Plaster Capsii (Transdermal patch) Instructions for Use

Marketing Authorization Holder

Veropharm, JSC (Russia)

ATC Code

N02BB02 (Metamizole sodium)

Dosage Form

Plaster Capsii

Patch: 3.8*3.8 cm, 4*10 cm, 6*10 cm, 10*8 cm or 12*18 cm 1, 2, 4, 6, 8, or 10 pcs.

Dosage Form, Packaging, and Composition

Plaster in the form of a strip of cotton fabric with perforation or without perforation with an adhesive layer of plaster mass from yellow-brown to brown color, specific smell, covered from above with an antiadhesive protective layer of polyethylene terephthalate film or siliconeized material, or two strips of cotton fabric with perforation or without perforation with an adhesive layer of plaster mass from yellow-brown to brown color, specific smell on one antiadhesive protective layer of polyethylene terephthalate film or siliconeized material; pepper plaster Doctor Perets with analgesic action should not have folds of fabric and places not covered with plaster mass and should hold sufficiently well on clean dry skin; plaster is produced in the following sizes: 3.8×3.8 cm, 4×10 cm, 6×10 cm, 10×18 cm and 12×18 cm; or in the form of sets, consisting of various sizes of perforated or non-perforated plasters.

Auxiliary substances : natural rubber Smoked sheet – 11 g/ 16.5 g/ 22 g, synthetic rubber SKS-30 ARKPN – 11 g/ 5.5 g, antioxidant additive (Agidol-1) – 0.6 g, pine rosin – 16 g, anhydrous lanolin – 18.6 g, medical vaseline oil – 2 g, dry wheat flour – 7.2 g, zinc oxide – 5 g.

Composition of the ground mass: natural rubber Smoked sheet – 25.7 g, antioxidant additive 4-methyl-2,6-di-tert-butylphenol (Agidol-1) – 0.75 g, pine rosin – 20.35 g, anhydrous lanolin – 9.9 g, medical vaseline oil – 11.3 g, zinc oxide (zinc white) – 32 g.

1 pc. – non-cell contour packaging (3.8 x 3.8 cm, 4 x 10 cm, 6 x 10 cm, 10 x 18 cm and 12 x 18 cm).
1 pc. – non-cell contour packaging (2) (3.8 x 3.8 cm, 4 x 10 cm, 6 x 10 cm, 10 x 18 cm and 12 x 18 cm).
1 pc. – non-cell contour packaging (4) (3.8 x 3.8 cm, 4 x 10 cm, 6 x 10 cm, 10 x 18 cm and 12 x 18 cm) – cardboard packs.
1 pc. – non-cell contour packaging (6) (3.8 x 3.8 cm, 4 x 10 cm, 6 x 10 cm, 10 x 18 cm and 12 x 18 cm) – cardboard packs.
1 pc. – non-cell contour packaging (8) (3.8 x 3.8 cm, 4 x 10 cm, 6 x 10 cm, 10 x 18 cm and 12 x 18 cm) – cardboard packs.
1 pc. – non-cell contour packaging (10) (3.8 x 3.8 cm, 4 x 10 cm, 6 x 10 cm, 10 x 18 cm and 12 x 18 cm) – cardboard packs.

Indications

• Symptomatic relief of mild to moderate pain of various origins, including musculoskeletal pain such as back pain, lumbago, and myalgia.
• As an adjunctive therapy for neuralgia and radiculitis to alleviate localized discomfort.
• For the temporary relief of pain associated with non-serious arthritis and joint inflammation.
• Use is strictly for the short-term management of acute pain syndromes and should not be employed for chronic pain conditions without thorough medical evaluation.

The plaster provides a localized counterirritant and analgesic effect through transdermal delivery of its active components directly to the affected area.

Contraindications

• Hypersensitivity to metamizole sodium, belladonna extract, piper longum extract, or any of the auxiliary substances, including natural or synthetic rubber. A history of agranulocytosis or other severe blood dyscrasias associated with pyrazolone derivatives is an absolute contraindication.
• Application to damaged skin, including wounds, abrasions, eczema, dermatitis, burns, or any form of skin infection. The plaster must not be used on mucous membranes.
• Patients with a known history of glaucoma, particularly angle-closure glaucoma, due to the anticholinergic effects of belladonna extract.
• Patients with severe hepatic impairment or severe renal impairment, as the clearance of active metabolites may be compromised, increasing the risk of toxicity.
• Pregnancy and lactation. The safety of the plaster’s components during pregnancy and breastfeeding has not been established; systemic absorption can occur and pose a risk to the fetus or infant.
• Children under the age of 12 years, due to the lack of sufficient safety and efficacy data in this population and the heightened risk of adverse reactions.
• Patients with prostatic hyperplasia or urinary retention, as belladonna extract may exacerbate these conditions.
• Concomitant use with other products containing metamizole sodium or other pyrazolone derivatives to avoid cumulative toxicity and an increased risk of severe adverse reactions such as agranulocytosis.

Dosage Regimen

For external use only. The dosage is determined by the size of the painful area. Select a plaster size that adequately covers the affected site without overlapping onto healthy surrounding skin. The standard adult dose is one plaster applied to the area of maximal pain.

Application Instructions: Ensure the skin is clean, dry, intact, and free of lotions or oils. Remove the protective antiadhesive layer and apply the plaster firmly, smoothing it out to ensure full contact with the skin. The plaster is typically designed to be worn for up to 12 hours, followed by a 12-hour plaster-free interval. Do not exceed a total application time of 12 hours in any 24-hour period.

Duration of Use: This product is intended for short-term use. If pain persists for more than 3-5 days, or if it worsens, the patient must discontinue use and consult a physician. Do not use the plaster continuously for more than 7 days without medical supervision. Do not cut the plaster, as this may disrupt the controlled release of active ingredients and increase the risk of skin irritation.

Adverse Reactions

Local reactions at the application site are the most commonly reported adverse effects. These may include erythema (redness), pruritus (itching), burning sensation, rash, or contact dermatitis. These reactions are usually mild and resolve upon removal of the plaster. If a severe skin reaction (e.g., blistering, intense burning, or swelling) occurs, use should be discontinued immediately.

Systemic reactions, though less common due to transdermal administration, are possible, especially with prolonged use, application to large body surface areas, or use on damaged skin. Systemic effects may include manifestations of belladonna toxicity, such as dry mouth, blurred vision, tachycardia (increased heart rate), urinary retention, and constipation.

The most serious potential adverse reaction associated with metamizole sodium is agranulocytosis, a life-threatening decrease in white blood cells. Patients should be advised to discontinue the product immediately and seek urgent medical attention if they experience signs of infection such as fever, sore throat, oral ulcers, or general malaise during or after treatment. Other rare but serious systemic reactions include anaphylaxis, hepatotoxicity, and renal impairment.

Drug Interactions

Concomitant use with other analgesics or antipyretics, especially other products containing metamizole or NSAIDs, should be avoided due to the increased risk of adverse effects, particularly hematological toxicity and gastrointestinal complications.

The belladonna extract component possesses anticholinergic properties and may interact with other anticholinergic drugs (e.g., tricyclic antidepressants like amitriptyline, antihistamines like diphenhydramine, drugs for Parkinson’s disease like benztropine, and antipsychotics like clozapine). This can lead to an additive effect, increasing the risk of adverse reactions such as severe dry mouth, constipation, urinary retention, and blurred vision.

Metamizole sodium can induce liver enzymes and may potentially alter the metabolism of other drugs. Caution is advised when used concomitantly with medications that have a narrow therapeutic index, such as warfarin (increased risk of bleeding), phenytoin, or cyclosporine. Close monitoring of International Normalized Ratio (INR) is recommended if used with warfarin.

Concomitant use with drugs that cause bone marrow suppression, such as chemotherapeutic agents (e.g., clozapine, carbamazepine), may potentiate the risk of agranulocytosis and other blood dyscrasias. This combination is generally contraindicated.

Overdose

Overdose from transdermal application is uncommon but can occur with inappropriate use, such as application of multiple plasters, use on large areas of skin, prolonged application beyond the recommended duration, or application to broken skin, which significantly enhances systemic absorption.

Symptoms of overdose are primarily related to the systemic effects of its components. Overdose of metamizole sodium may manifest as nausea, vomiting, abdominal pain, and signs of hematological toxicity including agranulocytosis. Overdose related to belladonna extract (atropine-like effects) may present as tachycardia, hyperthermia, flushed and dry skin, dilated pupils, blurred vision, confusion, hallucinations, and urinary retention.

Management: There is no specific antidote. In case of suspected overdose, remove the plaster(s) immediately and cleanse the application site thoroughly. Treatment is supportive and symptomatic. Management of severe anticholinergic symptoms may require the administration of physostigmine under strict medical supervision in a hospital setting. In cases of suspected agranulocytosis, immediate hospitalization for hematological monitoring and management of potential infections is mandatory.

Pharmacotherapeutic Group

Non-narcotic analgesic agent

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

Rx Only

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.