Nimide artrogel

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NIMID ARTHROGEL (NIMID ARTHROGEL)

Composition:

Active substance: nimesulide;

1 g of gel contains nimesulide 10 mg;

Excipients: benzyl alcohol, propylene glycol, carbomer 940, disodium edetate, sodium hydroxide, fragrance Cologne Comp 530, purified water.

Pharmaceutical form. Topical gel.

Main physicochemical properties: opaque, homogeneous, light-yellow colored gel.

Pharmacotherapeutic group.

Topical non-steroidal anti-inflammatory drugs. ATC code M02A A26.

Pharmacological properties.

Pharmacodynamics.

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID), a selective inhibitor of cyclooxygenase-2. In equimolar concentrations, nimesulide exhibits anti-inflammatory activity comparable to indomethacin and piroxicam during the initial stage of inflammation. By inhibiting prostaglandin synthesis at the site of inflammation, nimesulide has virtually no effect on the synthesis of regulatory prostaglandins in the gastric mucosa and kidneys. It suppresses the activity of platelet-activating factor, tumor necrosis factor-α, proteases, histamine, and the formation of free oxygen radicals. When applied topically, it reduces or eliminates pain at the application site, including joint pain, and decreases morning stiffness and joint swelling.

Pharmacokinetics.

With topical application of Nimid Arthrogel, gradual transdermal absorption of nimesulide into subcutaneous tissues and joint synovial fluid occurs.

Clinical characteristics.

Indications.

Local treatment of musculoskeletal disorders characterized by pain, inflammation, and restricted mobility, such as osteoarthritis, periarthritis, post-traumatic tendinitis, tenosynovitis, muscle strains, and severe physical stress on joints.

Contraindications.

• Hypersensitivity to nimesulide or to any other component of the drug.
• Pregnancy.
• Dermatitis and infectious skin diseases.
• Epidermal damage.
• Should not be used in patients in whom acetylsalicylic acid or other drugs that inhibit prostaglandin synthesis cause allergic reactions such as rhinitis, urticaria, or bronchospasm.

Interaction with other medicinal products and other forms of interaction.

When applied topically, no interactions of this drug with other medicinal products have been established. However, it should be taken into account that if nimesulide enters systemic circulation, it may enhance the efficacy and toxicity of many drugs due to displacement from plasma protein binding sites, thereby increasing their free fraction in the blood. Therefore, the drug should be administered with caution when used concomitantly with anticoagulants, digoxin, phenytoin, lithium-containing drugs, diuretics, antihypertensive agents, other NSAIDs, cyclosporine, methotrexate, and oral hypoglycemic agents.

When applying multiple non-steroidal anti-inflammatory agents locally at the same time, local irritation may develop, manifesting as urticaria, erythema, and desquamation.

Glucocorticoids and antirheumatic agents (gold preparations, aminoquinolones) enhance the anti-inflammatory effect of Nimid Artrogel.

Special precautions for use

Medical supervision is required when prescribing the drug to elderly patients with impaired kidney or liver function, or with congestive heart failure. The drug should be used under medical supervision in patients with gastroduodenal bleeding, peptic ulcers in the acute stage, or severe coagulation disorders.

The gel should not be used concurrently with other locally applied medicinal products.

The gel should be applied only to intact areas of skin, avoiding contact with open wounds. Contact of the gel with eyes and mucous membranes should be avoided. Do not use the gel under occlusive dressings.

To minimize the risk of adverse reactions, the lowest effective dose for the shortest duration necessary should be used. If the patient's condition does not improve, medical advice must be sought.

The drug should not be used in patients with known hypersensitivity to NSAIDs. If hypersensitivity reactions occur, treatment should be discontinued.

During treatment, photosensitivity reactions may occur. To reduce the risk of photosensitivity, patients should avoid exposure to UV radiation and refrain from visiting solariums.

The product contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding

Pregnancy

There are no clinical data on the use of Nimide Artrogel during pregnancy. Even though systemic exposure following topical application is lower than with oral administration, it is unknown whether the systemic exposure to Nimide Artrogel achieved after topical use could be harmful to the embryo/fetus.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors, including Nimide Artrogel, may cause cardiovascular and renal toxicity in the fetus. Prolonged bleeding time may occur in both mother and child near term, and labor may be prolonged. Therefore, Nimide Artrogel is contraindicated during pregnancy (see section "Contraindications").

Breastfeeding period

Do not use.

Effect on ability to drive or operate machinery

No effect.

Dosage and Administration.

Apply externally to adults. Before applying the gel, wash and dry the skin surface. Apply a thin layer of gel (approximately 3 cm strip) to the affected painful areas and gently rub in. The frequency of application is 3–4 times daily.

The duration of treatment is determined individually, depending on therapeutic efficacy, and should not exceed 4 weeks.

Children.

Do not use in children.

Overdose.

When the gel is applied to large skin areas or when recommended doses are exceeded, systemic adverse effects characteristic of nimesulide and other nonsteroidal anti-inflammatory drugs may occur: dyspepsia, headache, dizziness, epigastric pain.

Treatment: reduce the dose or discontinue the drug. Symptomatic therapy.

Adverse reactions.

Skin reactions: Local skin irritation of mild to moderate severity: erythema, rash, desquamation, pruritus, allergic reactions.

Immune system reactions: Hypersensitivity reactions, including anaphylactic reactions such as angioedema, vasomotor rhinitis, urticaria, and bronchospasm.

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after registration of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging.

Do not freeze.

Keep out of reach and sight of children.

Packaging.

30 g or 100 g in a tube. 1 tube per cardboard pack.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address and location of manufacturing site.

SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.

INSTRUCTIONS

for medical use of the medicinal product

NIMID ARTHROGEL

(NIMID ARTHROGEL)

Composition:

Active ingredient: nimesulide;

1 g of gel contains nimesulide 10 mg;

Excipients: benzyl alcohol, propylene glycol, carbomer 940, disodium edetate, sodium hydroxide, flavoring agent Cologne Comp 530, purified water.

Pharmaceutical form. Topical gel.

Main physicochemical properties: opaque, homogeneous, light-yellow colored gel.

Pharmacotherapeutic group.
Non-steroidal anti-inflammatory drugs for topical use. ATC code M02A A26.

Pharmacological Properties

Pharmacodynamics

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) and a selective inhibitor of cyclooxygenase-2. In equimolar concentrations, during the initial stage of inflammation, nimesulide exhibits anti-inflammatory activity comparable to that of indomethacin and piroxicam. By inhibiting the synthesis of prostaglandins at the site of inflammation, nimesulide has virtually no effect on the synthesis of regulatory prostaglandins in the gastric mucosa and kidneys. It suppresses the activity of platelet-activating factor, tumor necrosis factor-α, proteases, histamine, and the formation of free oxygen radicals. When applied topically, it reduces or eliminates pain at the site of application, including joint pain, and decreases morning stiffness and joint swelling.

Pharmacokinetics

Following topical application of Nimesil ArtroGel, there is a gradual transdermal absorption of nimesulide into the subcutaneous tissues and joint synovial fluid.

Clinical characteristics.

Indications.

Local treatment of musculoskeletal disorders characterized by pain, inflammation, and restricted mobility, such as osteoarthritis, periarthritis, post-traumatic tendinitis, tenosynovitis, muscle strains, and heavy physical stress on joints.

Contraindications.

• Hypersensitivity to nimesulide or to any other component of the drug.
• Pregnancy.
• Dermatitis and infectious skin diseases.
• Epidermal damage.
• Should not be used in patients who experience allergic reactions (such as rhinitis, urticaria, or bronchospasm) to acetylsalicylic acid or other drugs that inhibit prostaglandin synthesis.

Interaction with other medicinal products and other forms of interaction.

When applied topically, no interactions of the drug with other medicinal products have been established. However, it should be considered that if nimesulide enters systemic circulation, it may enhance the efficacy and toxicity of many drugs due to displacement from plasma protein binding sites, thereby increasing their free fraction in blood. Therefore, the drug should be administered with caution when used concomitantly with anticoagulants, digoxin, phenytoin, lithium preparations, diuretics, antihypertensive agents, other NSAIDs, cyclosporine, methotrexate, and oral hypoglycemic agents.

Simultaneous topical application of multiple nonsteroidal anti-inflammatory agents may lead to local irritation, such as urticaria, erythema, and desquamation.

Glucocorticoids and antirheumatic agents (gold preparations, aminoquinolones) enhance the anti-inflammatory effect of Nime ArthroGel.

Special precautions for use

Medical supervision is required when prescribing the drug to elderly patients with impaired kidney or liver function, or with congestive heart failure. The drug should be used under medical supervision in patients with gastroduodenal bleeding, peptic ulcers in the acute phase, or severe coagulation disorders.

Do not use simultaneously with other locally applied medicinal products.

The gel should be applied only to intact skin areas, avoiding contact with open wounds. Contact of the gel with eyes and mucous membranes should be avoided. Do not use the gel under occlusive dressings.

To minimize the risk of adverse reactions, the lowest effective dose for the shortest duration necessary should be used. If the patient's condition does not improve, medical advice must be sought.

Do not use in patients with known hypersensitivity to NSAIDs. If hypersensitivity reactions occur, treatment should be discontinued.

During treatment, photosensitivity reactions may occur. To reduce the risk of photosensitivity, patients should avoid exposure to UV radiation and refrain from visiting solariums.

The product contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding

Pregnancy

There are no clinical data on the use of Nimide ArtroGel during pregnancy. Even though systemic exposure is lower compared to oral administration, it is unknown whether systemic exposure to Nimide ArtroGel following topical application could be harmful to the embryo/fetus.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors, including Nimide ArtroGel, may cause cardiovascular and renal toxicity in the fetus. Towards the end of pregnancy, prolonged bleeding may occur in both mother and child, and labor may be prolonged. Therefore, Nimide ArtroGel is contraindicated during pregnancy (see section "Contraindications").

Breastfeeding period

Do not use.

Ability to influence reaction rate while driving or operating machinery

Does not affect.

Method of Administration and Dosage.

Apply externally to adults. Before applying the gel, wash and dry the skin surface. Apply a thin layer of gel (approximately 3 cm in length) to the affected painful areas and gently rub in. The frequency of application is 3–4 times daily.

The duration of treatment is determined individually depending on therapeutic efficacy and should not exceed 4 weeks.

Children.

Do not use in children.

Overdose.

When applying the gel to large skin areas or exceeding the recommended doses, systemic adverse effects characteristic of nimesulide and other nonsteroidal anti-inflammatory agents may occur: dyspepsia, headache, dizziness, epigastric pain.

Treatment: reduce the dose or discontinue the drug. Symptomatic therapy.

Adverse reactions.

Skin-related: Local skin irritation of mild to moderate severity: erythema, rash, desquamation, pruritus, allergic reactions.

Immune system-related: Hypersensitivity reactions, including anaphylactic reactions such as angioedema (Quincke's edema), vasomotor rhinitis, urticaria, and bronchospasm.

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after marketing authorization of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging.

Do not freeze.

Keep out of reach of children.

Packaging.

30 g or 100 g in a tube. 1 tube per cardboard package.

Availability.

Over-the-counter (without prescription).

Manufacturer.

LLC "GLEDFARM LTD".

Manufacturer's address and location of its business activities.

54 Davydovskoho Hryhoriia Street, Sumy, Sumy Oblast, 40020, Ukraine.