Edit the instructions. Tolperisone, in oral dosage forms with immediate release

July 22, 2016
Active substances:
ICD-10:
VI.G20-G26.G21    Secondary Parkinsonism
VI.G40-G47.G40    Epilepsy
VI.G80-G83.G80    Cerebral palsy
VI.G80-G83.G82.4    Spasmodic tetraplegia
VI.G80-G83.G82.1    Spastic paraplegia
VI.G80-G83.G81.1    Spastic hemiplegia
IX.I70-I79.I73.0    Raynaud's syndrome
IX.I70-I79.I73.1    Obliterating thromboangitis [Berger's disease]
IX.I70-I79.I73.9    Peripheral vascular disease, unspecified
IX.I70-I79.I79.2 *    Peripheral angiopathy in diseases classified elsewhere
XVIII.R25-R29.R25.2    Cramp and spasm
Tolperisone, midolkalm, tolizor, parkinsonism, epilepsy, cerebral palsy, cerebral palsy, plegia, Raynaud's syndrome, spasm treatment, cramps treatment, Berger's disease

The need to actualize instructions for the use of appropriate drugs has been identified.

According to current information, tolperisone in dosage forms for oral administration of an immediate release shows "for the symptomatic treatment of spasticity in adults caused by stroke" [1].

Contraindications to the use of tolperisone in oral dosage forms with immediate release are: "hypersensitivity to the components of the drug, myasthenia gravis gravis, children under 18, breastfeeding. "[1] Also, the" Contraindications "section of the instructions for use should be supplemented with information on excipients with proven effects on the body, if they are contained in the finished product, for example,in the case of lactose as an auxiliary in the preparation, the section should be supplemented with the following: lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

In addition, other pharmacological sections of the instructions for use, such as "Pharmacodynamics", "Pharmacokinetics", "Application in pregnancy and during breastfeeding", "Method of administration and dose", "Side effect", "Overdose", "Interaction with other medicinal products "," Special instructions "need to be revised taking into account the experience gained [1].

1. MYDETON 50 mg filmtabletta. National Institute of Pharmacy and nutrition. URL: http://www.ogvei.gov.hu/drug database / index.php? action = show details & item = 34666.