Selmevit^® Intensiv (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® Intensiv

Film-coated tablets: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light yellow to orange-yellow in color, round, biconvex, with a characteristic odor.

Excipients: ludipress 6.9 mg, low molecular weight povidone 3.4 mg, hypromellose 1 mg, magnesium stearate 6.9 mg, talc 6.9 mg, microcrystalline cellulose 41.9 mg, sucrose 67 mg, potato starch 60.7 mg.

Coating composition: opadry orange (opadry II orange 57M230000) 35 mg, incl. powder containing hypromellose 15 cP, polydextrose, titanium dioxide, quinoline yellow aluminum lake, talc, maltodextrin/dextrin, glycerol/glycerin, yellow iron oxide, sunset yellow aluminum lake, black iron oxide.

60 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Multivitamins with macro- and microelements

Pharmacotherapeutic Group

Multivitamin agent + minerals

Pharmacological Action

A combined multivitamin preparation with minerals. Selmevit^® Intensiv contains a complex of B vitamins and a complex of antioxidants. The compatibility of the components in 1 tablet is ensured by a special technology for the production of the drug.

The action of Selmevit^® Intensiv is due to the effects of its constituent components.

α-Tocopherol acetate (vitamin E) – has a positive effect on the functions of the gonads, nervous and muscle tissue. It has pronounced antioxidant activity, providing protection of cell membranes and preventing the development of complications of diabetes mellitus.

Retinol acetate (vitamin A) – plays an important role in redox processes. It helps to increase the body’s defenses, participates in the formation of visual pigments necessary for normal twilight and color vision, and improves the process of tissue epithelialization.

Thiamine hydrochloride (vitamin B₁) – plays an important role in carbohydrate and energy metabolism. It is involved in the conduction of nerve impulses and the regeneration of nervous tissue. It acts as a neuroprotector in diseases occurring with damage to nerve cells (polyneuropathies of various etiologies).

Riboflavin (vitamin B₂) – is the most important catalyst for cellular respiration and visual perception processes, participates in all types of metabolism; protects the retina from ultraviolet radiation.

Pyridoxine hydrochloride (vitamin B₆) participates in protein metabolism and the synthesis of neurotransmitters. It provides inhibition processes in the central nervous system. It is necessary for the normal functioning of the central and peripheral nervous systems. It has a neuroprotective effect in diabetes mellitus.

Cyanocobalamin (vitamin B₁₂) – participates in the synthesis of nucleotides, is an important factor for normal growth, hematopoiesis and the development of epithelial cells. It has a beneficial effect on processes in the nervous system.

Nicotinamide (vitamin PP) – participates in the processes of tissue respiration, fat and carbohydrate metabolism, prevents the development of chronic fatigue syndrome.

Ascorbic acid (vitamin C) – regulates blood clotting, normalizes capillary permeability, has anti-inflammatory and anti-allergic effects. It enhances reparative processes and increases resistance to infections.

Calcium pantothenate – accelerates the processes of regeneration of epithelium and endothelium, improves the energy supply of the contractile function of the myocardium, and participates in the transmission of nerve impulses.

Rutoside – participates in redox processes, has antioxidant properties, prevents oxidation and promotes the deposition of ascorbic acid in tissues, and reduces vascular permeability.

Folic acid – participates in the synthesis of amino acids, nucleotides, nucleic acids; it is necessary for normal erythropoiesis and improves the regeneration of damaged tissues.

Thioctic acid (lipoic acid) – participates in the regulation of lipid and carbohydrate metabolism, improves liver function. It enhances the interaction of insulin and receptors. It reduces lipid peroxidation in peripheral nerves.

Zinc – an immunostimulant, promotes the absorption of vitamin A, regeneration and hair growth, increases performance. It is necessary in the presence of diabetes mellitus or the risk of its development, being an integral part of the insulin molecule; it has an antioxidant effect, protecting nerve cells and microcirculatory vessels from damage.

Magnesium – plays an important role in the regulation of neuromuscular activity, participates in the energy conversion of carbohydrates. It alleviates symptoms of nervous tension: anxiety and irritability. It prevents convulsive muscle contraction, relieves vascular spasms, and has vasodilating and antispasmodic effects.

Selenious acid solution 0.9% in 90% 2,2-dichloropropionic acid – in combination with vitamins A, E and C, it has an antioxidant effect and improves the body’s adaptive capabilities under the influence of extreme factors.

Phosphorus – is necessary for cellular energy metabolism and the functioning of muscle tissue (skeletal muscles and heart muscle).

The drug provides a balanced intake of components necessary to maintain the optimal functioning of the body, and has a neuroprotective effect due to the complex action of the vitamins and minerals included in its composition. Therefore, the drug can be used in the complex therapy of neurological diseases and during remission as part of maintenance therapy in the treatment of neuropathies. The components included in the drug protect nerve cells from damage (in chronic fatigue syndrome, acute or chronic stress, polyneuropathies of various origins).

Indications

• Prevention and replenishment of deficiency of vitamins, macro- and microelements;
• Recovery period after past illnesses;
• Chronic fatigue syndrome;
• As part of combination therapy for polyneuropathies of various origins.

ICD codes

Dosage Regimen

Administer orally to adults and children over 12 years.

Take 1 tablet once daily after a meal to minimize potential gastrointestinal discomfort.

Swallow the tablet whole with a sufficient amount of water; do not crush or chew.

The standard treatment course duration is up to 3 months.

Initiate a repeated course only based on a physician’s recommendation following a medical assessment.

Do not exceed the recommended daily dose of one tablet.

Concomitant use with other multivitamin or mineral supplements is not advised due to risk of exceeding safe intake levels for components such as vitamins A and E.

Discontinue use and consult a physician if allergic reactions or other adverse effects occur.

Store the drug in its original container in a dry, dark place at temperatures below 25°C (77°F).

Keep the packaging out of reach of children to prevent accidental ingestion.

Adverse Reactions

Allergic reactions to the components of the drug are possible.

Contraindications

• Increased individual sensitivity to the components of the drug;
• Pregnancy;
• Lactation period;
• Children under 12 years of age.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

Do not exceed the recommended dosage.

Urine may turn intense yellow, which is due to the presence of riboflavin in the drug and is not dangerous.

Overdose

When using the drug in recommended doses, the likelihood of overdose is low.

Treatment: activated charcoal orally, gastric lavage, symptomatic treatment.

Drug Interactions

Concomitant use with other multivitamin complexes containing vitamins A and E, B vitamins is not recommended.

Storage Conditions

In a dry, light-protected place, out of reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

Over-the-counter.

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.