Combalgin^® (Gel) Instructions for Use

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

ATC Code

M02AA13 (Ibuprofen)

Active Substance

Ibuprofen (Rec.INN registered by WHO)

Dosage Form

Combalgin®

Gel for external use 5%: tubes 25 g, 30 g, 50 g, 60 g, 100 g, 120 g, 150 g, 180 g, or 200 g 1 or 2 pcs.; 20 g, 35 g, 40 g, 70 g, 80 g, 125 g, 130 g, 135 g, 140 g, or 145 g 1 pc.

Dosage Form, Packaging, and Composition

Gel for external use transparent or slightly opalescent, colorless, homogeneous, with a characteristic odor.

Excipients : isopropanol – 5 g, hydroxyethylcellulose – 1.8 g, sodium hydroxide – 1 g, benzyl alcohol – 1 g, purified water – 86.2 g.

20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (2) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (2) – cardboard packs.
35 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (2) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (2) – cardboard packs.
70 g – aluminum tubes (1) – cardboard packs.
80 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (2) – cardboard packs.
120 g – aluminum tubes (1) – cardboard packs.
120 g – aluminum tubes (2) – cardboard packs.
125 g – aluminum tubes (1) – cardboard packs.
130 g – aluminum tubes (1) – cardboard packs.
135 g – aluminum tubes (1) – cardboard packs.
140 g – aluminum tubes (1) – cardboard packs.
145 g – aluminum tubes (1) – cardboard packs.
150 g – aluminum tubes (1) – cardboard packs.
150 g – aluminum tubes (2) – cardboard packs.
180 g – aluminum tubes (1) – cardboard packs.
180 g – aluminum tubes (2) – cardboard packs.
200 g – aluminum tubes (1) – cardboard packs.
200 g – aluminum tubes (2) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

Drugs for external use for muscle and joint pain; non-steroidal anti-inflammatory drugs for external use

Pharmacological Action

NSAID, a derivative of phenylpropionic acid. When applied externally, it has an anti-inflammatory and analgesic effect. Reduces morning stiffness, helps increase the range of motion in the joints.

The mechanism of action is associated with the inhibition of COX activity, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins that play a major role in the pathogenesis of inflammation, pain, and fever. The analgesic effect is due to both a peripheral mechanism (indirectly, through the suppression of prostaglandin synthesis) and a central mechanism (by inhibiting the synthesis of prostaglandins in the central and peripheral nervous system).

Pharmacokinetics

After application to the skin, Ibuprofen is detected in the epidermis and dermis after 24 hours. It reaches a high therapeutic concentration in the underlying soft tissues, joints, and synovial fluid. Clinically significant systemic absorption practically does not occur. The C_max of ibuprofen in blood plasma with external use is 5% of the C_max level with oral administration of ibuprofen.

80% of the dose is excreted in the urine, mainly in the form of metabolites (70%), 10% – unchanged; 20% is excreted through the intestines in the form of metabolites.

Indications

As an analgesic and anti-inflammatory agent for conditions such as muscle pain, back pain, arthritis, pain from ligament injuries and sprains, sports injuries, neuralgia.

ICD codes

Dosage Regimen

Apply the gel externally to the affected area of skin.

Use a strip of gel 4 to 10 cm long, depending on the size of the area being treated.

Apply and rub in gently until fully absorbed.

Use the gel 2 to 3 times per day.

Maintain an interval of at least 4 hours between applications.

Do not exceed the maximum daily application area; treat no more than 15-20% of the body surface.

The maximum duration of continuous use is 14 days for self-medication.

Discontinue use and consult a physician if symptoms persist or worsen after 2-3 days of treatment.

Avoid contact with eyes, mucous membranes, and open wounds.

Do not apply to skin with broken integrity, including infected abrasions or eczema.

Wash hands thoroughly with soap and water after each application, unless the hands are the treatment area.

Do not use with an occlusive dressing.

Avoid exposing the treated area to direct sunlight or UV lamps.

Adverse Reactions

Local reactions with external use may include skin hyperemia, a sensation of burning or tingling.

Contraindications

Hypersensitivity to ibuprofen; “aspirin triad” (including in history); impaired skin integrity at the application site (including infected wounds and abrasions, weeping dermatitis, eczema); children under 14 years of age; pregnancy, lactation period.

With caution

In the presence of concomitant diseases of the liver and kidneys, gastrointestinal tract, exacerbation of hepatic porphyria, with bronchial asthma, urticaria, rhinitis, polyps of the nasal mucosa, chronic heart failure, as well as in elderly patients.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction. Use with caution in concomitant liver diseases.

Use in Renal Impairment

Contraindicated in severe renal dysfunction. Use with caution in concomitant kidney diseases.

Pediatric Use

Ibuprofen is contraindicated for external use in children under 14 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

When applying externally, avoid contact with eyes and lips.

Do not use under an occlusive (airtight) dressing.

Avoid sunlight on the application area.

Drug Interactions

Theoretically, with simultaneous use with other NSAIDs, an increase in side effects is possible.

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.