Europe — EMA
Mydocalm (Tolperisone Hydrochloride)
GNH USA supplies Mydocalm (Tolperisone), a centrally acting skeletal muscle relaxant for muscle spasm, low back pain and cervical pain.
Request sourcing
What is Tolperisone Hydrochloride?
Tolperisone, the active ingredient in Mydocalm, is a centrally acting skeletal muscle relaxant presented as an oral tablet for oral use. It is employed to relieve muscle spasm, musculoskeletal pain, low back pain and cervical pain in adult patients. GNH USA supplies Mydocalm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Tolperisone Hydrochloride used for?
Mydocalm (tolperisone) acts on the central nervous system to reduce muscle hypertonia and is indicated for several musculoskeletal conditions.
- Muscle spasm: alleviates involuntary muscle contraction and associated discomfort. - Low back pain: reduces pain and improves functional mobility in lumbar region. - Cervical pain: eases neck muscle tension and pain. - Musculoskeletal pain: diminishes general skeletal muscle discomfort.
What are the side effects of Tolperisone Hydrochloride?
Tolperisone is generally well tolerated, but adverse reactions can occur.
Common Side Effects: - Dizziness: sensation of light‑headedness or unsteadiness. - Drowsiness: increased sleepiness, especially after initial dosing. - Nausea: mild gastrointestinal upset. - Headache: transient cranial discomfort. - Dry mouth: reduced salivary flow. - Hypotension: mild lowering of blood pressure.
Serious or Rare Side Effects: - Severe skin reactions: such as Stevens‑Johnson syndrome. - Anaphylaxis: acute allergic response with breathing difficulty. - Blood dyscrasias: including agranulocytosis or leukopenia. - Hepatic enzyme elevation: abnormal liver function tests. - Cardiac arrhythmia: irregular heart rhythm. - Persistent hypotension: marked drop in blood pressure requiring medical attention.
What precautions apply to Tolperisone Hydrochloride?
When prescribing Mydocalm, clinicians should consider several safety aspects. - Renal impairment: use with caution and monitor renal function. - Hepatic impairment: adjust therapy if liver disease is present. - Elderly patients: start at lower dose and observe for increased sensitivity. - Concomitant CNS depressants: may enhance drowsiness or dizziness. - Driving and machinery: advise patients to avoid operating vehicles until they know how the drug affects them. - Store at ambient temperature: keep below 25 °C, in the original packaging, protected from moisture.
What does Tolperisone Hydrochloride interact with?
Tolperisone may interact with other medications, requiring attention to avoid adverse outcomes.
Major Interactions (Avoid): - Other centrally acting muscle relaxants: additive muscle relaxation and sedation. - CNS depressants (e.g., benzodiazepines, opioids): increased risk of profound drowsiness. - Alcohol: may potentiate sedative effects.
Moderate Interactions (Monitor Closely): - Antihypertensive agents: possible additive blood pressure lowering. - Antihistamines: may enhance drowsiness. - CYP450 inhibitors: could raise tolperisone plasma levels, requiring dose adjustment.



