Calcium Sedico (Granules) Instructions for Use

Marketing Authorization Holder

Sedico South Egypt Drug Industries, Co. (Egypt)

ATC Code

A12AX (Calcium preparations in combination with vitamin D and/or other drugs)

Active Substances

Colecalciferol (Rec.INN registered by WHO)

Ascorbic acid (Rec.INN registered by WHO)

Calcium carbonate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Calcium Sedico

Effervescent granules for the preparation of a solution for oral administration 180 mg+1.275 g+400 IU/1 sachet: 20 pcs.

Dosage Form, Packaging, and Composition

3.9 g – sachets made of combined material (20) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating calcium and phosphorus metabolism

Pharmacotherapeutic Group

Calcium-phosphorus metabolism regulator

Pharmacological Action

A combined drug that regulates calcium-phosphorus metabolism. It replenishes the deficiency of calcium, vitamin D₃, and ascorbic acid in the body.

Calcium is involved in the formation of bone tissue, blood clotting, maintaining stable cardiac activity, and in the transmission of nerve impulses.

Colecalciferol regulates the metabolism of calcium and phosphate ions, enhances calcium absorption in the intestines and reabsorption in the kidneys.

Ascorbic acid is necessary for the formation of collagen and reparative processes in tissues, and plays an important role in biological oxidation and reduction processes, as well as in cellular respiration.

Indications

Osteomalacia; rickets; osteoporosis (climacteric and senile); increased need for calcium (period of intensive growth in children and adolescents, pregnancy, lactation period); hypocalcemia (in cases of increased excretion or reduced absorption, during long-term glucocorticosteroid therapy, hypoparathyroidism, renal osteodystrophy).

ICD codes

Dosage Regimen

Administer orally once daily. Dissolve the entire contents of one sachet in a glass of water. Stir until the effervescence stops and a clear solution is obtained. Consume the prepared solution immediately.

For adults and adolescents, the standard dose is one sachet daily. Adhere strictly to the once-daily frequency. Do not exceed the recommended dosage.

Take the drug at the same time each day to maintain steady levels. Administer between meals or as directed by a physician. Monitor for signs of hypercalcemia during long-term therapy.

Consult a physician for dosage adjustments in specific patient populations or for conditions requiring prolonged use. Discontinue use and seek medical advice if adverse reactions occur.

Adverse Reactions

Possible: allergic reactions, dyspepsia.

With long-term use: hepatic insufficiency, pancreatitis.

Contraindications

Hypersensitivity to the components of the combination; hypercalcemia; hypercalciuria; nephrourolithiasis; chronic renal failure.

Use in Pregnancy and Lactation

Use is possible according to the dosing regimen.

Use in Renal Impairment

Contraindicated in chronic renal failure.

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age.

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.