INSTRUCTION for medical use of the medicinal product UNDEVIT (UNDEVIT)

Composition:

Active substances: 1 dragee contains:

vitamin A vitamin E vitamin B1	3300 IU, 10 mg, 2 mg,
vitamin B2	2 mg,
vitamin B6	3 mg,
vitamin B12	2 μg,
vitamin C	75 mg,
vitamin PP	20 mg,
vitamin Bc	0.07 mg,
vitamin B5	3 mg,
rutin	10 mg;

Excipients: wheat flour, starch syrup, talc, light mineral oil, sugar, yellow wax, flavoring agent "mint flavor".

Dosage form. Dragees.

Main physico-chemical properties: yellow-orange dragees with a characteristic odor. The dragees should have a spherical shape. The surface of the dragees should be smooth and uniformly colored.

Pharmacotherapeutic group. Multivitamin complexes without additives. ATC code A11BA. |iz|

Pharmacological properties.

Pharmacodynamics.

A multivitamin medicinal product. Belongs to medicinal agents that regulate metabolic processes. Normalizes metabolism, including during aging processes.

The pharmacological effect of the medicinal product is due to the active substances contained in 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 synthesis of rhodopsin (visual pigment), supports division of immunocompetent cells, normal synthesis of immunoglobulins and other factors protecting against infections.

Vitamin E (α-tocopherol 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 cellular metabolic processes. 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; 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.

Vitamin PP (nicotinamide) participates in tissue respiration, carbohydrate and lipid metabolism.

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

Rutin 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, necessary for normal formation of the tricarboxylic acid cycle, ATP (adenosine triphosphate) synthesis, hormone and antibody production, acetylcholine synthesis, and intestinal absorption of potassium ions, glucose, and vitamin E.

Pharmacokinetics.

After oral administration, the medicinal product is well absorbed from the small intestine into 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 following infectious diseases, in the postoperative period, and after prolonged therapy with broad-spectrum antibiotics.

Contraindications.

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

Interaction with other medicinal products and other types of interactions.

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

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

Vitamin E should not be used in combination with iron or silver preparations, or with agents creating an alkaline environment (sodium hydrogencarbonate, trisamine), and indirect-acting anticoagulants (dicoumarol, neodicoumarol). Vitamin E enhances the effect of steroid and non-steroidal anti-inflammatory agents (sodium diclofenac, ibuprofen, prednisolone). Medicinal products containing iron 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 effectiveness of tricyclic antidepressants, phenothiazine derivative neuroleptics, tubular reabsorption of amphetamine, and impair renal excretion of mexiletine.

Ascorbic acid can be taken only 2 hours after deferoxamine injection. Prolonged use of high doses of the drug reduces the effectiveness of disulfiram treatment.

Ascorbic acid increases the total clearance of ethanol. Ascorbic acid enhances oxalate excretion in urine and increases the risk of crystalluria during salicylate therapy.

The absorption of vitamin C is reduced when used concomitantly with oral contraceptives, fruit or vegetable juices, and alkaline beverages.

Folic acid, when used simultaneously with antithrombotic medicinal products, increases the risk of bleeding; with antihypertensive agents – leads to enhanced arterial hypotension; with lipid-lowering agents – increases the risk of their toxic effects; with antidiabetic agents – reduces their hypoglycemic effect; with methyldopa or beta-adrenergic blockers – leads to significant reduction in arterial pressure; with probenecid – reduces probenecid's effect. Folic acid reduces plasma concentrations of phenytoin; when used with other antiepileptic agents, mutual reduction in clinical efficacy is possible.

Vitamin B6 reduces the effect of levodopa and prevents or diminishes toxic manifestations observed during isoniazid and other antituberculosis drug therapy.

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

Vitamin B2 is incompatible with streptomycin and reduces the effectiveness of antibacterial agents (oxytetracycline, doxycycline, erythromycin, tetracycline, and lincomycin). Tricyclic antidepressants, imipramine, and amitriptyline inhibit riboflavin metabolism, especially in cardiac tissues.

PAS (para-aminosalicylic acid), cimetidine, calcium preparations, and ethanol reduce the absorption of vitamin B12. Use with caution in patients with angina pectoris, unstable angina, acute myocardial infarction, and in patients receiving nitrates, calcium channel antagonists, and beta-blockers.

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

Special precautions for use.

When using the medicinal product, it is necessary to adhere strictly to the recommended dosage and duration of treatment. The medicinal product should be administered with caution to patients with diabetes mellitus, dystrophic heart diseases, decompensated cardiac function, ischemic heart disease, hematopoietic organ disorders, iron metabolism disorders (hemossiderosis, hemochromatosis, thalassemia), gastrointestinal diseases, history of peptic ulcer of the stomach and duodenum, cholelithiasis, chronic pancreatitis, liver damage, acute nephritis, urolithiasis, glaucoma, hemorrhages, and moderate arterial hypotension. When using this medicinal product, monitoring of arterial pressure and renal function is required.

Use with caution in patients with neoplasms (except in cases associated with megaloblastic anemia).

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 medicinal product should not be taken with alkaline mineral water. Do not take the medicinal product with hot beverages (especially coffee) or alcohol. It is not recommended to take the medicinal product late in the day, as ascorbic acid has a mild stimulating effect. The recommended dose should not be exceeded. When using this product, as with other multivitamin preparations, a complete 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 (more than 10,000 IU) should not plan pregnancy earlier than 6–12 months after discontinuation. This is due to the risk of abnormal fetal development caused by high levels of vitamin A in the body during this period.

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

The medicinal product is not recommended to be prescribed together with other multivitamins, as this may lead to vitamin overdose.

The medicinal product contains wheat flour as an excipient, which should be considered in patients with celiac disease.

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

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

The daily dose of vitamin A should not exceed 5,000 IU in pregnant women and women planning pregnancy.

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

Ability to affect reaction speed 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.

Dosage and Administration

The medicinal product should be administered to adults and children aged 14 years and older orally, after meals:

For prophylactic purposes: 1 tablet twice daily.
For treatment: 2 tablets three times daily for 20–30 days. Repeat courses should be performed every 1–3 months.

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

The duration of treatment depends on the severity and course of the disease and is determined individually by the physician.

Children. The use of this medicinal product is contraindicated in children under 14 years of age.

Overdose

In case of overdose, dyspeptic symptoms (nausea, vomiting, diarrhea, epigastric pain), allergic reactions (itching, skin rashes), changes in skin and hair, liver function disorders, headache, drowsiness, lethargy, facial hyperemia, and irritability may occur. In such cases, administration of the medicinal product should be discontinued.

Treatment is symptomatic.

Prolonged use of high-dose vitamin C may lead to suppression of the pancreatic islet apparatus function and altered renal excretion of ascorbic acid and uric acid during urine acidification, with a risk of precipitation of oxalate calculi.

Adverse Reactions.

When the medicinal product is used at recommended doses, the following adverse reactions may occur.

Immune system disorders: hypersensitivity reactions to components of the medicinal product, including anaphylactic shock, angioneurotic edema, bronchospasm;

Cardiovascular system disorders: arterial hypertension;

Skin and subcutaneous tissue disorders: rash, urticaria, pruritus, erythema;

Gastrointestinal disorders: dyspeptic disorders, nausea, vomiting, stomach pain, belching, constipation, diarrhea, increased gastric juice secretion;

Nervous system disorders: headache, dizziness, increased excitability, drowsiness, sleep disturbances, fatigue;

Eye disorders: visual disturbances, dryness of skin/mucous membranes of eyes;

Metabolism and nutrition disorders: hypercalcemia, hypercalciuria, crystalluria, glucosuria;

Blood and lymphatic system disorders: impaired blood coagulation, hemolysis of erythrocytes in patients with glucose-6-phosphate dehydrogenase deficiency;

General disorders: hot flushes, which may be accompanied by palpitations, irritability, sweating, hyperthermia;

Other: yellow discoloration of urine.

The following adverse reactions may occur during prolonged administration of high doses:

Metabolism and nutrition disorders: hyperuricemia, impaired glucose tolerance, hyperglycemia, disturbances in zinc and copper metabolism;

Nervous system disorders: paresthesia, seizures, anorexia;

Cardiovascular system disorders: arrhythmias, arterial hypotension;

Blood and lymphatic system disorders: erythrocytopenia, neutrophilic leukocytosis;

Gastrointestinal disorders: gastrointestinal disturbances;

Skin and subcutaneous tissue disorders: hair loss, seborrhea, hyperpigmentation, dryness and cracking of palms and soles;

Renal and urinary disorders: impaired kidney function, renal failure;

Hepatobiliary disorders: jaundice, fatty liver degeneration;

Musculoskeletal and connective tissue disorders: myalgia, myopathy;

Laboratory findings: transient increase in levels of aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, elevated blood uric acid levels, electrolyte imbalance.

Shelf life. 1 year 6 months.

Storage conditions.

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

Keep out of reach of children.

Packaging.

50 dragees in containers (bottles).

50 dragees in a container (bottle); 1 container (bottle) in a carton.

Prescription status. Over-the-counter.

Manufacturer.

PJSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of manufacturing site.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua.

INSTRUCTION

for medical use of medicinal product

UNDEVIT

(UNDEVIT)

Composition:

Active ingredients: 1 dragee contains:

vitamin A vitamin E vitamin B1	3300 IU, 10 mg, 2 mg,
vitamin B2	2 mg,
vitamin B6	3 mg,
vitamin B12	2 mcg,
vitamin C	75 mg,
vitamin PP	20 mg,
vitamin Bc	0.07 mg,
vitamin B5	3 mg,
rutin	10 mg;

Excipients: wheat flour, starch syrup, talc, light mineral oil, sugar, yellow wax, “mint flavor” flavoring.

Pharmaceutical form. Dragees.

Main physicochemical properties: yellow-orange dragees with a characteristic odor. The dragees should have a spherical shape. The surface of the dragees should be smooth and uniformly colored.

Pharmacotherapeutic group. Multivitamin complexes without additives.

ATC code A11BA.

Pharmacological properties.

Pharmacodynamics.

A multivitamin medicinal product. Belongs to medicinal agents that regulate metabolic processes. Normalizes metabolism, including during aging processes.

The pharmacological effect of the medicinal product is determined by its active ingredients.

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 and bones, and for the synthesis of rhodopsin (visual pigment). It supports the division of immunocompetent cells, normal synthesis of immunoglobulins, and other factors protecting against infections.

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

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

Vitamin C (ascorbic acid) participates in the body's redox processes and hemoglobin synthesis, influences amino acid metabolism, accelerates iron absorption from the gastrointestinal tract, enhances non-specific resistance of the body, and is essential 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 tissue respiration, carbohydrate, and lipid metabolism.

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

Rutin normalizes capillary permeability, strengthens vessel walls, reduces platelet aggregation, exhibits antioxidant properties, prevents oxidation, and promotes tissue deposition of ascorbic acid.

Calcium pantothenate is a component of coenzyme A, necessary for the normal formation of the tricarboxylic acid cycle, ATP (adenosine triphosphate) synthesis, hormone and antibody production, acetylcholine synthesis, and for the intestinal absorption of potassium ions, glucose, and vitamin E.

Pharmacokinetics.

After oral administration, the medicinal product is well absorbed from the small intestine into systemic circulation and penetrates 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 in cases of premature aging, asthenic syndrome, during convalescence after infectious diseases, in the postoperative period, and after prolonged broad-spectrum antibiotic therapy.

Contraindications.

Hypersensitivity to any component of the medicinal product, nephrolithiasis, severe renal function impairment, chronic glomerulonephritis, gout, hyperuricemia, erythremia, erythrocytosis, tendency to thrombosis, thrombophlebitis, thromboembolism, 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), hypervitaminosis A and E, iron and copper metabolism disorders, hypercalcemia, fructose intolerance, glucose-galactose malabsorption syndrome.

Interaction with other medicinal products and other types of interactions.

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

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

Vitamin E should not be used together with iron or silver preparations, alkaline agents (sodium bicarbonate, trisamin), or indirect-acting anticoagulants (dicoumarin, neodicoumarin). Vitamin E enhances the effect of steroid and non-steroidal anti-inflammatory drugs (sodium diclofenac, ibuprofen, prednisolone). Iron-containing medicinal products reduce the effect of vitamin E.

Vitamin C enhances the action and toxicity of sulfonamides (risk of crystalluria), penicillin, increases iron absorption, and aluminum absorption (should be considered when treating simultaneously with aluminum-containing antacids). It reduces the effectiveness of heparin and indirect coagulants. High doses of the drug reduce the effectiveness of tricyclic antidepressants, phenothiazine derivative neuroleptics, tubular reabsorption of amphetamine, and disrupt renal excretion of mexiletine.

Ascorbic acid can be administered only 2 hours after deferoxamine injection. Prolonged use of high doses of the medicinal product reduces the effectiveness of disulfiram treatment.

Ascorbic acid increases the total clearance of ethyl alcohol. Ascorbic acid enhances oxalate excretion in urine and increases the risk of crystalluria during salicylate therapy.

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

Folic acid, when used simultaneously with antithrombotic medicinal products, increases the risk of bleeding; with antihypertensive agents, it leads to enhanced arterial hypotension; with hypolipidemic agents, it increases the risk of their toxic effects; with antidiabetic agents, it reduces their hypoglycemic effect; with methyldopa or beta-adrenergic blockers, it leads to significant reduction in arterial pressure; with probenecid, it reduces probenecid’s effect. Folic acid reduces plasma concentrations of phenytoin. When used with other antiepileptic drugs, mutual reduction in clinical effectiveness may occur.

Vitamin B6 reduces the effect of levodopa and prevents or reduces toxic manifestations observed during isoniazid and other antituberculosis drug therapy.

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

PAS (para-aminosalicylic acid), cimetidine, calcium preparations, and ethyl alcohol reduce vitamin B12 absorption. Use with caution in patients with angina pectoris, unstable angina, acute myocardial infarction, and in patients receiving nitrates, calcium channel blockers, and beta-blockers.

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

Special precautions.

When using the medicinal product, dosage and treatment duration must be strictly observed. The medicinal product should be used cautiously in patients with diabetes mellitus, cardiac dystrophic diseases, decompensated cardiac function, ischemic heart disease, hematopoietic organ disorders, iron metabolism disorders (hemochromatosis, hemosiderosis, thalassemia), gastrointestinal diseases, history of peptic ulcer of the stomach and duodenum, cholelithiasis, chronic pancreatitis, liver damage, acute nephritis, urolithiasis, glaucoma, hemorrhages, and moderate arterial hypotension. Blood pressure and kidney function should be monitored during treatment.

Use with caution in patients with neoplasms (except cases associated with megaloblastic anemia).

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

Women who have used high doses of retinol (more than 10,000 IU) should not plan pregnancy earlier than 6–12 months after discontinuation. This is due to the risk of fetal malformation caused by high vitamin A levels in the body during this period.

The medicinal product contains sugar, which should be considered by patients with diabetes mellitus.

The medicinal product is not recommended to be prescribed together with other multivitamins, as it may lead to vitamin overdose.

The medicinal product contains wheat flour as an excipient, which should be considered by patients with celiac disease.

Urine may turn yellow, which is completely harmless and due to the presence of riboflavin in the medicinal product.

Use during pregnancy or breastfeeding.

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 medicinal product should not exceed 1 dragee per day.

The vitamin A dose should not exceed 5,000 IU for pregnant women and women planning pregnancy.

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

Ability to affect reaction rate while driving or operating machinery.

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

Administration and dosage.

The medicinal product is prescribed orally to adults and children aged 14 years and older, after meals: for prophylaxis – 1 dragee twice daily; for treatment – 2 dragees three times daily for 20–30 days. Repeat courses should be conducted after 1–3 months.

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

The duration of treatment depends on the severity and course of the disease and is determined individually by a physician.

Children. The medicinal product is contraindicated in children under 14 years of age.

Overdose.

Overdose may cause dyspeptic symptoms (nausea, vomiting, diarrhea, epigastric pain), allergic reactions (itching, skin rash), skin and hair changes, liver function disorders, headache, drowsiness, lethargy, facial hyperemia, and irritability. In such cases, the use of the medicinal product should be discontinued.

Symptomatic therapy.

Prolonged use of high doses of vitamin C may suppress the function of the pancreatic islet apparatus, alter renal excretion of ascorbic and uric acids during urine acidification, and increase the risk of oxalate stone precipitation.

Adverse reactions.

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

Immune system: hypersensitivity reactions to components of the medicinal product, including anaphylactic shock, angioedema, bronchospasm;

Cardiovascular system: arterial hypertension;

Skin and subcutaneous tissues: rash, urticaria, itching, redness;

Gastrointestinal tract: dyspeptic disorders, nausea, vomiting, stomach pain, belching, constipation, diarrhea, increased gastric juice secretion;

Nervous system: headache, dizziness, increased excitability, drowsiness, sleep disturbances, increased fatigue;

Eyes: vision disturbances, dryness of skin/mucous membranes of the eyes;

Metabolism: hypercalcemia, hypercalciuria, crystalluria, glucosuria;

Blood and lymphatic system: coagulation disorders, hemolysis of erythrocytes in patients with glucose-6-phosphate dehydrogenase deficiency;

General disorders: hot flushes, possibly accompanied by palpitations, irritability, sweating, hyperthermia;

Other: yellow discoloration of urine.

With prolonged use of high doses, the following adverse reactions may occur:

Metabolism: hyperuricemia, impaired glucose tolerance, hyperglycemia, zinc and copper metabolism disorders;

Nervous system: paresthesia, seizures, anorexia;

Cardiovascular system: arrhythmias, arterial hypotension;

Blood and lymphatic system: erythrocytopenia, neutrophilic leukocytosis;

Gastrointestinal tract: gastrointestinal disturbances;

Skin and subcutaneous tissues: hair loss, seborrhea, hyperpigmentation, dryness and cracking of palms and soles;

Kidneys and urinary tract: kidney function disorders, renal failure;

Liver and biliary system: jaundice, fatty liver dystrophy;

Musculoskeletal and connective tissue: myalgia, myopathy;

Laboratory findings: temporary increase in aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase levels, increased blood uric acid levels, electrolyte imbalance.