Combalgin^® Ice (Gel) Instructions for Use

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Or

Tatkhimpharmpreparaty, JSC (Russia)

ATC Code

M02AA13 (Ibuprofen)

Active Substances

Ibuprofen (Rec.INN registered by WHO)

Levomenthol (Rec.INN registered by WHO)

Dosage Form

Combalgin® Ice

Gel for external use 50 mg+30 mg/1 g: jars 25 g 1 pc.; tubes 15 g, 25 g, 30 g, 50 g, 75 g, or 100 g 1 or 2 pcs., 20 g, 40 g, or 150 g 1 pc.

Dosage Form, Packaging, and Composition

Gel for external use transparent, colorless or yellowish in color, with a menthol odor; the presence of opalescence and air bubbles is allowed.

Excipients : ethanol (ethyl alcohol) 96% – 252.6 mg, propylene glycol – 147 mg, diisopropanolamine – 58 mg, carbomer (Carbopol^® Ultrez 10 NF Polymer) – 20 mg, purified water – 442.4 mg.

25 g – glass jars (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (2) – cardboard packs.
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.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (2) – cardboard packs.
75 g – aluminum tubes (1) – cardboard packs.
75 g – aluminum tubes (2) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (2) – cardboard packs.
150 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

NSAID

Pharmacological Action

Ibuprofen non-selectively blocks the enzymes COX-1 and COX-2, thereby suppressing the synthesis of prostaglandins – mediators of pain, inflammation, and hyperthermic reaction.

When applied topically, it has an analgesic and anti-inflammatory effect.

Levomenthol has a local irritant effect.

This combination reduces pain and inflammation, is effective for joint pain during movement and at rest, and reduces morning joint stiffness.

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.

C_max in blood plasma with topical application is 5% of the C_max level with oral administration.

Ibuprofen undergoes metabolism in the liver.

It is excreted by the kidneys (unchanged no more than 1%) and, to a lesser extent, with bile through the intestines.

Indications

Muscle pain, back pain, arthritis, pain from ligament damage and sprains, sports injuries, and neuralgia.

ICD codes

Dosage Regimen

Apply the gel externally to intact skin only. Use a thin layer over the affected area. Rub in gently until fully absorbed.

Apply up to four times within 24 hours. Maintain an interval of at least four hours between applications.

Do not exceed the maximum daily application area. The total area should not exceed 1000 cm² for adults. For smaller localized areas, use a gel strip no longer than 10 cm.

Wash hands thoroughly with soap and water immediately after application. Avoid washing the treated area for at least one hour after application.

The maximum duration of continuous use is 10 days for pain relief and 5 days for anti-inflammatory effect. Discontinue use and consult a physician if symptoms persist or worsen.

Do not apply to mucous membranes, eyes, or damaged skin including wounds, abrasions, or eczema. Do not use with occlusive dressings or bandages.

For adults and adolescents 14 years of age and older.

Adverse Reactions

From the immune system hypersensitivity reactions (non-specific allergic reactions and anaphylactic reactions).

From the respiratory system: bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea.

From the skin: itching, urticaria, purpura, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, erythema multiforme, eczema, photosensitivity, angioedema.

From the gastrointestinal tract abdominal pain, dyspepsia.

From the kidneys and urinary tract impaired renal function.

Contraindications

Hypersensitivity to ibuprofen, acetylsalicylic acid and other NSAIDs, complete or incomplete combination of bronchial asthma, recurrent nasal and sinus polyposis and intolerance to acetylsalicylic acid or other NSAIDs, impaired skin integrity at the application site, children under 14 years of age, pregnancy, lactation period.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and lactation.

Pediatric Use

Use is contraindicated in children under 14 years of age.

Special Precautions

Avoid contact with eyes, lips and other mucous membranes, damaged areas of skin. After application to the skin, an occlusive dressing should not be applied.

Drug Interactions

This combination may enhance the effect of drugs that increase photosensitivity.

Since even with topical use of ibuprofen the possibility of systemic action cannot be completely excluded, caution should be exercised when used concomitantly with the following drugs: anticoagulants and thrombolytic drugs, antihypertensive agents, acetylsalicylic acid, other NSAIDs.

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.