Setebe 500 - instructions for use, dose, side effects, contraindications

Ascorbic acid (vitamin C) is an indispensable substance for maintaining metabolism in the human body. Ascorbic and dehydroascorbic acids form an important redox system.

Vitamin C has an oxidation-reducing effect, it is a cofactor plurality of enzyme systems, for example in the synthesis of collagen, catecholamines, steroids hydroxylation of tyrosine and exogenous substances in the biosynthesis of carnitine regeneration tetrahydrofolic acid, α-amination peptide - including peptide hormones and neuropeptides. In addition, when vitamin C deficiency decreases the severity of the immune response, in particular, chemotaxis, activation of complement and interferon production.

Ascorbic acid improves the absorption of iron salts by transferring ferric iron to bivalent iron and forming chelatedcomplexes. It blocks chain reactions initiated by the activation of oxygen in the aquatic environment of the body.

Pharmacokinetics:

Ascorbic acid is absorbed in the proximal parts of the intestine. The degree of absorption depends on the concentration.

The drug contains vitamin C in a slowly releasing form, greatly increasing the bioavailability of vitamin C and its better absorption by the tissues of the body. The active component is absorbed completely, the bioavailability is 98.6%. After ingestion of two capsules of Setebo 500, the maximum plasma concentration of 2.1 mg / dL is achieved after 3 hours and lasts for 4-12 hours. It is excreted by the kidneys. Reducing the concentration to 1.5 mg / dL occurs gradually, within 12-16 hours. The half-life in the plasma is approximately 19 hours.

Indications:

- treatment and prevention of vitamin C deficiency;

- increase of protective properties of the organism to infectious diseases;

- complex therapy of "cold" diseases;

- conditions, accompanied by an increased need for vitamin C (alcohol abuse, stress, smoking, old age);

- unbalanced and malnutrition.

Contraindications:

hypersensitivity to the components of the drug, thrombophlebitis, a tendency to thrombosis, diabetes, children's age.

Carefully:Hyperoxaluria, renal insufficiency, hemochromatosis, thalassemia, polycythemia, leukemia, sideroblastic anemia, glucose-6-phosphate dehydrogenase deficiency, sickle cell anemia, progressive malignant diseases, pregnancy, lactation, kidney stone disease, oxalose.

Dosing and Administration:

Adults: 1 to 2 capsules per day.

If the duration of taking the drug for more than two weeks, consult a doctor. Do not exceed the indicated dose!

Side effects:

The drug usually does not cause side effects in the recommended doses.

When taking ascorbic acid, you can:

From the side of the central nervous system (CNS): headache, fatigue, with prolonged use of large doses - increased excitability of the central nervous system, sleep disturbances.

From the digestive system (with oral administration): irritation of the gastrointestinal mucosa, nausea, vomiting, diarrhea, spastic pain in the epigastric region.

On the part of the endocrine system: oppression of the function of the insular apparatus pancreas (manifested by hyperglycemia and glucosuria).

From the urinary system - hyperoxaluria and the formation of urinary stones from calcium oxalate.

From the cardiovascular system: thrombosis, when used in high doses - increased blood pressure, the development of microangiopathies, myocardial dystrophy.

Allergic reactions: skin rash, rarely - anaphylactic shock.

Changes in laboratory indicators: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia.

Also possible: hypervitaminosis, a feeling of heat, with prolonged use of large doses - sodium retention (Na⁺) and fluids, the disruption of zinc metabolism (Zn⁺), copper (Cu²⁺).

If taking ascorbic acid caused a change in the normal state of the body, it is necessary to stop taking it and immediately consult a doctor.

Overdose:

When taking more than 1g per day, heartburn, diarrhea, difficulty urinating and / or staining the urine red, hemolysis (in patients with deficiency of glucose-6-phosphate dehydrogenase) are possible.

With a single admission of 3 g - osmotic diarrhea is possible.

With a single admission 10 g - osmotic diarrhea and concomitant abdominal symptoms.

Treatment: symptomatic, stopping the intake of vitamin C.

Interaction:

Ascorbic acid improves absorption in the intestine of iron preparations (converts trivalent iron into bivalent); can increase the excretion of iron with simultaneous application with deferoxamine. Increases the concentration in the blood of benzylpenicillin and tetracycline; in a dose of 1 g / day increases the bioavailability of ethinyl estradiol.

Slows the excretion of acids by the kidneys, reduces the concentration of oral contraceptives in the blood, increases the excretion of drugs that have an alkaline reaction (including alkaloids). Reduces the effectiveness of heparin and indirect anticoagulants. With prolonged use reduces the chronotropic effect of isoprenaline. Reduces the therapeutic effect of phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants. Increases the clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body. Preparations of quinoline series (fluoroquinolones, etc.), calcium chloride, salicylates, glucocorticosteroids with long-term use deplete the stores of ascorbic acid. With prolonged use or use in high doses, it can disrupt the interaction of disulfiram-ethanol.In high doses increases the excretion of mexiletine with urine.

With the simultaneous administration of acetylsalicylic acid (ASA) and ascorbic acid, the absorption of ascorbic acid decreases (by about 30%), and its excretion in the urine increases. In contrast, ASA excretion decreases. With the simultaneous administration of short-acting salicylates and sulfonamides, the likelihood of developing crystalluria increases.

Also absorption and assimilation of ascorbic acid reduce oral contraceptives, fresh juices and alkaline drink.

Increase the excretion of ascorbic acid with urine barbiturates and primidon.

Special instructions:

In connection with the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, with prolonged intake of the drug, it is necessary to monitor kidney function and blood pressure. Since long-term use of large (more than 1g) doses of ascorbic acid may inhibit the function of the insulin apparatus, it is necessary to regularly monitor blood glucose and urine. Patients with elevated levels of iron in the blood ascorbic acid is prescribed in minimal doses.Assigning ascorbic acid to patients with rapidly proliferating and intensely metastatic tumors can aggravate the course of the process. As a chemical reducing agent, ascorbic acid can distort the results of various laboratory tests (blood glucose, bilirubin, transaminase activity, LDH).

Form release / dosage:

Capsules of prolonged action 500 mg.

Packaging:10 capsules per blister of PVC-aluminum foil film. For 3 or 6 blisters with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:P N008210

Date of registration:16.05.2008

The owner of the registration certificate:GlaxoSmithKline Consumer Helsker GmbH & Co. KGGlaxoSmithKline Consumer Helsker GmbH & Co. KG Germany

Manufacturer: & nbsp

GlaxoSmithKline Consumer Healthcare, GmbH & Co. KG. KG Germany

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp16.05.2008

Illustrated instructions

Instructions

Setwork 500 (Cetebe 500)