Undevit

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT UNDEVIT (UNDEVIT)

Composition:

Active ingredients: retinol (vit A), tocopherol (vit E), thiamine (vit B1), riboflavin (vit B2), pyridoxine (vit B6), cyanocobalamin, ascorbic acid (vit C), nicotinamide, folic acid, rutoside, calcium pantothenate;

1 dragee contains retinol acetate (vitamin A) recalculated to 100% substance –
0.001135 g (3300 IU), α-tocopherol acetate (vitamin E) recalculated to 100% substance – 0.01 g, thiamine hydrochloride (vitamin B1) recalculated to 100% substance – 0.002 g, riboflavin (vitamin B2) recalculated to 100% substance – 0.002 g, pyridoxine hydrochloride (vitamin B6) recalculated to 100% substance – 0.003 g, cyanocobalamin (vitamin B12) recalculated to 100% substance – 2 mcg, ascorbic acid (vitamin C) recalculated to 100% substance – 0.075 g, nicotinamide recalculated to 100% substance – 0.02 g, folic acid recalculated to 100% substance – 0.00007 g, rutoside recalculated to 100% substance – 0.01 g, calcium pantothenate recalculated to 100% substance – 0.003 g;

Excipients: starch syrup, sugar, peppermint oil, yellow wax, sunflower oil, talc.

Pharmaceutical form. Dragee.

Main physicochemical properties: yellow to orange dragees, spherical shape, with smooth, uniformly colored surface. A specific odor may be present.

Pharmacotherapeutic group. Vitamins. Multivitamin complexes without additives.

ATC code A11BA.

Pharmacological properties.

A multivitamin preparation. Belongs to medicinal products that regulate metabolic processes. The pharmacological effect of the drug is determined by the active ingredients contained in its composition.

Pharmacodynamics.

Vitamin A (retinyl acetate) 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 synthesis of rhodopsin (visual pigment), supports the division of immunocompetent cells, normal synthesis of immunoglobulins and other factors protecting against infections.

Vitamin E (α-tocopheryl acetate) is a fat-soluble vitamin exhibiting high antioxidant and radioprotective activity, protects cell membranes from damage by free radicals, participates in heme and protein biosynthesis, cell proliferation, and other important processes of cellular metabolism. Vitamin E improves tissue oxygen uptake. It exerts an angioprotective effect by influencing vascular tone and permeability, stimulating the formation of new capillaries.

Vitamin B1 (thiamine hydrochloride) is an essential coenzyme in carbohydrate metabolism and participates in the functioning of the nervous system.

Vitamin B2 (riboflavin) is an important catalyst in cellular respiration and visual perception processes.

Vitamin B6 (pyridoxine hydrochloride) acts as a coenzyme involved in protein metabolism and synthesis of neurotransmitters.

Vitamin B12 (cyanocobalamin) is a growth factor necessary for normal hematopoiesis and maturation of erythrocytes; it participates in the synthesis of amino acids, nucleic acids, and myelin.

Vitamin C (ascorbic acid) participates in redox processes of the body, hemoglobin synthesis, influences amino acid metabolism, accelerates iron absorption from the gastrointestinal tract, enhances non-specific resistance of the body, and is essential for growth and formation of bones, skin, teeth, as well as for normal functioning of the nervous and immune systems.

Nicotinamide participates in tissue respiration, carbohydrate and lipid metabolism.

Folic acid stimulates erythropoiesis and participates in the synthesis of amino acids and nucleic acids.

Rutoside trihydrate normalizes capillary permeability, strengthens vascular walls, reduces platelet aggregation, exhibits antioxidant properties, prevents oxidation, and promotes deposition of ascorbic acid in tissues.

Calcium pantothenate is a component of coenzyme A, which is necessary for the normal formation of the tricarboxylic acid cycle, ATP synthesis, hormone and antibody production, acetylcholine synthesis, and 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 and penetrates into all organs and tissues.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to any component of the drug, nephrolithiasis, severe renal function impairment, gout, chronic glomerulonephritis, hyperuricemia, erythremia, erythrocytosis, predisposition to thrombosis, thrombophlebitis, thromboembolism, fructose intolerance, glucose-galactose malabsorption syndrome, hypervitaminosis A and E, thyrotoxicosis, chronic heart failure, history of sarcoidosis, active peptic ulcer of the stomach and duodenum (due to possible increase in gastric juice acidity), severe hepatic function disorders, active hepatitis, neoplasms (except cases associated with megaloblastic anemia), arterial hypertension (severe forms), disturbances in iron and copper metabolism, hypercalcemia.

Interaction with other medicinal products and other types of interactions.

Vitamins A and E mutually enhance each other's effects and act as synergists.

Retinol reduces the anti-inflammatory effect of glucocorticoids. It should not be taken simultaneously with nitrates and cholestyramine, as they impair retinol absorption. Vitamin A must not be prescribed together with retinoids, as their combination is toxic.

Vitamin E must not be used concomitantly with iron-containing drugs, silver preparations, or agents with alkaline medium (sodium hydrogencarbonate, trisamin), and indirect-acting anticoagulants (dicoumarol, neodicoumarol). Alpha-tocopherol acetate enhances the effect of steroid and non-steroidal anti-inflammatory agents (sodium diclofenac, ibuprofen, prednisolone). Iron-containing preparations suppress the action of vitamin E.

Vitamin C enhances the action and toxicity of sulfonamides (risk of crystalluria), penicillin, increases iron absorption, enhances aluminum absorption (should be considered during concomitant treatment with antacids containing aluminum), and reduces the effectiveness of heparin and indirect coagulants.

High doses of the drug reduce the efficacy of tricyclic antidepressants, phenothiazine derivative neuroleptics, tubular reabsorption of amphetamine, and impair renal excretion of mexiletine.

Ascorbic acid may be taken only 2 hours after deferoxamine injection. Prolonged use of high doses reduces the effectiveness of disulfiram treatment. Ascorbic acid increases total clearance of ethanol, enhances oxalate excretion with urine, and increases the risk of crystalluria during salicylate therapy.

Absorption of vitamin C is reduced when used concomitantly with oral contraceptives, fruit or vegetable juices, and alkaline drinks.

Vitamin B6 reduces the effect of levodopa and prevents or diminishes toxic manifestations observed during treatment with isoniazid and other antituberculosis drugs.

Vitamin B1, by influencing polarization processes at neuromuscular synapses, may reduce the curare-like effect of muscle relaxants.

PAS, cimetidine, calcium preparations, and alcohol reduce the absorption of vitamin B12.

Folic acid reduces plasma concentrations of phenytoin; with other antiepileptic drugs, mutual reduction in clinical efficacy is possible. When used concomitantly with antithrombotic medicinal products, folic acid increases the risk of bleeding; with antihypertensive agents, it may lead to enhanced arterial hypotension; with lipid-lowering agents, the risk of their toxic effects increases; with antidiabetic agents, their hypoglycemic effect is reduced; with methyldopa or beta-adrenoreceptor blockers, it causes a significant decrease in arterial pressure; with probenecid, the effect of probenecid is diminished.

Riboflavin is incompatible with streptomycin and reduces the efficacy of antibacterial agents (oxytetracycline, doxycycline, erythromycin, tetracycline, and lincomycin). Tricyclic antidepressants—imipramine and amitriptyline—inhibit the metabolism of riboflavin, especially in cardiac tissues.

Use with caution in patients with angina pectoris, unstable angina, and acute myocardial infarction who are receiving nitrates, calcium channel antagonists, and beta-blockers.

Cases of rhabdomyolysis have been reported when nicotinic acid is used concomitantly with lovastatin.

Special precautions for use.

When using the drug, it is necessary to strictly follow the recommended dosage and duration of treatment.

Use with caution in patients with diabetes mellitus, liver disorders, gastrointestinal diseases, history of peptic ulcer of the stomach and duodenum, acute nephritis, urolithiasis, dystrophic heart diseases, cardiac decompensation, ischemic heart disease, blood disorders, iron metabolism disorders (hemochromatosis, hemosiderosis, thalassemia), gallstone disease, chronic pancreatitis, glaucoma, hemorrhages, and moderate arterial hypotension. When using this medicinal product, monitoring of arterial pressure and kidney function is required.

It should be noted that high-dose administration of ascorbic acid may alter certain laboratory parameters (blood glucose, transaminases, uric acid, creatinine). Concurrent intake of ascorbic acid with alkaline drinks reduces its absorption; therefore, the drug should not be taken with alkaline mineral water. The medicinal product should not be taken with hot beverages (especially coffee) or alcohol. It is not recommended to take the drug late in the day, as ascorbic acid has a mild stimulating effect. The recommended dose should not be exceeded. When using this drug, as with other multivitamin preparations, a protein-rich diet is necessary to promote better absorption and metabolism of vitamins, particularly water-soluble ones.

Women who have taken high doses of retinol (over 10,000 IU) should plan pregnancy no earlier than 6–12 months after discontinuation. This is due to the risk of fetal developmental abnormalities caused by high levels of vitamin A in the body during this period.

Yellow discoloration of urine may occur, which is completely harmless and is due to the presence of riboflavin in the drug.

The drug contains sugar, which should be taken into account in patients with diabetes mellitus.

Undevit is not recommended to be used concomitantly with other multivitamin preparations, as this may lead to vitamin overdose.

Use during pregnancy or breastfeeding.

Use during pregnancy or breastfeeding is possible only if the expected benefit to the mother outweighs the potential risk to the fetus/infant. During pregnancy, to prevent the risk of teratogenic effects, the daily dose should not exceed 1 tablet per day.

Vitamin A intake should not exceed 5,000 IU per day in pregnant women and women planning pregnancy.

High doses of retinol (over 10,000 IU) should not be taken by women during breastfeeding due to the risk of developing hypervitaminosis A in nursing infants.

Ability to influence reaction rate when driving or operating machinery.

Drivers and operators of complex machinery should be aware of the possible occurrence of adverse effects such as dizziness, drowsiness, and visual disturbances.

Method of Administration and Dosage

Undevit tablets should be taken orally by adults and elderly individuals after meals.

For prophylactic use:

Adults: – 1 tablet once daily;

Elderly individuals: – 1 tablet twice daily.

For treatment:

Adults and elderly individuals: – 2 tablets three times daily for 20–30 days. Repeat courses should be administered after 1–3 months.

During pregnancy, to prevent the risk of teratogenic effects, the daily dose should not exceed 1 tablet per day.

The duration of treatment depends on the severity and course of the disease.

Children: The use of this drug is not recommended in children.

Overdose.

Symptoms: dyspeptic symptoms (nausea, vomiting, diarrhea, epigastric pain), allergic reactions (itching, skin rashes), skin and hair changes, liver function disturbances, headache, drowsiness, lethargy, facial hyperemia, irritability. In such cases, the drug should be discontinued.

Treatment: symptomatic therapy.

Prolonged use of high-dose vitamin C may lead to suppression of the islet apparatus of the pancreas, changes in renal excretion of ascorbic acid and uric acid, and during urine acidification, there is a risk of precipitation of oxalate stones.

Side effects.

When used at recommended doses, the following adverse reactions may occur:

• Immune system: allergic reactions are possible in individuals hypersensitive to the components of the medicinal product, including anaphylactic shock, angioneurotic edema, hyperthermia, rarely bronchospasm in individuals hypersensitive to vitamins A, C, and B-complex vitamins;
• Cardiovascular system: arterial hypertension;
• Skin and subcutaneous tissue: skin rashes, urticaria, pruritus, skin redness, dry skin;
• Gastrointestinal tract: dyspeptic disorders, nausea, vomiting, stomach pain, belching, constipation, diarrhea, increased gastric juice secretion;
• Nervous system: headache, dizziness, increased excitability, drowsiness, sweating, sleep disturbances, fatigue, hot flushes that may be accompanied by palpitations, irritability;
• Visual organs: visual disturbances, dryness of the eye mucous membranes;
• Metabolism: hypercalcemia, hypercalciuria, crystalluria, glucosuria;
• Blood and lymphatic system: impaired blood coagulation, hemolysis of erythrocytes in patients with glucose-6-phosphate dehydrogenase deficiency;
• Other: possible yellow discoloration of urine.

When used long-term at high doses, the following adverse reactions may occur:

• Metabolism: hyperuricemia, decreased glucose tolerance, hyperglycemia, disturbances in zinc and copper metabolism;
• Nervous system: paresthesia, seizures, anorexia;
• Cardiovascular system: arrhythmias, arterial hypotension;
• Blood and lymphatic system: erythrocytopenia, neutrophilic leukocytosis;
• Gastrointestinal tract: gastrointestinal disturbances, irritation of the gastrointestinal mucosa, transient increase in the activity of aspartate aminotransferase (AST), lactate dehydrogenase (LDH), alkaline phosphatase;
• Skin and subcutaneous tissue: hair loss, seborrheic rashes, hyperpigmentation, dryness and cracking of palms and soles;
• Kidneys and urinary tract: impaired kidney function, renal failure;
• Liver and biliary system: jaundice, fatty liver degeneration;
• Musculoskeletal and connective tissue: myalgia, myopathy;
• Laboratory findings: increased blood uric acid levels, electrolyte imbalance.

Shelf life. 1 year.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

50 dragees per container.

50 dragees per container, 1 container per carton.

Prescription status. Over-the-counter.

Manufacturer.

JSC "VITAMINS".

Manufacturer's location and address of business activity.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.

Marketing authorization holder.

JSC "VITAMINS".

Address of the marketing authorization holder and/or its representative.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.