• Muscoril Capsule contains
    Thiocolchicoside 4mg
  • Muscoril Injection contains
    Thiocolchicoside 4mg

Muscoril Indications & Recommended Dosage

Muscoril capsules and injections are used as an adjuvant treatment of painful muscle contractures in acute spinal pathology.

Muscoril Capsules and Injections

 

For oral use: The recommended and maximal dose of Muscoril is 8 mg every 12 hours (i.e. 16 mg per day). The treatment duration is limited to 7 consecutive days.

For IM use: The recommended and maximal dose of Muscoril Injection is 4 mg every 12 hours (i.e. 8 mg per day). The treatment duration is limited to 5 consecutive days.

Applies To Oral And IM Forms: Doses exceeding recommended doses or long-term use should be avoided. Moreover, Muscoril is not recommended for use in children below the age of 16 years.

When to avoid Muscoril? > Contraindications

  • Known hypersensitivity to thiocolchicoside or to any excipients in the formulation
  • Pregnancy and Lactation
  • In women of childbearing potential who are not using effective contraception.

Special Drug Warnings

  • Applies To The Oral And IM Forms
    In preclinical studies, one of Muscoril (thiocolchicoside) metabolites (SL59.0955) induced aneuploidy (i.e. unequal number of chromosomes in dividing cells) at concentrations close to human exposure observed at doses 8mg twice daily per os. Aneuploidy is reported as a risk factor for teratogenicity, embryofetotoxicity/spontaneous abortion, cancer, and impaired male fertility. As a precautionary measure, use of the product at doses exceeding the recommended dose or long-term use should be avoided.
  • Post-marketing cases of cytolytic and cholestatic hepatitis have been reported with Muscoril. Severe cases (i.e. fulminant hepatitis) have been reported in patients concomitantly taking NSAIDs or Paracetamol. Patients should be advised to report any sign of liver toxicity.
  • Muscoril may precipitate seizures, especially in patients with epilepsy or those at risk for seizures.
  • Patients should be carefully informed about the potential risk of a possible pregnancy and about effective contraception measures to be followed.
  • Applies to formulations containing lactose/saccharose only: Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
  • Due to the presence of saccharose, patients with rare hereditary problems of fructose intolerance should not take Muscoril.

In case of diarrhea the treatment with Muscoril should be stopped. When using Muscoril Injections, cases of syncope vasovagal have been observed and therefore, the patient should be monitored after the injection.

Muscoril during Pregnancy and Lactation

Studies conducted in animals have shown a reproductive toxicity including teratogenic effects. There are insufficient clinical data to evaluate safety of use in pregnancy. Thus, the potential hazards for the embryo and fetus are unknown. In consequence, Muscoril is contraindicated in pregnancy and women of childbearing potential who are not using effective contraception. Moreover, since it passes into the mother’s milk, the use of Muscoril is contraindicated during breastfeeding.

Driving a Vehicle or Performing Other Hazardous Tasks after Taking Muscoril

There are no data available of the effect on driving vehicles and using machines. Clinical studies concluded that Muscoril has no effect on the psychomotor performance. However, somnolence may occur commonly, this has to be taken into account when driving vehicles and operating machines.