Revit

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT REVIT

Composition:

Active substances:

1 dragee contains:

vitamin A 2,500 IU;

thiamine hydrochloride (vitamin B1) 1 mg;

riboflavin (vitamin B2) 1 mg;

ascorbic acid (vitamin C) 35 mg;

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

Pharmaceutical form. Dragees.

Main physicochemical properties: orange-colored dragees. The dragees should have a spherical shape. The surface of the dragees should be smooth, even, and uniformly colored.

Pharmacotherapeutic group. Vitamins. Multivitamin complexes without additional components. 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, affects amino acid metabolism, accelerates iron absorption from the gastrointestinal tract, enhances non-specific resistance of the body, and is necessary 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 systemic circulation and penetrates into all organs and tissues.

Clinical characteristics.

Indications.

To be prescribed as a prophylactic and therapeutic agent in conditions associated with increased body requirements for vitamins: increased physical and neuropsychic stress, especially under adverse environmental conditions; convalescence 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 vitamin overdose in the body.

Retinol reduces the anti-inflammatory effect of glucocorticoids. It should not be used 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, by affecting polarization processes at neuromuscular synapses, may weaken curare-like effects.

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 cardiac tissues.

Vitamin C enhances the action and toxicity of sulfonamides (risk of crystalluria), penicillin, increases iron utilization, aluminum absorption (should be considered during concomitant treatment with antacids containing aluminum), and reduces the effectiveness of heparin and indirect anticoagulants. High doses of the drug reduce the effectiveness of tricyclic antidepressants, neuroleptics – phenothiazine derivatives, renal tubular reabsorption of amphetamine, impair mexiletine excretion by the kidneys, and affect vitamin B12 resorption.

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

Prolonged use of high doses of the drug reduces the effectiveness of disulfiram treatment and inhibits the disulfiram-alcohol reaction.

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

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

Medicinal products of the quinoline group, calcium chloride, salicylates, and corticosteroids reduce ascorbic acid reserves in the body during prolonged use.

When the drug is used simultaneously with acetylsalicylic acid, excretion of ascorbic acid in urine increases, while excretion of acetylsalicylic acid decreases. Intake of acetylsalicylic acid reduces absorption of ascorbic acid by approximately one-third, requiring appropriate dose increase of vitamin C.

Special precautions for use.

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

When high doses are used or the drug is administered 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 coagulability.

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 use of the drug with alkaline beverages reduces the absorption of ascorbic acid; therefore, 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, transaminase activity, and lactate dehydrogenase activity.

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 malformations 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 formulation.

The drug is not recommended for concomitant use with other multivitamin preparations, 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 strict adherence to recommended doses. For correction of vitamin deficiency in pregnant and lactating women, specialized vitamin-mineral complexes should be preferred.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Dosage and Administration.

The medicinal product should be taken orally 10–15 minutes after a meal.

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

Pregnant women should use the product 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 aged 11 years and older, the recommended prophylactic dose is 1 tablet per day.

For children aged 3 to 10 years, the therapeutic dose is 2 tablets per day; for children aged 11 to 14 years – 3 tablets per day.

The duration of treatment is 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.

Symptoms. In case of overdose, an intensification of the drug's adverse effects may occur.

Ascorbic acid is generally well tolerated. It is a water-soluble vitamin, and excess amounts are excreted in urine. However, prolonged administration of high doses of vitamin C may suppress the function of the islet apparatus of the pancreas, requiring monitoring of pancreatic status. Overdose may alter renal excretion of ascorbic and uric acids during urine acidification, increasing the risk of precipitation of oxalate calculi. High-dose administration may cause vomiting, nausea, or diarrhea, which resolve after discontinuation of the drug.

Overdose of vitamin B1 may lead to hypercoagulation and disturbances in purine metabolism.

Treatment. Symptomatic therapy.

Adverse Reactions.

When 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 in individuals with hypersensitivity to vitamins A, C, and B-complex vitamins;

Skin and subcutaneous tissue disorders: skin rashes, urticaria, pruritus, skin redness, eczema;

Gastrointestinal disorders: dyspeptic disorders, nausea, vomiting, diarrhea;

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

Renal and urinary disorders: glomerular damage, crystalluria, formation of urate, cystine and/or oxalate calculi in kidneys and urinary tract, renal failure;

Cardiovascular disorders: arterial hypertension/hypotension, myocardial dystrophy;

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

Metabolism and nutrition disorders: disturbances in zinc and copper metabolism, anorexia;

Hepatobiliary disorders: alterations in liver enzyme activity;

Endocrine disorders: damage to the islet apparatus of the pancreas, glucosuria and impaired glycogen synthesis up to the development of diabetes mellitus;

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

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

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.

80 dragees per container (bottle).

80 dragees per container (bottle); 1 container (bottle) per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and place of business.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua