Plaster Capsi (Transdermal patch) Instructions for Use

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

ATC Code

M02AB (Capsaicin and similar agents)

Dosage Form

Plaster Capsi

Patch: 4*10 cm, 6*10 cm, 10*18 cm or 12*18 cm 1, 2, 4, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Plaster in the form of a strip of fabric with or without perforation (calico, madapolam, calico, viscose yarn fabric or imported fabric registered in the Russian Federation) with a uniform layer of plaster mass from yellow-brown to brown in color, with a characteristic odor, covered on top with a protective layer of polyethylene terephthalate film or imported film registered in the Russian Federation, or silicone-coated paper or imported paper registered in the Russian Federation, or imported polyethylene film registered in the Russian Federation, or two fabric strips on one protective layer; the pepper plaster must not have fabric folds, lumps of mass, foreign mechanical inclusions in the mass, or places not covered with the plaster mass; the pepper plaster is produced in the following sizes: 4×0.2 cm, 6×0.2 cm, 10×0.3 cm, 10×0.2 cm, 12×0.3 cm and 18×0.5 cm.

Excipients: natural rubber Smoked sheet – 21.5 g/ 20.5 g, synthetic rubber SKS-30 ARKPN – 21.5 g/ 20.5 g, antioxidant additive (Agidol-1) – 600 mg, pine rosin – 22.2 g, anhydrous lanolin – 18.6 g, medical vaseline oil – 2 g, zinc oxide – 5 g.

1 pc. – non-cell contour packaging (1) (4 x 10 cm, 6 x 10 cm, 10 x 18 cm and 12 x 18 cm).
1 pc. – non-cell contour packaging (2) (4 x 10 cm, 6 x 10 cm, 10 x 18 cm and 12 x 18 cm).
1 pc. – non-cell contour packaging (4) (4 x 10 cm, 6 x 10 cm, 10 x 18 cm and 12 x 18 cm).
1 pc. – non-cell contour packaging (10) (4 x 10 cm, 6 x 10 cm, 10 x 18 cm and 12 x 18 cm) – cardboard packs – cardboard boxes.
1 pc. – non-cell contour packaging (20) (4 x 10 cm, 6 x 10 cm, 10 x 18 cm and 12 x 18 cm) – cardboard packs – cardboard boxes.

Pharmacotherapeutic Group

Local irritant of natural origin

Pharmacological Action

Combined agent with analgesic and local irritant action.

Indications

• Radiculitis
• Myositis
• Lumbago
• Arthralgia

Apply the plaster to intact skin at the site of pain. Use for the symptomatic relief of musculoskeletal pain.

Ensure the skin is clean and dry before application. The plaster provides a local warming and analgesic effect.

ICD codes

Dosage Regimen

Apply the plaster externally to the area of pain. Use one plaster per application site. The plaster can be left on for up to two days if no severe irritation is felt.

Do not apply to broken or irritated skin. Remove the plaster immediately if a severe burning sensation or skin reaction occurs. Do not cut the plaster.

Adverse Reactions

Possible adverse reactions include localized skin reactions such as burning, itching, and erythema at the application site. Allergic contact dermatitis is also possible.

Discontinue use and remove the plaster if a severe skin reaction develops. In case of a systemic allergic reaction, seek immediate medical attention.

Contraindications

• Impaired skin integrity, including wounds, abrasions, eczema, or dermatitis, at the intended application sites.
• Known hypersensitivity to any component of the plaster, including belladonna extract, Piper longum extract, or natural rubber latex.

Do not apply to mucous membranes or areas with thin, sensitive skin. Avoid use in children.

Drug Interactions

No specific drug interactions are known. Exercise caution when using other topical medications on the same area, as this may increase the risk of skin irritation.

Concurrent use with other topical analgesics or counterirritants is not recommended due to the potential for additive skin effects.

Overdose

Overdose is unlikely with correct external use. Excessive application or prolonged use may lead to severe local skin reactions, including blistering and ulceration.

In case of accidental ingestion, seek medical help immediately. Symptoms of ingestion may include dry mouth, dilated pupils, and tachycardia due to belladonna alkaloids.

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.