Revit

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

Composition:

Active substances: 1 dragee contains: retinol acetate (vitamin A) – 0.86 mg (2500 IU), thiamine hydrochloride (vitamin B1) – 1 mg, riboflavin (vitamin B2) – 1 mg, ascorbic acid (vitamin C) – 35 mg;

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

Pharmaceutical form. Dragees.

Main physicochemical properties: orange-colored, spherical dragees.

Pharmacotherapeutic group.

Vitamins. Multivitamin complexes without additives. ATC code A11BA.

Pharmacological properties.

Pharmacodynamics.

A multivitamin complex. The pharmacological effect of the medicinal product is determined by the properties of the vitamins it contains. 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 C (ascorbic acid) participates in redox processes of the body, hemoglobin synthesis, influences amino acid metabolism, accelerates 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.

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.

To be prescribed as a prophylactic and therapeutic agent in conditions accompanied by increased body requirements for vitamins: increased physical and neuropsychological stress, especially under adverse environmental conditions; recovery period after illnesses; to enhance general resistance of the body to infectious diseases (including colds).

Contraindications.

Chronic heart failure, arterial hypertension (severe forms), hypersensitivity to the components of the drug, fructose intolerance, glucose-galactose malabsorption syndrome, hypervitaminosis A, disorders of iron or copper metabolism. Thrombosis, predisposition to thrombosis, thrombophlebitis, diabetes mellitus, chronic glomerulonephritis, severe kidney, liver diseases, active hepatitis, peptic ulcer of the stomach and duodenum, neoplasms, sarcoidosis in medical history. Urolithiasis – when doses exceeding 1 g per day are used.

Interaction with other medicinal products and other types of interactions.

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

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 should not be prescribed with retinoids, as their combination is toxic.

Thiamine hydrochloride, affecting polarization processes at neuromuscular synapses, may weaken curare-like effects.

Riboflavin 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.

Vitamin C enhances the action and toxicity of sulfonamides (risk of crystalluria), penicillin, increases iron absorption, aluminum absorption (consider when treating simultaneously with antacids containing aluminum), reduces the effectiveness of heparin and indirect coagulants. High doses of the drug reduce the effectiveness of tricyclic antidepressants, neuroleptics – phenothiazine derivatives, renal tubular reabsorption of amphetamine, impair renal excretion of mexiletine, and affect vitamin B12 resorption.

Simultaneous intake of vitamin C and deferoxamine increases tissue toxicity of iron, especially in myocardium, which may lead to circulatory decompensation. Vitamin C may be taken only 2 hours after deferoxamine injection.

Prolonged intake of large doses of the drug reduces the effectiveness of disulfiram treatment and suppresses the disulfiram-alcohol reaction.

Ascorbic acid increases the total clearance of ethanol. Vitamin C enhances oxalate excretion with urine, thus increasing the risk of urinary oxalate stone formation, and increases the risk of crystalluria during salicylate therapy.

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

Quinoline derivatives, calcium chloride, salicylates, and corticosteroids reduce ascorbic acid reserves in the body when used long-term.

When used simultaneously with acetylsalicylic acid, the drug increases urinary excretion of ascorbic acid and decreases excretion of acetylsalicylic acid. Intake of acetylsalicylic acid reduces absorption of ascorbic acid by approximately one-third, which requires appropriate dose adjustment of vitamin C.

Special precautions.

Use with caution in patients with acute nephritis, decompensated cardiac function, cholelithiasis, chronic pancreatitis, progressive oncological diseases, allergic disorders, idiopathic reactions, and in patients with diabetes mellitus.

When high doses are administered or the drug is used for prolonged periods, renal function, arterial blood pressure, and pancreatic function should be monitored. The drug should be used cautiously in patients with a history of kidney disease.

In patients with urolithiasis, the daily dose of ascorbic acid should not exceed 1 g.

High doses of the drug should not be prescribed to patients with increased blood coagulation.

Since ascorbic acid enhances iron absorption, its use in high doses may be hazardous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia. Patients with high iron levels in the body should receive the drug in minimal doses.

Concurrent intake of the drug with alkaline beverages reduces the absorption of ascorbic acid; therefore, the tablets should not be taken with alkaline mineral water. Additionally, absorption of ascorbic acid may be impaired in intestinal dyskinesia, enteritis, and achylia.

As a reducing agent, ascorbic acid may interfere with laboratory test results, for example, in determining blood glucose, bilirubin levels, and the activity of transaminases and lactate dehydrogenase.

Women who have taken high doses of retinol (over 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 vitamin A levels 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 is not recommended to be prescribed together with other multivitamins, as this may lead to vitamin overdose.

Use during pregnancy or breastfeeding.

Use during pregnancy or breastfeeding is possible only for prophylactic purposes after consultation with a physician and with strict adherence to recommended doses. For correction of vitamin deficiency in pregnant and breastfeeding women, specialized vitamin-mineral complexes should be preferred.

Ability to affect reaction rate when driving or operating machinery.

The medicinal product does not affect the reaction rate when driving or operating machinery.

Dosage and Administration

The drug should be taken orally 10–15 minutes after eating.

For adults, for prophylaxis: 1 tablet twice daily; for treatment: 2 tablets three times daily.

During pregnancy, administration is recommended only as prescribed and under medical supervision:
1st trimester – no more than 1 tablet per day; 2nd–3rd trimesters – no more than 2 tablets per day.

For children, prophylactic dosing is recommended from age 11: 1 tablet per day.

For therapeutic purposes, children aged 3 to 10 years: 2 tablets per day; aged 11 to 14 years: 3 tablets per day.

Duration of treatment should be determined individually by a physician and may last 1–2 months. Dosages may be increased depending on the body's need for vitamins.

Children

The use of this medicinal product is contraindicated in children under 3 years of age.

Overdose

In case of overdose, adverse effects of the drug may intensify. Treatment is symptomatic.

Ascorbic acid is well tolerated. It is a water-soluble vitamin, and any excess is excreted in urine. However, prolonged use of high doses of vitamin C may lead to suppression of the endocrine function of the pancreas, requiring monitoring of pancreatic status. Overdose may cause changes in renal excretion of ascorbic and uric acids during urine acidification, with a risk of precipitation of oxalate calculi. Administration of high doses may result in vomiting, nausea, or diarrhea, which resolve after discontinuation of the drug.

In case of vitamin B1 overdose: hypercoagulability, disturbances in purine metabolism.

Side effects.

When using the drug at recommended doses, the following adverse reactions are possible:

Immune system side effects: hypersensitivity reactions to the drug components, including anaphylactic shock, angioneurotic edema, bronchospasm.

Skin and subcutaneous tissue side effects: skin rashes, urticaria, itching sensation, skin redness, eczema.

Gastrointestinal side effects: dyspeptic disorders, nausea, vomiting, diarrhea.

Nervous system side effects: headache, dizziness, increased excitability, drowsiness, sleep disturbances, fatigue.

Renal and urinary system side effects: glomerular apparatus damage, crystalluria, formation of urate, cystine and/or oxalate calculi in kidneys and urinary tract, renal failure.

Cardiovascular system side effects: arterial hypertension/hypotension, myocardial dystrophy.

Blood and lymphatic system side effects: erythrocytopenia, neutrophilic leukocytosis, thrombocytosis, hyperprothrombinemia, thrombus formation. In patients with glucose-6-phosphate dehydrogenase deficiency of erythrocytes, hemolysis of erythrocytes and hemolytic anemia may occur (in patients with glucose-6-phosphate dehydrogenase deficiency).

Metabolic side effects: disturbances in zinc and copper metabolism, anorexia.

Hepatobiliary side effects: disturbances in liver enzyme activity.

Endocrine system side effects: damage to the islet apparatus of the pancreas, glucosuria and impaired glycogen synthesis up to the development of diabetes mellitus.

Other side effects: visual disturbances, hyperthermia, sweating, possible yellow discoloration of urine, sensation of warmth.

With prolonged use at high doses, irritation of the gastrointestinal mucosa, arrhythmias, paresthesias, hyperuricemia, decreased glucose tolerance, hyperglycemia, impaired kidney function, dryness and cracking of palms and soles, hair loss, seborrheic rashes may occur.

Shelf life. 1 year.

Storage conditions.

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

Keep out of reach of children.

Packaging. 75 or 100 dragees per container.

Dispensing category.

Over-the-counter (without prescription).

Manufacturer.

JSC "Tekhnolohiya".

Manufacturer's address and location of business activity.

8 Stara Prorizna Street, City of Uman, Cherkasy Region, Ukraine, 20300.