Producer: Innothera Chouzy (Innoter Shuzi) France
Code of automatic telephone exchange: N05CM
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredients: Eshsholtion extract of dry 20,0 mg; Hawthorn extract of dry 75,0 mg; Magnesium oxide of 124,35 mg, it is equivalent to elementary magnesium of 75,0 mg;
Excipients: cellulose microcrystallic - 122,0 mg, sodium carboxymethylstarch - 15,0 mg, the stearic acid micronized - 3,65 mg;
Structure of a film cover: Protective glaze of 2,0 mg: гуммилак - 1,554 mg, povidone - 0,223 mg, glyceryl monoacetate - 0,223 mg; The Painted powder of 13,0 mg: a gipromelloza - 7,150 mg, titanium dioxide (E171) - 3,704 mg, a macrogoal of 6000 - 1,788 mg, indigo carmine (Е 132) - 0,344 mg, an azoruby (Е 122) - 0,013 mg, ferrous oxide yellow (Е 172) - 0,001 mg, talc traces.
Description. Round biconvex tablets, film coated blue color.
Drug has sedative effect, eliminates a condition of alarm and the related vegetative disturbances, tachycardia and sleep disorders. Biologically active agents of extract of a hawthorn – triterpenovy connections and flavonoids have spasmolytic effect, selectively expanding vessels of heart and brain, reduce excitability of the central nervous system and myocardium. Extract of an eshsholtion has anxiolytic, sedative effect, reduces time of backfilling and improves quality of a dream at easy forms of a dyssomnia. Alkaloids of an eshsholtion of group of a protopin increase in vitro communication of piperidic acid with brain receptors, sensitive to it. Magnesium improves regulation of transmembrane exchange of ions of sodium and potassium, is an antagonist of calcium ions, reduces ability to carrying out excitement on neuromuscular synapses, to reduction smooth and cross - striped muscles; renders also neurosedative, spasmolytic and anxiolytic action.
Pharmacokinetics. Magnesium oxide in a stomach turns in magnesium chloride which is absorbed in a small intestine by means of the mechanism of passive absorption, the level of absorption does not exceed 50%. Magnesium excretion, is generally carried out with urine. Action of components is complicated for kinetic observations.
Indications to use:
- the conditions of emotional pressure and a stress which are followed by a hyperexcitability, concern, an acrimony, alarm, fear, increased fatigue, heartbeat.
- sleep disorders (easy form).
Route of administration and doses:
On 2 tablets 2 times a day (in the morning and in the evening) to food, washing down with water. Duration of treatment is 3-4 weeks. Interval between courses of treatment of 3 weeks.
Features of use:
Influence on ability to manage vehicles
During treatment it is necessary to be careful at occupation potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions (control of vehicles, work with moving mechanisms, etc.).
From digestive tract: diarrhea, pains in epigastric area.
If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.
Interaction with other medicines:
It is not recommended to combine drug with the medicines containing quinidine since renal excretion of quinidine in connection with alkalization of urine decreases and overdose development is possible (in connection with increase in concentration of quinidine in a blood plasma).
Hypersensitivity to drug components, a heavy renal failure (the clearance of creatinine is lower than 30 ml/min.), age up to 18 years.
Use at pregnancy and during breastfeeding
It is not recommended to apply during pregnancy and breastfeeding.
To store at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to use after the period of validity specified on packaging.
Tablets are film coated. On 20 tablets in PVC / the aluminum blister. On 2 or 3 blisters with the application instruction in a cardboard pack.