Sedavit®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SEDAVIT® (SEDAVIT)

Composition:

Active ingredients: 1 tablet contains Sedavit® dry extract, calculated as dry substance* – 170.0 mg; vitamin B6 (pyridoxine hydrochloride, calculated as 100% substance) – 3.0 mg; vitamin PP (nicotinamide, calculated as 100% substance) – 15.0 mg;

Excipients: potato starch; sodium croscarmellose; lactose monohydrate; microcrystalline cellulose; calcium stearate.

* 1 g of Sedavit® dry extract contains: flavonoids extracted with 35% ethanol (1:4.5) from a mixture: valerian rhizomes with roots (2 parts), hawthorn fruits (2 parts), St. John's wort herb (1 part), peppermint leaves (2 parts), hops cones (2 parts) – not less than 0.01 g (calculated as dry substance and rutin).

Pharmaceutical form. Tablets.

Main physicochemical characteristics: tablets from beige to brown in color, with speckles, oval-shaped, biconvex surface, with a score line on one side of the tablet.

Pharmacotherapeutic group. Hypnotics and sedatives.

ATC code N05CM.

Pharmacological Properties

Pharmacodynamics

The complex extract for Sedavit**®** is obtained from the rhizomes with roots of valerian, hawthorn fruits, St. John's wort herb, peppermint leaves, and hops cones. The pharmacological effect of the preparation is determined by the properties of its constituent components. Biologically active substances of the herbal extracts exert a beneficial effect on the functioning of the central nervous and cardiovascular systems, producing mainly sedative and anxiolytic effects, and relieving feelings of fear and mental tension. Vitamins are components of enzyme systems involved in redox processes in the body. Pyridoxine hydrochloride (vitamin B6) normalizes the function of the central and peripheral nervous systems. Nicotinamide (vitamin PP) participates in tissue respiration, lipid and carbohydrate metabolism.

Pharmacokinetics

The pharmacological efficacy of the preparation depends on the combined action of its components; therefore, kinetic studies are not feasible, as all components together cannot be traced using markers or biological assays.

Clinical characteristics.

Indications.

Persistent mental stress (the so-called "executive syndrome"); neurasthenia and neurasthenic reactions accompanied by irritability, anxiety, fear, fatigue, inattention, memory impairment, and mental exhaustion; neurocirculatory dystonia of the hypertensive and cardiac types; asthenic syndrome (hypersthenic form); stage I arterial hypertension; insomnia (mild forms); pruritic dermatoses (eczema, urticaria); headache due to nervous strain; migraine; as a symptomatic agent in climacteric syndrome and mild forms of dysmenorrhea.

Contraindications. Hypersensitivity to the components of the drug, depression and conditions associated with suppression of central nervous system activity, bronchial asthma, spasmophilia, pronounced arterial hypotension, bradycardia, myasthenia, peptic ulcer of the stomach and duodenum, ischemic heart disease, liver diseases, hyperuricemia, gout, decompensated diabetes mellitus, urolithiasis.

Interaction with other medicinal products and other types of interactions. The drug enhances the effect of substances exerting a sedative effect on the central nervous system, as well as alcohol. Mutual weakening of the effects of levodopa and pyridoxine hydrochloride is possible.

Concomitant use of cycloserine, hydralazine, isoniazid, penicillamine, and oral contraceptives increases the requirement for pyridoxine.

Hypericum perforatum (St. John's wort) may induce isoenzymes 3A4, 1A2, and 2C9 of cytochrome P450, which may reduce the efficacy of other concurrently administered drugs metabolized by these isoenzymes. Therefore, concomitant use of the drug is not recommended with:

• indinavir or other antiretroviral drugs;
• cyclosporine, digoxin, theophylline, irinotecan, tacrolimus, lipid-lowering agents (simvastatin and others), fexofenadine, tricyclic antidepressants (amitriptyline, nortriptyline), antiepileptic agents (carbamazepine, phenobarbital, phenytoin), selective serotonin reuptake inhibitors (citalopram, fluvoxamine, sertraline, paroxetine), buspirone, as well as triptans (sumatriptan, naratriptan, zolmitriptan) and antihypertensive drugs – calcium channel blockers;
• warfarin and other anticoagulants – coumarin derivatives;
• oral contraceptives (due to reduced contraceptive efficacy, irregular bleeding, and possible unintended pregnancy).

Concomitant use with cardiac glycosides is not recommended.

Diuretics – when used in combination with pyridoxine, the effect of diuretics is enhanced.

Hypnotics and sedatives – when used in combination with pyridoxine, the hypnotic effect is reduced.

Antiparkinson agents – when used in combination with pyridoxine, the efficacy of drugs for Parkinson's disease is diminished.

Corticosteroids – when used in combination with pyridoxine, the amount of vitamin B6 in the body is reduced.

Concomitant use of nicotinic acid with antithrombotic agents or acetylsalicylic acid may lead to bleeding.

Use with antihypertensive agents leads to enhanced arterial hypotension; use with antidiabetic agents results in reduced hypoglycemic effect of the latter.

Use with other lipid-lowering agents increases the risk of developing toxic effects of the drug; use with spasmolytics enhances the effect of spasmolytics.

Concomitant use with methyldopa leads to a significant reduction in arterial pressure; with probenecid – to reduced probenecid efficacy.

Possible enhancement of the photosensitizing effect of other medicinal products that have a photosensitizing effect (e.g., sulfonamides, tetracycline antibiotics, and fluoroquinolones).

Special precautions for use.

The drug contains lactose. This medicinal product is contraindicated in patients with rare hereditary disorders of carbohydrate metabolism, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.

During treatment with this drug, patients—especially those with fair skin—should avoid prolonged exposure to ultraviolet radiation (sunbathing, solarium use, diathermy).

In patients with gastroesophageal reflux (heartburn), an exacerbation of heartburn symptoms may occur.

Use with caution in patients with fluctuating blood pressure or diabetes mellitus. Blood pressure and blood glucose levels should be monitored.

Do not use with alcohol.

Use during pregnancy or breastfeeding.
The use of this drug is not recommended during pregnancy or breastfeeding.

Effect on ability to drive or operate machinery.
Patients should refrain from driving or operating potentially hazardous machinery while taking this drug.

Method of Administration and Dosage.

For adults and children aged 12 years and older, the recommended dose is 2 tablets three times daily. The tablets should be taken whole, without chewing, with a small amount of liquid. If nausea occurs, the medication should be taken during meals. If necessary, the single dose may be increased to 3 tablets. In case of adverse reactions from the nervous system (drowsiness, dizziness), the dose should be reduced to 1 tablet three times daily. The interval between doses should be 8 hours. The medication may also be used on a single occasion, 2–3 tablets taken 30–60 minutes before anticipated emotional stress.

The duration of treatment depends on the form and severity of the disease symptoms, concomitant therapy, and the therapeutic response achieved, and is determined by the physician.

Children. The safety and efficacy of Sedavit® in children under 12 years of age have not been established; therefore, the medication should only be used in children aged 12 years and older.

Overdose. Symptoms: intensification of adverse effects. Later, these symptoms may be accompanied by numbness, joint pain, and a feeling of heaviness in the stomach. Symptoms of nicotinamide overdose may also occur: dizziness, seizures, tremor, sweating, cough, skin rashes, arterial hypotension. Symptoms typical of peripheral neuropathy may also appear.

Treatment: discontinue the medication, symptomatic therapy.

Adverse Reactions. In isolated cases, the following undesirable effects may occur:

Allergic reactions, including hyperemia, rash, pruritus, edema, urticaria, anaphylactic reactions, including anaphylactic shock.

Central and peripheral nervous system: drowsiness, fatigue, dizziness, depressed mood, excitement, headache, paresthesia, weakness, reduced work capacity.

Gastrointestinal tract: nausea, abdominal pain and spasms, vomiting, heartburn, increased gastric secretion, intestinal dysfunction (diarrhea, constipation).

Cardiovascular system: bradycardia, decreased blood pressure, tachycardia, arrhythmia.

Skin: photosensitization in sensitive individuals, dermatitis, dry skin.

Musculoskeletal system: numbness of extremities, muscle weakness.

Metabolism: with prolonged use at high doses – decreased glucose tolerance.

Biochemical parameter deviations from normal: increased levels of aspartate aminotransferase (AST), lactate dehydrogenase (LDH), alkaline phosphatase, blood glucose, hyperuricemia.

Shelf Life. 2 years.

Storage Conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. Tablets, 10 in a blister pack, 2 blisters per carton.

Prescription Category. Over-the-counter (without prescription).

Manufacturer. JSC "Kyivmedpreparat".

Manufacturer's Address and Location of Business Activity.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.