Calcium-d3 nicomed forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALCIUM-D3 NYCOMED FORTE (CALCIUM-D3 NYCOMED FORTE)

Composition:

Active ingredient: Each tablet contains calcium carbonate 1250 mg, equivalent to 500 mg of calcium, cholecalciferol (vitamin D3) – 10 μg (400 IU) in the form of cholecalciferol concentrate* 4 mg;

Excipients: xylitol (E 967), lemon flavored granulate (isomalt (E 953), lemon flavoring, mono- and diglycerides of fatty acids), povidone, magnesium stearate, sucralose (E 955).

*Composition of cholecalciferol concentrate: cholecalciferol, DL-α-tocopherol, medium-chain triglycerides, modified corn starch, sucrose, sodium ascorbate, colloidal anhydrous silicon dioxide.

Pharmaceutical form. Chewable tablets.

Main physicochemical properties: round, white, biconvex uncoated tablets; presence of specks and minor edge irregularities is acceptable. A small amount of powder at the bottom of the bottle is possible.

Pharmacotherapeutic group.

Mineral supplements. Calcium, combinations with vitamin D and/or other agents.

ATC code A12AX.

Pharmacological properties.

Pharmacodynamics.

Vitamin D3 increases calcium absorption in the intestine.

Administration of calcium and vitamin D3 prevents the increase in parathyroid hormone (PTH) levels caused by calcium deficiency, which leads to enhanced bone resorption (leaching of calcium from bones).

A clinical study in hospitalized patients with vitamin D deficiency showed that daily intake of 2 calcium tablets of 500 mg and vitamin D at a dose of 400 IU for 6 months normalized the level of 25-hydroxylated metabolite of vitamin D3 and reduced manifestations of secondary hyperparathyroidism and alkaline phosphatase levels.

Pharmacokinetics.

Absorption. Overall, approximately 30% of the administered calcium dose is absorbed through the gastrointestinal tract.

Distribution and biotransformation. 99% of calcium is concentrated in hard tissues of the body (bones, teeth); 1% of calcium is present in intracellular and extracellular environments. Approximately 50% of calcium in blood is in the physiologically active ionized form, nearly 10% is complexed with citrates, phosphates, and other anions, and the remaining 40% is protein-bound, primarily to albumins.

Elimination. Calcium is excreted in feces, urine, and sweat. Renal excretion depends on glomerular filtration rate and tubular reabsorption of calcium.

Absorption. Vitamin D3 is readily absorbed in the small intestine.

Distribution and biotransformation. Cholecalciferol and its metabolites circulate in the blood in a bound form to a specific globulin. In the liver, cholecalciferol is converted via hydroxylation into 25-hydroxycholecalciferol. This is further converted into the active form, 1,25-dihydroxycholecalciferol, in the kidneys. 1,25-dihydroxycholecalciferol is the metabolite responsible for enhanced calcium absorption. Unmetabolized vitamin D3 is stored in adipose and muscle tissues.

Elimination. Vitamin D3 is excreted in feces and urine.

Clinical characteristics.

Indications.

Prevention and treatment of calcium and vitamin D deficiency in adult patients at risk.

Additional use of vitamin D and calcium as a supplement to specific osteoporosis therapy in patients at risk of developing calcium and vitamin D deficiency.

Contraindications.

• Hypersensitivity to the active substance or to any of the excipients;
• severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m²);
• diseases and/or conditions associated with hypercalcemia and/or hypercalciuria;
• urolithiasis (nephrolithiasis);
• hypervitaminosis D.

Interaction with other medicinal products and other types of interactions.

Thiazide diuretics reduce urinary calcium excretion. During concomitant therapy, serum calcium levels should be monitored, as the risk of hypercalcemia may increase.

Calcium carbonate may interfere with the absorption of tetracycline-class drugs; therefore, these drugs should be taken at least 2 hours before or 4–6 hours after taking Calcium-D3 Nicomed Forte.

Hypercalcemia may potentiate the toxicity of cardiac glycosides when calcium and vitamin D preparations are used. Monitoring of cardiac function by ECG, serum calcium levels, and the patient’s clinical status is required.

To avoid reduced absorption of bisphosphonates, it is recommended to take Calcium-D3 Nicomed Forte no sooner than 1 hour after bisphosphonate administration.

Concomitant use of calcium may reduce the efficacy of levothyroxine due to decreased absorption. Levothyroxine should be taken at least 4 hours after taking Calcium-D3 Nicomed Forte.

Simultaneous administration of calcium may affect the absorption of quinolone antibiotics. Quinolone antibiotics should be taken at least 2 hours before or 6 hours after taking Calcium-D3 Nicomed Forte.

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

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

Special precautions for use.

During prolonged treatment with the drug, it is necessary to monitor serum calcium and creatinine levels and renal function, especially in elderly patients receiving concomitant therapy with cardiac glycosides or diuretics (see section "Interaction with other medicinal products and other forms of interactions") and in patients with a high predisposition to dental calculus formation. If signs of hypercalcemia or impaired renal function occur, the dose should be reduced or treatment discontinued.

The drug should be used with caution in patients with hypercalcemia or signs of impaired renal function, and serum levels of calcium and phosphates should be monitored. The risk of soft tissue calcification should be kept in mind. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol cannot be properly metabolized; therefore, other forms of vitamin D should be used. Simultaneous intake of vitamin D from other sources, including medicinal products or foods containing calcium (e.g., milk), may lead to hypercalcemia and milk-alkali syndrome, resulting in impaired renal function. In such patients, serum calcium levels and renal function should be monitored regularly.

Calcium-D3 Nikomed Forte should be used with caution in patients with sarcoidosis due to the risk of increased metabolism of vitamin D3 into its active form. Serum and urinary calcium levels should be monitored.

Calcium-D3 Nikomed Forte should be used with caution in immobilized patients with osteoporosis due to the risk of developing hypercalcemia.

To avoid overdose, intake of calcium and vitamin D3 from other sources should be taken into account within the recommended daily intake levels of calcium and vitamin D3.

The drug should not be used in patients with rare hereditary fructose intolerance, sucrase-isomaltase deficiency, or glucose-galactose malabsorption, as the drug contains isomalt and sucrose.

Use during pregnancy or breastfeeding.

Pregnancy.
Calcium-D3 Nikomed Forte may be used during pregnancy in cases of calcium and vitamin D deficiency. The daily dose should not exceed 2500 mg of calcium and 4000 IU of vitamin D. Animal studies have shown that high doses of vitamin D have reproductive toxicity. Pregnant women should avoid overdosing, as prolonged hypercalcemia may have adverse effects on the fetus. There is no evidence that vitamin D at recommended doses causes teratogenic effects in humans.

Breastfeeding.
Calcium-D3 Nikomed Forte may be used during breastfeeding. Calcium, vitamin D3, and its metabolites may pass into breast milk; therefore, intake of calcium and vitamin D3 from other sources into the infant's body should be taken into account.

Ability to influence reaction rate while driving or operating machinery.
There are no known data on the effect of Calcium-D3 Nikomed Forte on the ability to drive or operate machinery.

Dosage and Administration.

The medication is intended for oral use. The tablet should be chewed or dissolved.

Adults and elderly patients:
1 tablet twice daily.

Patients with hepatic insufficiency:
No dose adjustment is required.

Patients with severe renal impairment:
The medication should not be used (see section "Contraindications").

Children:
The medication is not intended for use in children.

Overdose.

Symptoms:
Overdose of the medication may lead to vitamin D hypervitaminosis and hypercalcemia. Symptoms of hypercalcemia include:
anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, increased fatigue, mental disorders, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis, cardiac arrhythmias in severe cases. Severe hypercalcemia may lead to coma and fatal outcome. Persistent high calcium levels in the body may result in irreversible kidney damage and soft tissue calcification.

In patients taking large amounts of calcium and absorbable alkalis, milk-alkali syndrome may develop; such patients require hospitalization.

Treatment:
Symptomatic and supportive therapy. The medication should be discontinued. Therapy with thiazide diuretics and cardiac glycosides should also be discontinued (see section "Interaction with other medicinal products and other forms of interaction"). Gastric lavage should be performed in patients with impaired consciousness. High fluid intake should be ensured, and a diet low in calcium should be followed. Depending on the severity of overdose, administration of loop diuretics, bisphosphonates, calcitonin, corticosteroids, either alone or in combination, may be necessary. Serum electrolyte levels, renal function, and diuresis should be monitored. In severe cases, continuous monitoring of electrocardiogram (ECG) and central venous pressure (CVP) is required.

Adverse Reactions

Undesirable effects are classified by frequency of occurrence as follows:

uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), not known (frequency cannot be determined from available data).

Immune system disorders.

Not known: hypersensitivity reactions, including angioneurotic edema, laryngeal edema.

Metabolism and nutrition disorders.

Uncommon: hypercalcemia, hypercalciuria.

Very rare: milk-alkali syndrome (frequent need to urinate, persistent headache, persistent loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcemia, alkalosis, renal failure) – observed only in cases of overdose (see section "Overdose").

Gastrointestinal disorders.

Rare: constipation, dyspepsia, flatulence, nausea, abdominal pain, diarrhea.

Skin and subcutaneous tissue disorders.

Very rare: pruritus, rash, urticaria.

Special patient groups.

Patients with renal impairment: risk of hyperphosphatemia, nephrolithiasis, and nephrocalcinosis may occur (see section "Special precautions for use").

Shelf life.
30 months.

Storage conditions.
Store the bottle tightly closed at a temperature not exceeding 30°C. Keep out of reach of children!

Packaging.
30, 60, or 120 tablets per bottle. 1 bottle in a cardboard box.

Pharmaceutical supply category.
Over-the-counter.

Manufacturer.
Asker Contract Manufacturing AS, Norway / Asker Contract Manufacturing AS, Norway.

Manufacturer's address and place of business.
Drammensveien 852, NO-1383 Asker, Norway / Drammensveien 852, NO-1383 Asker, Norway.