Europe — EMA
Mydocalm (Tolperisone Hydrochloride)
GNH USA supplies Mydocalm (Tolperisone Hydrochloride), a centrally acting skeletal muscle relaxant for muscle spasm, back pain and spasticity.
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What is Tolperisone Hydrochloride?
Tolperisone Hydrochloride, the active ingredient in Mydocalm, is a centrally acting skeletal muscle relaxant presented as an oral tablet for oral use. It is employed to reduce muscle tone and alleviate spasm‑related discomfort in adults with musculoskeletal conditions. GNH USA supplies Mydocalm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Tolperisone Hydrochloride used for?
Tolperisone Hydrochloride acts on skeletal muscle spasm and related pain syndromes. - Muscle spasm: reduces involuntary contraction and associated discomfort. - Skeletal muscle pain: alleviates pain caused by over‑use or strain. - Spasticity: diminishes heightened muscle tone in neurological disorders. - Back pain: eases tension‑related lumbar discomfort. - Musculoskeletal disorders: improves functional mobility by relaxing affected muscles.
What are the side effects of Tolperisone Hydrochloride?
Tolperisone Hydrochloride may cause a range of adverse reactions.
Common Side Effects: - Dizziness: transient sensation of light‑headedness. - Nausea: mild to moderate stomach upset. - Dry mouth: reduced salivation. - Headache: mild to moderate intensity. - Fatigue: feeling of tiredness. - Gastrointestinal discomfort: abdominal pain or dyspepsia.
Serious or Rare Side Effects: - Agranulocytosis: severe reduction in white blood cells. - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis. - Hepatic dysfunction: elevated liver enzymes or hepatitis. - Blood dyscrasias: anemia or thrombocytopenia. - Anaphylaxis: acute allergic reaction with airway compromise. - Cardiac arrhythmia: irregular heart rhythm.
What precautions apply to Tolperisone Hydrochloride?
When prescribing Tolperisone Hydrochloride, clinicians should consider several safety measures. - Renal or hepatic impairment: monitor liver and kidney function regularly. - Elderly patients: observe for increased sensitivity to muscle relaxation. - Concomitant CNS depressants: watch for additive sedation or dizziness. - Pregnancy: safety not established; avoid unless benefit outweighs risk. - Driving and machinery: may cause dizziness; advise caution. - Store at ambient temperature: keep in the original container, protect from moisture.
What does Tolperisone Hydrochloride interact with?
Tolperisone Hydrochloride can interact with other medicines, requiring attention to potential effects.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): may raise Tolperisone levels and increase adverse events. - Strong CYP3A4 inducers (e.g., rifampicin): may lower drug exposure, reducing efficacy.
Moderate Interactions (Monitor Closely): - Other muscle relaxants: additive central nervous system depression. - Alcohol: enhanced sedative effect and dizziness. - Antihypertensives: possible additive hypotensive effect.



