Sedasen forte
Producer: JV LLC Sperko Ukraina Ukraine
Code of automatic telephone exchange: N05CM50
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
Main physical and chemical properties: capsules of white color with a green cover, capsule contents — powder or granules from light brown till brown color with a specific smell. The yellowish or grayish shade, and also existence of dark and white impregnations is allowed;
structure: 125 mg of extract of a valerian, 25 mg of extract of a peppermint, 25 mg of extract of bergamot mint (melissa); excipients: lactose, talc.
Pharmacological properties:
Pharmacodynamics. The combined drug of a plant origin which effect is caused by synergy effects of the components which are its part. Biologically active agents of a valerian (esters of baras camphor and isovaleric acid, a valeropotriata, alkaloids валерин and хотенин) reduce excitability central and the autonomic nervous system, reduce tension and irritation at mental overfatigue, have expressed sedative, somnolent, spasmolytic effects, strengthen effect of other hypnotic drugs and sedative drugs. Besides, the complex of biologically active agents of a valerian has cholagogue effect, increases secretory activity of a mucous membrane of a GIT, slows down a cordial rhythm and expands coronary vessels.
Leaves of a peppermint contain 1-3% of essential oil which part menthol (to 70%) and its ethers, ketone-menthone, olein and ursolovy acids, flavonoids is. At intake the specified peppermint components at the expense of irritation of receptors of mucous membranes render in the reflex way moderate spasmolytic, sedative, somnolent, and also cholagogue action, reduce nausea, softly stimulate secretion of digestive glands.
The main active ingredients of a melissa – components of essential oil (0,06-1,0%): citral (to 62%), geraniol, меналоол, пераль, karyophyllene, etc. is rendered by sedative, anticonvulsant, hypotensive, antiarrhytmic, spasmolytic and antiemetic effects. Besides, active components of a melissa improve digestion processes, render soft cholagogue effect, normalize reduced appetite, promote recovery of saprophytic flora of intestines and secretion of digestive enzymes. Thanks to a difficult complex of biologically active agents drugs of a melissa show the expressed antihypoxemic effect which is the cornerstone of them kardio-, neuro, nefro-and immunoprotective properties. Melissa components also eliminate easy forms of a dysmenorrhea, display of toxicosis of pregnancy, climacteric frustration, normalize function of gonads at men. Drug does not cause dependence.
Pharmacokinetics. It was not studied.
Indications to use:
The easy forms of a neurasthenia and neurosis which are followed by irritability, alarm, sensation of fear, depression, fatigue, the absent-mindedness increased by nervous irritability, tension; the easy forms of frustration of a dream connected with excitement; the attacks of a headache, migraines caused by a nerve strain; easy forms of a dysmenorrhea; menopausal syndrome; functional diseases of the digestive system (dyskinesia of biliary tract, dispeptic syndrome, irritable colon); vegeto-vascular dystonia with tachycardia, a cardialgia and arterial hypertension; I stage of an idiopathic hypertensia; the allergodermatoza which are followed by a skin itch (urticaria, atopic dermatitis, eczema, seborrheal eczema); constant mental tension ("manager's syndrome"); insufficient concentration of attention, decrease in memory.
Route of administration and doses:
To adults and children 12 years are more senior appoint on one capsule 2-3 times a day; at an easy form of sleeplessness – on 1-2 capsules in 1 hour prior to a dream. The maximum dose makes 6 capsules a day divided into 3 receptions. Usually the course of treatment lasts from several weeks to 3 months, but in case of need and the chronic course of a disease can be increased up to 6-12 months. If necessary courses of treatment can be repeated.
Features of use:
It is not necessary to exceed the recommended drug doses. At emergence of side effects drug should be cancelled. In an initiation of treatment before definition of individual sensitivity, for the purpose of prevention of excessive oppression of TsNS use of drug is not recommended during control of the vehicles and other mechanisms demanding the increased concentration of attention. With care use drug at the expressed liver failure.
Use during pregnancy and a lactation. Extracts of officinal herbs, such as a valerian, mint, a melissa are traditionally used at pregnant women in complex treatment of such frustration as a hyperexcitability of TsNS, neurotic and vegetative disturbances, gestational hypertensia and gestoses of pregnant women. Post-market researches of drug did not show negative influence in relation to mother and a fruit. But use of any medicines during pregnancy has to be carried out when the expected advantage for mother exceeds potential risk for a fruit and remains on a reasoning of the doctor. It is unknown whether active ingredients of officinal herbs in breast milk therefore in need of prolonged course treatment the Sedaseny fort breastfeeding needs to be limited for the period of drug use are emitted.
Side effects:
Drug is well transferred, but at exceeding of the recommended doses development of slackness, depression, weakness, decrease in working capacity and concentration of attention, drowsiness, dizziness is possible. At inclined persons it is theoretically possible to expect development of allergic reactions, but during post-marketing observation of drug those were not registered.
Interaction with other medicines:
Drug can exponentiate effect of hypnotic drugs, sedative, spasmolytic, antihypertensives of the central action, alcohol.
Contraindications:
Hypersensitivity to drug components, children to 12-year age.
Overdose:
Development of depression, slackness, block, drowsiness, dizziness, lowering of arterial pressure, dispepsichesky frustration is possible. There is no specific treatment, it is necessary to carry out a gastric lavage, symptomatic therapy.
Storage conditions:
To store at the room temperature in the dry, protected from light place. To store in the place, unavailable to children. The period of validity is specified on packaging after the words "Use to …"
Issue conditions:
Without recipe
Packaging:
On 20 and 40 capsules in plastic containers and cardboard packs.