Hexavit

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

Composition:

Active substances: retinol (vit A), thiamine (vit B1), riboflavin (vit B2), pyridoxine (vit B6), ascorbic acid (vit C), nicotinamide;

1 dragee contains: retinol acetate (vitamin A), calculated as 100 % substance – 1.72 mg (5000 IU), thiamine hydrochloride (vitamin B1), calculated as 100 % substance – 2 mg, riboflavin (vitamin B2), calculated as 100 % substance – 2 mg, pyridoxine hydrochloride (vitamin B6), calculated as 100 % substance – 2 mg, ascorbic acid (vitamin C), calculated as 100 % substance – 70 mg, nicotinamide, calculated as 100 % substance – 15 mg;

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

Pharmaceutical form. Dragees.

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

Pharmaco-therapeutic group.

Vitamins. Multivitamin complexes without additives.

ATC code A11B A.

Pharmacological properties.

The pharmacological action of the drug is determined by the properties of the vitamins contained in its composition. The drug regulates metabolic processes and normalizes metabolism.

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, synthesis of immunoglobulins, and other factors protecting against infections.

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

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

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

Vitamin C (ascorbic acid) participates in redox processes of the body, hemoglobin synthesis, influences amino acid metabolism, enhances iron absorption from the gastrointestinal tract, increases 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.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

− Prevention and treatment of hypovitaminosis;

− during prolonged antibiotic therapy;

− to enhance the body's resistance to infectious diseases.

Contraindications.

Hypersensitivity to individual components of the drug, severe renal function impairment, gout, hyperuricemia, predisposition to thrombosis, thrombosis, thrombophlebitis, thromboembolism, history of sarcoidosis, nephrolithiasis, fructose intolerance, glucose-galactose malabsorption syndrome, hypervitaminosis A, chronic glomerulonephritis, gastric and duodenal peptic ulcer in the phase of exacerbation (due to possible increase in gastric juice acidity), severe liver function disorders, active hepatitis, arterial hypertension (severe forms), disturbances in iron or copper metabolism.

Interaction with other medicinal products and other types of interactions.

Hexavit is not recommended to be administered concomitantly with other multivitamins, as it may lead to vitamin overdose in the body.

Rétinol 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 administered with retinoids, as their combination is toxic.

Thiamine hydrochloride, by affecting polarization processes at neuromuscular synapses, may weaken the curare-like action of muscle relaxants.

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

Vitamin B6 reduces the effect of levodopa and enhances the action of diuretics; it prevents or reduces toxic manifestations occurring during isoniazid and other antituberculosis drug administration.

Vitamin C enhances the action and toxicity of sulfonamides (risk of crystalluria), penicillin, increases iron absorption, aluminum absorption (should be considered during concomitant treatment with aluminum-containing antacids), 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 the total clearance of ethanol. Ascorbic acid enhances oxalate excretion in urine and increases the risk of crystalluria during salicylate therapy.

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

Cases of rhabdomyolysis have been reported when nicotinamide was used with lovastatin.

Special precautions.

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

The medicinal product should be prescribed with caution to patients with acute nephritis, urolithiasis, severe liver damage, gastrointestinal disorders, history of peptic ulcer of the stomach and duodenum, ischemic heart disease, cardiac decompensation, dystrophic heart diseases, blood-forming organ disorders, iron metabolism disorders (hemochromatosis, hemosiderosis, thalassemia), cholelithiasis, chronic pancreatitis, allergic conditions, idiosyncrasy, diabetes mellitus, glaucoma, hemorrhages, and moderate arterial hypotension. When using the drug, monitoring of blood 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. When using this drug, 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 (over 10,000 IU) should not plan pregnancy earlier than 6–12 months after discontinuation, as there remains a risk of fetal maldevelopment due to high levels of vitamin A in the body during this period.

The drug should not be prescribed together with other medicinal products containing vitamins, as this may lead to vitamin overdose.

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

Discoloration of urine to yellow color may occur, which is completely harmless and due to the presence of riboflavin in the drug.

Use during pregnancy or breastfeeding.

Use during pregnancy or breastfeeding is possible only for prophylactic purposes, after consultation with a physician, strictly adhering to recommended doses, and considering the benefit to the mother over the potential risk to the fetus/child.

To prevent the risk of teratogenic effects in the II–III trimesters of pregnancy and during breastfeeding, Hexavit should be used only for prophylactic purposes, strictly on medical prescription and under medical supervision, at a dose not exceeding 1 tablet per day.

The dose of vitamin A should not exceed 5,000 IU 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 while driving or operating machinery.

There are no specific data on the effect on reaction speed while driving or operating machinery; however, drivers and operators of complex machinery should consider the possibility of such adverse effects as dizziness, drowsiness, and visual disturbances.

Method of Administration and Dosage

Hexavit is taken orally after meals.

Adults

Treatment: 1 tablet three times a day.

Prevention of hypovitaminosis: 1 tablet per day.

Children aged 14 years and older

Treatment of hypovitaminosis: 1 tablet per day.

Pregnant and breastfeeding women

Prevention of hypovitaminosis: during the II–III trimesters of pregnancy and during breastfeeding, administer 1 tablet per day (maximum daily dose). The duration of preventive treatment is determined individually by a physician. Therapeutic doses should not be used in pregnant and breastfeeding women.

The drug may be used for up to 30 days. The treatment course may be repeated 2–3 times per year. The duration of intake and frequency of treatment courses depend on the specific indication, severity and form of the pathological condition, and the patient's age.

Children

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

Overdose

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

Treatment: symptomatic therapy, gastric lavage, sorbents.

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

Side effects.

When the drug is used in recommended doses, adverse reactions are very rare:

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

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

• Metabolism and nutrition: 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), and alkaline phosphatase;
• Skin and subcutaneous tissues: hair loss, seborrheic rashes, dryness and cracking of palms and soles, hyperpigmentation;
• Renal and urinary system: impaired kidney function, renal failure;
• Hepatobiliary system: jaundice, fatty liver degeneration;
• Musculoskeletal and connective tissue: myalgia, myopathy;
• Laboratory findings: electrolyte imbalance, hyperuricemia.

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 name and address.

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

Marketing Authorization Holder.

JSC "VITAMINS".

Address of the Marketing Authorization Holder and/or its representative.

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