FITOSEPT

INSTRUCTIONS FOR MEDICAL USE OF VITAMIN C

VITAMIN C

COMPOSITION:

active substance: ascorbic acid, sodium ascorbate;

1 tablet contains ascorbic acid 199.5 mg, sodium ascorbate 338.0 mg (in terms of ascorbic acid 300.5 mg);

excipients:

chewable tablets

sorbitol (E 420), microcrystalline cellulose, potassium acesulfame (E 950), aspartame (E 951), magnesium stearate, colloidal silicon dioxide anhydrous, tartrazine dye (E 102);

chewable tablets with orange flavor

sorbitol (E 420), microcrystalline cellulose, potassium acesulfame (E 950), aspartame (E 951), magnesium stearate, colloidal silicon dioxide anhydrous, natural orange flavor, yellow FCF dye (E 110).

PHARMACEUTICAL FORM.

Chewable tablets.

MAIN PHYSICOCHEMICAL PROPERTIES:

chewable tablets

tablets of yellow color, flat-cylindrical shape with a chamfer; uneven color (inclusions of white and yellow color) is allowed; the presence of a powdery coating on the surface of the tablet is allowed;

chewable tablets with orange flavor

tablets of pink-orange color, flat-cylindrical shape with a chamfer; uneven color (inclusions of white and pink-orange color) is allowed; the presence of a powdery coating on the surface of the tablet is allowed.

PHARMACOTHERAPEUTIC GROUP.

Simple ascorbic acid preparations (vitamin C). Ascorbic acid (vitamin C).

ATC code A11G A01.

PHARMACOLOGICAL PROPERTIES.

PHARMACODYNAMICS.

Ascorbic acid (vitamin C) belongs to the group of water-soluble vitamins.

Ascorbic acid has pronounced reducing properties, participates in many oxidation-reduction reactions, in the regulation of carbohydrate, lipid, and protein metabolism; affects the metabolism of aromatic amino acids, folic acid, histamine, thyroxine, steroid hormones, insulin; necessary for the synthesis of intercellular substance, regeneration of connective and bone tissue. Ascorbic acid participates in important hydroxylation reactions, including the formation of the neurotransmitter norepinephrine from dopamine and the conversion of proline to hydroxyproline (i.e., participates in the processes of collagen synthesis and maturation of connective tissue). Ascorbic acid plays an important role in the exchange of metal ions, including the absorption of iron from the gastrointestinal tract

(increases iron absorption) and its transport to tissues and organs. Ascorbic acid affects the synthesis of hemoglobin and the maturation of erythrocytes, stabilizes the walls of capillaries, is necessary for blood clotting. Ascorbic acid contributes to the increase of the body's resistance to infections and the negative effects of the environment, improves appetite, contributes to the normalization of sleep; has antioxidant and radioprotective properties, reduces hemorrhagic manifestations of radiation sickness and stimulates hematopoiesis.

A deficiency of ascorbic acid in food leads to the development of ascorbic acid deficiency, since it is not synthesized in the body. Under certain conditions, the body's need for ascorbic acid may increase, for example, during active growth, with physical or mental overexertion, during acute respiratory and other infectious diseases.

PHARMACOKINETICS.

ABSORPTION

After oral administration, ascorbic acid is well absorbed in the gastrointestinal tract, mainly in the small intestine.

DISTRIBUTION

The maximum concentration of ascorbic acid in plasma is reached within 4-7 hours. Easily penetrates into leukocytes, platelets, erythrocytes (concentration in leukocytes and platelets is higher than in erythrocytes and plasma), and then into all tissues. Deposited in the posterior part of the pituitary gland, adrenal cortex, intermediate cells of the seminal glands, ovaries, thyroid gland, pancreas, intestinal wall, brain, eye epithelium, spleen, lungs, kidneys, heart, and muscles. The physiological level of ascorbic acid deposition in the body is approximately 1.5 g.

METABOLISM

Metabolized mainly in the liver to dehydroascorbic acid and further to diketogulonic and oxalic acids.

EXCRETION

Ascorbic acid that enters the body in excess amounts (usually > 200 mg/day) is quickly excreted; ascorbic acid in its unchanged form and its inactive metabolites are excreted mainly with urine. The amount of ascorbic acid excreted in its unchanged form with urine depends on the dose; a slight diuretic effect is possible. When using large doses of ascorbic acid, when the concentration in plasma is more than 1.4 mg/dl, excretion is sharply increased, and increased excretion can persist after the cancellation of the drug.

Ascorbic acid penetrates through the placenta and into breast milk.

CLINICAL CHARACTERISTICS.

INDICATIONS.

For the treatment of ascorbic acid deficiency.

Ensuring increased body needs for ascorbic acid:

• during acute respiratory and other infectious diseases;
• during the period of convalescence after severe illnesses, surgical interventions;
• with various intoxications, hemorrhagic diathesis, diseases of connective tissue (rheumatoid arthritis), bleeding (nose, lung, uterus);
• with radiation sickness, hepatitis, cholecystitis, Addison's disease, with soft tissue injuries that heal poorly, infected wounds, and bone fractures.

CONTRAINDICATIONS.

Increased sensitivity to ascorbic acid and other components of the drug, tendency to thrombophlebitis, thrombophlebitis, diabetes, severe kidney disease, urolithiasis (when using doses over 1000 mg per day), hyperoxaluria, phenylketonuria.

Childhood up to 14 years. Pregnancy or breastfeeding.

INTERACTION WITH OTHER DRUGS AND OTHER TYPES OF INTERACTIONS.

When used simultaneously, ascorbic acid increases the absorption of penicillin, tetracycline, ethinyl estradiol, and iron from the gastrointestinal tract.

When used simultaneously with ascorbic acid with desferrioxamine (deferoxamine), the excretion of iron with urine increases. There have been reports of cardiomyopathy with congestive heart failure in patients with idiopathic hemochromatosis and thalassemia who, while taking desferrioxamine, began taking ascorbic acid. The use of ascorbic acid in this group of patients requires caution and monitoring of heart function.

When used simultaneously with ascorbic acid and antacids containing aluminum, aluminum excretion with urine may increase. Simultaneous use of ascorbic acid and antacids is not recommended, especially for patients with renal insufficiency.

Ascorbic acid reduces the toxicity of sulfonamide drugs, reduces the effectiveness of heparin and indirect anticoagulants.

When used simultaneously, ascorbic acid reduces the chronotropic effect of isoproterenol.

Ascorbic acid in large doses reduces the therapeutic effect of tricyclic antidepressants, neuroleptics (phenothiazine derivatives), increases the renal excretion of amphetamine, mexiletine; affects the absorption of vitamin B12.

The use of ascorbic acid in combination with disulfiram, especially for a long period or in large doses, reduces the effectiveness of disulfiram treatment.

Ascorbic acid increases the overall clearance of ethyl alcohol.

Simultaneous use with acetylsalicylic acid (aspirin) reduces the absorption of ascorbic acid by about a third, which, accordingly, requires an increase in the dose of the latter. When used simultaneously with acetylsalicylic acid, the excretion of ascorbic acid with urine increases; the excretion of acetylsalicylic acid with urine is not affected and does not lead to a decrease in its anti-inflammatory effect. Ascorbic acid increases the risk of developing crystaluria when treated with salicylates.

Drugs of the quinoline series, calcium chloride, salicylates, tetracyclines, glucocorticosteroids with prolonged use reduce the reserves of ascorbic acid in the body.

SPECIAL FEATURES OF USE.

Simultaneous intake of the drug with alkaline drinks reduces the absorption of ascorbic acid, so it should not be washed down with alkaline mineral water. The process of ascorbic acid absorption can be disrupted in intestinal dyskinesia, enteritis, achilia (suppressed gastric secretion), helminthic invasion, lambliasis.

The drug should be used with special caution in patients:

• with glucose-6-phosphate dehydrogenase deficiency (ascorbic acid can provoke hemolytic anemia);
• with a history of nephrolithiasis (risk of hyperoxaluria and deposition of oxalates in the urinary tract after taking large doses of ascorbic acid);
• with iron metabolism disorders (hemochromatosis, thalassemia, hemosiderosis).

Since ascorbic acid increases iron absorption, its use in large doses can be hazardous for patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia. Patients with a high iron content in the body should use ascorbic acid in minimal doses.

The drug should be used with caution in patients with a history of kidney disease. Ascorbic acid enhances the excretion of oxalates with urine, increasing the risk of forming oxalate stones in the kidneys. Patients at risk of developing hyperoxaluria should not take ascorbic acid in doses exceeding 1000 mg, but patients who do not belong to this group are not at risk. In urolithiasis, the daily dose of ascorbic acid should not exceed 1000 mg (see "Contraindications").

Large doses of ascorbic acid should not be used in patients with increased blood coagulation. The drug should be used with caution in patients with progressive oncological diseases, as its use can complicate the course of the disease.

When using large doses or prolonged use of ascorbic acid, it is necessary to monitor kidney function and blood pressure due to the stimulating effect of ascorbic acid on the production of corticosteroid hormones.

Prolonged use of ascorbic acid in large doses can lead to suppression of the function of the insulin apparatus of the pancreas, which requires monitoring of its condition.

Long-term use of large doses of ascorbic acid can accelerate its renal clearance, which can lead to a paradoxical deficiency of ascorbic acid after a sharp decrease in dose or cancellation of treatment.

Do not exceed the recommended dose.

Do not use simultaneously with other drugs containing ascorbic acid.

Since ascorbic acid has a mild stimulating effect on the central nervous system, the drug VITAMIN C is not recommended to be taken at the end of the day.

EFFECT ON LABORATORY TEST RESULTS

Ascorbic acid, as a reducing agent, can affect the results of laboratory tests for glucose, bilirubin, uric acid, creatinine, inorganic phosphates, lactate dehydrogenase, transaminases in blood; can cause false-positive or false-negative results (depending on the method used) when determining glucose in urine; can affect the results of biochemical determination of creatinine, uric acid in urine. When using large doses of ascorbic acid, a false-negative result of the study for hidden blood in feces may be possible.

1 tablet of the drug VITAMIN C contains 1.7 mmol (or 39 mg) of sodium, so patients who follow a diet with controlled sodium content should use this drug with caution.

1 chewable tablet of the drug VITAMIN C contains 506.26 mg of sorbitol (E 420).

1 chewable tablet with orange flavor of the drug VITAMIN C contains 484.80 mg of sorbitol (E 420).

In case of established intolerance to some sugars, you should consult a doctor before taking this drug. It is necessary to take into account the additive effect of concomitantly used drugs containing sorbitol (or fructose), as well as the consumption of sorbitol (or fructose) with food. The content of sorbitol in oral drugs can affect the bioavailability of other oral drugs when used concomitantly.

The drug contains aspartame (E 951) - a source of phenylalanine, which is hazardous to patients with phenylketonuria (see "Contraindications").

The drug contains tartrazine dye (E 102) or yellow FCF dye (E 110), which can cause allergic reactions.

USE DURING PREGNANCY OR BREASTFEEDING.

The drug in this dosage form is not intended for use during pregnancy or breastfeeding.

EFFECT ON THE ABILITY TO DRIVE VEHICLES AND WORK WITH MECHANISMS.

There is no data that the drug can have a negative effect on the reaction rate while driving a vehicle or working with complex mechanisms when following the recommended dosage regimen.

ADMINISTRATION AND DOSAGE.

The drug should be taken orally after meals, chewing the tablet.

For adults and children over 14 years old, for therapeutic purposes, it is necessary to take 1 tablet (500 mg) per day. The treatment duration is 10-15 days.

For acute respiratory and other infectious diseases, adults are recommended to take 1-2 tablets (500-1000 mg) per day (in 2 doses) for 7-10 days. For children, 250 mg per day. For such dosing, ascorbic acid preparations with the corresponding content of the active substance should be used.

The duration of treatment depends on the nature and course of the disease and is determined by the doctor individually.

CHILDREN.

Children under 14 years old are recommended to use the drug in a different dosage form.

OVERDOSE.

Acute overdose of the drug is practically impossible. Ascorbic acid that enters the body in excess amounts is quickly excreted. When using doses over 3000 mg per day, unabsorbed ascorbic acid is excreted mainly in its unchanged form with feces.

Symptoms. The use of ascorbic acid in large doses can cause diarrhea and the formation of oxalate stones in the kidneys. Symptomatic treatment may be required.

The use of ascorbic acid in large doses can lead to vomiting, nausea, which disappear after the cancellation of the drug.

Ascorbic acid can cause the development of acidosis or hemolytic anemia in some patients with glucose-6-phosphate dehydrogenase deficiency.

Prolonged use of large doses of ascorbic acid can lead to suppression of the function of the insulin apparatus of the pancreas, disruption of kidney function, increased blood pressure, and the development of other side effects listed in the "Side Effects" section.

Massive overdose of ascorbic acid can lead to kidney failure.

Treatment. If an excessive dose of ascorbic acid was taken recently, the stomach should be rinsed, otherwise, general supportive measures should be taken. Ascorbic acid can be removed from the body using hemodialysis.

SIDE EFFECTS.

The drug is very well tolerated in the recommended dose, and usually, when following the recommended dosage regimen, side effects do not occur. However, with prolonged use in large doses, the following side effects are possible.

From the psyche: increased excitability, increased fatigue, sleep disturbances.

From the nervous system: increased excitability of the central nervous system, headache.

From the cardiovascular system: myocardial dystrophy, arterial hypertension, flushing.

From the blood and lymphatic system: thrombosis, hyperprothrombinemia, thrombocytosis, erythrocytopenia, neutrophilic leukocytosis; hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency, possible hemolysis of erythrocytes.

From the gastrointestinal tract: irritation of the mucous membrane of the gastrointestinal tract, heartburn, nausea, vomiting, spasms of the stomach; when using doses over 1000 mg per day - diarrhea.

From the endocrine system: damage to the insulin apparatus of the pancreas (hyperglycemia, glycosuria), disruption of glycogen synthesis up to the appearance of diabetes.

From metabolism: disruption of zinc and copper metabolism.

From the urinary system: damage to the glomerular apparatus of the kidneys, crystaluria, formation of urate, cystine, and/or oxalate stones in the kidneys and urinary tract, kidney failure, when using doses over 600 mg per day - diuretic effect.

From the immune system: allergic reactions, angioneurotic edema, anaphylactic shock in the presence of sensitization.

From the skin and subcutaneous tissue: redness of the skin, rashes on the skin (including urticaria), itching, eczema.

General disorders: feeling of heat, erosion of tooth enamel, sometimes - back pain.

SHELF LIFE.

2 years.

STORAGE CONDITIONS.

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

Store in a place inaccessible to children.

PACKAGING.

8 tablets in a blister pack; 3 or 7 blister packs in a carton.

RELEASE CATEGORY.

Over-the-counter.

MANUFACTURER.

INTERRYM LLC.

MANUFACTURER'S LOCATION AND ADDRESS.

Ukraine, 65025, Odessa, 21 km of Starokyivska road, 40-a.