Composition of the medicinal product.

Active ingredients:

1 tablet contains

vitamin A (as vitamin A palmitate)

or

vitamin A (as retinol acetate)

vitamin E (as α-tocopherol acetate)

vitamin B1 (as thiamine hydrochloride)

- 3300 MO (1.817 mg)

- 3300 MO (1.135 mg),

- 10 mg,

- 2 mg,

vitamin B2 (riboflavin)

- 2 mg,

vitamin B6 (pyridoxine hydrochloride)

- 3 mg,

vitamin B12 (cyanocobalamin)

- 2 mcg,

vitamin C (ascorbic acid)

- 75 mg,

nicotinamide

- 20 mg,

folic acid

- 0.07 mg,

routine

- 10 mg,

calcium D-pantothenate

- 3 mg,

auxiliary substances: wheat flour, starch syrup, talc, light mineral oil, sugar, yellow wax, mint aroma.

Dosage form. Dragee.

Basic physical and chemical properties: yellow-orange dragee with a characteristic odor. In appearance, the dragee should have a spherical shape. The surface of the dragee should be smooth and uniform in color.

Pharmacotherapeutic group. Multivitamin complexes without additives.

Pharmacological properties.

Pharmacodynamics. Multivitamin medicine. Refers to drugs that regulate metabolic processes. Normalizes metabolism, including aging processes. The pharmacological action of the drug is due to the active ingredients that make up its composition. Vitamin A (retinol) plays a key role in the synthesis of enzyme proteins and structural components of tissues, is necessary for the formation of epithelial cells, bones and the synthesis of rhodopsin (visual pigment), supports the division of immunocompetent cells, the normal synthesis of immunoglobulins and other factors of protection against infections. Vitamin E (α-tocopherol acetate) is a fat-soluble vitamin with a high antioxidant and radioprotective effect, protects cell membranes from damage by free radicals, takes part in the biosynthesis of heme and proteins, cell proliferation and other important processes of cellular metabolism. Vitamin E improves tissue oxygen uptake. Shows an angioprotective effect, affecting the tone and permeability of blood vessels, stimulating the formation of new capillaries. Vitamin B1 (thiamine hydrochloride) is an important coenzyme in carbohydrate metabolism and is involved in the functioning of the nervous system. Vitamin B2 (riboflavin) is an important catalyst for the processes of cellular respiration and visual perception. Vitamin B6 (pyridoxine hydrochloride) as a coenzyme is involved in protein metabolism and the synthesis of neurotransmitters. Vitamin B12 (cyanocobalamin) is a growth factor, necessary for the normal course of hematopoiesis and erythrocyte maturation, takes part in the synthesis of amino acids, nucleic acids and myelin. Vitamin C (ascorbic acid) takes part in the redox processes of the body, the synthesis of hemoglobin, affects the exchange of amino acids, accelerates the absorption of iron from the gastrointestinal tract, increases the bodys nonspecific resistance, is necessary for the growth and formation of bones, skin, teeth and for normal the functioning of the nervous and immune systems. Vitamin PP (nicotinamide) takes part in the processes of tissue respiration, carbohydrate and lipid metabolism. Folic acid stimulates erythropoiesis, takes part in the synthesis of amino acids, nucleic acids. Rutin normalizes capillary permeability, strengthens the walls of blood vessels, reduces platelet aggregation, exhibits antioxidant properties, prevents oxidation and promotes the deposition of ascorbic acid in tissues. Calcium pantothenate is a part of coenzyme A, it is necessary for the normal formation of the tricarboxylic acid cycle, the synthesis of ATP (adenosine triphosphate), the production of hormones and antibodies, the synthesis of acetylcholine, the absorption of potassium ions, glucose, vitamin E from the intestine.

Pharmacokinetics. After oral administration, the drug is well absorbed from the small intestine into the systemic circulation, penetrates into all organs and tissues. Clinical characteristics.

Indications. As a prophylactic and therapeutic agent for improving metabolic processes and general condition in people of working age and the elderly, including with premature aging, asthenic syndrome, as well as during the period of convalescence after infectious diseases, in the postoperative period, after prolonged therapy with broad-spectrum antibiotics.

Contraindications. Hypersensitivity to any component of the drug, nephrolithiasis, severe renal dysfunction, chronic glomerulonephritis, gout, hyperuricemia, erythremia, erythrocytosis, tendency to thrombosis, thrombophlebitis, thromboembolism, thyrotoxicosis, chronic heart failure, gastric ulcer and intestinal sarcoidosis (due to a possible increase in the acidity of gastric juice), severe liver dysfunction, active hepatitis, neoplasms (except for cases accompanied by megaloblastic anemia), arterial hypertension (severe forms), hypervitaminosis A and E, impaired metabolism of iron and copper, hypercalcemia, intolerance to fructose, glucose-galactose malabsorption syndrome.

Interaction with other medicinal products and other types of interactions. Vitamins A and E mutually enhance the effect and are synergistic. Vitamin A reduces the anti-inflammatory effect of glucocorticoids. Cannot be used simultaneously with nitrites and cholestyramine, as they interfere with the absorption of retinol. Vitamin A should not be prescribed with retinoids, as their combination is toxic. Vitamin E should not be used together with iron and silver preparations, agents that have an alkaline environment (sodium bicarbonate, trisamine), indirect anticoagulants (dicumarin, neodikumarin). Vitamin E enhances the effect of steroidal and non-steroidal anti-inflammatory drugs (sodium diclofenac, ibuprofen, prednisolone). Medicines containing iron inhibit the effect of vitamin E. Vitamin C enhances the effect and toxicity of sulfonamides (the possibility of crystalluria), penicillin, increases the absorption of iron, the absorption of aluminum (taken into account while treating with antacids containing aluminum), reduces the effectiveness of heparin and indirect coagulants. Large doses of the drug reduce the effectiveness of tricyclic antidepressants, neuroleptics - phenothiazine derivatives, tubular reabsorption of amphetamine, disrupt the excretion of mexiletine by the kidneys. Ascorbic acid can only be used 2 hours after deferoxamine injection. Long-term use of large doses of the drug reduces the effectiveness of disulfiram treatment. Ascorbic acid increases the total clearance of ethyl alcohol. Ascorbic acid enhances urinary excretion of oxalates and increases the risk of crystalluria when treated with salicylates. The absorption of vitamin C decreases with simultaneous use with oral contraceptives, the use of fruit or vegetable juices, and alkaline drinks. Folic acid, when used simultaneously with antithrombotic drugs, increases the risk of bleeding, with antihypertensive drugs - leads to increased arterial hypotension, with hypolipidemic drugs - increases the risk of their toxic effects, with antidiabetic drugs - reduces the hypoglycemic effect of the latter, with methyldopa or beta blockers adrenergic receptors - leads to a significant decrease in blood pressure, with probenecid - reduces the effect of probenecid. Folic acid reduces plasma concentrations of phenytoin; when used with other antiepileptic drugs, a mutual decrease in clinical efficacy is possible. Vitamin B6 weakens the effect of levodopa, prevents or reduces the toxic manifestations observed with isoniazid and other anti-tuberculosis drugs. Vitamin B1, influencing the polarization processes in the area of ​​neuromuscular synapses, can weaken the curariform effect of muscle relaxants. Vitamin B2 is incompatible with streptomycin and reduces the effectiveness of antibacterial drugs (oxytetracycline, doxycycline, erythromycin, tetracycline and lincomycin). The tricyclic antidepressants, imipramine and amitriptyline, inhibit riboflavin metabolism, especially in the heart tissues. PASK (paraaminosalicylic acid), cimetidine, calcium preparations, ethyl alcohol reduce the absorption of vitamin B12. Prescribe with caution to patients with angina pectoris, with unstable angina pectoris and acute myocardial infarction, patients receiving nitrates, calcium channel antagonists and beta-blockers. When using nicotinic acid with lovastatin, cases of rhabdomyolysis have been reported.

Features of the application. When using the drug, it is necessary to observe the dosage and duration of the course of use. The drug should be used with caution in patients with diabetes mellitus, dystrophic heart diseases, with decompensation of cardiac activity and ischemic heart disease, with diseases of the hematopoietic system, with impaired iron metabolism (hemosiderosis, hemochromatosis, thalassemia), with gastrointestinal diseases, peptic ulcer of the stomach and a history of duodenal ulcers, cholelithiasis, chronic pancreatitis, liver lesions, patients with acute nephritis, urolithiasis, glaucoma, hemorrhages, moderate arterial hypotension. When using the drug, it is necessary to monitor blood pressure and kidney condition. Use with caution in patients with neoplasms (except for cases accompanied by megaloblastic anemia). It should be borne in mind that the use of ascorbic acid in high doses can change some laboratory parameters (glucose in the blood, transaminases, uric acid, creatinine). The simultaneous use of ascorbic acid with an alkaline drink reduces its absorption, so you should not drink the drug with alkaline mineral water. Do not use the medicine with hot drinks (especially coffee), alcohol. It is not recommended to use the drug at the end of the day, since ascorbic acid has a slight stimulating effect. Do not exceed the recommended dose. When using the drug, like other multivitamin preparations, a full-fledged protein diet is required, which promotes better absorption and metabolism of vitamins, especially water-soluble ones. Women who have used high doses of retinol (more than 10,000 IU) can plan pregnancy no earlier than 6–12 months. This is due to the fact that during this time there is a risk of abnormal development of the fetus under the influence of high vitamin A content in the body. The medicinal product contains sugar, which should be taken into account in patients with diabetes. The drug is not recommended to be prescribed together with other multivitamins, since the latter can be overdose in the body. The drug contains wheat flour in the composition of excipients, which should be taken into account by patients with celiac disease. It is possible that urine is stained yellow, which is a completely harmless factor and is explained by the presence of riboflavin in the drug.

Application during pregnancy or lactation. Application during pregnancy or lactation is possible only with regard to the benefits of the benefits to the mother over the potential risk to the fetus / child. During pregnancy, to prevent the risk of a teratogenic effect, the daily dose of the drug should not exceed 1 tablet per day. The dose of vitamin A should not exceed 5,000 IU for pregnant women and women planning to become pregnant. Large doses of retinol (over 10,000 IU) should not be used in women during breastfeeding due to the threat of hypervitaminosis A in infants.

The ability to influence the reaction rate when driving vehicles or other mechanisms. Drivers and operators of complex machinery should take into account the likelihood of side effects such as dizziness, drowsiness, and visual impairment.

Method of administration and dosage. The drug is prescribed for adults and children from 14 years of age inside, after meals: for prophylactic purposes - 1 tablet 2 times a day, for treatment - 2 tablets 3 times a day for 20-30 days. Repeated courses should be carried out in 1-3 months. During pregnancy, to prevent the risk of a teratogenic effect, the daily dose of the drug should not exceed 1 tablet per day. The course of treatment depends on the severity and course of the disease and is determined by the doctor individually.

Children. The use of the drug is contraindicated in children under 14 years of age.

Overdose. In case of an overdose of a drug, dyspeptic phenomena (nausea, vomiting, diarrhea, epigastric pain), allergic reactions (itching, skin rash), changes in the skin and hair, liver dysfunction, headache, drowsiness, lethargy, facial flushing, irritability. In such cases, the use of the drug should be discontinued. Therapy is symptomatic. With prolonged use of vitamin C in large doses, it is possible to suppress the function of the insular apparatus of the pancreas, change the renal secretion of ascorbic and uric acids during urine acetylation with the risk of precipitation of oxalate calculi.

Adverse reactions. When using the drug in the recommended doses, the following side reactions are possible. From the immune system: hypersensitivity reactions to the components of the drug, including anaphylactic shock, angioedema, bronchospasm; on the part of the cardiovascular system: arterial hypertension; from the skin and subcutaneous tissues: rash, urticaria, itching, redness; from the gastrointestinal tract: dyspeptic disorders, nausea, vomiting, stomach pain, belching, constipation, diarrhea, increased secretion of gastric juice; from the nervous system: headache, dizziness, increased excitability, drowsiness, sleep disturbances, increased fatigue; on the part of the organs of vision: blurred vision, dry skin / mucous membranes of the eyes; from the side of metabolism: hypercalcemia, hypercalciuria, crystalluria, glucosuria; on the part of the blood and lymphatic system: blood coagulation disorder, hemolysis of erythrocytes in patients with glucose-6-phosphate dehydrogenase deficiency; general disorders: hot flashes, which may be accompanied by a feeling of palpitations, irritability, sweating, hyperthermia; others: urine staining yellow. During long-term use of high doses, the following adverse reactions may occur. From the side of metabolism: hyperuricemia, impaired glucose tolerance, hyperglycemia, impaired metabolism of zinc, copper; from the nervous system: paresthesia, convulsions, anorexia; from the cardiovascular system: arrhythmias, arterial hypotension; from the blood and lymphatic system: erythrocytopenia, neutrophilic leukocytosis; from the gastrointestinal tract: gastrointestinal disorders; on the part of the skin and subcutaneous tissues: hair loss, seborrhea, hyperpigmentation, dryness and cracks on the palms and feet; on the part of the kidneys and urinary tract: impaired renal function, renal failure; from the liver and biliary tract: jaundice, fatty degeneration of the liver; from the musculoskeletal and connective tissue: myalgia, myopathy; laboratory data: a temporary increase in the level of aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, an increase in the level of uric acid in the blood, electrolyte imbalance.

Shelf life. 1 year 6 months.

Storage conditions. Store in original packaging at a temperature not exceeding 25 С. Keep out of the reach of children.

Packaging. 50 pills in containers (jars). 50 pills in a container (jar), 1 container (jar) in a pack.

Vacation category. Without recipe.

Manufacturer. JSC "KIEVSKIY VITAMINNY ZAVOD". Location of the manufacturer and address of the place of its activities. 04073, Ukraine, Kiev, st. Kopylovskaya, 38