Nimedal

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NIMEDAR (NIMEDAR)

Composition:

Active substance: nimesulide;

1 g of gel contains nimesulide 10 mg;

Excipients: dimethyl sulfoxide, propylene glycol, levomenthol, macrogol 400, carbomer 980, tromethamine, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: yellow or yellow with a greenish tint, almost transparent gel with a weak specific odor. It should be homogeneous in appearance.

Pharmacotherapeutic group. Non-steroidal anti-inflammatory drugs for topical use.

ATC code M02A A26.

Pharmacological Properties.

Pharmacodynamics.

Nimedal is a nonsteroidal anti-inflammatory drug (NSAID), a selective inhibitor of cyclooxygenase-2. In terms of anti-inflammatory activity, nimesulide is equivalent to indomethacin and piroxicam at equimolar concentrations during the initial phase 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 site of application, including joint pain at rest and during movement, decreases morning stiffness and joint swelling, and promotes an increase in range of motion.

Pharmacokinetics.

After topical application of Nimedal, a gradual transdermal infusion of nimesulide into subcutaneous tissues and joint synovial fluid occurs. The drug practically does not penetrate into systemic circulation, which explains the absence of significant systemic effects.

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 components of the medicinal product.

Skin dermatitis and infectious skin diseases. Epidermal damage. Do not use in patients who experience allergic reactions (rhinitis, urticaria, or bronchospasm) to acetylsalicylic acid or other drugs that inhibit prostaglandin synthesis. Third trimester of pregnancy.

Interaction with other medicinal products and other forms of interaction.

No interactions with other medicinal products have been established following topical application of the drug. However, it should be taken into account that if systemic absorption occurs, nimesulide 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 medicinal product should be used with caution when administered concomitantly with anticoagulants, digoxin, phenytoin, lithium-containing preparations, diuretics, antihypertensive agents, other NSAIDs, cyclosporine, methotrexate, and oral hypoglycemic agents.

When applying several NSAIDs topically at the same time, local irritation such as urticaria, erythema, and skin desquamation may occur.

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

Special precautions for use

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

It is not recommended to use simultaneously with other locally applied medicinal products.

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

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

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

During treatment with the medicinal product, photosensitivity reactions may occur. To reduce the risk of photosensitivity, patients should avoid UV irradiation and solarium use.

Important information about excipients

The medicinal product contains dimethyl sulfoxide and propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding

There are no clinical data on the use of Nimedaru during pregnancy. Even though systemic exposure is lower compared to oral administration, it is unknown whether systemic exposure to Nimedaru achieved after topical application may be harmful to the embryo/fetus. During the first and second trimesters of pregnancy, Nimedaru should not be used unless clearly necessary. If use is required, the dose should be as low as possible and the duration of treatment as short as possible.

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

Ability to influence reaction rate when driving or operating machinery

No effect.

Method of Administration and Dosage.

Apply externally to adults. Before applying the gel, wash and dry the skin surface. Apply a strip of gel approximately 3 cm in length to the affected areas of the body as a thin layer and gently rub in. 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 NSAIDs may occur: dyspepsia, headache, dizziness, epigastric pain.

Treatment. Reduce the dose or discontinue the medication; symptomatic therapy.

Side effects.

Immune system side effects: rarely, anaphylactic reactions such as angioedema, vasomotor rhinitis, urticaria, bronchospasm may occur in sensitive patients.

Skin and subcutaneous tissue side effects: local skin irritation of mild to moderate severity: erythema, rash, peeling, itching, allergic reactions.

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after medicinal product registration is an important procedure. It enables continuous monitoring of the benefit-risk ratio for the respective medicinal product. Healthcare professionals must report any suspected adverse reactions through the national reporting system.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

30 g in a tube; 1 tube in a carton.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and location of business activity.

13, Boryspilska Street, Kyiv, 02093, Ukraine.