Soligamma^® (Tablets) Instructions for Use

Marketing Authorization Holder

Woerwag Pharma GmbH & Co. KG (Germany)

Manufactured By

Saneca Pharmaceuticals, a.s. (Slovakia)

ATC Code

A11CC05 (Colecalciferol)

Active Substance

Colecalciferol (Rec.INN registered by WHO)

Dosage Form

Soligamma®

Film-coated tablets, 10,000 IU: 10, 20, 30, or 40 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from white to slightly yellowish, oblong, slightly biconvex, with an imprint “10” on one side.

Excipients: sodium ascorbate, DL-alpha-tocopherol, modified starch, sucrose, medium-chain triglycerides, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose (PH102), magnesium stearate, Opadry II 85F18422 white, which contains: polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, talc.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating calcium and phosphorus metabolism

Pharmacotherapeutic Group

Vitamins. Vitamin D and its analogues

Pharmacological Action

Vitamin D₃, an anti-rachitic agent. It is involved in the regulation of calcium-phosphorus metabolism, enhances calcium absorption in the intestines and phosphate reabsorption in the kidneys, promotes bone mineralization, and is necessary for the normal functioning of the parathyroid glands. It is involved in the processes of lymphokine and ATP synthesis.

Calcium and/or vitamin D₃ deficiency causes hypersecretion of parathyroid hormone. As a result of this secondary hyperparathyroidism, bone tissue remodeling increases, leading to bone fragility and fractures. The use of calcium and vitamin D₃ in the recommended dose range causes a decrease in parathyroid hormone secretion.

Pharmacokinetics

After oral administration, Colecalciferol is absorbed from the small intestine. C_max in tissues is reached after 4-5 hours, after which the concentration decreases somewhat, remaining at a constant level for a long time. Colecalciferol in blood plasma binds to the Colecalciferol-binding protein and is transported to the liver, where microsomal hydroxylation occurs to form the inactive metabolite 25-hydroxycholecalciferol (calcifediol). The concentration of circulating calcifediol in the blood is an indicator of the level of vitamin D₃ in the body. Then calcifediol enters the kidneys, where it undergoes repeated hydroxylation to form the active metabolite 1,25-dihydroxycholecalciferol (calcitriol). Vitamin D₃ and its metabolites can accumulate in muscle and adipose tissues, where their concentration can persist for several months. After taking high doses of vitamin D₃, the concentration of calcifediol in the blood serum can remain elevated for several months. Hypercalcemia due to vitamin D₃ overdose can persist for several weeks. Calcitriol undergoes further hydroxylation before being excreted from the body. The main route of excretion of vitamin D₃, as well as its hydroxylated and sulfate derivatives, is bile (feces), and at least 2% of these substances are excreted in the urine. Colecalciferol crosses the placental barrier. It is excreted in breast milk.

Indications

Prevention of rickets and osteomalacia in children and adults; prevention of diseases associated with vitamin D₃ insufficiency (deficiency) in healthy children and adults without malabsorption; prevention of rickets in full-term and premature newborns; prevention of diseases associated with vitamin D₃ insufficiency (deficiency) in children and adults with malabsorption syndrome (chronic diseases of the small intestine, biliary cirrhosis of the liver, conditions after resection of the stomach and/or small intestine).

Treatment of rickets and osteomalacia in newborns, children and adults (against the background of mineral metabolism disorders in patients over 45 years of age, prolonged immobilization due to injuries, adherence to diets with avoidance of milk and dairy products).

Maintenance therapy for osteoporosis in adults.

Treatment of hypoparathyroidism in adults.

ICD codes

Dosage Regimen

Determine the dosage individually based on the clinical indication, severity of deficiency, and patient age.

For prevention of rickets and osteomalacia in adults and children without malabsorption, administer one tablet (10,000 IU) once weekly or as directed by a physician.

For prevention in patients with malabsorption syndromes (e.g., chronic small intestine disease, biliary cirrhosis, post-resection states), use a higher dosage as medically indicated.

For treatment of established rickets or osteomalacia, administer one to two tablets (10,000-20,000 IU) daily or as prescribed, based on biochemical parameters.

For maintenance therapy in osteoporosis, administer one tablet (10,000 IU) once weekly, typically in combination with specific osteoporosis treatments.

For treatment of hypoparathyroidism, use a significantly higher dosage under strict medical supervision with frequent monitoring of serum calcium levels.

Adjust the dosage for elderly patients and those with prolonged immobilization to mitigate hypercalcemia risk.

In pediatric populations, use only formulations specifically intended for children and adolescents under 18 years of age.

For all patients, monitor serum and urinary calcium levels periodically, especially during long-term therapy exceeding 1000 IU daily or when co-administered with thiazide diuretics or cardiac glycosides.

Adverse Reactions

Symptoms due to hypercalcemia and/or hypercalciuria are most likely with hypersensitivity to colecalciferol and overdose: anorexia, nausea, vomiting, headache, heart disorders, muscle and joint pain, weakness, irritability, depression, weight loss, severe thirst, polyuria, kidney stone formation, nephrocalcinosis, calcification of soft tissues.

Contraindications

Hypersensitivity to colecalciferol, hypervitaminosis D, hypercalcemia, hypercalciuria, urolithiasis with calcium stones, pseudohypoparathyroidism, acute and chronic diseases of the liver and kidneys; depending on the dosage form used – sarcoidosis, active form of pulmonary tuberculosis.

With caution

Patients on immobilization; taking cardiac glycosides; taking additional amounts of vitamin D₃ and calcium (e.g., as part of other drugs), with impaired excretion of calcium and phosphates in the urine, when treated with benzothiadiazine derivatives and in immobilized patients (risk of hypercalcemia and hypercalciuria); in infants with a predisposition to early closure of fontanelles; with atherosclerosis, heart failure, organic heart lesions; with granulomatoses; hyperphosphatemia, phosphate nephrourolithiasis; with gastrointestinal diseases, gastric and duodenal ulcers; with hypothyroidism.

Use in Pregnancy and Lactation

Should not be used in high doses during pregnancy.

When used in high doses in a nursing mother, symptoms of overdose may develop in the child.

During pregnancy and breastfeeding, the dose is set individually by the doctor.

Use in Hepatic Impairment

Acute and chronic liver diseases.

Use in Renal Impairment

Acute and chronic kidney diseases.

Pediatric Use

In children and adolescents under 18 years of age, use in dosage forms intended for this category of patients.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

May be used in combination with calcium carbonate.

Use with caution in elderly patients, as well as in patients with prolonged immobilization.

When used concomitantly with thiazide diuretics, blood and urine calcium levels should be monitored every 3-6 months.

During long-term treatment with vitamin D₃ in a daily dose exceeding 1000 IU, blood calcium levels should be monitored.

Use in pediatrics

In children and adolescents under 18 years of age, use in dosage forms intended for this category of patients.

For children in conditions of increased insolation, the single and, accordingly, course dose should be reduced.

Drug Interactions

Phenytoin, primidone and drugs of the barbiturate group increase the need for vitamin D₃ due to an increase in the rate of biotransformation of colecalciferol into inactive metabolites, due to a decrease in the level of calcifediol in blood plasma.

Concomitant therapy with corticosteroids may reduce the effectiveness of vitamin D₃.

Concomitant therapy with cardiac glycosides (digitalis) may increase their toxic potential due to the development of hypercalcemia (risk of cardiac arrhythmia). In such patients, it is necessary to monitor ECG parameters and calcium levels in blood plasma and urine, and adjust the doses of cardiac glycosides. It is also necessary to monitor plasma levels of digoxin and digitoxin if indicated.

Vitamin D₃ can be combined with metabolites or analogues of vitamin D₃ only in exceptional cases and under the control of serum calcium levels.

Thiazide diuretics can reduce the excretion of calcium in the urine and, accordingly, increase the risk of hypercalcemia. In such patients, constant monitoring of blood and urine calcium levels is necessary during long-term use of the drug.

Rifampicin and isoniazid may reduce the effectiveness of the drug due to an increase in the rate of biotransformation of vitamin D₃.

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

Rx Only

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.