Sedavit syrup 100 ml

Sedavit (SEDAVIT) instructions for use

Composition of the medicinal product

1 ml of the drug contains

active ingredients: Sedavit extract liquid (Extractum-ethanol 35% v / v) (1: 4.5) from the mixture of LRS: valerian rhizome with roots (Valerianae Rhizoma cum Radicibus), hawthorn fruit (Crataegi fructus), St. John's wort (Hyperici herba), peppermint leaves (Menthae piperitae folium), hop cones (Lupuli flos) - 0.94 ml; pyridoxine hydrochloride (vitamin B 6) - 0.6 mg Nicotinamide (vitamin PP) - 3 mg.
auxiliary substances: sorbitol (E 420).

Dosage form

Oral solution. Fluid from light brown to brown. During storage, a slight deposit may form.

Pharmacological group

Sleeping pills and sedatives. ATS code N05C M.

The effect 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 system and have a predominantly sedative, anxiolytic effect, eliminate a sense of fear and tension.

Indications

Status of persistent mental stress (manager's syndrome); 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 is sorbitol. Patients with a rare hereditary intolerance to fructose or glucose-galactose malabsorption should not take this drug.

When using drugs, patients, especially those with fair skin, should avoid prolonged exposure to ultraviolet radiation (sun baths, tanning beds, 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

Do not use 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 should be prescribed 3 times a day for 5 ml. If necessary, increase the single dose to 10 ml. In case of adverse reactions from the nervous system (drowsiness, dizziness), appoint 2.5 ml in the morning and in the afternoon and 5 ml at night. The interval between receptions is 8:00. The drug can be used once for 5-10 ml for 20-30 minutes before the possible emotional stress. The drug should be taken undiluted or along with drinks (tea, juice). In case of nausea, the drug should be taken with food.

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 of feeling depressed and drowsy. Later, these symptoms can be accompanied by nausea, muscle weakness, numbness, joint pain and a feeling of heaviness in the stomach, paresthesia. Symptoms of an overdose of nicotinamide (tachycardia, headache, dizziness, convulsions, tremor, nausea, vomiting, diarrhea, sweating, coughing, skin rashes, arterial hypotension) may also occur.

Treatment: cancellation of the drug. Symptomatic therapy, which is determined by the doctor.

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 types of interactions.

The drug enhances the effect of substances that have a sedative effect on the central nervous system, as well as alcohol. Possible mutual weakening of the 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 lead to a decrease in the effect of other drugs, simultaneously being taken and matabolized by these isoenzymes. In this regard, simultaneous application with:

• indinavir or other antiretroviral drugs
• cyclosporin, digoxin, theophylline, irinotecan, tacrolimus, hypolipidemic agents (symbolstatin), 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 emergence of irregular bleeding 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 increased arterial hypotension.

The use of lipid-lowering drugs increases the risk of development of toxic effects of the drug, with antispasmodics - 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

For 100 ml in a vial or jar; 1 bottle or a can in a pack; on 200 ml in a vial or flask, on 1 vial or flask in a pack.

Category of leave

Without recipe.