Cetebe 500 (Capsules) Instructions for Use

Marketing Authorization Holder

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

ATC Code

A11GA01 (Ascorbic acid (vitamin C))

Active Substance

Ascorbic acid (Rec.INN registered by WHO)

Dosage Form

Cetebe 500

Extended-release capsules 500 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Extended-release capsules hard gelatin, size 0, of the opening type, with an yellow opaque cap and a yellow transparent body; the capsule contents are round pellets from white to slightly yellowish in color.

Excipients: sucrose, corn starch, stearic acid, shellac, talc, tartaric acid, water, riboflavin, gelatin.

10 pcs. – blisters (3) – cardboard boxes.
10 pcs. – blisters (6) – cardboard boxes.

Clinical-Pharmacological Group

Vitamin preparation

Pharmacotherapeutic Group

Vitamin

Pharmacological Action

Vitamin C. Ascorbic acid is necessary for the formation of intracellular collagen and is required for strengthening the structure of teeth, bones, and capillary walls. It participates in redox reactions, tyrosine metabolism, the conversion of folic acid to folinic acid, carbohydrate metabolism, the synthesis of lipids and proteins, iron metabolism, cellular respiration processes, and activates the synthesis of steroid hormones. It reduces the need for vitamins B₁, B₂, A, E, folic acid, pantothenic acid, and helps increase the body’s resistance to infections; improves iron absorption, promoting its deposition in the reduced form. It has antioxidant properties.

Pharmacokinetics

After oral administration, Ascorbic acid is completely absorbed from the gastrointestinal tract. It is widely distributed in body tissues.

The concentration of ascorbic acid in blood plasma is normally approximately 10-20 µg/ml.

The concentration of ascorbic acid in leukocytes and platelets is higher than in erythrocytes and plasma. In deficiency states, the concentration in leukocytes decreases later and more slowly and is considered a better criterion for assessing deficiency than plasma concentration.

Binding to plasma proteins is about 25%.

Ascorbic acid is reversibly oxidized to form dehydroascorbic acid; a portion is metabolized to form ascorbate-2-sulfate, which is inactive, and oxalic acid, which is excreted in the urine.

Ascorbic acid taken in excessive amounts is rapidly excreted unchanged in the urine; this usually occurs when the daily dose exceeds 200 mg.

Indications

For systemic use: prevention and treatment of hypo- and avitaminosis of vitamin C; meeting the increased body demand for vitamin C during periods of growth, pregnancy, lactation, during heavy exertion, fatigue, during convalescence after prolonged serious illnesses; in the winter period, with an increased risk of developing infectious diseases.

ICD codes

Dosage Regimen

Take orally. Swallow the capsule whole with a sufficient amount of water. Do not crush or chew the extended-release pellets.

For the prevention of vitamin C deficiency, take one 500 mg capsule daily.

For the treatment of established vitamin C deficiency, take one 500 mg capsule twice daily or as directed by a physician.

To meet increased demand during pregnancy, lactation, convalescence, or periods of physical strain, take one 500 mg capsule daily.

The maximum daily dose for adults is 1000 mg (two capsules). Do not exceed this dose without medical supervision.

For pediatric use, follow the specific dosage recommendations provided by a healthcare professional based on the child’s age and clinical need.

Take at approximately the same time each day to maintain consistent plasma levels. The duration of use depends on the indication and should be determined by a physician.

Discontinue use and consult a doctor if symptoms of hypersensitivity, such as skin rash or difficulty breathing, occur.

Adverse Reactions

From the central nervous system: headache, feeling of tiredness, insomnia.

From the digestive system: stomach cramps, nausea and vomiting.

Allergic reactions: isolated cases of skin reactions and manifestations from the respiratory system have been described.

From the urinary system: when used in high doses – hyperoxaluria and the formation of renal stones from calcium oxalate.

Other: sensation of heat.

Contraindications

Hypersensitivity to ascorbic acid.

Use in Pregnancy and Lactation

The minimum daily requirement for ascorbic acid in the second and third trimesters of pregnancy is about 60 mg.

Ascorbic acid crosses the placental barrier. It should be borne in mind that the fetus can adapt to high doses of ascorbic acid taken by the pregnant woman, and then the newborn may develop ascorbic acid deficiency disease as a withdrawal reaction. Therefore, during pregnancy, ascorbic acid should not be taken in increased doses, except in cases where the expected benefit outweighs the potential risk.

The minimum daily requirement during lactation (breastfeeding) is 80 mg. Ascorbic acid is excreted in breast milk. A maternal diet containing an adequate amount of ascorbic acid is sufficient to prevent deficiency in the infant. It is not known whether the use of high doses of ascorbic acid by the mother is dangerous for the child. Theoretically, this is possible. Therefore, it is recommended that nursing mothers do not exceed the maximum daily requirement for ascorbic acid, except in cases where the expected benefit outweighs the potential risk.

Use in Renal Impairment

Use with caution in patients with hyperoxaluria, impaired renal function, or a history of urolithiasis.

Pediatric Use

Approved for use in children and adolescents under 18 years of age in appropriate doses.

Geriatric Use

Approved for use in elderly patients.

Special Precautions

Use with caution in patients with hyperoxaluria, impaired renal function, or a history of urolithiasis.

Since Ascorbic acid increases iron absorption, its use in high doses may be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia.

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

Use with caution in patients with glucose-6-phosphate dehydrogenase deficiency.

The use of ascorbic acid in high doses may cause exacerbation of sickle cell anemia.

Data on the diabetogenic effect of ascorbic acid are contradictory. However, with long-term use of ascorbic acid, blood glucose levels should be monitored periodically.

It is believed that the use of ascorbic acid in patients with rapidly proliferating and widely disseminated tumors may exacerbate the course of the process. Therefore, ascorbic acid should be used with caution in patients with progressive cancer.

The absorption of ascorbic acid is reduced with the simultaneous consumption of fresh fruit or vegetable juices, alkaline drinks.

Drug Interactions

With simultaneous use with barbiturates, primidone, the excretion of ascorbic acid in the urine increases.

With simultaneous use of oral contraceptives, the concentration of ascorbic acid in blood plasma decreases.

With simultaneous use with iron preparations, Ascorbic acid, due to its reducing properties, converts ferric iron to ferrous iron, which improves its absorption.

Ascorbic acid in high doses can reduce urine pH, which, with simultaneous use, reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.

With simultaneous use, acetylsalicylic acid reduces the absorption of ascorbic acid by about one third.

With simultaneous use with warfarin, a decrease in the effects of warfarin is possible.

With simultaneous use, Ascorbic acid increases iron excretion in patients receiving deferoxamine. When using ascorbic acid at a dose of 500 mg/day, impaired left ventricular function is possible.

With simultaneous use with tetracycline, the excretion of ascorbic acid in the urine increases.

A case of decreased plasma concentration of fluphenazine in a patient receiving ascorbic acid 500 mg twice daily has been described.

An increase in the plasma concentration of ethinyl estradiol is possible with its simultaneous use as part of oral contraceptives.

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.