Sedavit tablets №20

Sedavit (SEDAVIT) instructions for use

Composition of the medicinal product

active ingredients: 1 tablet contains sedate thick extract in terms of dry matter * - 170.0 mg, vitamin B 6 (pyridoxine hydrochloride in terms of 100% substance) - 3.0 mg, vitamin PP (nicotinamide in terms of 100% substance ) - 15.0 mg
auxiliary substances: potato starch; croscarmellose sodium; lactose monohydrate, microcrystalline cellulose, calcium stearate.

* - 1 g sedavit extract thick contains flavonoids not less than 0.01 g (in terms of dry matter and rutin) extracted with ethanol 35% (1: 4.5) from the mixture: rhizomes with the roots of valerian (2 parts), hawthorn fruit ( 2 parts), St. John's wort (1 part), peppermint leaves (2 parts), hop cones (2 parts).

Dosage form

Pills. Tablets from beige to brown, with impregnations, oval, with a facet, with a notch on one side of the tablet.

Pharmacological group

Sleeping pills and sedatives. ATS code N05C M.

Complex extract for the preparation Sedavit is obtained from rhizomes with the roots of valerian, hawthorn fruit, St. John's wort, peppermint leaves, hop cones. Pharmacological action of the drug is due to the properties of the components that make up its composition. Biologically active substances of extracts of medicinal plants have a positive effect on the functioning of the nervous and cardiovascular system and have a predominantly sedative, anxiolytic effect, eliminate a sense of fear, mental stress. Vitamins are components of enzyme systems involved in oxidation-reduction processes in the body. Pyridoxine hydrochloride (vitamin B 6) - normalizes the functioning of the central and peripheral nervous system, nicotinamide (vitamin PP) - is involved in the processes of tissue respiration, fat and carbohydrate metabolism.

Pharmacological effectiveness of the drug depends on the combined effect of its components, therefore, carrying out kinetic studies is impossible, since together the components can not be traced with the help of markers or biological studies.

Indications

The state of constant mental stress (syndrome "manager"); neurasthenia and neurasthenic reactions, accompanied by irritability, anxiety, fear, fatigue, inattention, memory impairment, mental exhaustion; neurocirculatory dystonia in hypertensive and cardiac type; asthenic syndrome (hypersthenic form) arterial hypertension of the first stage; insomnia (light forms); itching dermatoses (eczema, urticaria) headaches caused by nervous tension; Migraine as a symptomatic agent for menopausal syndrome and mild forms of dysmenorrhea; as well as for the treatment of symptoms arising from thyroid disorders and diabetes (except decompensated diabetes mellitus).

Contraindications

Hypersensitivity to the components of the drug, depression and conditions accompanied by depression of the central nervous system, bronchial asthma, spasmophilia, severe arterial hypotension, bradycardia, myasthenia gravis, stomach and duodenal ulcer, coronary heart disease, liver disease, hyperuricemia, gout, decompensated sugar diabetes, urolithiasis.

Appropriate safety measures for use

The composition of the drug includes lactose. Patients with rare hereditary disorders of carbohydrate metabolism, in particular intolerance to galactose, Lapp-lactase deficiency or glucose-galactose malabsorption syndrome should not take this drug.

During the use of the drug, patients, especially with light skin, should avoid prolonged exposure to ultraviolet radiation (sun baths, solarium, diathermy).

Patients with gastroesophageal reflux (heartburn) may have an increase in heartburn.
With caution apply the drug to patients with differences in blood pressure and diabetes. It is necessary to control blood pressure and blood glucose.

Do not use with alcohol.

Use during pregnancy and lactation

It is not recommended to prescribe the drug during pregnancy and lactation.

The ability to influence the reaction rate when driving vehicles or other mechanisms

When using the drug should refrain from driving and working with potentially dangerous mechanisms.

Children

Safety and effectiveness of Sedavit for children under 12 years is not established, so the drug can be used in children aged 12 years.

Dosing and Administration

Adults and children over 12 years of age, the drug is prescribed 2 tablets 3 times a day. The drug is not chewed, squeezed a small amount of liquid. In case of nausea, the drug should be taken with food. If necessary, a single dose is increased to 3 tablets. In case of appearance of undesirable reactions from the nervous system (drowsiness, dizziness) - 1 tablet 3 times a day. The interval between doses is 8:00. The drug can be used once for 2-3 tablets for 30-60 minutes before the estimated emotional load.

The duration of treatment depends on the form and severity of the symptoms of the disease, the nature of concomitant therapy, the effect of treatment achieved and determined by the doctor.

Overdose

Symptoms: increased side effects. Later these symptoms can be accompanied by a feeling of numbness, joint pain and a feeling of heaviness in the stomach. Symptoms of nicotinamide overdose, dizziness, convulsions, tremors, sweating, coughing, skin rashes, arterial hypotension may also occur. Symptoms characteristic of peripheral neuropathy.

Treatment: withdrawal of the drug, symptomatic therapy.

Side effects

In rare cases, the following undesirable effects may occur: Allergic reactions, including flushing, rash, itching, swelling, urticaria, anaphylactic reactions, including anaphylactic shock. From the central and peripheral nervous system: drowsiness, fatigue, dizziness, depressed emotional state, agitation, headache, paresthesia, weakness, decreased efficiency. From the side of the digestive tract: nausea, pain and cramps in the abdomen, vomiting, heartburn, increased gastric secretion, impaired bowel function (diarrhea, constipation). From the cardiovascular system: bradycardia, lowering blood pressure, tachycardia, arrhythmia.
From the skin: photosensitization in sensitive people, dermatitis, dry skin.

From the musculoskeletal system: numbness of limbs, muscle weakness.
From the side of metabolism: with prolonged use in high doses, a decrease in glucose tolerance.

Deviation of biochemical parameters from the norm: increase in the level of AsAt (AST), lactate dehydrogenase (LDH), alkaline phosphatase, glucose in the blood, hyperuricemia.

Interaction with other drugs and other interactions

The drug enhances the effect of substances that have a sedative effect on the central nervous system, as well as alcohol. Perhaps the mutually weakened action of levodopa and pyridoxine hydrochloride.
Simultaneous use of cycloserine, hydrolazine, isoniazid, penicillamine and oral contraceptives causes an increased need for pyridoxine.

St. John's wort perforated can cause induction of isoenzymes ZA4, 1A2 and 2C9 of cytochrome P450, which can cause a decrease in the effect of other drugs, are simultaneously taken and matabolized by these isoenzymes.

In this regard, simultaneous application with:

• indinavir or other antiretroviral drugs
• cyclosporine, digoxin, theophylline, irinotecan, tacrolimus, lipid-lowering agents (symbolstatine and others), fexofenadine, tricyclic antidepressants (amitriptyline, nortriptyline), antiepileptic drugs (carbamazepine, phenobarbital, phenytoin), selective serotonin reuptake inhibitors (citalopram, fluvoxamine, sertraline, paroxetine), buspirin, as well as triptans (sumatriptan, naratriptan, zolmitriptan) and hypotensive - calcium channel blockers;
• warfarin and other anticoagulants - coumarin derivatives;
• oral contraceptives (due to a decrease in the effectiveness of contraceptives with the occurrence of irregular bleeding, it is not excluded the onset of unwanted pregnancy).

It is not recommended for use with cardiac glycosides.

Diuretics - when combined with pyridoxine, the effect of diuretics is increased.

Sleeping and sedatives - when combined with pyridoxine, the hypnotic effect is reduced.

Antiparkinsonian means - in combined use with pyridoxine, the effectiveness of agents for the treatment of Parkinson's disease decreases.

Corticosteroids - when combined with pyridoxine, the amount of vitamin B 6 in the body decreases.

With the simultaneous use of nicotinic acid with anticoagulants means or acetylsalicylic acid, the risk of bleeding.

Application with antihypertensive drugs leads to an increase in arterial hypotension, with hypoglycemic agents - to reduce the hypoglycemic effect of the latter.

Application with other lipid-lowering agents increases the risk of development of toxic effects of the drug, with spasmolytics - the effect of antispasmodics is enhanced.

Simultaneous use with methyldopa leads to a significant reduction in blood pressure, with probenecid - a decrease in the effect of probenecid.

It is possible to enhance the photosensitizing effect of other drugs that have a photosensitizing effect (eg, sulfonamides, antibiotics of the tetracycline group and fluoroquinolones).

Shelf life

2 years.

Storage conditions

Store in the original packaging at a temperature not higher than 25 ° C. Keep out of the reach of children.

Packaging

Tablets No. 10 in a blister, 2 blisters in a pack.

Category of leave

Without recipe.