Mialays^® (Gel) Instructions for Use

Marketing Authorization Holder

Biosintez, PJSC (Russia)

ATC Code

M01AX17 (Nimesulide)

Active Substance

Nimesulide (Rec.INN registered by WHO)

Dosage Form

Mialays®

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

Dosage Form, Packaging, and Composition

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

Excipients: purified water, ethyl alcohol (ethanol) 95%, dimethyl sulfoxide, carbomer (reocar), macrogol 400 (polyethylene oxide 400).

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

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

Nonsteroidal anti-inflammatory drug

Pharmacological Action

NSAID from the sulfonanilide class, a selective competitive reversible inhibitor of COX-2. When applied externally, it exerts a local analgesic and anti-inflammatory effect.

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 conduction in the spinal cord. The decrease in the concentration of prostaglandin E₂ (a mediator of inflammation and pain) reduces the activation of EP-type prostanoid receptors, which is manifested by analgesic and anti-inflammatory effects.

When applied externally, it causes a reduction or disappearance of pain at the site of application of the drug, including joint pain at rest and during movement, reduces morning stiffness and joint swelling. It helps to increase the range of motion.

Pharmacokinetics

When applied externally, the concentration of the active substance in the systemic circulation is extremely low. C_max after a single application is noted by the end of the first day, its value is more than 300 times lower than that for oral dosage forms of nimesulide. Traces of the main metabolite of nimesulide – 4-hydroxynimesulide – are not detected in the blood.

Indications

Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system: joint syndrome during exacerbation of gout; rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; osteoarthritis; osteochondrosis with radicular syndrome; radiculitis; inflammatory lesions of ligaments, tendons, bursitis; sciatica, lumbago; muscle pain of rheumatic and non-rheumatic origin; post-traumatic inflammation of soft tissues and the musculoskeletal system (injuries and ruptures of ligaments, contusions).

ICD codes

Dosage Regimen

Apply the gel externally to the affected area three to four times per day.

Use a quantity sufficient to cover the skin with a thin, even layer.

Apply only to intact skin, avoiding contact with open wounds, mucous membranes, or eyes.

Do not apply under occlusive or airtight dressings.

Wash hands thoroughly with soap and water after each application.

The maximum duration of use without consulting a physician is 10 days.

If symptoms persist or worsen, discontinue use and seek medical advice.

For pediatric patients over 7 years of age, use with caution and under medical supervision.

In elderly patients and those with hepatic or renal impairment, use with caution and monitor for potential adverse effects.

Do not exceed the recommended daily application frequency.

Adverse Reactions

Local reactions itching, urticaria, peeling, transient skin discoloration (not requiring treatment discontinuation).

Systemic reactions when applied to large areas of skin or with prolonged use, heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration of the gastrointestinal mucosa, increased activity of liver transaminases; headache, dizziness; fluid retention, hematuria; allergic reactions (anaphylactic shock, skin rash); thrombocytopenia, leukopenia, anemia, agranulocytosis, prolonged bleeding time are possible.

Contraindications

Hypersensitivity to nimesulide, erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, gastrointestinal bleeding, dermatoses, damage to the epidermis and skin infections in the area of application, severe renal failure (creatinine clearance <30 ml/min), severe hepatic failure, history of bronchospasm in connection with the use of acetylsalicylic acid or other NSAID, pregnancy, lactation (breastfeeding), children under 7 years of age.

With caution

Hepatic insufficiency; renal insufficiency; severe heart failure; arterial hypertension; type 2 diabetes mellitus; elderly age, children’s age.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and while breastfeeding.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

With caution in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal failure (creatinine clearance < 30 ml/min).

With caution in renal insufficiency.

Pediatric Use

Contraindicated in children under 7 years of age.

With caution the drug should be prescribed to children over 7 years of age.

Geriatric Use

With caution the drug should be prescribed to elderly patients.

Special Precautions

It is recommended to apply only to intact skin areas, avoiding contact with open wounds.

Should not be used under airtight dressings.

Drug Interactions

Pharmacokinetic interaction with drugs competing for binding to plasma proteins cannot be excluded.

Nimesulide should be used with caution simultaneously with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, antihypertensive and hypoglycemic agents.

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

Over-the-Counter

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.