The dragee is yellow-orange in color with a characteristic odor. The dragee should have a spherical shape in appearance. The dragee surface should be smooth and uniform in color.
Pharmacological properties
Pharmacotherapeutic group: Multivitamin complexes without additives.
ATX code A11B A.
Pharmacological properties.
Pharmacodynamics. Multivitamin drug. Belongs to drugs that regulate metabolic processes. Normalizes metabolism, including during aging processes. The pharmacological action of the drug is due to the active substances that make up its composition. Vitamin A (retinol) plays a key role in the synthesis of protein enzymes 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, normal synthesis of immunoglobulins and other factors of protection against infections. Vitamin E (α-tocopherol acetate) is a fat-soluble vitamin that exhibits high antioxidant and radioprotective effects, protects cell membranes from damage by free radicals, participates in the biosynthesis of heme and proteins, cell proliferation and other important processes of cellular metabolism. Vitamin E improves oxygen consumption by tissues. It has 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, participates 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 participates 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, participates in the synthesis of amino acids, nucleic acids and myelin. Vitamin C (ascorbic acid) participates in the redox processes of the body, the synthesis of hemoglobin, affects the metabolism of amino acids, accelerates the absorption of iron from the gastrointestinal tract, increases the nonspecific resistance of the body, necessary for the growth and formation of bones, skin, teeth and for the normal functioning of the nervous and immune systems. Vitamin PP (nicotinamide) participates in the processes of tissue respiration, carbohydrate and lipid metabolism. Folic acid stimulates erythropoiesis, participates 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 part of coenzyme A, which 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, and the absorption of potassium ions, glucose, and vitamin E from the intestine.
Pharmacokinetics. After oral administration, the drug is well absorbed from the small intestine into the systemic circulation, penetrating into all organs and tissues. Clinical characteristics.
Indications for use
As a preventive and therapeutic agent to improve metabolic processes and general condition in able-bodied and elderly people, including 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.
Contraindication
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, sarcoidosis in history, active peptic ulcer of the stomach and duodenum (due to possible increased 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, disorders of iron and copper metabolism, hypercalcemia, fructose intolerance, glucose-galactose malabsorption syndrome.
Vitamins A and E mutually enhance the effect and are synergists. Vitamin A reduces the anti-inflammatory effect of glucocorticoids. It cannot be taken simultaneously with nitrites and cholestyramine, because they disrupt the absorption of retinol. Vitamin A cannot be prescribed with retinoids, because their combination is toxic. Vitamin E cannot be used together with iron, silver preparations, agents with an alkaline environment (sodium bicarbonate, trisamine), indirect anticoagulants (dicoumarin, neodicoumarin). Vitamin E enhances the effect of steroidal and non-steroidal anti-inflammatory drugs (diclofenac sodium, ibuprofen, prednisolone). Iron-containing drugs inhibit the action of vitamin E. Vitamin C enhances the action and toxicity of sulfonamides (possibility of crystalluria), penicillin, increases iron absorption, aluminum absorption (consider when simultaneously treating with aluminum-containing antacids), 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 be taken only 2 hours after the injection of deferoxamine. 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 increases the excretion of oxalates in the urine and increases the risk of crystalluria during treatment with salicylates. Vitamin C absorption is reduced when used simultaneously with oral contraceptives, fruit or vegetable juices, alkaline drinks. Folic acid when used simultaneously with antithrombotic drugs - increases the risk of bleeding, with hypotensive drugs - leads to increased arterial hypotension, with hypolipidemic drugs - increases the risk of their toxic effects, with antidiabetic drugs - reduces the sugar-lowering effect of the latter, with methyldopa or beta-adrenoreceptor blockers - 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 toxic manifestations observed with the use of isoniazid and other antituberculosis drugs. Vitamin B1, affecting the processes of polarization in the area of neuromuscular synapses, can weaken the curare-like effect of muscle relaxants. Vitamin B2 is incompatible with streptomycin and reduces the effectiveness of antibacterial drugs (oxytetracycline, doxycycline, erythromycin, tetracycline and lincomycin). Tricyclic antidepressants, imipramine and amitriptyline, inhibit riboflavin metabolism, especially in heart tissues. PAS (para-aminosalicylic acid), cimetidine, calcium preparations, ethyl alcohol reduce the absorption of vitamin B12. It is prescribed with caution to patients with angina pectoris, with unstable angina and acute myocardial infarction, to patients receiving nitrates, calcium channel antagonists and beta-blockers. When using nicotinic acid with lovastatin, cases of rhabdomyolysis have been reported.
When using the drug, it is necessary to adhere to the dosage and duration of the course of administration. The drug should be taken with caution in patients with diabetes mellitus, dystrophic heart diseases, with decompensation of cardiac activity and ischemic heart disease, with diseases of the hematopoietic organs, with impaired iron metabolism (hemosiderosis, hemochromatosis, thalassemia), with gastrointestinal diseases, peptic ulcer of the stomach and duodenum in history, cholelithiasis, chronic pancreatitis, with liver damage, patients with acute nephritis, with urolithiasis, with 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 in cases accompanied by megaloblastic anemia). It should be taken into account that the use of ascorbic acid in high doses may change some laboratory parameters (blood glucose, transaminases, uric acid, creatinine). Simultaneous administration of ascorbic acid with alkaline drinks reduces its absorption, so the drug should not be washed down with alkaline mineral water. Do not take the drug with hot drinks (especially coffee), alcohol. It is not recommended to take the drug at the end of the day, since ascorbic acid has a mild stimulating effect. The recommended dose should not be exceeded. When using the drug, as well as other multivitamin preparations, a complete protein diet is necessary, which contributes to better absorption and metabolism of vitamins, especially water-soluble ones. Women who have taken high doses of retinol (more than 10,000 IU) can plan pregnancy no earlier than after 6–12 months. This is due to the fact that during this time there is a risk of abnormal fetal development under the influence of high vitamin A content in the body. The drug contains sugar, which should be taken into account by patients with diabetes. The drug is not recommended to be prescribed together with other multivitamins, since an overdose of the latter in the body is possible. The drug contains wheat flour as an excipient, which should be taken into account by patients with celiac disease. Urine may turn yellow, which is a completely harmless factor and is explained by the presence of riboflavin in the drug.
Use during pregnancy and lactation
Use during pregnancy or breastfeeding is possible only if the benefit to the mother outweighs the potential risk to the fetus/child. During pregnancy, to prevent the risk of teratogenic effects, 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. Women should not take large doses of retinol (over 10,000 IU) during breastfeeding due to the risk of hypervitaminosis A in infants.
Ability to influence reaction speed when driving vehicles or other mechanisms
Drivers and operators of complex mechanisms should consider the possibility of developing side effects such as dizziness, drowsiness, and visual impairment.
Method of administration and doses
The drug is prescribed to adults and children over 14 years of age orally, after meals: for preventive purposes - 1 tablet 2 times a day, for treatment - 2 tablets 3 times a day for 20–30 days. Repeated courses are carried out after 1–3 months. During pregnancy, to prevent the risk of teratogenic effects, 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 overdose with the drug, dyspeptic phenomena (nausea, vomiting, diarrhea, epigastric pain), allergic reactions (itching, skin rashes), changes in the skin and hair, liver dysfunction, headache, drowsiness, lethargy, facial flushing, irritability may occur. In such cases, the drug should be discontinued. Symptomatic therapy. With prolonged use of vitamin C in large doses, inhibition of the function of the insular apparatus of the pancreas, changes in renal secretion of ascorbic and uric acids during urine acetylation with the risk of precipitation of oxalate stones are possible.
When using the drug in recommended doses, the following side effects are possible. From the immune system: hypersensitivity reactions to the components of the drug, including anaphylactic shock, angioedema, bronchospasm; from 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 disorders, fatigue; from the organs of vision: visual impairment, dry skin/mucous membranes of the eyes; from the metabolism: hypercalcemia, hypercalciuria, crystalluria, glucosuria; from the blood and lymphatic system: blood clotting disorders, 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: yellow urine color. During prolonged use of high doses, the following adverse reactions may occur. From the metabolic side: hyperuricemia, impaired glucose tolerance, hyperglycemia, impaired zinc and copper metabolism; from the nervous system: paresthesias, convulsions, anorexia; from the cardiovascular system: arrhythmias, arterial hypotension; from the blood and lymphatic system: erythrocytopenia, neutrophilic leukocytosis; from the gastrointestinal tract: gastrointestinal disorders; from the skin and subcutaneous tissues: hair loss, seborrhea, hyperpigmentation, dryness and cracks on the palms and soles; Kidney and urinary tract: renal dysfunction, renal failure; Liver and biliary tract: jaundice, fatty liver; Musculoskeletal and connective tissue: myalgia, myopathy; Laboratory data: transient increase in aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, increased uric acid in the blood, electrolyte imbalance.
Expiration date
1 year 6 months.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Release form
50 dragees in containers (jars). 50 dragees in a container (jar); 1 container (jar) in a pack.
Release category: Over-the-counter.
Producer
Manufacturer: JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and address of the place of its activity. 04073, Ukraine, Kyiv, Kopylivska St., 38.
