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 formulation for oral use. It helps relieve muscle spasm, stiffness and associated musculoskeletal pain in adult patients. Mydocalm is marketed in the European Union and is prescribed for conditions that involve involuntary muscle contraction and discomfort.

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

Mydocalm (tolperisone hydrochloride) acts on the central nervous system to reduce abnormal muscle tone and is used for several musculoskeletal conditions.

  • Muscle spasm: alleviates involuntary contractions and associated pain.
  • Musculoskeletal pain: reduces discomfort linked to strain or injury of muscles and joints.
  • Muscle stiffness: improves flexibility by decreasing excessive muscle tone.

How It Works

  • Tolperisone hydrochloride blocks voltage‑gated sodium channels in the spinal cord, which diminishes the activity of muscle spindles and interrupts reflex arcs. This central inhibition leads to reduced muscle spindle firing, producing relaxation of skeletal muscles without significant peripheral neuromuscular blockade.

Side Effects

Mydocalm may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Dizziness: sensation of light‑headedness or unsteadiness.
  • Drowsiness: increased sleepiness, especially after initial dosing.
  • Nausea: mild stomach upset or urge to vomit.
  • Dry mouth: reduced salivation leading to a parched feeling.
  • Headache: mild to moderate cranial pain.
  • Gastrointestinal discomfort: abdominal cramps or mild diarrhea.

Serious or Rare Side Effects

  • Severe hypotension: marked drop in blood pressure requiring medical attention.
  • Allergic reactions: rash, itching, swelling, or anaphylaxis.
  • Hepatic enzyme elevation: abnormal liver function tests.
  • Blood dyscrasias: rare blood cell abnormalities such as agranulocytosis.
  • Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

Before prescribing Mydocalm, clinicians should consider several safety aspects.

  • Renal impairment: adjust use in patients with reduced kidney function.
  • Hepatic impairment: monitor liver function and use cautiously.
  • Concomitant CNS depressants: avoid excessive sedation when combined with other depressants.
  • Pregnancy and breastfeeding: safety not established; use only if clearly needed.
  • Elderly patients: start at lower doses due to increased sensitivity.
  • Store below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Mydocalm can interact with other medicines, 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): heightened drowsiness and respiratory depression.
  • Antihypertensive agents: possible enhancement of blood‑pressure‑lowering effects.

Moderate Interactions (Monitor Closely)

  • Anticoagulants: potential increase in bleeding risk.
  • Antidiabetic drugs: may affect blood‑glucose control.
  • Anticholinergic agents: increased risk of dry mouth and constipation.

Frequently Asked Questions

Mydocalm, containing tolperisone hydrochloride, is prescribed to relieve muscle spasm, reduce muscle stiffness, and alleviate musculoskeletal pain that results from strain, injury, or neurological disorders. It is used in adult patients where involuntary muscle contraction causes discomfort or functional limitation.

Tolperisone hydrochloride blocks voltage‑gated sodium channels in the spinal cord, decreasing the excitability of muscle spindles. This central action reduces reflex muscle activity, leading to relaxation of skeletal muscles without directly affecting the neuromuscular junction.

The dosage of Mydocalm is individualized by the prescribing clinician based on the patient’s condition, age, renal and hepatic function, and response to therapy. The prescriber determines the appropriate strength, frequency, and duration of treatment.

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

To place an order, submit an enquiry on the Mydocalm 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 other centrally acting muscle relaxants such as baclofen or tizanidine, tolperisone has a lower incidence of sedation and does not act on GABA receptors. Its mechanism focuses on sodium‑channel blockade, which may result in a different side‑effect profile and suitability for patients sensitive to drowsiness.

Mydocalm should be stored below 25 °C in a dry place, kept in its original packaging, and protected from moisture and direct sunlight. This helps maintain the stability and potency of the oral formulation throughout its shelf life.

Mydocalm is taken orally, usually with a glass of water. The tablet should be swallowed whole and not chewed or crushed, unless the prescriber provides specific instructions for a different administration method.

Serious risks, though rare, include severe hypotension, allergic reactions such as anaphylaxis, significant liver enzyme elevations, and rare blood disorders like agranulocytosis. Patients should seek immediate medical attention if they experience symptoms such as fainting, rash, difficulty breathing, or unusual bruising.

Mydocalm is contraindicated in patients with known hypersensitivity to tolperisone hydrochloride or any excipients in the formulation. Caution is also advised for individuals with severe hepatic or renal impairment, uncontrolled hypertension, or those taking multiple CNS depressants without close monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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