Hexavit

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

Composition:

Active ingredients: 1 dragee contains: retinol acetate (vitamin A) – 1.72 mg (5000 IU); thiamine hydrochloride (vitamin B1) – 2 mg; riboflavin (vitamin B2) – 2 mg; pyridoxine hydrochloride (vitamin B6) – 2 mg; nicotinamide (vitamin PP) – 15 mg; ascorbic acid (vitamin C) – 70 mg;

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

Pharmaceutical form. Dragees.

Main physicochemical properties: yellow-orange spherical dragees with a weak characteristic odor.

Pharmacotherapeutic group. Vitamins. Multivitamin complexes without additives.

ATC code A11B A.

Pharmacological properties.

Pharmacodynamics.

A multivitamin complex preparation. The pharmacological effect of the medicinal product is determined by the properties of the vitamins included in its composition. The drug regulates metabolic processes and normalizes metabolism.

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 the division of immunocompetent cells, normal synthesis of immunoglobulins and other factors protecting against infections.

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 synthesis of neurotransmitters.

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 (vitamin PP) 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 in adults, treatment of hypovitaminosis in children, to enhance body resistance to infections and colds, during prolonged use of antibiotics. Also indicated for individuals whose professional operator activities require constant high visual acuity (pilots, drivers).

Contraindications.

Hypersensitivity to any component of the drug, nephrolithiasis, severe renal function impairment, gout, hyperuricemia, chronic glomerulonephritis, predisposition to thrombosis, thrombophlebitis, thromboembolism, 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, arterial hypertension (severe forms), hypervitaminosis A, disorders of iron and copper metabolism, fructose intolerance, glucose-galactose malabsorption syndrome.

Interaction with other medicinal products and other types of interactions.

Hexavit is not recommended to be prescribed together with other multivitamins, as it may lead to overdose of vitamins in the body.

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 with retinoids, as their combination is toxic.

Vitamin C enhances the action and toxicity of sulfonamides (risk of crystalluria), penicillin, increases iron absorption, aluminum absorption (consider when co-administering with antacids containing aluminum), reduces the effectiveness of heparin and indirect coagulants. High doses of the drug reduce the efficacy of tricyclic antidepressants, neuroleptics—phenothiazine derivatives, tubular reabsorption of amphetamine, and impair renal excretion of mexiletine.

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

Ascorbic acid increases the total clearance of ethyl alcohol. Ascorbic acid 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, consumption of fruit or vegetable juices, or 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.

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.

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

Special precautions for use.

When using the drug, it is necessary to follow the recommended dosage and duration of treatment. The medicinal product should be administered with caution to patients with diabetes mellitus, dystrophic heart diseases, cardiac decompensation, ischemic heart disease, disorders of the hematopoietic system, gastrointestinal disorders, history of peptic ulcer of the stomach and duodenum, cholelithiasis, chronic pancreatitis, hepatic impairment, patients with acute nephritis, urolithiasis, glaucoma, hemorrhages, and moderate arterial hypotension. When using the drug, monitoring of arterial pressure and renal function is required.

It should be noted that administration of high doses 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. The drug should not be taken with hot beverages (especially coffee) or alcohol. It is not recommended to take the drug at the end of 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 complete protein-rich diet is necessary to promote better absorption and metabolism of vitamins, especially 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 fetal developmental abnormalities caused by high levels of vitamin A in the body during this period.

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

Hexavit is not recommended to be prescribed together with other multivitamin preparations, as this may lead to vitamin overdose.

Possible yellow discoloration of urine may occur, which is completely harmless and is 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/infant.

To prevent the risk of teratogenic effects, during the II–III trimesters of pregnancy and during breastfeeding, Hexavit may be used only for prophylactic purposes, strictly under medical supervision and 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 breastfed infants.

Ability to influence reaction speed when driving or operating machinery.

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

Method of Administration and Dosage

Take Hexavit 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: from the age of 14 years – 1 tablet per day.

Pregnant and breastfeeding women

Prevention of hypovitaminosis: during the II and III trimesters of pregnancy, as well as during breastfeeding, administer 1 tablet per day (maximum daily dose). The duration of preventive treatment is determined individually by a physician. Therapeutic doses must 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 (after consultation with a physician). The duration of intake and frequency of treatment courses are determined individually by a physician and depend on the specific indication, severity and form of the pathological condition, and the patient’s age.

Children

To be used in children aged 14 years and older.

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, the drug should be discontinued.

Treatment is symptomatic.

With prolonged use of high-dose vitamin C, suppression of the pancreatic islet apparatus function may occur, along with changes in renal excretion of ascorbic acid and uric acid during urine acidification, increasing the risk of precipitation of oxalate calculi.

Adverse reactions.

Possible adverse reactions when using the medicinal product at recommended doses:

Immune system disorders: hypersensitivity reactions to the 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, dryness of the skin/mucous membranes of the eyes;

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, hot flashes which may be accompanied by palpitations, fatigue, irritability, sweating;

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

Metabolism and nutrition disorders: crystalluria, glucosuria;

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

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

Laboratory findings: impaired blood coagulation, crystalluria, glucosuria;

Other: visual disturbances, hyperthermia, hemolysis of erythrocytes in patients with glucose-6-phosphate dehydrogenase deficiency, yellow discoloration of urine.

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

Metabolism and nutrition disorders: 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 the levels of aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, 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.

Availability. Over-the-counter.

Manufacturer.

JSC "Tekhnolog".

Manufacturer's address and place of business.

8 Stara Prorynna Street, Uman, Cherkasy Oblast, 20300, Ukraine.