Instructions Muscomed hard capsules 8 mg blister No. 20
Composition
active ingredient: thiocolchicoside;
1 hard capsule contains thiocolchicoside 4 mg or 8 mg;
excipients: lactose monohydrate; corn starch; magnesium stearate; capsule composition: titanium dioxide (E 171); gelatin.
Dosage form
The capsules are hard.
Main physicochemical properties:
4 mg capsules - hard gelatin capsules, size No. 3, matte white cap and body, containing yellow powder;
8 mg capsules - hard gelatin capsules, size No. 2, matte white cap and body, containing yellow powder.
Pharmacotherapeutic group
Muscle relaxants with a central mechanism of action. ATC code M03B X05.
Pharmacological properties
Pharmacodynamics
Muscomed contains the active ingredient thiocolchicoside, a semi-synthetic muscle relaxant derived from the natural glycoside colchicoside. The drug exhibits selective affinity for gamma-aminobutyric acid (GABA) and glycine receptors, which determines its action at different levels of the nervous system, both in local spasms and in spasms of central origin.
Muscomed does not have a curare-like effect, does not cause paralysis, and does not affect the cardiovascular and respiratory systems.
Pharmacokinetics
Thiocolchicoside is rapidly absorbed after oral administration. Peak plasma concentrations are reached after approximately 60 minutes. According to available data, in healthy volunteers, after oral administration of 8 mg of the drug, the bioavailability was 24% compared to that after intramuscular administration.
Plasma protein binding is 13%. Thiocolchicoside binds to albumin.
The half-life is 2.5-5 hours.
It is metabolized mainly in the blood, hepatic enzymes do not participate in metabolism. Approximately 20% of the dose is excreted in the urine as unchanged metabolites, 75-81% is excreted in the feces.
Indication
For additional short-term relief of painful muscle contractures.
Contraindication
– Hypersensitivity to the components of the drug;
– muscle hypotension;
– mild paralysis.
Interaction with other medicinal products and other types of interactions
There is no data on drug interactions. However, caution is recommended when taking it simultaneously with other muscle relaxants.
When used simultaneously with drugs that depress the central nervous system (CNS), including alcohol, antihypertensive drugs, and curare-like drugs, increased muscle relaxation and CNS depression, and the development of hypotension are possible.
When used simultaneously with anticoagulants, the risk of bleeding increases.
Application features
Muscomed should be used with caution in patients with impaired renal or hepatic function. The drug should be used with caution in patients with epilepsy or at risk of seizures.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product, as this medicinal product contains lactose monohydrate.
Use during pregnancy or breastfeeding
Contraindicated during pregnancy and breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
During the treatment period, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
Method of administration and doses
Take orally after meals.
The maximum daily dose is 8-16 mg in 2 divided doses.
The recommended course of treatment is 5-7 days.
When preparing for physiotherapy procedures, the muscle relaxation period is 1-2 hours after taking the drug.
Children
The drug is contraindicated in children under 16 years of age.
Overdose
There are no data on overdose.
Symptoms: possible increase in adverse reactions.
Treatment is symptomatic, supportive therapy.
Adverse reactions
Rare: skin rash, edema, allergic and pseudoallergic reactions (allergic vasculitis), stomach pain, diarrhea.
Very rare: hypotension, irritability and drowsiness.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
10 capsules in a blister, 1 or 2 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
WORLD MEDICINE ILAС SAN. VE TIC. AS, Turkey.
Location of the manufacturer and address of its place of business
Evren Mach. Jami Yolu Jad. No. 50, 34212 Guneshli Bagjilar, Istanbul, Turkey / Evren Mah. Cami Yolu Cad. No.50, 34212 Gunesli-Bagcilar, Istanbul, Turkey.
Applicant
WORLD MEDICINE ILAС SAN. VE TIC. AS, Turkey.
