TsENTRAL-B CENTRAL-B TRADE NAME of Central-B, Central-B DOSAGE FORM Solid gelatin capsules. Description: capsules size No. 0, the body of pink color, a cap of green color filled with brown powder with impregnations of white color with a characteristic smell. STRUCTURE the Capsule contains Active agents: dry aqueous-alcoholic extract of a passionflower of 25 mg dry aqueous-alcoholic extract of a hawthorn of 25 mg dry aqueous-alcoholic extract of a valerian of 100 mg Excipients: magnesium carbonate of the main easy, silicon dioxide colloidal anhydrous, magnesium stearate, cellulose microcrystalline, lactose. Structure of a cover of the capsule: gelatin, titan dioxide, sodium indigotindisulfonat, erythrosine, iron oxide yellow, iron oxide red, iron oxide black. The CODE of DRUG ON ATX N05CM PHARMACOTHERAPEUTIC the Sedative of Plant Origin GROUP. The PHARMACOLOGICAL Central PHARMACODYNAMICS PROPERTIES B – the combined phytodrug possessing sedative action. Three components – dry aqueous-alcoholic extracts of herbs are its part: passionflowers, hawthorn and valerian. Extract of a passionflower contains alkaloids and a flavonoid – viteksin, possesses soft soothing action on the central nervous system, promotes restoration of a dream, reduces concern and nervousness, possesses spasmolytic action on unstriated muscles, improves cardiac performance, has sedative effect. Extract of a hawthorn contains flavonoids, sincaline, acetylcholine, tannins, phytoserines, etc. Thanks to existence of triterpenovy connections and flavonoids has spasmolytic effect, selectively expanding vessels of heart and brain, hypotensive action, contributes to normalization of venous pressure, improves functions of vascular walls. Possesses soft sedative action. Extract of a valerian contains essential oil, kotorogoyavlyatsya by the main component ester of baras camphor and isovaleric acid and also free valerianic acid and baras camphor, organic acids (including the valerianic acid having spasmolytic effect), alkaloids (valerin and hatinin), tannins, sugar and other biologically active agents. Possesses sedative action, reduces the tension and irritability characteristic of mental overfatigue and a neurasthenia. Has spasmolytic effect. The PHARMACOKINETICS Effect of drug is provided with cumulative action of the components which are its part therefore carrying out kinetic observations is not possible. INDICATIONS – the increased nervous irritability, – nervous tension, – irritability, – feeling of alarm, depression, – sleep disorders, insomnia. CONTRAINDICATIONS – hypersensitivity to drug components, – children’s age up to 12 years. SIDE EFFECT the Drug Central-B is usually well transferred. Seldom: allergic reactions, weakness. The ROUTE OF ADMINISTRATION AND DOSES of Central-B is accepted inside, washing down with enough water. Drug is intended for adults and children at the age of 12 years and is more senior. At the increased nervous irritability, nervous tension, irritability, feeling of alarm and depression usually appoint on 1-2 capsule 3 times a day. The maximum daily dose – 6 capsules. In a sleep disorder and insomnia the dose of drug makes 2 capsules for half an hour to a dream. OVERDOSE Symptoms: dizziness, a spastic abdominal pain, compression in breasts, expansion of pupils, nausea, vomiting. Treatment: gastric lavage, if necessary symptomatic therapy is possible. FEATURES of USE Duration of use of the drug Central-B is not limited. At drug withdrawal the abstinence syndrome does not develop. Drug is contraindicated after transferring of any serious disease. Central-B apply at easy forms of a sleep disorder and nervous irritability. At use of drug it is recommended to refrain from alcohol intake. INFLUENCE ON ABILITY TO DRIVING of MOTOR TRANSPORT AND to CONTROL of MECHANISMS during treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions since drowsiness development during the day is possible. USE AT PREGNANCY AND the LACTATION At pregnancy and in the period of a lactation use of drug is recommended only if the expected advantage for mother considerably exceeds possible risk for a fruit. INTERACTION WITH OTHER Central-B MEDICINES strengthens effect of cardiac glycosides, tranquilizers, the substances having the oppressing impact on central nervous system and also alcohol. The FORM of RELEASE of Central-B No. 15 15 of solid gelatin capsules in the blister. 1 blister together with a leaf insert in cardboard packing. Central-B No. 30 15 of solid gelatin capsules in the blister. 2 blisters together with a leaf insert in cardboard packing. Central-B No. 45 15 of solid gelatin capsules in the blister. 3 blisters together with a leaf insert in a cardboard box. To Store STORAGE CONDITIONS in the dry, protected from light place at a temperature not over 250C. To store out of children’s reach. The EXPIRATION DATE 3 years of date of production. Not to apply after an expiration date. PRESCRIPTION STATUS Without prescription. The Central-B PRODUCER is a product and a trademark of the ROTAFARM LIMITED company, Great Britain (ROTAPHARM LIMITED, Great Britain).