Revit

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT REVIT

Composition:

Active ingredients: retinol (vit A), thiamine (vit B1), riboflavin (vit B2), ascorbic acid (vit C);

1 tablet 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, sugar, peppermint oil, yellow wax, sunflower oil, talc.

Pharmaceutical form. Dragees.

Main physicochemical properties: yellow to orange-colored dragees. A specific odor may be present.

Pharmacotherapeutic group.

Vitamins. Multivitamin complexes without minerals.

ATC code A11B A.

Pharmacological Properties.

A multivitamin complex. The pharmacological action of the medicinal product 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, normal synthesis of immunoglobulins and other factors protecting against infections.

Vitamin B1 (thiamine hydrochloride) – an essential coenzyme in carbohydrate metabolism, participates in the functioning of the nervous system.

Vitamin B2 (riboflavin) – 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, 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.

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 used as a prophylactic and therapeutic agent in conditions associated with increased body requirements for vitamins – increased physical and neuropsychological stress, especially under adverse environmental conditions; convalescence period after illnesses; to enhance body resistance to infectious and cold-related diseases.

Contraindications.

Chronic heart failure, arterial hypertension (severe forms), hypersensitivity to the drug components, fructose intolerance, glucose-galactose malabsorption syndrome, hypervitaminosis A, thrombosis, predisposition to thrombosis, thrombophlebitis, diabetes mellitus, chronic glomerulonephritis, severe kidney, liver diseases, active hepatitis, peptic ulcer of the stomach and duodenum, neoplasms, history of sarcoidosis, disorders of iron or copper metabolism, pediatric age under 3 years. Urolithiasis – when doses exceeding 1 g per day are used.

Interaction with other medicinal products and other forms 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, since their combination is toxic.

Thiamine hydrochloride, by affecting polarization processes at neuromuscular junctions, 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, enhances aluminum absorption (should be considered when treating concomitantly 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, tubular reabsorption of amphetamine, impair renal excretion of mexiletine, and affect vitamin B12 resorption.

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

Prolonged use of high doses reduces the effectiveness of disulfiram treatment and suppresses the disulfiram-alcohol reaction. Ascorbic acid increases the total clearance of ethyl alcohol.

Vitamin C enhances oxalate excretion with urine, thus increasing the risk of urinary oxalate stone formation, and increases the risk of crystalluria during salicylate treatment.

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

Choline-containing agents, calcium chloride, salicylates, and corticosteroids, when used long-term, reduce ascorbic acid reserves in the body.

When used concomitantly with acetylsalicylic acid, urinary excretion of ascorbic acid increases, while excretion of acetylsalicylic acid decreases. Intake of acetylsalicylic acid reduces absorption of ascorbic acid by approximately one-third, requiring appropriate increase in vitamin C dosage.

Special precautions for use

Administer with caution to patients with acute nephritis, decompensated cardiac function, cholelithiasis, chronic pancreatitis, progressive oncological diseases, allergic disorders, idiosyncrasy, or diabetes mellitus.

Women who have taken high doses of retinol (over 10,000 IU) should plan pregnancy no 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.

The drug is not recommended to be prescribed concomitantly with other multivitamins, as this may lead to their overdose in the body.

When high doses are administered or prolonged treatment is required, it is necessary to monitor kidney function, arterial blood pressure, and pancreatic function.

Use the drug 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, or 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, ascorbic acid absorption may be impaired in intestinal dyskinesia, enteritis, and achylia. As a reducing agent, ascorbic acid may interfere with laboratory test results, for example, blood glucose, bilirubin, transaminase activity, and lactate dehydrogenase levels.

Yellow discoloration of urine 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 physician consultation and with strict adherence to recommended doses.

To correct vitamin deficiency in pregnant women and breastfeeding mothers, specialized vitamin complexes containing minerals are preferred.

Ability to affect reaction speed when driving or operating machinery

There are no data regarding the effect on reaction speed during driving or operating machinery; however, possible adverse effects should be taken into account.

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:

• First trimester: 1 tablet daily.
• Second and third trimesters: no more than 2 tablets daily.

For prophylaxis in children aged 11 years and older: 1 tablet daily.

For therapeutic use:

• Children aged 3 to 10 years: 2 tablets daily.
• Children aged 11 to 14 years: 3 tablets daily.

The duration of treatment is determined individually by a physician and may last 1–2 months.

Under medical supervision, the recommended doses may be increased.

Children

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

Overdose

Symptoms: intensification of the drug's adverse effects.

Treatment: symptomatic therapy.

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

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

Side effects.

When used at recommended doses, adverse reactions are very rare:

• Immune system disorders: allergic reactions including anaphylactic shock, angioedema (Quincke's edema), hyperthermia, and rarely bronchospasm in individuals hypersensitive to vitamins A, C, and B-complex vitamins;
• Skin and subcutaneous tissue disorders: skin rashes, urticaria, pruritus, erythema, eczema;
• Gastrointestinal disorders: dyspeptic symptoms, nausea, vomiting, diarrhea;
• Nervous system disorders: headache, dizziness, increased excitability, drowsiness, sweating, sleep disturbances, increased fatigue;
• Hepatobiliary disorders: altered liver enzyme activity;
• Endocrine system disorders: damage to the islet apparatus of the pancreas, glucosuria, and impaired glycogen synthesis, potentially leading to diabetes mellitus;
• Renal and urinary disorders: crystalluria, damage to the glomerular apparatus of kidneys, formation of urate, cystine, and/or oxalate calculi in kidneys and urinary tract, renal failure;
• Blood and lymphatic system disorders: thrombocytosis, erythrocytopenia, neutrophilic leukocytosis, hyperprothrombinemia, thrombus formation. In patients with glucose-6-phosphate dehydrogenase deficiency, hemolysis of erythrocytes and hemolytic anemia may occur;
• Cardiovascular disorders: arterial hypertension/hypotension, myocardial dystrophy;
• Metabolism and nutrition disorders: disturbances in zinc and copper metabolism, anorexia;
• Other: visual disturbances, possible yellow discoloration of urine. With prolonged use at high doses, irritation of the gastrointestinal mucosa, arrhythmias, paresthesia, 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 the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

80 or 100 dragees per container.

80 or 100 dragees per container, 1 container per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

JSC "VITAMINS".

Manufacturer's address and place of business.

31 Uspenska Street, Uman, Cherkasy Oblast, 20300, Ukraine.

Marketing Authorization Holder.

JSC "VITAMINS".

Address of the Marketing Authorization Holder.

31 Uspenska Street, Uman, Cherkasy Oblast, 20300, Ukraine.