Tablets "Mydocalm" are used for the symptomatic treatment of muscle spasm in adults after a stroke.
The active ingredient is tolperisone hydrochloride (one coated tablet contains 50 mg of tolperisone hydrochloride).
core: citric acid, monohydrate; colloidal anhydrous silicon dioxide; stearic acid; talc; microcrystalline cellulose; corn starch; lactose;
shell: anhydrous colloidal silicon dioxide, titanium dioxide (E 171), lactose monohydrate, macrogol 6000, hypromellose.
hypersensitivity to the active substance or similar in chemical composition to eperisone, or to any of the excipients;
myasthenia gravis;
lactation period.
The preparation should be taken after meals with one glass of water. Insufficient food intake can reduce the bioavailability of tolperisone.
Adults: depending on individual needs and tolerance - 150-450 mg per day in 3 divided doses.
Pregnant
According to animal studies, tolperisone has no teratogenic effect. Due to the lack of significant clinical data on the use of this preparation, "Mydocalm" should not be used during pregnancy.
Since it is not known whether tolperisone penetrates into breast milk, the use of the preparation "Mydocalm" during breastfeeding is contraindicated.
Children
The safety and efficacy of tolperisone in children have not been studied.
Drivers
Given the possibility of developing symptoms such as dizziness, drowsiness, impaired attention, epilepsy, blurred vision, the preparation should be used with caution when driving or working with other mechanisms.
Data on overdose of tolperisone are insufficient.
Overdose symptoms can mainly include drowsiness, manifestations of the gastrointestinal tract (nausea, vomiting, epigastric pain), tachycardia, hypertension, bradykinesia and vertigo. In severe cases, seizures and coma have been reported.
There is no specific antidote for tolperisone. In case of overdose, symptomatic treatment is recommended.
The safety profile of tablets containing tolperisone is based on data from more than 12,000 patients. In accordance with these data, the most common side reactions were disorders of the skin and subcutaneous tissue, systemic disorders, disorders of the nervous and digestive systems.
Store at a temperature not exceeding 30 ° C, out of the reach of children.
The shelf life is 3 years.
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