Celascon^® Vitamin C (Tablets) Instructions for Use

Marketing Authorization Holder

Zentiva, a.s. (Slovakia)

Manufactured By

Saneca Pharmaceuticals, a.s. (Slovakia)

ATC Code

A11GA01 (Ascorbic acid (vitamin C))

Active Substance

Ascorbic acid (Rec.INN registered by WHO)

Dosage Form

Celascon® Vitamin C

Effervescent tablets (blood orange flavor) 500 mg: 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets with blood orange flavor round, smooth, marbled light pink in color, hygroscopic.

Excipients: anhydrous citric acid, sodium bicarbonate, anhydrous lactose, orange flavor type Bolexo, macrogol 6000, acesulfame potassium, Allura Red AC dye, sorbitol.

10 pcs. – polypropylene tubes (1) – cardboard packs.
10 pcs. – polypropylene tubes (3) – cardboard packs.
20 pcs. – polypropylene tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Vitamin preparation

Pharmacotherapeutic Group

Vitamin

Pharmacological Action

Ascorbic acid is essential for the normal functioning and formation of connective tissue, especially for its intracellular mass and collagen.

In the process of collagen synthesis, Ascorbic acid is involved in the hydroxylation of proline and lysine in the peptide chain.

It is part of many redox reactions occurring in the body and participates in the metabolism of phenylalanine, tyrosine, folic acid, norepinephrine, histamine and some enzyme systems involved in the synthesis of lipids, proteins and the hydroxylation of carnitine and serotonin.

It stabilizes the integrity of the capillary wall and promotes increased iron absorption.

Pharmacokinetics

Absorption: Ascorbic acid is easily absorbed from the gastrointestinal tract and distributed in all tissues.

Maximum concentrations are found in the adrenal glands, pituitary gland and intestinal wall.

Most of the ascorbic acid is reversibly oxidized to dehydroascorbic acid, which has the biological activity of vitamin C.

Biotransformation occurs in the liver.

The main metabolite of ascorbic acid is oxalic acid and 2-sulfurylylascorbic acid, which are excreted in the urine.

The renal threshold for vitamin C is 1.4 mg/100 ml.

Excretion in the urine is a sign of saturation of the body with vitamin C.

Indications

Prevention and treatment of conditions caused by vitamin C deficiency

• Hypo- and avitaminosis of vitamin C (scurvy).

As part of complex therapy

• “colds” to increase the body’s resistance;
• During the convalescence period after long-term illnesses;
• Bleeding (pulmonary, hemorrhagic diathesis);
• In gastrointestinal diseases accompanied by impaired absorption of vitamin C;
• In alcohol and nicotine dependence;
• In slowly healing wounds;
• Methemoglobinemia.

ICD codes

Dosage Regimen

For prophylactic use in adults, take 500 mg once daily.

For therapeutic use in adults, take 1000 mg once daily.

Always dissolve the effervescent tablet in a glass of approximately 150 ml of water before ingestion.

Do not chew or swallow the tablet whole.

Administer the dissolved solution immediately after the effervescence has ceased.

For long-term use exceeding one to two weeks, monitor renal function and blood pressure.

In patients with a history of renal impairment, use with caution and monitor for oxalate crystalluria.

Avoid concomitant intake with acetylsalicylic acid, oral contraceptives, fresh juices, or alkaline drinks as they may reduce absorption.

Do not exceed the recommended daily dose without medical supervision.

Discontinue use and consult a physician if adverse reactions such as gastrointestinal irritation or headache occur.

Adverse Reactions

From the central nervous system: headache, feeling of fatigue, with long-term use of large doses – increased excitability of the central nervous system, sleep disturbance.

From the gastrointestinal tract: irritation of the gastrointestinal mucosa, nausea, vomiting, diarrhea, stomach cramps.

From the endocrine system: inhibition of the function of the pancreatic islet apparatus (hyperglycemia, glucosuria).

From the urinary system: when used in high doses – hyperoxaluria and the formation of urinary stones from calcium oxalate, damage to the glomerular apparatus of the kidneys.

From the cardiovascular system: decreased capillary permeability and deterioration of tissue trophism, thrombosis, when used in high doses – increased blood pressure, development of microangiopathy, myocardial dystrophy.

Allergic reactions: skin rash, rarely – anaphylactic shock.

Laboratory parameters: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia.

Other: hypervitaminosis, metabolic disorders, feeling of heat, with long-term use of large doses – sodium and fluid retention, impaired metabolism of zinc, copper.

Contraindications

• Hypersensitivity to the components of the drug.

For the administration of large doses

• Hypercoagulation;
• Thrombophlebitis;
• Tendency to thrombosis;
• Diabetes mellitus;
• Urolithiasis;
• Glucose-6-phosphate dehydrogenase deficiency.

With caution – hyperoxalaturia, renal failure, hemochromatosis, thalassemia, polycythemia, leukemia, sideroblastic anemia, sickle cell anemia, malignant neoplasms.

Use in Pregnancy and Lactation

The minimum requirement for ascorbic acid in the II-III trimesters of pregnancy is about 60 mg.

The minimum daily requirement during breastfeeding is 80 mg.

A maternal diet containing an adequate amount of ascorbic acid is sufficient to prevent vitamin C deficiency in the infant (it is recommended that a nursing mother does not exceed the maximum monthly requirement for ascorbic acid).

Use in Renal Impairment

With caution – renal failure.

Special Precautions

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

With long-term use of large doses, inhibition of the function of the pancreatic islet apparatus 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.

The prescription of ascorbic acid to patients with rapidly proliferating and intensively metastasizing tumors may worsen the course of the process.

Ascorbic acid, as a reducing agent, can distort the results of various laboratory tests (blood glucose, bilirubin, transaminase activity).

Long-term use of high doses of ascorbic acid can accelerate its metabolism, so paradoxical hypovitaminosis may develop after discontinuation of the drug.

Drug Interactions

Ascorbic acid increases the concentration of benzylpenicillin and tetracyclines in the blood; at a dose of 1 g/day increases the bioavailability of ethinyl estradiol (in oral contraceptives).

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

Reduces the effectiveness of heparin, indirect anticoagulants, antibiotics.

Acetylsalicylic acid, oral contraceptives, fresh juices and alkaline drinks reduce the absorption and assimilation of ascorbic acid.

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 one third.

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

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

Drugs of the quinoline series, calcium chloride, salicylates, corticosteroids with long-term use deplete the reserves of ascorbic acid.

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

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

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

Barbiturates and primidone increase the excretion of ascorbic acid in the urine.

Reduces the therapeutic effect of antipsychotics (phenothiazine derivatives), tubular reabsorption of amphetamine and tricyclic antidepressants.

Storage Conditions

Store in a place inaccessible to children at a temperature below 30°C (86°F).

Shelf Life

Shelf life – 2 years.

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.