AC-Glenvitol (Tablets) Instructions for Use

Marketing Authorization Holder

Glenmer Biotechnologies Fez – Bishkek, LLC (Kyrgyz Republic)

ATC Code

A11GB (Ascorbic acid (vitamin C) in combination with other drugs)

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Dextrose (Ph.Eur. European Pharmacopoeia)

Sucrose (Ph.Eur. European Pharmacopoeia)

Dosage Form

AC-Glenvitol

Tablets 25 mg+0.83 g+2.064 g: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets without fruit flavor, (orange, cherry, pear, lemon, mint, blackcurrant).

2 pcs. – non-blister contour packs (10) – cardboard packs.

Clinical-Pharmacological Group

Vitamin preparation

Pharmacotherapeutic Group

Vitamin

Pharmacological Action

A vitamin agent that has a metabolic effect, participates in the regulation of redox processes, carbohydrate metabolism, blood coagulation, tissue regeneration, and the synthesis of steroid hormones.

It increases the body’s resistance to infections, reduces vascular permeability, and decreases the need for vitamins B₁, B₂, A, E, folic acid, and pantothenic acid.

Indications

Hypo- and avitaminosis C.

Increased need for ascorbic acid (period of intensive growth, pregnancy, lactation period, increased physical exertion, convalescence period).

ICD codes

Dosage Regimen

Administer orally. All doses are expressed in terms of ascorbic acid content.

For prophylactic use in adults, prescribe 50-100 mg once daily. For the prophylactic regimen in children, administer 25 mg once daily.

For therapeutic purposes in adults, prescribe 50-100 mg taken three to five times per day. For therapeutic use in children, administer 50-100 mg two to three times daily.

During pregnancy and lactation, prescribe 300 mg daily for an initial period of 15 days. Subsequently, reduce the dosage to a maintenance level of 100 mg once daily.

Adjust the therapeutic dose based on the severity of the vitamin deficiency and individual patient response. The maximum daily dose must be determined by a physician.

For all patient groups, the duration of treatment is determined by the prescribing physician. Do not exceed the recommended dosage without medical supervision.

Adverse Reactions

Possible allergic reactions, irritation of the gastrointestinal mucosa (nausea, vomiting, diarrhea, gastrointestinal spasm); inhibition of the function of the insular apparatus of the pancreas (hyperglycemia, glucosuria); when used in high doses – hyperoxaluria and nephrocalcinosis (oxalate).

Changes in laboratory parameters thrombocytosis, hyperprothrombinemia, erythrocytopenia, neutrophilic leukocytosis, hypokalemia.

Contraindications

Hypersensitivity to the components of the combination; childhood (under 3 years).

With caution

Diabetes mellitus, glucose-6-phosphate dehydrogenase deficiency; for use in high doses – hemochromatosis, sideroblastic anemia, thalassemia, hyperoxaluria, nephrourolithiasis.

Use in Pregnancy and Lactation

Used as indicated for increased need for ascorbic acid during pregnancy and lactation.

Pediatric Use

Contraindication — childhood (under 3 years).

Special Precautions

Due to the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor kidney function and blood pressure.

With long-term use of large doses, inhibition of the function of the insular apparatus of the pancreas is possible, so it must be regularly monitored during treatment.

In patients with increased iron content in the body, ascorbic acid should be used in minimal doses.

Prescription of ascorbic acid to patients with rapidly proliferating and intensively metastasizing tumors may exacerbate the course of the process.

Ascorbic acid as a reducing agent may distort the results of various laboratory tests (blood glucose, bilirubin, activity of liver transaminases and LDH).

Drug Interactions

Ascorbic acid: increases the concentration in the blood of benzylpenicillin and tetracyclines; at a dose of 1 g/day increases the bioavailability of ethinylestradiol (including that which is part of oral contraceptives).

Improves the absorption in the intestine of iron preparations (converts ferric iron to ferrous); may increase iron excretion when used concomitantly with deferoxamine.

Reduces the effectiveness of heparin and indirect anticoagulants.

Acetylsalicylic acid, oral contraceptives, fresh juices and alkaline drinks reduce absorption and assimilation. With simultaneous use with acetylsalicylic acid, the urinary excretion of ascorbic acid increases and the excretion of acetylsalicylic acid decreases. Acetylsalicylic acid reduces the absorption of ascorbic acid by approximately 30%.

Increases the risk of crystalluria during treatment with short-acting salicylates and sulfonamides, slows the renal excretion of acids, increases the excretion of drugs with an alkaline reaction (including alkaloids), reduces the concentration in the blood of oral contraceptives.

Increases the total clearance of ethanol, which, in turn, reduces the concentration of ascorbic acid in the body.

Quinoline drugs, calcium chloride, salicylates, corticosteroids with long-term use deplete ascorbic acid reserves.

With simultaneous use, it reduces the chronotropic effect of isoprenaline.

With long-term use or use in high doses, it may impair the disulfiram-ethanol interaction.

In high doses, it increases the renal excretion of mexiletine.

Barbiturates and primidone increase the urinary excretion of ascorbic acid.

Reduces the therapeutic effect of antipsychotic drugs (neuroleptics) – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.