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



