Properties
What is it?
CALCIUM D3 NICOMED FORTE International Nonproprietary Name - colecalciferol, calcium carbonate ATC classification code - A12AX Clinical-pharmacological group - Agents affecting phosphorus and calcium metabolism. Regulators of bone tissue metabolism; Vitamin D3 preparations Nosological group - Preventive and therapeutic agent for osteoporosis and calcium deficiency Composition and dosage form 30, 60, 100, and 120 chewable tablets One tablet contains active ingredients: Calcium carbonate - 1250 mg (equivalent to 500 mg calcium), Cholecalciferol (Vitamin D3) - 400 IU (10 mcg) Excipients: Sorbitol, Povidone, Isomalt, Lemon oil, Mono- and diglycerides of fatty acids, Aspartame, Magnesium stearate, Tocopherol, Vegetable oil, Sucrose, Gelatin, Corn starch. Description Round, white tablets with a lemon flavor. Pharmacological properties A combined preparation that regulates calcium and phosphorus metabolism in the body. It reduces resorption (absorption) and increases bone tissue density, replenishing calcium and vitamin D deficiency in the body. Calcium participates in the regulation of nerve conduction, muscle contraction, and is a component of the blood coagulation system. Pharmacokinetics Vitamin D increases calcium absorption in the intestines. The use of calcium and D3 counteracts the increased production of parathyroid hormone, which is a stimulant of bone resorption (calcium leaching from bones). Pharmacokinetic properties: Vitamin D3 is absorbed in the small intestine. Calcium, in ionized form, is absorbed in the proximal part of the small intestine through an active vitamin D-dependent transport mechanism. Indications - Prevention of osteoporosis, complex therapy (menopausal, senile, steroid, idiopathic, and others) and its complications (bone fractures). - Calcium and/or vitamin D deficiency. Dosage and administration Consult your doctor before use. For the prevention of osteoporosis, the course is 2 tablets per day: one in the morning, the second in the evening, preferably during meals. The tablet can be chewed or swallowed whole. Side effects Intestinal dysfunction (constipation or diarrhea, flatulence, nausea, abdominal pain) may occur. In rare cases, hypercalcemia and hypercalciuria (increased calcium content in blood and urine) are observed. Contraindications - Hypersensitivity to any component of the preparation. - Hypercalcemia or hypercalciuria (increased calcium concentration in blood or urine), including that caused by prolonged immobilization. - Sarcoidosis. - Renal failure. Pregnancy and lactation During pregnancy, the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Breastfeeding: Vitamin D3 and calcium pass into breast milk. Therefore, during this period, the use of Calcium-D3 Nicomed should be under medical supervision. Special instructions - Calcium-D3 Nicomed tablets contain aspartame, which is transformed into phenylalanine in the body. Therefore, the preparation cannot be taken by patients with phenylketonuria. - For children under 12 years of age, the use of the preparation is recommended only under medical supervision. - In patients taking cardiac glycosides and/or diuretics simultaneously, it is necessary to monitor calcium and creatinine levels in blood serum. - In case of increased calcium and creatinine levels in blood serum, it is necessary to reduce the dose of the preparation or temporarily discontinue treatment. - To avoid overdose, it is necessary to consider additional sources of vitamin D intake. Overdose In case of overdose, consult your doctor. Overdose may cause anorexia, thirst, decreased urination, nausea, vomiting, hypercalciuria, hypercalcemia, hypercreatininemia. In this case, it is recommended to administer a large amount of fluid, use loop diuretics (e.g., furosemide), corticosteroids, calcitonin, bisphosphonates. Interactions with other drugs The activity of vitamin D3 may be reduced when taken simultaneously with phenytoin or barbiturates. - When treated simultaneously with cardiac glycosides, ECG and clinical monitoring are necessary, as calcium preparations potentiate the therapeutic and toxic effects of cardiac glycosides. - Calcium and vitamin D preparations enhance the absorption of tetracyclines from the gastrointestinal tract. Therefore, the interval between taking tetracycline group preparations and Calcium-D3 Nicomed Forte should be at least 3 hours. - To avoid reduced absorption of bisphosphonate preparations or sodium fluoride, Calcium-D3 Nicomed Forte should be taken at least 2 hours after their administration. - Corticosteroids reduce calcium absorption, so corticosteroid treatment may require an increase in the dose of Calcium-D3 Nicomed Forte. - Simultaneous treatment with cholestyramine preparations and laxatives based on mineral or vegetable oil may reduce the absorption of vitamin D3. - Concomitant use of thiazide diuretics increases the risk of hypercalcemia, as they increase tubular reabsorption of calcium. Furosemide and other loop diuretics, on the contrary, increase calcium excretion by the kidneys. Storage conditions and shelf life Store in a dry place, inaccessible to children, at a temperature of 15°C to 25°C. Shelf life: 3 years. The preparation cannot be used after the expiry date. Dispensing from pharmacy Over-the-counter. Manufacturer, country Nycomed Pharma A/S, Norway. Norway