. If you have diseases of the gastrointestinal tract, it is advisable to take the drug at the end of a meal or after a meal. The maximum daily dose for adults is 200 mg. Patients with chronic renal failure require a reduction in the daily dose to 100 mg.

Side effect

The frequency of side effects is classified depending on the frequency of occurrence of the case: often - (1-10%), sometimes (0.1-1%), rarely (0.01-0.1%), very rarely (less than 0.01% ), including individual messages.

Allergic reactions: rarely - hypersensitivity reactions; very rarely - anaphylactoid reactions.

From the central nervous system: infrequently - dizziness; rarely - a feeling of fear, nervousness, nightmares; very rarely - headache, drowsiness, encephalopathy (Reis syndrome).

From the skin: uncommon - itching, rash, increased sweating; rarely: erythema, dermatitis; very rare: urticaria, angioedema, facial swelling, erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

From the urinary system: infrequently - swelling; rarely - dysuria, hematuria, urinary retention, hyperkalemia; very rarely - renal failure, oliguria, interstitial nephritis.

From the gastrointestinal tract: often - diarrhea, nausea, vomiting; infrequently - constipation, flatulence, gastritis; very rarely - abdominal pain, stomatitis, tarry stools, gastrointestinal bleeding, ulcer and/or perforation of the stomach or duodenum. From the liver and biliary system: often - increased liver transaminases; very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis. From the hematopoietic organs: rarely - anemia, eosinophilia; very rarely - thrombocytopenia, pancytopenia, purpura, prolonged bleeding time From the respiratory system: infrequently - shortness of breath; very rarely - exacerbation of bronchial asthma, bronchospasm. From the senses: rarely - blurred vision.

From the cardiovascular system: infrequently - arterial hypertension; rarely - tachycardia, hemorrhages, hot flashes. Other: rarely - general weakness; very rarely - hypothermia.

Overdose

Symptoms: apathy, drowsiness, nausea, vomiting. Gastrointestinal bleeding, increased blood pressure, acute renal failure, and respiratory depression may occur.

Treatment: Symptomatic treatment of the patient and supportive care are required. There is no specific antidote. If an overdose occurs within the last 4 hours, it is necessary to induce vomiting, take activated carbon (60-100 g per adult), and osmotic laxatives. Forced diuresis and hemodialysis are ineffective due to the high binding of the drug to proteins.

Interaction with other drugs

The effect of medications that reduce blood clotting is enhanced when used simultaneously with nimesulide.

Nimesulide may reduce the effect of furosemide. Nimesulide may increase the possibility of side effects while taking methotrexate.

Plasma lithium levels increase when lithium and nimesulide are taken simultaneously.

Nimesulide may enhance the effect of cyclosporine on the kidneys.

Use with glucocorticosteroids and serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

special instructions

Since Nise ® is partially excreted by the kidneys, its dose for patients with impaired renal function should be reduced, depending on creatinine clearance. Given reports of visual disturbances in patients taking other NSAIDs, treatment should be stopped immediately if any visual disturbance occurs and the patient should be examined by an ophthalmologist.

The drug can cause fluid retention in tissues, so patients with high blood pressure and cardiac problems should use Nise ® with extreme caution.

Patients should undergo regular medical monitoring if they, along with nimesulide, take medications that are characterized by an effect on the gastrointestinal tract.

If signs of liver damage appear (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased levels of liver transaminases), you should stop taking the drug and consult your doctor. The drug should not be used simultaneously with other NSAIDs.

The drug can change the properties of platelets, but does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases. The use of the drug may adversely affect female fertility and is not recommended for women planning pregnancy.

After 2 weeks of using the drug, monitoring of biochemical indicators of liver function is necessary.

This dosage form is contraindicated for children under 12 years of age, but if it is necessary to use nimesulide in children over 7 years of age, 50 mg dispersible tablets and suspension can be used in strict accordance with the instructions for medical use attached to them.

Since the drug can cause drowsiness, dizziness and blurred vision, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form

Tablets 100 mg. 1, 2 or 10 PVC/aluminum blisters of 10 tablets, along with instructions for use, are packed in a cardboard box.

Storage conditions

List B.
In a dry place, protected from light, at a temperature not exceeding 25°C.
Keep out of the reach of children!

Best before date

3 years.
Do not use after the expiration date stated on the packaging.

Conditions for dispensing from pharmacies

On prescription.

Manufacturer

Dr. Reddy's Laboratories Ltd., 7-1-27, Ameerpet, Hyderabad - 500016, Andhra Pradesh, India

Address of production place

Dr. Reddy's Laboratories Ltd.

1. Plot No. 42, 45 and 46, Bachupally Village, Qutbullapur Mandal, Ranga Reddy District, Andhra Pradesh, India

2. Khol Village, Nalagarh Road, Baddi Consumer complaints should be sent to the following address: Representative office of the company "Dr. Reddy" with Laboratories Ltd.: 115035, Moscow, Ovchinnikovskaya embankment, 20, building 1, Solan district, Himachal Pradesh , India

The medicine Nise belongs to non-steroidal anti-inflammatory drugs (NSAIDs) and has a whole range of medicinal properties. This wonderful analgesic has anti-inflammatory and antipyretic effects. Its antioxidant effects are known to slow down the formation of toxins in the human body.

What does Nise help with?

The drug Nise has a wide range of applications. Thanks to nimesulide, the medicine helps with many inflammatory joint diseases. It is effective for ailments that result in swelling, pain, and fever.

These include the following diseases:

• Chronic radiculitis of different parts;
• Osteochondrosis of varying degrees;
• Arthritis of any origin;
• Lumbago, arthralgia of all types.

Nise helps with diseases of the musculoskeletal system:

• Primary and secondary ischiasis;
• For rheumatoid arthritis;
• For diseases of muscle tissue - myalgia;
• In the treatment of acute and chronic bursitis; inflammation and rupture of tendons and ligaments;
• Osteoarthrosis;
• Gout and rheumatism;
• For the treatment of ankylosing spondylitis.

The drug is used for pain:

• Dental and head;
• Postoperative;
• Post-traumatic;
• Menstrual.

Nise helps to get rid of febrile conditions that appear as a consequence of inflammation, infections, injuries and other factors.

Contraindications for use

Despite its wide range of uses, the drug Nise has serious contraindications.

The medicine is prohibited for the following ailments:

• Bronchial asthma;
• Ulcers and bleeding of the stomach and intestines;
• Hemophilia;
• Kidney failure;
• For liver diseases and heart failure;
• After bypass surgery (within 2 - 3 months);
• Children under two years of age;
• Hypersensitivity to the main components of the product;
• Pregnant and lactating women;
• For alcoholism and drug addiction.

How and how much to take Nise

The main component of this product is nimesulide.

The drug is released in the form:

1. Tablets of 0.05 and 0.1 g;
2. Gel containing 0.01 g of nimesulide in each gram;
3. Suspension used for internal administration.

Nise is a potent drug and should be taken strictly following your doctor's instructions.

Adults are usually prescribed 0.1 g, twice a day before meals. The maximum dosage is 0.4 g per day. The medicine is taken for 10 days.

Children from 2 to 12 years old are prescribed a suspension, and older ones are prescribed tablets. For a child weighing up to 40 kg, a single dose is prescribed at the rate of 0.005 mg per kilogram of weight. If you weigh more, an adult dose is possible.

Caution should be exercised when taking it with other medications.

When using the gel, you must remember that it is not rubbed into the skin, but applied in a thin layer to problem areas. Several procedures can be performed per day, but the daily dose is only 30 g. The course of treatment is 10 days.

Side effects

When using the gel, side effects occur that require stopping its use. These include skin rashes and other ailments.

Taking pills can cause stomach pain, vomiting, nausea, and diarrhea. Possible headache and dizziness, anaphylactic shock and bronchospasm, changes in blood count.

Nice and alcohol

It is necessary to completely give up alcohol. The simultaneous use of these incompatible components can cause gastritis and ulcers, lead to disorders of the nervous system, and can create a cause for more serious problems, including death.