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 muscle relaxant presented as an oral tablet for oral use. It is employed to alleviate muscle spasm, musculoskeletal pain, and spasticity associated with neurological disorders. It is marketed across the European Union and is prescribed by physicians for conditions requiring reduction of excessive skeletal muscle tone.

GNH India supplies Mydocalm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution.

Manufacturer / TM Owner

Gedeon Richter România S.A.

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Indications & Clinical Uses

  • Mydocalm (tolperisone hydrochloride) acts on skeletal muscle hyperexcitability and is used in the following clinical situations:
  • Muscle spasm: reduces involuntary muscle contractions and associated pain.
  • Musculoskeletal pain: alleviates pain related to strain or injury of muscles and joints.
  • Spasticity: improves muscle tone in neurological disorders such as multiple sclerosis or post‑stroke conditions.

How It Works

  • Tolperisone hydrochloride is presumed to block voltage‑gated sodium channels in peripheral motor neurons, decreasing sodium influx and dampening neuronal excitability. This reduces repetitive action potentials, leading to lowered muscle hyperexcitability and relaxation of skeletal muscle tone without significant central nervous system depression.

Side Effects

Adverse reactions to Mydocalm are generally mild but may occur.

Common Side Effects

  • Dizziness
  • Drowsiness
  • Nausea
  • Dry mouth

Serious or Rare Side Effects

  • Severe hypotension
  • Allergic skin reactions (rash, urticaria)
  • Hepatic enzyme elevation
  • Agranulocytosis (very rare)

Precautions & Warnings

  • When prescribing Mydocalm, clinicians should consider the following precautions:
  • Pregnancy: safety category unknown; use only if benefits outweigh risks.
  • Liver impairment: monitor hepatic function and adjust dose if necessary.
  • Elderly patients: start with the lowest effective dose due to increased sensitivity.
  • Concomitant CNS depressants: may enhance drowsiness; monitor closely.
  • Hypotension: observe blood pressure, especially in patients on antihypertensives.
  • Store at below 25°C: keep in the original packaging, protect from moisture.

Avoid Interactions

Mydocalm may interact with other medicines; notable interactions include:

Major Interactions (Avoid)

  • Other centrally acting muscle relaxants: additive CNS depression.
  • MAO inhibitors: risk of severe hypotension.

Moderate Interactions (Monitor Closely)

  • Antihypertensive agents: may potentiate blood‑pressure‑lowering effect.
  • CYP3A4 inhibitors (e.g., ketoconazole): may increase tolperisone plasma levels.
  • Alcohol: can enhance drowsiness and dizziness.

Frequently Asked Questions

Mydocalm contains tolperisone hydrochloride and is prescribed to relieve muscle spasm, reduce musculoskeletal pain, and improve spasticity associated with neurological conditions such as multiple sclerosis or post‑stroke muscle stiffness.

Tolperisone hydrochloride is thought to block voltage‑gated sodium channels on peripheral motor neurons, decreasing neuronal excitability and limiting repetitive firing. This reduces excessive skeletal muscle tone and eases muscle stiffness without strong central nervous system depression.

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. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety data for tolperisone hydrochloride in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and under medical supervision.

To request Mydocalm, submit an enquiry on the product page at gnhindia.com indicating 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 many centrally acting relaxants such as baclofen or tizanidine, tolperisone has a lower propensity for sedation and does not act directly on the central nervous system. Its primary action is peripheral sodium‑channel blockade, which may result in fewer CNS‑related side effects for some patients.

Mydocalm tablets should be stored at temperatures below 25 °C, in the original packaging, and protected from moisture and direct sunlight. Keep the product out of reach of children and discard any tablets that appear discoloured or damaged.

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. Administration timing (e.g., with meals) is determined by the prescriber.

Serious but rare risks include severe hypotension, allergic reactions such as rash or urticaria, hepatic enzyme elevations, and agranulocytosis. Patients should seek immediate medical attention if they experience signs of an allergic reaction, unexplained dizziness, or signs of infection.

Mydocalm is contraindicated in patients with known hypersensitivity to tolperisone or any excipients in the tablet. Caution is advised for individuals with severe liver impairment, uncontrolled hypotension, or those taking other potent CNS depressants. Pregnant or nursing women should only use it when clearly indicated by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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