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What is it?
CALCEMIN® ADVANCE film-coated tablets Trade name of the preparation: CALCEMIN® ADVANCE Dosage form: film-coated tablets Description: Pink oval tablets with a score on one side Composition: Active ingredients: Calcium (calcium citrate and calcium carbonate) 500mg, Vitamin D3 200 IU, Magnesium (magnesium oxide) 40mg, Zinc (zinc oxide) 7.5mg, Copper (copper oxide) 1mg, Manganese (manganese sulfate) 1.8mg, Boron (sodium borate) 250 mcg Excipients: Microcrystalline cellulose (E460), Stearic acid (E570), Croscarmellose sodium, Maltodextrin, Soy polysaccharide, Sodium lauryl sulfate Coating: Hypromellose, Magnesium silicate (E553a), Titanium dioxide (E171), Triacetin (E1518), Mineral oil (E905), FD&C Red #40 Lake (E129), FD&C Blue #1 Lake (E133), FD&C Yellow #6 Lake (E110) Pharmacotherapeutic group: Mineral supplements. Combination of calcium and vitamin D and/or other agents. ATC code: A12AX Pharmacological properties: Combined preparation containing vitamins, macro-/microelements. The action is related to the properties of its ingredients. Pharmacokinetics: Calcium is mainly absorbed by the proximal part of the small intestine via an active vitamin D-dependent transport mechanism. After absorption, calcium is distributed to organs and systems, primarily entering bone tissue. Calcium ion release in the stomach is pH-dependent. The absorption of calcium, in the form of calcium carbonate, is 20-30% and is mainly absorbed in the duodenum by vitamin D-dependent, enriched, active transport. Excretion occurs via urine, feces, and sweat. Calcium excretion with urine is a glomerular filtration function and tubular reabsorption of calcium. Vitamin D is absorbed by the small intestine. Bioavailability reaches 50-70%. It binds to specific alpha-globulins and is transported to the liver, where it is metabolized to 25-hydroxycholecalciferol. Further hydroxylation to 1,25-dihydroxycholecalciferol occurs in the kidneys. This metabolite is responsible for increasing calcium absorption. Unmetabolized vitamin D is deposited in fat and muscle tissues. Vitamin D is excreted via feces and urine. Minerals are absorbed mainly by the upper part of the small intestine and excreted by the kidneys. Partial excretion via feces is also possible. Indications for use: To replenish deficiencies of calcium, vitamin D, and trace elements when the requirement is not met by an appropriate diet, especially during prolonged deficiency, irregular and unbalanced nutrition, and increased requirements, particularly during certain periods of life: - Adolescence - Postmenopause - Pregnancy and breastfeeding (based on clinical indications and/or doctor's recommendation) - Elderly age, as well as: - As a supplement for the prevention and specific therapy of osteoporosis. Dosage and administration: Adults and adolescents over 12 years of age: 1 tablet twice daily with meals. Elderly patients: no special instructions. Patients with impaired renal function: contraindicated in patients with severe renal insufficiency. With mild and moderate renal impairment - with caution, controlling calcium and phosphorus concentrations in blood and urine. Patients with impaired liver function: no special instructions. Duration of treatment: When replenishing calcium and vitamin D deficiency, the average course of treatment is at least 4-6 weeks. The average duration of the course for osteoporosis prevention is 2 months; for osteoporosis treatment - 3 months. The number of course repetitions per year is determined by the doctor. Side effects: Gastrointestinal tract: in rare cases, constipation, bloating, abdominal pain, diarrhea, nausea, vomiting. Immune system: allergic and anaphylactic reactions, very rarely anaphylactic shock, hypersensitivity reactions, including asthmatic syndrome, mild to moderately severe skin reactions (rash, urticaria, swelling, itching) and/or respiratory system, gastrointestinal tract, and/or cardiovascular system (symptoms may include respiratory distress syndrome). Prolonged use of the preparation may increase calcium levels in urine and serum calcium concentration, which should be monitored by a doctor. For any of the above side effects, as well as reactions not described in the leaflet, consult a doctor. Contraindications: Increased individual sensitivity to any component of the preparation. Hypercalcemia, severe hypercalciuria, nephrolithiasis, hypervitaminosis D, severe renal insufficiency. Overdose: There is no evidence that the preparation can cause overdose when used at recommended doses. All, or most, reports of overdose have been associated with high doses of mono- and/or polyvitamin preparations. Intake of calcium and vitamin D exceeding 2500 mg of calcium and 4000 IU/day of vitamin D can cause toxic effects. Patients with hypercalcemia or conditions associated with hypercalcemia, renal insufficiency, and/or a tendency to nephrolithiasis may experience toxic effects of calcium and vitamin D even at much lower doses. Patients with impaired renal function have a higher risk of developing hyperphosphatemia, as well as kidney stones and nephrocalcinosis. Acute or prolonged overdose of calcium and vitamin D, especially in predisposed patients, can cause hypervitaminosis D, hypercalcemia, hypercalciuria, and hyperphosphatemia. Consequences may include renal failure, "milk-alkali syndrome," calcification of blood vessels and soft tissues, including calcinosis, leading to nephrolithiasis. Symptoms of acute overdose may include sudden headache, clouded consciousness, gastrointestinal disturbances such as constipation, diarrhea, nausea, and vomiting. If the above symptoms occur, treatment should be discontinued, and a doctor should be consulted. Laboratory and clinical manifestations of toxicity and hypercalcemia vary and depend on the patient's perception and concomitant circumstances. Symptoms may also include anorexia, weight loss, thirst, polyuria, and impaired absorption of other minerals. Changes in laboratory parameters are also possible: increased plasma concentrations of aspartate aminotransferase and alanine aminotransferase. Chronic overdose can cause calcification of blood vessels and organs due to hypercalcemia. Particularly high levels of hypercalcemia can lead to coma and death. Treatment: Rehydration, administration of loop diuretics (e.g., furosemide), glucocorticosteroids, calcitonin, bisphosphonates, in severe cases, hemodialysis. Precautions: Increasing the recommended dose is not advisable. Simultaneous use of the preparation with high-dose vitamin D sources and/or medicinal products or nutrients (such as milk) containing calcium should be used under strict medical supervision. In this case, regular monitoring of calcium in serum and urine is necessary. For long-term treatment with combined calcium and vitamin D preparations, it is necessary to monitor calcium in serum and urine, as well as kidney function by serum creatinine levels, especially in elderly patients, and during therapy with cardiac glycosides, calcium channel blockers, and/or thiazide diuretics. This also applies to patients prone to kidney stones. In case of signs of hypercalcemia or impaired renal function, reduce the dose or discontinue treatment. Vitamin D should be taken with caution by patients with mild to moderate renal impairment, with monitoring of calcium and phosphate in serum. The risk of soft tissue calcification should be remembered. Patients with severe renal insufficiency: Vitamin D is not metabolized to cholecalciferol. Therefore, they should use other forms of vitamin D. Patients with sarcoidosis, due to their increased ability to metabolize vitamin D into its active form, should use the preparation with caution. For these patients, it is recommended to determine calcium levels in blood and urine. The preparation is not intended for children under 12 years of age. Combined vitamin preparations should be prescribed with caution to immobilized patients with osteoporosis due to the high risk of hypercalcemia. Medical consultation is necessary for the use of the preparation in kidney diseases, urolithiasis, thyroid diseases, and bone metastatic tumors. Interactions with other medicinal products: Phenytoin, barbiturates, carbamazepine, rifampicin: can reduce the effect of vitamin D3 by increasing its metabolism to an inactive metabolite. Bisphosphonates, fluorides: absorption of bisphosphonates and sodium fluoride may be reduced in the gastrointestinal tract. Their administration is recommended at least 1-2 hours before or 1-2 hours after taking CALCEMIN® ADVANCE. It is best to take bisphosphonates and calcium preparations at different times of the day. Tetracyclines: absorption of tetracyclines may be reduced by the gastrointestinal tract. It is recommended to take them 2-3 hours before or 4-6 hours after taking CALCEMIN® ADVANCE. Cardiac glycosides, calcium channel blockers: toxicity of cardiac glycosides may increase (risk of lethal arrhythmias). ECG monitoring and determination of calcium concentration in blood are recommended. The effectiveness of calcium channel blockers, such as verapamil, is reduced in atrial fibrillation. Simultaneous administration is not recommended. Levothyroxine: absorption of levothyroxine may be impaired. It is recommended to take it 2-4 hours before or 4-6 hours after taking CALCEMIN® ADVANCE. Quinolones, antiviral agents: absorption of quinolone group antibacterial agents (e.g., ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, nalidixic acid) and antiviral agents (protease inhibitors) may be impaired. It is recommended to take them 2-4 hours before or 4-6 hours after taking CALCEMIN® ADVANCE. Thiazide diuretics: thiazide diuretics reduce calcium excretion in urine. Due to the risk of developing hypercalcemia caused by the simultaneous use of thiazide diuretics and calcium preparations, regular monitoring of serum calcium levels is recommended for long-term treatment. Glucocorticosteroids, hormonal contraceptives: reduce calcium absorption, may reduce the effect of vitamin D3. Dose adjustment of CALCEMIN® ADVANCE may be necessary. Ion-exchange resins, such as cholestyramine, laxatives, orlistat: simultaneous administration with this preparation may reduce the absorption of vitamin D3 in the gastrointestinal tract. It is recommended to take them 2 hours before or 4-6 hours after using vitamin D. Iron, zinc, magnesium, strontium ranelate: Calcium may reduce the absorption of iron, magnesium, zinc, and strontium ranelate: if simultaneous use is necessary, an interval of at least 2 hours before or 4-6 hours after taking the calcium preparation should be observed. Food products: may interact with certain food products (e.g., those containing oxalic acid, phosphates, phytic acid, or products with a high content of phytic acid). Due to the risk of reduced calcium absorption, it is recommended to maintain an interval of at least 2 hours between taking calcium preparations and these food products. Pregnancy and lactation: CALCEMIN® ADVANCE can be used during pregnancy and lactation at the recommended dose if clinically indicated. The daily dose for pregnant women should not exceed 1500 mg of calcium and 600 IU of vitamin D3, as chronic overdose of calcium and vitamin D3 can harm the fetus and newborn. Hypercalcemia during pregnancy can cause side effects in the fetus: effects on parathyroid hormone, hypocalcemia, tetany, epileptic seizures, and aortic stenosis syndrome, symptoms of which may include retinopathy, delayed mental development or growth retardation, and hypercalcemia in newborns. For breastfeeding mothers, it should be considered that cholecalciferol and calcium pass into breast milk. This must be taken into account when administering additional vitamin D3 to the child. Driving and operating machinery: Does not affect the ability to drive or operate machinery. Storage conditions: At a temperature not exceeding 25°C, out of reach of children. Shelf life: 3 years. Do not use after the expiry date indicated on the packaging. Packaging: 30, 60, 120 tablets in a bottle. The bottle with the leaflet is placed in a carton. Dispensing conditions: Over-the-counter