Properties
What is it?
Composition: Active ingredients: Calcium (calcium citrate and calcium carbonate) 500mg, Vitamin D3 200IU, 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. Pharmacological properties: Combined preparation containing vitamins, macro-/microelements. The action is related to the properties of its ingredients. Indications for use: To replenish deficiencies of calcium, vitamin D, and microelements when the requirement is not met by an appropriate diet, especially during prolonged insufficiency, irregular and unbalanced nutrition, and increased requirements, particularly during certain periods of life. - Adolescence - Postmenopause - Pregnancy and breastfeeding (on clinical indication and/or doctor's recommendation) - Elderly age, as well as: - As an adjunct for the prevention of specific osteoporosis therapy. Dosage and administration: - Adults and adolescents from 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. In 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 prevention course for osteoporosis is 2 months; for osteoporosis treatment - 3 months. - The number of courses to be repeated annually 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, edema, 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: - Most cases of overdose were associated with high doses of mono- and/or multivitamin preparations. - Intake of calcium and vitamin D exceeding doses of 2500 mg calcium and 4000 IU/day 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 chronic 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 calcification leading to nephrolithiasis. - Signs 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 lead to 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, hemodialysis in severe cases. Precautions: - It is not recommended to exceed the recommended dose. - Simultaneous use of the preparation with high-dose vitamin D sources and/or medications or nutrients (such as milk) containing calcium should be used under strict medical supervision with Calcium Advance. 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 renal 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 do not metabolize vitamin D 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 regarding 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: possible reduction in the absorption of bisphosphonates and sodium fluoride from the gastrointestinal tract. Their administration is recommended at least 1-2 hours before or 1-2 hours after taking Calcium Advance. It is best to take bisphosphonates and calcium preparations at different times of the day. - Tetracyclines: possible reduction in the absorption of tetracyclines from 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: possible increase in the toxicity of cardiac glycosides (risk of fatal arrhythmias). ECG monitoring and determination of serum calcium concentration are recommended. The effectiveness of calcium channel blockers, such as verapamil, is reduced in atrial fibrillation. Simultaneous administration is not recommended. - Levothyroxine: possible impairment of levothyroxine absorption. It is recommended to take it 2-4 hours before or 4-6 hours after taking Calcium Advance. - Quinolones, antiviral agents: possible impairment of absorption of quinolone group antibacterial agents (e.g., ciprofloxacin, levofloxacin, norfloxacin, ofloxacin, nalidixic acid) and antiviral agents (protease inhibitors). It is recommended to take them 2-4 hours before or 4-6 hours after taking Calcium 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. - Glucocorticoids, 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 from the gastrointestinal tract. It is recommended to take it 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 adverse effects on the fetus: influence on parathyroid hormone, hypocalcemia, tetany, epileptic seizures, and aortic stenosis syndrome, symptoms of which may include retinopathy, delayed mental development or growth retardation, development of hypercalcemia in newborns. For breastfeeding mothers, it should be taken into account that cholecalciferol and calcium pass into breast milk. This must be taken into account when prescribing additional vitamin D3 to the child. Effect on ability to drive and use machines: Does not affect. 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. Dispensing conditions: Over-the-counter Manufacturer: Bayer Consumer Care AG, Peter Merian-Strasse 84, 4052 Basel, Switzerland Contract Pharmacal Corporation, 135 Adams Avenue, Hauppauge, New York 11788, USA