Complivit^®-Activ (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

Complivit®-Activ

Film-coated tablets: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light green to green in color, biconvex, oblong; the cross-section is yellow-gray with inclusions of different colors.

Excipients: talc, potato starch, citric acid, low molecular weight povidone (low molecular weight polyvinylpyrrolidone), calcium stearate, stearic acid, sucrose (sugar).

Shell composition hypromellose, macrogol 4000, low molecular weight povidone (low molecular weight polyvinylpyrrolidone), titanium dioxide, talc, indigo carmine, quinoline yellow dye (E104).

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

Clinical-Pharmacological Group

Multivitamins with macro- and microelements

Pharmacotherapeutic Group

Multivitamin agent + multimineral

Pharmacological Action

A combined multivitamin preparation with micro- and macroelements.

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.

Retinol acetate ensures the normal function of the skin, mucous membranes, as well as vision.

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

Ergocalciferol is involved in maintaining calcium and phosphorus metabolism, improves their absorption in the small intestine, and prevents the development of rickets.

Thiamine hydrochloride, as a coenzyme, is involved in carbohydrate metabolism and the functioning of the nervous system.

Riboflavin is the most important catalyst for cellular respiration and visual perception processes.

Pyridoxine hydrochloride, as a coenzyme, participates in protein metabolism and the synthesis of neurotransmitters.

Ascorbic acid ensures the synthesis of collagen, participates in the formation and maintenance of the structure and function of cartilage, bones, teeth, affects the formation of hemoglobin, and the maturation of erythrocytes.

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

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

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

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

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

Iron is involved in erythropoiesis, as part of hemoglobin, it ensures the transport of oxygen to tissues.

Cobalt regulates metabolic processes and 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 starvation of organs and tissues, contributes to the prevention of osteoporosis. It strengthens the walls of blood vessels.

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

Magnesium plays an important role in protein biosynthesis and energy metabolism, reduces nervous system excitability, and prevents the formation of kidney stones.

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

Manganese is necessary for normal growth, metabolism, osteogenesis processes, carbohydrate and lipid metabolism.

Selenious acid solution 0.9% in 90% 2,2-dichloropropionic acid is involved in the regulation of tissue elasticity, has an antioxidant effect, and protects the body’s cells and tissues from the effects of adverse environmental factors.

Iodine is part of thyroid hormones, which control the intensity of energy metabolism, actively influence a person’s mental and physical development, and the state of the central nervous system.

Fluorine is an essential element for the normal growth and development of the body, and reduces the frequency of dental caries development.

Pharmacokinetics

The action of the drug Complivit^®-Activ is the combined action of its components, therefore conducting kinetic observations is not possible; all components together cannot be traced using markers or bioassays.

Indications

For children and adolescents aged 7 to 12 years

• For the prevention and treatment of hypovitaminosis, avitaminosis, deficiency of minerals and trace elements in the body during the period of growth and development;
• To increase the body’s resistance during increased physical and mental stress, during regular sports activities;
• With insufficient and unbalanced nutrition;
• For regions with unfavorable environmental conditions.

ICD codes

Dosage Regimen

Administer the drug orally.

Take one tablet once daily.

Ingest the tablet after a meal.

Swallow the tablet whole with a sufficient amount of liquid; do not chew.

The standard course of treatment is one month.

This regimen is intended for children and adolescents aged 7 to 12 years.

Do not exceed the recommended daily dose.

For long-term use beyond one month, consult a physician.

Avoid concomitant use of other multivitamin preparations to prevent overdose.

Discontinue use immediately if allergic reactions occur and seek medical advice.

Adverse Reactions

Possible allergic reactions to the components of the drug.

Contraindications

• Children under 7 years of age;
• Hypervitaminosis A;
• Increased content of calcium and iron in the body;
• Hypersensitivity to the components of the drug.

Use is not recommended for pernicious B₁₂-deficiency anemia.

Special Precautions

If allergic reactions to the components of the drug Complivit^®-Activ occur, it should be discontinued.

Concomitant use of other multivitamin preparations is not recommended to avoid the development of an overdose.

During the use of Complivit-Activ, urine may turn bright yellow, which has no clinical significance and is explained by the presence of riboflavin in the drug.

Overdose

The patient should be informed that in case of accidental overdose, a doctor should be consulted.

Treatment: temporary discontinuation of the drug, gastric lavage, intake of activated charcoal, and symptomatic therapy.

Drug Interactions

The preparation contains Iron and Calcium, therefore it delays the absorption from the gastrointestinal tract of antibiotics from the tetracycline group and fluoroquinolone derivatives.

With the simultaneous use of vitamin C and short-acting sulfonamide drugs, the risk of crystalluria increases.

Antacid preparations containing aluminum, Magnesium, Calcium, as well as cholestyramine reduce the absorption of iron.

With the simultaneous administration of thiazide diuretics, the risk of hypercalcemia increases.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.