Europe — EMA
Mydocalm (Tolperisone Hydrochloride)
GNH USA supplies Mydocalm (Tolperisone Hydrochloride), a centrally acting muscle relaxant for muscle spasm, musculoskeletal pain and skeletal muscle
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What is Tolperisone Hydrochloride?
Tolperisone Hydrochloride, the active ingredient in Mydocalm, is a centrally acting muscle relaxant presented as an oral tablet for oral use and marketed in the European Union. It reduces muscle tone and is employed to treat muscle spasm, musculoskeletal pain, and other skeletal muscle disorders in adult patients.
GNH USA supplies Mydocalm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on quality and regulatory compliance.
What is Tolperisone Hydrochloride used for?
Mydocalm (tolperisone hydrochloride) is used to manage conditions involving skeletal muscle hypertonicity.
- Muscle spasm: provides relief of involuntary muscle contraction and associated discomfort. - Musculoskeletal pain: reduces pain by relaxing over‑active muscles contributing to the pain syndrome. - Skeletal muscle disorders: improves functional mobility by decreasing abnormal muscle tone.
What are the side effects of Tolperisone Hydrochloride?
Mydocalm may cause a range of adverse reactions, which are categorized by frequency.
Common Side Effects: - Dizziness - Drowsiness - Nausea - Dry mouth - Headache - Mild hypotension
Serious or Rare Side Effects: - Stevens‑Johnson syndrome or severe skin reactions - Agranulocytosis or other blood dyscrasias - Significant hepatic dysfunction or elevated liver enzymes - Anaphylactic‑type hypersensitivity reactions
What precautions apply to Tolperisone Hydrochloride?
When prescribing Mydocalm, clinicians should consider several safety precautions to minimize risk.
- Renal or hepatic impairment: assess function before initiating therapy. - Blood pressure monitoring: watch for hypotension, especially in patients on antihypertensives. - Concomitant CNS depressants: use with caution as additive sedation may occur. - Elderly patients: start at lower dose and monitor for dizziness. - Known hypersensitivity: avoid if patient has previous allergic reaction to tolperisone. - Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture.
What does Tolperisone Hydrochloride interact with?
Mydocalm can interact with other medicines, altering its efficacy or safety profile.
Major Interactions (Avoid): - Other centrally acting muscle relaxants: may increase risk of excessive muscle weakness and sedation. - MAO inhibitors: can potentiate hypotensive effects. - Strong CYP450 inhibitors (e.g., ketoconazole): may raise tolperisone plasma levels.
Moderate Interactions (Monitor Closely): - Antihypertensive agents: additive blood pressure lowering. - CNS depressants (benzodiazepines, opioids): enhanced sedation and dizziness.



