Sedasen Fort Capsule № 20

Sedasen Forte (SEDASEN FORTE) user manual

General characteristics:

basic physical and chemical properties: capsules of white color with a green lid, contents of a capsule powder or granules from light brown to brown with a specific odor. A yellowish or grayish shade is allowed, as well as the presence of dark and white impregnations;
composition: 125 mg of valerian extract, 25 mg of peppermint extract, 25 mg of lemon balm extract (lemon balm);auxiliary substances: lactose, talc.

Form of issue

Capsules.

Pharmacotherapeutic group

Sleeping and sedatives. ATS code N05CM50

Pharmacological properties

Pharmacodynamics. Combined preparation of plant origin, the effect of which is due to the synergistic effects of its constituent components. Biologically active substances of valerian (esters of borneol and isovaleric acid, valeropotriates, valerine alkaloids and hotenin) reduce the excitability of the central and autonomic nervous system, reduce tension and irritation in mental fatigue, have a pronounced sedative, hypnotic, spasmolytic effects, enhance the effect of other hypnotics and sedatives preparations. In addition, the complex of biologically active substances valerian has a choleretic effect, enhances the secretory activity of the mucous membrane of the gastrointestinal tract, slows the heart rate and dilates the coronary vessels.

Leaves peppermint contains 1-3% essential oil, which includes menthol (up to 70%) and its esters, ketone-menton, oleic and ursolic acid, flavonoids. When ingested, these components of peppermint by reflex reflex due to irritation of receptors of mucous membranes have moderate spasmolytic, sedative, hypnotics, and also choleretic effect, reduce nausea, gently stimulate the secretion of digestive glands.

The main active substances of lemon balm essential oil components (0.06-1.0%): citral (up to 62%), geraniol, menalool, peral, caryophyllene, etc. have sedative, anticonvulsant, antihypertensive, antiarrhythmic, spasmolytic and antiemetic effects. In addition, the active components of melissa improve the digestive process, have a mild choleretic effect, normalize the reduced appetite, contribute to the restoration of saprophyte flora of the intestine and the secretion of digestive enzymes. Thanks to a complex complex of biologically active substances, melissa preparations show a pronounced antihypoxic effect, which underlies their cardio-, neuro-, nephro- and immunoprotective properties. Melissa components also eliminate mild forms of dysmenorrhea, manifestations of pregnancy toxicity, climacteric disorders, normalize the function of the sex glands in men. The drug does not cause addiction.

Pharmacokinetics . Not studied.

Indications for use

Light forms of neurasthenia and neurosis, accompanied by irritability, anxiety, a sense of fear, depression, fatigue, absent-mindedness, increased nervous excitability, tension; light forms of sleep disorders associated with agitation;attacks of headache, migraine caused by nervous overexertion; mild forms of dysmenorrhea; climacteric syndrome;functional diseases of the digestive system (biliary dyskinesia, dyspeptic syndrome, irritable bowel syndrome);vegetovascular dystonia with tachycardia, cardialgia and arterial hypertension; I stage of hypertension; allergic dermatosis, accompanied by itching of the skin (hives, atopic dermatitis, eczema, seborrheic eczema); constant mental stress (manager's syndrome); inadequate concentration of attention, memory loss.

Dosing and Administration

Adults and children over 12 years of age are prescribed one capsule 2-3 times a day; with mild insomnia 1-2 capsules 1 hour before bedtime. The maximum dose is 6 capsules per day, divided into 3 doses. Usually the course of treatment lasts from several weeks to 3 months, but if necessary, the chronic course of the disease can be increased to 6-12 months. If necessary, treatment courses can be repeated.

Side effect

The drug is well tolerated, but when the recommended dosage is exceeded, it may develop lethargy, depression, weakness, decrease in efficiency and concentration of attention, drowsiness, dizziness. In the case of people who are prone, it is theoretically possible to expect the development of allergic reactions, but during the post-marketing surveillance of the drug, these were not recorded.

Contraindications

Hypersensitivity to the components of the drug, children under 12 years of age.

Overdose

Perhaps the development of depression, lethargy, inhibition, drowsiness, dizziness, lower blood pressure, dyspeptic disorders. There is no specific treatment, it is necessary to perform gastric lavage, symptomatic therapy.

Application features

Do not exceed the recommended dose of the drug. If any side effects occur, the drug should be discarded. At the beginning of treatment, before the determination of individual sensitivity, in order to prevent excessive CNS suppression, the use of the drug during the management of vehicles and other mechanisms requiring increased concentration of attention is not recommended. With caution apply the drug with severe hepatic insufficiency.

Use during pregnancy and lactation

Extracts of medicinal herbs such as valerian, mint, and melissa are traditionally used in pregnant women in the complex treatment of such disorders as increased CNS excitability, neurotic and vegetative disorders, gestational hypertension and gestosis of pregnant women. Postmarketing studies of the drug showed no negative effect on the mother and the fetus. But the use of any medicines during pregnancy should be carried out when the expected benefit for the mother exceeds the potential risk to the fetus and remains on the doctor's reasoning. It is not known whether active medicinal herbs are excreted in breast milk, so if long-term treatment with Sedasen forte is necessary, breastfeeding should be limited for the duration of the drug.

Interaction with other drugs

The drug can potentiate the effect of hypnotics, sedatives, spasmolytic, hypotensive agents of central action, alcohol.

Terms and conditions of storage

Store at room temperature in a dry, dark place. Keep out of the reach of children. Shelf life is indicated on the package after the words Use before

Leave conditions

Without recipe.

Packaging

For 20 and 40 capsules in plastic containers and cartons.