GNH USA

Europe — EMA

Mydocalm (Tolperisone Hydrochloride)

GNH USA supplies Mydocalm (Tolperisone Hydrochloride), a centrally acting muscle relaxant for muscle spasm, pain and spasticity. Request a quote for supply.

Request sourcing

1
Pack/s

What is 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 USA 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.

What is Tolperisone Hydrochloride used for?

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.

What are the side effects of Tolperisone Hydrochloride?

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)

What precautions apply to Tolperisone Hydrochloride?

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.

What does Tolperisone Hydrochloride interact with?

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

What is Mydocalm used for?+
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.
How does tolperisone hydrochloride work?+
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.
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. Patients should follow the prescriber’s instructions and not adjust the dose on their own.
Is Mydocalm safe during pregnancy or breastfeeding?+
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.
How do I order Mydocalm from GNH USA?+
To request Mydocalm, submit an enquiry on the product page at gnh-usa.com indicating 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 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.
How should Mydocalm be stored and handled?+
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.
How is Mydocalm administered?+
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.
What are the most serious risks associated with Mydocalm?+
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.
Who should not use Mydocalm?+
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.
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 România S.A.
Origin
EU

Related products