Deep Relief (Gel) Instructions for Use

Marketing Authorization Holder

Mentholatum Company, Ltd. (United Kingdom)

Contact Information

DELTA MEDICAL LLC (Russia)

ATC Code

M02AA (Topical non-steroidal anti-inflammatory drugs)

Active Substances

Ibuprofen (Rec.INN registered by WHO)

Levomenthol (Rec.INN registered by WHO)

Dosage Form

Deep Relief

External use gel 50 mg+30 mg/1 g: tubes 15 g, 50 g, or 100 g

Dosage Form, Packaging, and Composition

Gel for external use transparent, with a menthol odor.

Excipients: purified water, denatured ethanol 96%, propylene glycol, diisopropanolamine, carbomer.

15 g – aluminum tubes (1) – cardboard boxes.
30 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.
100 g – aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

NSAID

Pharmacological Action

A combined preparation for external use, containing Ibuprofen and Levomenthol.

Ibuprofen is an NSAID; when applied externally, it has an analgesic, anti-inflammatory, and anti-exudative effect in the symptomatic treatment of joints, tendons, ligaments, and muscles.

Levomenthol (menthol) has a local irritant effect, which causes the development of the drug’s rapid analgesic effect.

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

Indications

• Diseases of the musculoskeletal system (including rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, lumbago, sciatica);
• Rheumatic diseases of soft tissues (including tenosynovitis, bursitis, damage to periarticular tissues);
• Post-traumatic inflammation of soft tissues and joints (including due to sprains, strains, and bruises);
• Back pain, lower back pain.

ICD codes

Dosage Regimen

The preparation is applied externally.

For adults and children over 14 years of age, a small amount of gel (3-5 cm) is applied up to 4 times/day in a thin layer to the skin over the inflammation site and gently rubbed in.

After using Deep Relief, hands should be washed if they are not the area being treated.

The duration of use of the preparation without consulting a doctor is no more than 10 days.

Adverse Reactions

Allergic reactions generalized skin rash, urticaria, angioneurotic edema, bronchospastic reactions, photosensitivity, eczema, contact dermatitis (including itching, redness, swelling of the treated skin area, papules, vesicles, peeling).

Contraindications

• Bronchial asthma provoked by taking acetylsalicylic acid or other NSAIDs;
• Impaired skin integrity;
• Pregnancy;
• Lactation period (breastfeeding);
• Children under 14 years of age;
• Hypersensitivity to ibuprofen or other components of the preparation.

Use with caution in exacerbation of hepatic porphyria, erosive and ulcerative lesions of the gastrointestinal tract, severe impairment of liver and kidney function, chronic heart failure, bronchial asthma, in elderly patients.

Use in Pregnancy and Lactation

The use of the preparation is contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Use the preparation with caution in exacerbation of hepatic porphyria, severe impairment of liver function.

Use in Renal Impairment

Use the preparation with caution in severe impairment of kidney function.

Pediatric Use

Deep Relief should not be used in children under 14 years of age without a corresponding doctor’s recommendation.

Geriatric Use

Use the preparation with caution in elderly patients.

Special Precautions

Patients with kidney diseases should consult a doctor before using the preparation.

The gel should be applied to intact skin, avoiding contact with eyes, mucous membranes, and open wound surfaces. After application, an occlusive (airtight) bandage should not be applied.

With long-term use of the preparation in large doses, there is a risk of developing side effects.

Use in pediatrics

Deep Relief should not be used in children under 14 years of age without a corresponding doctor’s recommendation.

Overdose

Cases of overdose have not been described.

Drug Interactions

Deep Relief may enhance the effect of drugs causing photosensitivity.

Clinically significant interaction with other medicinal products has not been described.

Storage Conditions

The preparation should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The preparation is approved for use as an over-the-counter product.

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.