Instructions for Muscomed cream 2.5 mg/g tube 30 g
Composition
active ingredient: thiocolchicoside;
1 g of cream contains 2.5 mg of thiocolchicoside;
excipients: polysorbate 80, hydrogenated lanolin, cetyl alcohol, cetyl wax esters, stearic acid, methylparaben (E 218), ethylparaben (E 214), sodium alginate, sodium lauryl sulfate, linden essence, purified water.
Dosage form
Cream.
Main physicochemical properties: light yellow homogeneous cream.
Pharmacotherapeutic group
Means used locally for joint and muscle pain. ATX code M02A X10.
Pharmacological properties
Pharmacodynamics.
Thiocolchicoside is a semi-synthetic muscle relaxant derived from the natural glycoside colchicoside.
Thiocolchicoside has a muscle relaxant effect, but does not exhibit the effect of curare-like drugs.
Pharmacokinetics.
After topical application of thiocolchicoside at recommended doses for the treatment of painful muscle contractures, its plasma levels were below the minimum detection limit, indicating no systemic absorption.
Indication
Symptomatic treatment of painful muscle contractures:
acute period of lumbosacral radiculitis;
cervicobrachial neuralgia;
spastic torticollis;
post-traumatic pain;
Postoperative pain.
Contraindication
Hypersensitivity to the active substance and/or excipients of the medicinal product;
flaccid paralysis;
muscle hypotension;
pregnancy;
breastfeeding period.
Interaction with other medicinal products and other types of interactions
There is no data on any clinically significant interactions with other drugs.
Application features
Prolonged use of thiocolchicoside may cause sensitization reactions. In this case, the drug should be discontinued and appropriate treatment should be initiated.
The medicinal product contains methylparaben (E 218) and ethylparaben (E 214), which may cause delayed (contact dermatitis) and immediate (urticaria and bronchospasm) hypersensitivity reactions.
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 necessary, use of the drug should be discontinued.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no data on the effect of thiocolchicoside on the ability to drive or use machines. In very rare cases, drowsiness may occur, which should be taken into account when driving or using machines.
Method of administration and doses
The medicine is intended for external use by adults.
Apply the cream to the affected area of the body 2–3 times a day, rubbing it lightly into the skin. In case of adverse reactions, the dose of the drug should be reduced (according to the doctor's recommendation). The duration of use of the drug depends on the indications and effectiveness of the treatment.
Children.
There are no data on the topical use of thiocolchicoside in children. The drug should not be used in children.
Overdose
There are no data on cases of overdose. Possible increase in adverse reactions.
Side effects
In rare cases, hypersensitivity reactions may develop (contact dermatitis, urticaria, bronchospasm, angioedema).
In case of adverse reactions, the dose of the drug should be reduced (according to the doctor's recommendation).
Reporting of suspected adverse reactions.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ºС in a place inaccessible to children.
Packaging
30 g in a tube, 1 tube in a cardboard box.
Vacation category
According to the recipe.
Producer
WORLD MEDICINE ILAC SAN. VE TIC. AS, Turkey.
Location of the manufacturer and address of its place of business.
15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey / 15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey.
Applicant
WORLD MEDICINE LLC, Ukraine / WORLD MEDICINE, LLC, Ukraine.
