Selmevit^® (Tablets) Instructions for Use

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Pharmstandard-UfaVITA OJSC (Russia)

ATC Code

A11AA04 (Multivitamins and trace elements)

Dosage Form

Selmevit®

Coated tablets: 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Coated tablets pink in color, round, biconvex, with a characteristic odor; the cross-section shows two layers: a non-uniformly colored core and a pink coating.

* in the form of a powder containing retinol acetate – 1650 IU, sucrose – 0.1155 mg, modified starch – 0.594 mg, sodium aluminosilicate – 0.0099 mg, butylated hydroxytoluene – 0.00462 mg, gelatin – 0.825 mg, purified water – up to 3.3 mg;
** in the form of a powder containing DL-α-tocopherol acetate – 7.5 mg, maltodextrin – 3.675 mg, modified food starch – 3.675 mg, silicon dioxide – 0.15 mg.

Excipients: potato starch – 59.38 mg, citric acid monohydrate – 10.8 mg, povidone (low molecular weight polyvinylpyrrolidone, povidone K17) – 1.85 mg, calcium stearate – 5.4 mg, talc – 2 mg, sucrose (granulated sugar) – 18.82 mg, colloidal silicon dioxide (aerosil) – 1.4 mg, Kollicoat^® Protect (copolymer of macrogol and polyvinyl alcohol 55-65%, polyvinyl alcohol 35-45%, silicon dioxide 0.1-0.3%) – 0.22 mg.

Coating composition sucrose (granulated sugar) – 140.75 mg, wheat flour – 49.33 mg, magnesium carbonate – 74 mg, methylcellulose (water-soluble methylcellulose) – 1.31 mg, gelatin – 0.16 mg, titanium dioxide – 3.71 mg, dye azorubine (E122) – 0.03 mg, beeswax – 0.36 mg, talc – 0.35 mg.

10 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Multivitamins with macro- and microelements and amino acids

Pharmacotherapeutic Group

Multivitamin agent + minerals

Pharmacological Action

A vitamin-mineral complex with antioxidants, containing 11 vitamins and 9 minerals, lipoic acid and Methionine.

The compatibility of components in one tablet is ensured by a special technology for the production of vitamin-mineral complexes.

The pharmacological action of the drug is due to the properties of the vitamins and minerals included in its composition (including those with antioxidant action).

Retinol acetate ensures the normal function of the skin, mucous membranes, integrity of epithelial tissues; participates in the formation of visual pigments, necessary for twilight and color vision; necessary for bone growth, normal reproductive function; has antioxidant properties.

α-Tocopherol acetate has antioxidant properties, maintains erythrocyte stability, prevents hemolysis, has a positive effect on the functions of the gonads, nervous and muscle tissue.

Thiamine hydrochloride plays an important role in carbohydrate, protein and fat metabolism, the functioning of the nervous system, and participates in the processes of nerve impulse transmission in synapses.

Riboflavin is a key catalyst for cellular respiration processes, participates in all types of metabolism, in maintaining normal visual function of the eye, and hemoglobin synthesis.

Pyridoxine hydrochloride as a coenzyme participates in protein metabolism; plays an important role in the processes of heme hemoglobin synthesis and in the synthesis of neurotransmitters. It is necessary for the normal functioning of the central and peripheral nervous system.

Ascorbic acid participates in the regulation of redox processes, has pronounced antioxidant properties; ensures collagen synthesis; participates in the formation and maintenance of the structure and function of cartilage, bones, teeth; affects hemoglobin formation, erythrocyte maturation; normalizes capillary permeability.

Nicotinamide participates in the processes of tissue respiration, fat and carbohydrate metabolism.

Folic acid participates in the synthesis of amino acids, nucleotides, nucleic acids; necessary for normal erythropoiesis.

Rutoside participates in redox processes, has antioxidant properties, promotes the deposition of ascorbic acid in tissues.

Calcium pantothenate as a component of coenzyme A participates in acetylation and oxidation processes; promotes the building and regeneration of epithelium and endothelium.

Cyanocobalamin participates in the synthesis of nucleotides, is an important factor for normal growth, hematopoiesis and the development of epithelial cells; necessary for the metabolism of folic acid and myelin synthesis.

Lipoic acid participates in the regulation of lipid and carbohydrate metabolism, has a lipotropic effect, affects cholesterol metabolism, improves liver function.

Methionine has metabolic, hepatoprotective, antioxidant effects. It participates in the metabolism of many biologically important compounds, activates the action of hormones, vitamins, enzymes, and proteins.

Iron participates in erythropoiesis, as part of hemoglobin it ensures oxygen transport to tissues.

Cobalt regulates metabolic processes, increases the body’s defenses.

Calcium is necessary for the formation of bone substance, blood clotting, the process of nerve impulse transmission, contraction of skeletal and smooth muscles, and normal myocardial activity.

Copper prevents anemia and oxygen deprivation of organs and tissues, contributes to the prevention of osteoporosis. Strengthens vascular walls.

Zinc participates in the metabolism of nucleic acids, proteins, fats, carbohydrates, fatty acids and hormones.

Magnesium normalizes blood pressure, has a calming effect, stimulates together with calcium the production of calcitonin and parathyroid hormone, prevents the formation of kidney stones.

Phosphorus strengthens bone tissue and teeth, enhances mineralization, is part of ATP – the source of energy for cells.

Manganese affects the development of bone tissue, participates in tissue respiration, immune reactions, and participates in the antioxidant defense of body cells.

Selenious acid solution 0.9% in 90% 2,2-dichloropropionic acid has an antioxidant effect, reduces the impact on the body of external negative factors (adverse ecology, stress, smoking, chemical carcinogens, radiation) that can enhance the formation of free radicals.

Indications

Prevention and treatment of vitamin and mineral deficiency, including that arising

• During increased physical and mental stress, stressful situations;
• When exposed to adverse environmental factors;
• When living in environmentally unfavorable and Selenious acid solution 0.9% in 90% 2,2-dichloropropionic acid-deficient areas.

ICD codes

Dosage Regimen

Selmevit^® is taken orally after meals.

For the prevention of vitamin and mineral deficiencyadults and children over 12 years are prescribed 1 tab./day. The course of administration is 30 days. Repeated courses are possible on the recommendation of a doctor.

To replenish the deficiency of vitamins and mineralsadults and children over 12 years are prescribed 1 tab. 2 times/day. The course of administration is 30 days.

Adverse Reactions

Allergic reactions to the components of the drug.

Contraindications

• Pregnancy;
• Breastfeeding period;
• Children under 12 years of age;
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
• Increased individual sensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and breastfeeding is contraindicated.

Pediatric Use

Contraindicated for use in children under 12 years of age.

Special Precautions

It is not recommended to take other drugs containing multivitamins with microelements simultaneously and to exceed the recommended daily dose.

Effect on the ability to drive vehicles, machinery

The drug does not have a negative effect on the ability to drive vehicles and perform other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms nausea, weakness, gastrointestinal disorders. In case of overdose, it is necessary to consult a doctor.

Treatment activated charcoal orally, gastric lavage, symptomatic treatment.

Drug Interactions

Ascorbic acid increases the concentration in the blood of salicylates, ethinyl estradiol, benzylpenicillin and tetracyclines; reduces the concentration of oral contraceptives; reduces the anticoagulant effect of coumarin derivatives.

Calcium preparations, cholestyramine, neomycin reduce the absorption of retinol acetate.

α-Tocopherol acetate enhances the effect of cardiac glycosides, steroid and non-steroidal anti-inflammatory drugs.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.