Gedeon Richter Publishes Mydocalm Patient Information in Russia

Gedeon Richter Plc., a multinational pharmaceutical company, has published the official medical use instructions for its product Mydocalm (tolperisone) in Russia. The drug is indicated for the symptomatic treatment of muscle spasticity in adults resulting from stroke, and for moderate to severe myofascial pain syndrome.

Mydocalm functions as a centrally acting muscle relaxant. While its exact mechanism is not fully understood, it is known to have a high affinity for nervous tissue, affecting spinal reflex arcs and reducing the excitability of motor neurons and afferent fibers. It achieves this by dose-dependently inhibiting voltage-gated sodium channels, thereby reducing the amplitude and frequency of action potentials. Inhibition of voltage-gated calcium channels is also believed to contribute to its effect.

The patient information leaflet specifies that Mydocalm should be taken orally with a glass of water after meals to maximize bioavailability. The recommended daily dose ranges from 150 mg to 450 mg, divided into three administrations, with individual dosage adjustments based on patient tolerance and need.

Contraindications include hypersensitivity to tolperisone or chemically similar substances, myasthenia gravis, pregnancy, breastfeeding, and use in individuals under 18 years of age. Patients with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should also avoid the medication. Caution is advised for patients with moderate renal or hepatic impairment, requiring medical supervision and dose adjustment, while use is not recommended in severe cases.

Safety data derived from post-marketing surveillance involving over 12,000 patients indicates that the most frequently reported adverse events were related to skin and subcutaneous tissue disorders, general disorders, and nervous system disorders. Gedeon Richter Plc. is a Hungarian multinational pharmaceutical and biotechnology company.