Calcium-D3 Nycomed (Tablets) Instructions for Use

ATC Code

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

Active Substances

Calcium carbonate (Ph.Eur.)

Colecalciferol (Rec.INN)

Clinical-Pharmacological Group

Drug regulating calcium and phosphorus metabolism

Pharmacotherapeutic Group

Calcium-phosphorus metabolism regulator

Pharmacological Action

A combined drug that regulates the metabolism of calcium and phosphorus in the body (in bones, teeth, nails, hair, muscles).

It reduces resorption and increases bone density, compensating for the deficiency of calcium and vitamin D₃ in the body, and is necessary for tooth mineralization.

Calcium is involved in the regulation of nerve conduction, muscle contractions, and is a component of the blood coagulation system. Adequate calcium intake is especially important during growth, pregnancy, and lactation.

Vitamin D₃ increases calcium absorption in the intestine.

The use of calcium and vitamin D₃ prevents an increase in the production of parathyroid hormone, which is a stimulator of increased bone resorption (leaching of calcium from bones).

Pharmacokinetics

Calcium

Absorption

Usually, the amount of calcium absorbed from the gastrointestinal tract is approximately 30% of the administered dose.

Distribution and Metabolism

99% of calcium in the body is concentrated in the rigid structure of bones and teeth. The remaining 1% is found in intra- and extracellular fluids. About 50% of the total calcium content in the blood is in the physiologically active ionized form, of which approximately 10% is complexed with citrate, phosphate, or other anions, and the remaining 40% is bound to proteins, primarily albumin.

Excretion

Calcium is excreted through the intestines, kidneys, and sweat glands. Renal excretion depends on glomerular filtration and tubular reabsorption of calcium.

Colecalciferol

Absorption

Colecalciferol is readily absorbed from the small intestine (about 80% of the administered dose).

Distribution and Metabolism

Colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is metabolized in the liver by hydroxylation to 25-hydroxycolecalciferol. It is then converted in the kidneys to the active form, 1,25-dihydroxycolecalciferol. 1,25-dihydroxycolecalciferol is the metabolite responsible for increasing calcium absorption. Unchanged Colecalciferol is stored in adipose and muscle tissue.

Excretion

Colecalciferol is excreted by the kidneys and through the intestines.

Indications

For adults and children over 3 years of age

• Prevention and treatment of calcium and/or vitamin D₃ deficiency;
• Supplement to specific therapy and prevention of osteoporosis and its complications (bone fractures).

ICD codes

Dosage Regimen

Tablets

The drug is taken orally. The tablets can be chewed or dissolved and taken with meals.

For prevention and treatment of calcium and/or vitamin D₃ deficiency, adults and children over 12 years are prescribed 1 tablet 2 times/day, children from 5 to 12 years – 1-2 tablets/day, children from 3 to 5 years – dosage according to the doctor’s recommendations. The average duration of the treatment course is at least 4-6 weeks. The number of repeated courses during the year is determined individually.

As a supplement to specific therapy and prevention of osteoporosis and its complications (bone fractures), adults – 1 tablet 2-3 times/day. The duration of treatment is determined by the doctor individually.

For patients with impaired liver function, no dose adjustment is required.

The drug should not be used in severe renal failure.

Elderly patients are prescribed the same dose as for adults. Possible decrease in creatinine clearance should be taken into account.

Adverse Reactions

The frequency of adverse effects of the drug is assessed as follows: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000); very rare (<1/10,000); frequency unknown (cannot be estimated from the available data).

Immune system disorders frequency unknown – hypersensitivity reactions, such as angioedema or laryngeal edema.

Metabolism and nutrition disorders uncommon – hypercalcemia, hypercalciuria; very rare – milk-alkali syndrome (Burnett’s syndrome), usually noted only with overdose.

Gastrointestinal disorders rare – constipation, flatulence, nausea, abdominal pain, diarrhea, dyspepsia.

Skin and subcutaneous tissue disorders very rare – pruritus, rash, urticaria.

Contraindications

• Hypercalcemia;
• Hypercalciuria;
• Nephrolithiasis;
• Hypervitaminosis D;
• Severe renal failure;
• Active form of tuberculosis;
• Hypersensitivity to the components of the drug, soy or peanuts.

The drug in the form of tablets is not used in children under 3 years of age.

With caution

Pregnancy, breastfeeding period, renal failure.

Calcium Carbonate with colecalciferol should be prescribed with caution to patients with sarcoidosis due to the risk of increased metabolism of vitamin D₃ into its active form. In these patients, it is necessary to monitor the concentration of calcium in blood serum and urine.

Use in Pregnancy and Lactation

Calcium-D₃ Nycomed is used during pregnancy to compensate for the deficiency of calcium and vitamin D₃ in the body. The total daily intake during pregnancy should not exceed 2500 mg of calcium and 4000 IU of vitamin D. Hypercalcemia due to overdose during pregnancy can have an adverse effect on the developing fetus.

Calcium-D₃ Nycomed is used during lactation. Calcium and vitamin D₃ can pass into breast milk, so the intake of calcium and vitamin D from other sources in the mother and child must be taken into account.

Use in Renal Impairment

The drug is contraindicated in severe renal failure.

Pediatric Use

The tablet dosage form is not used in children under 3 years of age.

Special Precautions

During long-term therapy, the content of calcium and creatinine in the blood serum should be monitored. Monitoring is especially important in elderly patients with simultaneous treatment with cardiac glycosides and diuretics and in patients with an increased tendency to form kidney stones. In cases of hypercalcemia or signs of impaired renal function, the dose should be reduced or treatment discontinued.

Vitamin D₃ should be taken with caution by patients with renal failure. In this case, it is necessary to monitor the content of calcium and phosphates in the blood serum. The risk of calcification of soft tissues should also be taken into account.

To avoid overdose, additional intake of vitamin D and calcium from other sources must be taken into account.

Calcium and vitamin D₃ should be used with caution in immobilized patients with osteoporosis due to the risk of hypercalcemia.

Concomitant use with tetracycline or quinolone antibiotics is generally not recommended or should be done with caution.

Excipients

Calcium-D₃ Nycomed contains aspartame, which is transformed into phenylalanine in the body. Therefore, the drug should not be taken by patients with phenylketonuria.

Chewable tablets (orange, mint) contain sorbitol, isomalt and sucrose. Chewable tablets (strawberry-watermelon) contain sorbitol and sucrose. Use is not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

Influence on the ability to drive vehicles and mechanisms

There are no data on the effect of the drug Calcium D₃ Nycomed on the ability to drive vehicles and mechanisms.

Overdose

Overdose can lead to hypercalcemia and hypervitaminosis D.

Symptoms of hypercalcemia manifestations – anorexia, thirst, polyuria, muscle weakness, nausea, vomiting, constipation, abdominal pain, increased fatigue, bone pain, mental disorders, polydipsia, nephrocalcinosis, urolithiasis and, in severe cases, cardiac arrhythmias. With long-term use of excessive doses (over 2500 mg of calcium) – kidney damage, calcification of soft tissues. Milk-alkali syndrome (Burnett’s syndrome) can occur in patients taking large amounts of calcium and well-absorbed alkaline solutions orally.

If symptoms of overdose are detected, the patient must stop taking calcium and vitamin D₃, as well as thiazide diuretics and cardiac glycosides, and consult a doctor.

Treatment: gastric lavage, fluid loss replacement, use of “loop” diuretics (e.g., furosemide), corticosteroids, calcitonin, bisphosphonates. It is necessary to monitor the content of electrolytes in the blood plasma, kidney function and diuresis. In severe cases, it is necessary to measure central venous pressure and monitor ECG.

Drug Interactions

Hypercalcemia can potentiate the toxic effects of cardiac glycosides when used concomitantly with calcium and vitamin D preparations. Monitoring of ECG and serum calcium levels is necessary.

Calcium preparations can reduce the absorption of tetracyclines from the gastrointestinal tract. Therefore, tetracycline drugs should be taken at least 2 hours before or 4-6 hours after taking Calcium-D₃ Nycomed.

To prevent reduced absorption of bisphosphonate drugs, they are recommended to be taken at least 1 hour before taking Calcium-D₃ Nycomed.

Corticosteroids reduce calcium absorption, so corticosteroid treatment may require an increase in the dose of Calcium-D₃ Nycomed.

When used concomitantly with thiazide diuretics, the risk of hypercalcemia increases, as they increase tubular reabsorption of calcium. With concomitant use of thiazide diuretics, serum calcium levels should be monitored regularly.

Calcium reduces the effectiveness of levothyroxine by reducing its absorption. The time interval between taking levothyroxine and Calcium-D₃ Nycomed should be at least 4 hours.

The absorption of quinolone antibiotics is reduced when used concomitantly with calcium preparations. Therefore, quinolone antibiotics should be taken 2 hours before or 6 hours after taking Calcium-D₃ Nycomed.

Calcium salts may reduce the absorption of iron, zinc and strontium ranelate. Therefore, iron, zinc or strontium ranelate preparations should be taken at least 2 hours before or 2 hours after taking Calcium-D₃ Nycomed.

Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (e.g., vitamin D₃).

Storage Conditions

The drug should be stored out of the reach of children, in a tightly closed bottle, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 2.5 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.