Instructions for use Sedavit oral solution glass bottle 100 ml
Composition
1 ml of the medicinal product contains:
active ingredients: Sedavit® liquid extract (Extractum sedaviti fluidum) (extractant – ethanol 35% v/v) (1:4.5) – 0.94 ml from a mixture of LRS: valerian rhizome with roots (Valerianae Rhizoma cum Radicibus), hawthorn fruits (Crataegi fructus), St. John's wort herb (Hyperici herba), peppermint leaves (Menthae piperitae folium), hop cones (Lupuli flos); pyridoxine hydrochloride (vitamin B6) – 0.6 mg; nicotinamide (vitamin PP) – 3.0 mg;
excipient: sorbitol (E 420).
Dosage form
Oral solution.
Main physical and chemical properties: light brown to brown liquid. A slight precipitate may form during storage.
Pharmacotherapeutic group
Sleeping pills and sedatives.
ATX code N05C M.
Pharmacological properties
Pharmacodynamics.
The effect of the drug is due to the properties of the components that make up its composition. Biologically active substances of medicinal plant extracts have a positive effect on the functioning of the nervous system and have a predominantly sedative, anxiolytic effect, eliminating feelings of fear and tension.
Pharmacokinetics.
Data is missing.
Indication
A state of constant mental tension (manager's syndrome); neurasthenia and neurasthenic reactions accompanied by irritability, anxiety, fear, fatigue, inattention, memory impairment, mental exhaustion; neurocirculatory dystonia of the hypertensive and cardiac type; asthenic syndrome (hypersthenic form); stage I arterial hypertension; insomnia (mild forms); itchy dermatoses (eczema, urticaria); headache caused by nervous tension; migraine. It is used as a symptomatic remedy for climacteric syndrome and mild forms of dysmenorrhea.
Contraindication
Increased individual sensitivity to the components of the drug, depression and conditions accompanied by suppression of the central nervous system, bronchial asthma, spasmophilia, severe arterial hypotension, bradycardia, myasthenia gravis, gastric and duodenal ulcers, ischemic heart disease, liver disease, hyperuricemia, gout, decompensated diabetes mellitus, urolithiasis.
Interaction with other medicinal products 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. Mutual weakening of the effect of levodopa and pyridoxine hydrochloride is possible.
Concomitant use of cycloserine, hydralazine, isoniazid, penicillamine, and oral contraceptives causes an increased need for pyridoxine.
St. John's wort may induce cytochrome P450 isoenzymes 3A4, 1A2 and 2C9, which may reduce the effect of other drugs metabolized by these isoenzymes. Therefore, concomitant use of the drug with:
indinavir or other antiretroviral drugs;
cyclosporine, digoxin, theophylline, irinotecan, tacrolimus, hypolipidemic agents (simvastatin), fexofenadine, tricyclic antidepressants (amitriptyline, nortriptyline), antiepileptic agents (carbamazepine, phenobarbital, phenytoin), selective serotonin reuptake inhibitors (citalopram, fluvoxamine, sertraline, paroxetine), buspirine, as well as triptans (sumatriptan, naratriptan, zolmitriptan) and antihypertensive agents (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, the occurrence of unwanted pregnancy cannot be ruled out).
Not recommended for use with cardiac glycosides.
Diuretics – when used in combination with pyridoxine, the effect of diuretics is enhanced.
Sleeping pills and sedatives - when used in combination with pyridoxine, the sleeping pill effect is reduced.
Antiparkinsonian drugs – when used in combination with pyridoxine, the effectiveness of drugs for the treatment of Parkinson's disease is reduced.
Corticosteroids – when used in combination with pyridoxine, the amount of vitamin B6 in the body decreases.
With the simultaneous use of nicotinic acid with antithrombotic agents or acetylsalicylic acid, bleeding may develop.
Use with antihypertensive agents leads to increased arterial hypotension.
Use with hypolipidemic agents increases the risk of developing toxic effects of the drug, with antispasmodics - the effect of antispasmodics is enhanced.
Simultaneous use with methyldopa leads to a significant decrease in blood pressure, and with probenecid - to a decrease in the effect of probenecid.
It is possible to enhance the photosensitizing effect of other drugs that have a photosensitizing effect (for example, sulfonamides, tetracycline antibiotics and fluoroquinolones).
Application features
While using the drug, patients, especially those with fair skin, should avoid prolonged exposure to ultraviolet radiation (sunbathing, solarium, diathermy).
In patients with gastroesophageal reflux (heartburn), heartburn may worsen.
Use the drug with caution in patients with blood pressure fluctuations and diabetes. Blood pressure and blood glucose levels should be monitored.
Do not use with alcohol.
Use during pregnancy or breastfeeding
The drug should not be used during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using the drug, you should refrain from driving vehicles and working with potentially dangerous mechanisms.
Method of administration and doses
Adults and children over 12 years of age should be given the drug 3 times a day, 5 ml. If necessary, increase the single dose to 10 ml. In case of adverse reactions from the nervous system (drowsiness, dizziness), 2.5 ml should be given in the morning and during the day and 5 ml at night. The interval between doses is 8 hours. The drug can be used once, 5–10 ml, 20–30 minutes before possible emotional stress. The drug should be taken undiluted or with drinks (tea, juice). In case of nausea, the drug should be taken with meals.
The duration of treatment depends on the form and severity of the symptoms of the disease, the nature of concomitant therapy, the achieved treatment effect and is determined by the doctor.
Children. The safety and efficacy of Sedavit® in children under 12 years of age have not been established, therefore the drug can be used in children over 12 years of age.
Overdose
Symptoms: increased side effects; feeling depressed and drowsy. Later, these symptoms may be accompanied by nausea, muscle weakness, numbness, joint pain and a feeling of heaviness in the stomach, paresthesia. Symptoms of nicotinamide overdose may also occur (tachycardia, headache, dizziness, convulsions, tremor, nausea, vomiting, diarrhea, sweating, cough, skin rashes, arterial hypotension).
Treatment: drug withdrawal. Symptomatic therapy, as determined by the doctor.
Side effects
In rare cases, the following undesirable effects may occur. Allergic reactions, including hyperemia, rash, itching, edema, urticaria, anaphylactic reactions, including anaphylactic shock. From the central and peripheral nervous system: drowsiness, fatigue, dizziness, depressed emotional state, agitation, headache, paresthesia, weakness, decreased performance. From the digestive tract: nausea, abdominal pain and cramps, vomiting, heartburn, increased gastric secretion, intestinal dysfunction (diarrhea, constipation). From the cardiovascular system: bradycardia, decreased blood pressure, tachycardia, arrhythmia.
Skin: photosensitivity in sensitive people, dermatitis, dry skin.
Musculoskeletal system: numbness of the extremities, muscle weakness.
Metabolic: with prolonged use in high doses - decreased glucose tolerance.
Biochemical abnormalities: increased levels of aspartate aminotransferase (AST), lactate dehydrogenase (LDH), alkaline phosphatase, blood glucose, hyperuricemia.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
100 ml in a bottle or jar; 1 bottle or jar in a pack; 200 ml in a bottle, 1 bottle in a pack.
Leave category. Without a prescription.
Vacation category
Without a prescription.
Producer
PJSC "Halychpharm".
Address
79024, Ukraine, Lviv, Opryshkivska St., 6/8.
