Instructions for Hexavit dragee container No. 50
Composition
active ingredients: retinol (vitamin A), thiamine (vitamin B1), riboflavin (vitamin B2), pyridoxine (vitamin B6), ascorbic acid (vitamin 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.
Dosage form
Dragee.
Main physicochemical properties: pills from yellow to orange in color, spherical in shape, with a smooth, uniform surface. The presence of a specific odor is allowed.
Pharmacotherapeutic group
Vitamins. Multivitamin complexes without additives.
ATX code A11B A.
Pharmacological properties
The pharmacological action of the drug is determined by the properties of the vitamins included in its composition. The drug regulates metabolic processes, normalizes metabolism.
Pharmacodynamics.
Vitamin A (retinol acetate) 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, the synthesis of immunoglobulins and other factors of protection against infections.
Vitamin B1 (thiamine hydrochloride) is a coenzyme in carbohydrate metabolism and is involved in the functioning of the nervous system.
Vitamin B2 (riboflavin) is a catalyst for cellular respiration and visual perception.
Vitamin B6 (pyridoxine hydrochloride) as a coenzyme participates in protein metabolism and the synthesis of neurotransmitters.
Vitamin C (ascorbic acid) participates in the body's redox processes, hemoglobin synthesis, affects amino acid metabolism, accelerates the absorption of iron from the gastrointestinal tract, increases the body's nonspecific resistance, and is necessary for the growth and formation of bones, skin, and teeth, and for the normal functioning of the nervous and immune systems.
Nicotinamide participates in the processes of tissue respiration, carbohydrate and lipid metabolism.
Pharmacokinetics.
After oral administration, the drug is well absorbed from the small intestine into the systemic circulation, penetrating into all organs and tissues.
Indication
Prevention and treatment of hypovitaminosis;
with prolonged treatment with antibiotics;
to enhance the body's resistance to infectious diseases.
Contraindication
Hypersensitivity to individual components of the drug, severe renal dysfunction, gout, hyperuricemia, tendency to thrombosis, thrombosis, thrombophlebitis, thromboembolism, sarcoidosis in history, nephrolithiasis, fructose intolerance, glucose-galactose malabsorption syndrome, hypervitaminosis A, chronic glomerulonephritis, gastric and duodenal ulcer in the acute phase (due to a possible increase in the acidity of gastric juice), severe liver dysfunction, active hepatitis, arterial hypertension (severe forms), disorders of iron or copper metabolism.
Interaction with other medicinal products and other types of interactions
Hexavit is not recommended to be prescribed together with other multivitamins, as an overdose of the latter in the body is possible.
Retinol reduces the anti-inflammatory effect of glucocorticoids. It should not be taken simultaneously with nitrites and cholestyramine, as they impair the absorption of retinol.
Vitamin A should not be prescribed with retinoids, as their combination is toxic.
Thiamine hydrochloride, by affecting the polarization processes in the area of neuromuscular synapses, can weaken the curare-like effect of muscle relaxants.
Riboflavin 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.
Vitamin B6 weakens the effect of levodopa and enhances the effect of diuretics, prevents or reduces toxic phenomena that occur when taking isoniazid and other anti-tuberculosis drugs.
Vitamin C enhances the effect 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.
Vitamin C absorption is reduced when taken simultaneously with oral contraceptives, fruit or vegetable juices, or alkaline drinks.
Cases of rhabdomyolysis have been reported with the use of nicotinamide with lovastatin.
Application features
When using the drug, it is necessary to adhere to the dosage and duration of the course of administration.
The drug should be prescribed with caution to patients with acute nephritis, urolithiasis, severe liver damage, gastrointestinal diseases, a history of peptic ulcer of the stomach and duodenum, ischemic heart disease, decompensation of cardiac activity, dystrophic heart diseases, diseases of the blood-forming organs, disorders of iron metabolism (hemosiderosis, hemochromatosis, thalassemia), cholelithiasis, chronic pancreatitis, allergic diseases, idiosyncrasies, patients with diabetes mellitus, glaucoma, hemorrhages, moderate arterial hypotension. When using the drug, it is necessary to monitor blood pressure and kidney function.
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 you should not wash down the drug 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. When using the drug, as well as other multivitamin preparations, a full-fledged 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 (over 10,000 IU) should not plan pregnancy until 6-12 months after taking it, as during this time there is a risk of abnormal fetal development due to the high content of vitamin A in the body.
The drug is not recommended to be prescribed together with other medications that contain vitamins, as an overdose of the latter in the body is possible.
The drug contains sugar, which should be taken into account by patients with diabetes.
The urine may turn yellow, which is a completely harmless factor and is explained by the presence of riboflavin in the preparation.
Use during pregnancy or breastfeeding
Use during pregnancy or breastfeeding is possible only for preventive purposes after consulting a doctor with strict adherence to recommended doses, taking into account the advantage of the benefit to the mother over the potential risk to the fetus/child.
To prevent the risk of teratogenic effects in the 2nd and 3rd trimesters of pregnancy and during breastfeeding, Hexavit can be used only for preventive purposes, only as prescribed and under the supervision of a doctor in a dose of no more than 1 tablet per day.
The dose of vitamin A should not exceed 5,000 IU for pregnant women and women planning a pregnancy.
Women should not take large doses of retinol (over 10,000 IU) during breastfeeding due to the risk of developing hypervitaminosis A in infants.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no data on the effect on the reaction speed when driving vehicles or other mechanisms, but drivers and operators of complex mechanisms should take into account the likelihood of developing such side effects as dizziness, drowsiness, and visual impairment.
Method of administration and doses
Hexavit should be taken orally after meals.
Adults
Treatment: 1 tablet 3 times a day.
Prevention of hypovitaminosis: 1 tablet per day.
Children aged 14 and over
Treatment of hypovitaminosis: 1 tablet per day.
Pregnant and breastfeeding women
Prevention of hypovitaminosis: in the II-III trimesters of pregnancy, as well as during breastfeeding, prescribe 1 dragee per day (maximum daily dose). The duration of the preventive course is determined by the doctor individually. Therapeutic doses should not be used by pregnant women and breastfeeding mothers.
The drug can be used for 30 days. The course of treatment should be repeated 2-3 times a year. The duration of treatment and the frequency of courses of therapy depend on the specific indication for use, the severity and form of the pathological process, and the patient's age.
Children
The use of the drug is contraindicated in children under 14 years of age.
Overdose
Symptoms: dyspeptic phenomena (nausea, vomiting, abdominal pain, belching, constipation, diarrhea), allergic reactions (itching, skin rashes), changes in the skin and hair, liver dysfunction, drowsiness, lethargy, irritability, headache, facial flushing. In such cases, the drug should be discontinued.
Treatment: symptomatic therapy, gastric lavage, sorbents.
Prolonged use of vitamin C in large doses may lead to 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.
Side effects
from the immune system: in individuals with hypersensitivity to the components of the drug, allergic reactions are possible, including anaphylactic shock, angioedema, hyperthermia, rarely - bronchospasm in individuals with hypersensitivity to vitamins A, C, and B vitamins;
Cardiovascular system: arterial hypertension;
Skin and subcutaneous tissue disorders: skin rash, urticaria, itching, redness of the skin, dry skin;
Gastrointestinal tract: stomach pain, belching, constipation, increased secretion of gastric juice, dyspeptic disorders, nausea, vomiting, diarrhea;
from the nervous system: headache, dizziness, increased excitability, drowsiness, sweating, sleep disturbances; hot flashes, which may be accompanied by a feeling of palpitations; increased fatigue, irritability;
on the part of the organs of vision: visual impairment, dryness of the mucous membranes of the eyes;
Metabolic: crystalluria, glycosuria;
from the blood and lymphatic system: blood clotting disorders, erythrocyte hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency;
laboratory data: blood clotting disorders, crystalluria, glycosuria;
Others: possible yellow discoloration of urine.
During prolonged use of high doses, the following side effects may occur:
Metabolic: decreased glucose tolerance, hyperglycemia, impaired zinc and copper metabolism;
from the nervous system: paresthesia, convulsions, anorexia;
from the cardiovascular system: arrhythmias, arterial hypotension;
from the blood and lymphatic system: erythrocytopenia, neutrophilic leukocytosis;
Gastrointestinal: gastrointestinal disorders, irritation of the digestive tract mucosa, transient increase in the activity of aspartate aminotransferase (AST), lactate dehydrogenase (LDH), alkaline phosphatase;
Skin and subcutaneous tissue disorders: hair loss, seborrheic rashes, dryness and cracks on the palms and soles, hyperpigmentation;
Kidney and urinary tract disorders: renal dysfunction, renal failure;
Liver and biliary tract: jaundice, fatty liver;
Musculoskeletal and connective tissue disorders: myalgia, myopathy;
laboratory data: electrolyte imbalance, hyperuricemia.
Expiration date
1 year.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
50 pills in a container.
50 tablets per container, 1 container per pack.
Vacation category
Without a prescription.
Producer
JSC "VITAMINS".
Address
Ukraine, 20300, Cherkasy region, Uman city, Uspenska st., 31.
Applicant
JSC "VITAMINS".
