Calcium-d3 nicomed osteoforte

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

Composition:

Active substances:
calcium carbonate, cholecalciferol;

One tablet contains: calcium carbonate 2500 mg, equivalent to 1000 mg of calcium, cholecalciferol (vitamin D3) – 20 μg (800 IU) in the form of cholecalciferol concentrate* 8 mg;

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

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

Pharmaceutical form.
Chewable tablets.

Main physicochemical properties:
white, round, biconvex, uncoated tablets; minor specks and slight edge irregularities are 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 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 administration of calcium tablets (1000 mg) and vitamin D at a dose of 800 IU for 6 months normalized the levels of 25-hydroxyvitamin D3 metabolite 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 the hard tissues of the body (bones, teeth); 1% of calcium is present in intracellular and extracellular fluids. Approximately 50% of calcium in the blood exists 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.

Excretion. Calcium is excreted in feces, urine, and sweat. Renal excretion depends on glomerular filtration 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 bound to a specific globulin. In the liver, cholecalciferol is converted via hydroxylation into 25-hydroxycholecalciferol. It is further transformed into its 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.

Excretion. 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 an adjunct 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 impairment (glomerular filtration rate < 30 mL/min/1.73 m²);
• diseases and/or conditions associated with hypercalcemia and/or hypercalciuria;
• nephrolithiasis (kidney stones);
• hypervitaminosis D.

Interaction with other medicinal products and other types of interaction.

Thiazide diuretics reduce urinary excretion of calcium. During concomitant therapy, serum calcium levels must be monitored regularly, as the risk of hypercalcemia increases.

Calcium carbonate may interfere with the absorption of tetracycline antibiotics when administered simultaneously; therefore, these agents should be taken at least 2 hours before or 4–6 hours after oral administration of Calcium-D3 Nikomed OSTEOFORTE.

Hypercalcemia may potentiate the toxicity of cardiac glycosides when calcium and vitamin D preparations are used. It is necessary to monitor cardiac function by electrocardiography (ECG), serum calcium levels, and the patient’s clinical status.

To prevent reduced absorption of bisphosphonates when co-administered with Calcium-D3 Nikomed OSTEOFORTE, the latter should be taken no earlier than 1 hour after bisphosphonate intake.

Concomitant use of calcium may reduce the efficacy of levothyroxine due to decreased absorption. Therefore, levothyroxine should be taken 4 hours before or 4 hours after administration of the product.

Concomitant use of calcium may impair the absorption of quinolone antibiotics. Quinolone antibiotics should be taken at least 2 hours before or 6 hours after administration of Calcium-D3 Nikomed OSTEOFORTE.

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 the product.

Treatment with orlistat may potentially impair 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 interaction") and in patients with a high predisposition to stone formation. If signs of hypercalcemia or impaired renal function occur, the dose should be reduced or treatment discontinued.

The medicinal product should be used with caution in patients with hypercalcemia or signs of impaired renal function, and 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 may not be properly metabolized; therefore, other forms of vitamin D should be used.

Concomitant 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, followed by impaired renal function. To avoid overdose when other medicinal products containing vitamin D are prescribed concurrently, the vitamin D content in the product Calcium-D3 Nicomed OSTEOFORTE (800 IU) must be taken into account. Additional doses of calcium or vitamin D should be taken under medical supervision. Such patients require regular monitoring of serum calcium levels and renal function.

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

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

The product is contraindicated in patients with rare hereditary fructose intolerance, sucrase-isomaltase deficiency, or glucose-galactose malabsorption, as it contains isomalt (E 953) and sucrose.

Use during pregnancy or breastfeeding.

Pregnancy.
Calcium-D3 Nicomed OSTEOFORTE 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, when used at recommended doses, causes teratogenic effects in humans.

Breastfeeding.
Calcium-D3 Nicomed OSTEOFORTE may be used during breastfeeding. Calcium, vitamin D3, and its metabolites may pass into breast milk; therefore, intake of calcium and vitamin D 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 regarding the effect of Calcium-D3 Nicomed OSTEOFORTE on the ability to drive or operate machinery.

Dosage and Administration.

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

Adults and elderly patients:
1 tablet once daily.

Patients with hepatic impairment:
Dose adjustment is not 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 and adolescents.

Overdose.

Symptoms.

Overdose of the medication may lead to vitamin D hyperactivity and hypercalcemia.

Symptoms of hypercalcemia include: anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis, and cardiac arrhythmias in severe cases. In very severe cases, hypercalcemia may lead to coma and death. Prolonged overdose with high doses of the medication may cause irreversible kidney damage and soft tissue calcinosis. Milk-alkali syndrome may develop with the use of high doses of calcium and readily absorbable alkali substances.

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 emptying should be performed in patients with impaired consciousness. Rehydration should be carried out and a diet low in calcium should be followed. Depending on the severity of the overdose, administration of loop diuretics, bisphosphonates, calcitonin, and corticosteroids, either alone or in combination, may be necessary. Serum electrolyte levels, kidney function, and diuresis should be monitored. In severe cases, ECG parameters and central venous pressure should be monitored.

Adverse Reactions.

Undesirable effects are classified by frequency of occurrence as follows:

uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), not known (frequency cannot be estimated from available data).

From the immune system.

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

From the metabolism and nutrition disorders.

Uncommon: hypercalcemia, hypercalciuria.

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

From the gastrointestinal tract.

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

From the skin and subcutaneous tissue.

Very rare: pruritus, rash, urticaria.

Special patient groups.

Patients with renal impairment: risk of hyperphosphatemia, nephrolithiasis, and nephrocalcinosis may occur (see section "Special Warnings and 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 and sight of children!

Packaging.
30, 60, or 90 tablets in a bottle; 1 bottle in a cardboard box.

Prescription status.
Over-the-counter.

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

Address of manufacturer’s location and place of business.
Drammensveien 852, NO-1383 Asker, Norway / Drammensveien 852, NO-1383 Asker, Norway.