GNH USA

Europe — EMA

Mydocalm (Tolperisone Hydrochloride)

GNH USA supplies Mydocalm (Tolperisone Hydrochloride), a centrally acting skeletal muscle relaxant for muscle spasm, stiffness and musculoskeletal pain.

Request sourcing

1
Pack/s

What is 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 USA supplies Mydocalm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Tolperisone Hydrochloride used for?

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.

What are the side effects of Tolperisone Hydrochloride?

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.

What precautions apply to Tolperisone Hydrochloride?

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.

What does Tolperisone Hydrochloride interact with?

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

What conditions is Mydocalm used to treat?+
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.
How does tolperisone hydrochloride work in the body?+
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.
What is the usual dose of Mydocalm?+
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.
Is Mydocalm safe to use during pregnancy or breastfeeding?+
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.
How do I order Mydocalm from GNH USA?+
To place an order, submit an enquiry on the Mydocalm product page at gnh-usa.com, specifying the required quantity. GNH USA 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.
How does Mydocalm compare with other muscle relaxants?+
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.
What are the recommended storage conditions for Mydocalm?+
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.
How is Mydocalm administered?+
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.
What are the most serious risks associated with Mydocalm?+
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.
Who should not use Mydocalm?+
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.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Tolperisone Hydrochloride
Route
Oral Use
Manufacturer
Gedeon Richter Plc.
Origin
EU

Related products