Product image of Mydocalm (Tolperisone Hydrochloride) supplied by GNH India

Mydocalm

Active Ingredient:
Tolperisone Hydrochloride
Origin:
EU

Mydocalm (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 India supplies Mydocalm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

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.

How It Works

  • Tolperisone Hydrochloride blocks voltage‑gated sodium channels in peripheral nerves and spinal cord neurons, which dampens the transmission of reflex arcs. By decreasing spinal reflex activity, it lowers muscle tone and interrupts the cycle of spasm, providing relief without significant central nervous system depression.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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.

Frequently Asked Questions

Mydocalm, containing Tolperisone Hydrochloride, is prescribed to relieve muscle spasm, reduce skeletal muscle pain, manage spasticity associated with neurological disorders, alleviate back pain, and improve symptoms of various musculoskeletal disorders by relaxing over‑active muscles.

Tolperisone Hydrochloride blocks voltage‑gated sodium channels in peripheral nerves and spinal neurons, which diminishes spinal reflex activity. This reduction in reflex firing lowers muscle tone and eases involuntary contractions, providing relief from spasm without strong central sedation.

The appropriate dose of Mydocalm is determined by the prescribing clinician based on the individual’s condition, severity, age, and response to therapy. Patients should follow the prescriber’s instructions and not adjust the dose without medical guidance.

Safety data for Tolperisone Hydrochloride in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any possible risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.

To request Mydocalm, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details, and any necessary import documentation.

Compared with traditional centrally acting relaxants such as baclofen or tizanidine, Tolperisone Hydrochloride has a lower propensity for strong sedation and respiratory depression. Its mechanism focuses on sodium‑channel blockade, offering effective spasm relief while generally producing milder central effects.

Mydocalm should be stored at ambient temperature, below 25 °C, in its original packaging. Keep the product away from moisture, direct sunlight, and excessive heat to maintain its stability and potency.

Mydocalm is taken orally, usually with a glass of water. The tablet should be swallowed whole and not crushed or chewed unless otherwise directed by a healthcare professional.

Serious risks, though rare, include agranulocytosis, severe skin reactions such as Stevens‑Johnson syndrome, hepatic dysfunction, and anaphylactic reactions. Patients should seek immediate medical attention if they notice signs of infection, rash, jaundice, or breathing difficulties.

Mydocalm is contraindicated in individuals with known hypersensitivity to Tolperisone Hydrochloride or any excipients in the formulation. Caution is also advised for patients with severe hepatic or renal impairment, and it should be avoided in pregnancy unless absolutely necessary.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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