Muscumed

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT MUSKOMED (MUSKOMED)

Composition:

Active substance: thiocolchicoside;

1 g of cream contains thiocolchicoside 2.5 mg;

Excipients: polysorbate 80, hydrogenated lanolin, cetyl alcohol, cetostearyl wax, stearic acid, methylparaben (E 218), ethylparaben (E 214), sodium alginate, sodium lauryl sulfate, linden essence, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: light yellow homogeneous cream.

Pharmacotherapeutic group.

Topical agents used for joint and muscular pain. ATC code M02AX10.

Pharmacological properties.

Pharmacodynamics.

Thiocolchicoside is a semi-synthetic muscle relaxant derived from the natural glycoside colchicoside.

Thiocolchicoside exerts a muscle relaxant effect, but does not exhibit curare-like effects.

Pharmacokinetics.

After topical administration of thiocolchicoside at recommended doses for the treatment of painful muscle contractures, plasma levels were below the minimum detectable level. This indicates the absence of systemic absorption.

Clinical characteristics.

Indications.

Symptomatic treatment of painful muscle contractures:

• acute phase of lumbo-sacral radiculitis;
• cervicobrachial neuralgia;
• spasmodic torticollis;
• post-traumatic pain;
• postoperative pain.

Contraindications.

• Hypersensitivity to the active substance and/or excipients of the medicinal product;
• flaccid paralysis;
• muscle hypotonia;
• pregnancy;
• breastfeeding.

Interaction with other medicinal products and other forms of interactions.

There are no data on any clinically significant interactions with other medicinal products.

Special precautions for use

Prolonged use of thiocolchicoside may lead to sensitization reactions. In such cases, the drug should be discontinued and appropriate treatment initiated.

The medicinal product contains methylparaben (E 218) and ethylparaben (E 214), which may cause delayed-type hypersensitivity reactions (contact dermatitis) and immediate-type hypersensitivity reactions (urticaria and bronchospasm).

The medicinal product contains cetyl alcohol and hydrogenated lanolin, which may cause local skin reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding

There are no data on the topical use of thiocolchicoside in pregnant women. The drug is contraindicated during pregnancy.

If use of the drug is necessary, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery

There are no data on the effect of thiocolchicoside on the ability to drive or operate machinery. In very rare cases, somnolence may occur; this should be taken into account when driving or operating machinery.

Dosage and Administration.

The medicinal product is intended for external use in adults.

Apply the cream to the affected area of the skin 2–3 times daily, gently rubbing it in. If adverse reactions develop, the dose of the medicinal product should be reduced (according to physician's recommendation). The duration of treatment depends on the indication and therapeutic response.

Children.

There are no data regarding topical use of thiocolchicoside in children. The medicinal product should not be used in children.

Overdose.

There are no data on cases of overdose. Overdose may result in increased adverse reactions.

Side effects.

In rare cases, hypersensitivity reactions may occur (contact dermatitis, urticaria, bronchospasm, angioedema).

If side effects occur, the dose of the medicinal product should be reduced (according to physician's recommendation).

Reporting suspected side effects.

Reporting of suspected adverse reactions after medicinal product registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

30 g in a tube, 1 tube per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

UORLID MEDICINE ILAC SAN. VE TIC. A.S., Turkey /
WORLD MEDICINE ILAC SAN. VE TIC. A.S., Turkey.

Manufacturer's address and place of business.

COSB G.O.Pasa Mah. 6. Cad. No:30, Cerkezkoy/Tekirdag, Turkey.

Marketing Authorization Holder.

LLC "WORLD MEDICINE", Ukraine /
WORLD MEDICINE, LLC, Ukraine.