Vitamin c 500
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VITAMIN C 500 (Vitamin C 500)
Composition:
Active substance: ascorbic acid;
One tablet contains 200 mg of ascorbic acid (vitamin C) and 337 mg of sodium ascorbate (corresponding to 300 mg of ascorbic acid);
Excipients:
Peach-flavored tablets
sorbitol (E 420), aspartame (E 951), acesulfame potassium, microcrystalline cellulose, calcium stearate, peach flavoring, colloidal anhydrous silicon dioxide, curcumin coloring agent (E 100);
Orange-flavored tablets
sorbitol (E 420), aspartame (E 951), acesulfame potassium, microcrystalline cellulose, calcium stearate, orange flavoring, colloidal anhydrous silicon dioxide, yellow sunset FCF coloring agent (E 110);
Lemon-flavored tablets
sorbitol (E 420), aspartame (E 951), acesulfame potassium, microcrystalline cellulose, calcium stearate, lemon flavoring, colloidal anhydrous silicon dioxide, quinoline yellow coloring agent (E 104).
Pharmaceutical form. Chewable tablets.
Main physicochemical properties:
Peach-flavored tablets
light brown-yellow colored tablets with yellow and/or yellow-orange inclusions, round-shaped, with flat surface, a score line and bevelled edge. White specks may be present on the surface;
Orange-flavored tablets
pink-orange colored tablets, round-shaped, with flat surface, a score line and bevelled edge, or round-shaped with flat surface, with a citrus cross-section design engraved on one side. White specks may be present on the surface;
Lemon-flavored tablets
light yellow colored tablets, round-shaped, with flat surface, a score line and bevelled edge, or round-shaped with flat surface, with a citrus cross-section design engraved on one side. White specks may be present on the surface.
Pharmacotherapeutic group. Vitamins. Simple ascorbic acid (vitamin C) preparations. ATC code A11G A01.
Vitamin C (ascorbic acid) belongs to the group of water-soluble vitamins.
Pharmacological properties.
Pharmacodynamics.
Ascorbic acid is essential for the proper functioning and formation of connective tissues, particularly intercellular substance and collagen. In collagen synthesis, it participates in the hydroxylation of proline and lysine in the peptide chain. Ascorbic acid is involved in numerous redox reactions in the body and participates, for example, in the metabolism of phenylalanine, tyrosine, folic acid, norepinephrine, histamine, and certain enzyme systems involved in the synthesis of lipids, proteins, and in the hydroxylation of carnitine or serotonin. Ascorbic acid stabilizes capillary walls and enhances iron absorption.
Pharmacokinetics.
Ascorbic acid is readily absorbed in the gastrointestinal tract and penetrates into tissues. The highest concentrations are found in the adrenal glands, pituitary gland, and intestinal wall. It is biotransformed in the liver. The main metabolite of ascorbic acid is oxalic acid, which is excreted in urine. Urinary excretion is an indicator of vitamin C saturation in the body. Ascorbic acid crosses the placenta and is excreted into breast milk. It can be removed from the body by hemodialysis.
Clinical characteristics.
Indications.
For the treatment of hypovitaminosis and avitaminosis C.
To meet increased body requirements for vitamin C:
- during acute respiratory and infectious diseases;
- during the convalescence period after severe illnesses or surgical interventions;
- in various intoxications, hemorrhagic diatheses, connective tissue diseases (rheumatoid arthritis), and bleeding (nasal, pulmonary, uterine);
- in radiation sickness, hepatitis, cholecystitis, Addison's disease, slowly healing soft tissue injuries, infected wounds, and bone fractures.
Contraindications.
Hypersensitivity to ascorbic acid and other components of the medicinal product.
Predisposition to thrombosis; thrombophlebitis; diabetes mellitus; urolithiasis.
Children under 14 years of age.
Should be prescribed with special caution to patients with iron metabolism disorders (hemochromatosis, hemosiderosis, thalassemia).
Fructose intolerance; glucose/galactose malabsorption syndrome.
Severe kidney diseases. Phenylketonuria (since the preparation contains aspartame).
Interaction with other medicinal products and other types of interactions.
When used concomitantly, ascorbic acid enhances the gastrointestinal absorption of iron, penicillin, and ethinylestradiol. A similar effect applies to aluminum; therefore, this should be taken into account when treating simultaneously with antacids containing aluminum.
Ascorbic acid reduces the effectiveness of heparin and anticoagulants when used concomitantly.
Absorption of ascorbic acid is reduced when used concomitantly with oral contraceptives, fruit or vegetable juices, and alkaline drinks. Concurrent
administration of vitamin C and deferoxamine increases tissue toxicity of iron, 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 of ascorbic acid reduces the effectiveness of disulfiram treatment.
High doses of the drug reduce the effectiveness of tricyclic antidepressants, neuroleptics – phenothiazine derivatives, tubular reabsorption of amphetamine, and impair renal excretion of mexiletine.
Ascorbic acid increases the total clearance of ethanol. Quinolone derivatives, calcium chloride, salicylates, tetracyclines, and corticosteroids reduce ascorbic acid reserves in the body when used long-term.
At high doses, ascorbic acid affects the resorption of vitamin B12.
Vitamin C enhances oxalate excretion in urine, thereby increasing the risk of urinary oxalate stone formation. Vitamin C increases the risk of crystalluria during treatment with salicylates.
Special precautions for use
Since vitamin C has a mild stimulating effect, it is not recommended to take this medicinal product at the end of the day.
Due to the stimulating effect of ascorbic acid on the production of corticosteroid hormones, kidney function and arterial blood pressure should be monitored when high doses are administered.
The medicinal product should be used with caution in patients with increased blood coagulation.
Particular caution is required when prescribing to patients:
- with glucose-6-phosphate dehydrogenase deficiency (high doses of ascorbic acid may provoke hemolytic anemia);
- with a history of nephrolithiasis (risk of hyperoxaluria and deposition of oxalate crystals in the urinary tract after administration of high doses of ascorbic acid).
Prolonged use of high doses of ascorbic acid may accelerate its own metabolism, which could lead to paradoxical hypovitaminosis after discontinuation of treatment. The recommended dose should not be exceeded.
Concomitant use with other products containing vitamin C is not recommended.
The medicinal product should be used cautiously in patients with polycythemia or leukemia.
Absorption of ascorbic acid may be altered in conditions involving impaired intestinal motility, enteritis, or achylia (suppressed gastric secretion).
It should be noted that high-dose vitamin C administration may alter certain laboratory test results (blood glucose, bilirubin, transaminases, uric acid, creatinine, inorganic phosphates). Fecal occult blood testing may yield false-negative results.
The product contains aspartame (E 951), a source of phenylalanine, which may be harmful to patients with phenylketonuria. The product contains the dye sunset yellow FCF (E110), which may cause allergic reactions.
Patients with known intolerance to certain sugars should consult their physician before taking this medicinal product. The product contains sorbitol (E 420); therefore, patients with rare hereditary fructose intolerance should not take this medicinal product.
Use during pregnancy or breastfeeding
Prolonged use of high-dose vitamin C during pregnancy may adversely affect fetal development; therefore, the recommended dosage should be strictly observed.
Breastfeeding women should avoid taking this medicinal product, as ascorbic acid passes into breast milk.
Ability to influence reaction rate while driving or operating machinery. No effect.
Dosage and Administration
Take the medicinal product orally after meals, chewing the tablet.
For adults and children aged 14 years and older, the recommended therapeutic dose is 1 tablet (500 mg) daily. Treatment duration is 10–15 days.
In acute respiratory and infectious diseases, adults are advised to take 1–2 tablets (500–1000 mg) daily (in two divided doses) for 7–10 days.
Afterwards, reduce to ½ tablet (250 mg) daily. To achieve the required dosage, tablets containing the appropriate amount of active ingredient should be used.
The duration of treatment should be determined by a physician, depending on the patient's condition and disease course.
Children. The medicinal product is not recommended for children under 14 years of age; another pharmaceutical form is preferred for this age group.
Overdose.
Vitamin C is generally well tolerated. Ascorbic acid is a water-soluble vitamin, and excess amounts are excreted in urine. However, prolonged administration of high doses of vitamin C may lead to suppression of the pancreatic islet apparatus function, 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.
Administration of high doses of the drug may cause vomiting, nausea, or diarrhea, which resolve after discontinuation of the drug.
Treatment: symptomatic.
Adverse reactions.
Vitamin C is well tolerated at recommended doses; however, the following adverse reactions may occur:
- Gastrointestinal tract: when administered at doses exceeding 1000 mg per day – irritation of the gastrointestinal mucosa, heartburn, nausea, vomiting, diarrhea, stomach cramps;
- Urinary system: glomerular apparatus damage of kidneys, renal failure, crystalluria, formation of urate, cystine, and oxalate stones in kidneys and urinary tract;
- Allergic reactions: occasionally – eczema, urticaria, itching, skin rash, angioneurotic edema, anaphylactic shock in case of sensitization;
- Endocrine system: damage to the islet apparatus of the pancreas (hyperglycemia, glucosuria) and impaired glycogen synthesis up to the development of diabetes mellitus;
- Cardiovascular system: arterial hypertension, myocardial dystrophy;
- Hematopoietic system: thrombocytosis, thrombosis, hemolytic anemia, hyperprothrombinemia, erythrocytopenia, neutrophilic leukocytosis; in patients with glucose-6-phosphate dehydrogenase deficiency of erythrocytes, hemolysis of red blood cells is possible;
- Nervous system: increased excitability, fatigue, sleep disturbances, headache;
- Metabolism: disturbances in zinc and copper metabolism;
- Other: sensation of warmth.
Shelf life. 2 years.
Storage conditions.
Store in original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
10 tablets in blisters.
10 tablets in a blister; 3 blisters per carton.
10 tablets in a blister; 6 blisters per carton.
30 tablets in containers (bottles).
30 tablets in a container (bottle); 1 container (bottle) per carton.
Availability category. Over-the-counter.
Manufacturer. JSC "KYIV VITAMIN PLANT".
Manufacturer's address and location of business activity.
38 Kopilivska Street, Kyiv, 04073, Ukraine.
Web-site: www.vitamin.com.ua