Instructions for use: Calcemin Advance film-coated tablets, bottle No. 30
Composition
active ingredients:
1 tablet contains: calcium (calcium carbonate, calcium citrate) 500 mg, vitamin D3 (cholecalciferol) 200 IU, magnesium (magnesium oxide) 40 mg, zinc (zinc oxide) 7.5 mg, copper (copper oxide) 1 mg, manganese (manganese sulfate) 1.8 mg, boron (sodium borate) 250 mcg;
excipients: maltodextrin, microcrystalline cellulose, croscarmellose sodium, acacia, hypromellose, stearic acid, soy polysaccharide, titanium dioxide (E 171), sodium lauryl sulfate, magnesium silicate, triacetin, mineral oil, special red AC (E 129), sunset yellow FCF (E 110), diamond blue FCF (E 133).
Dosage form
Film-coated tablets.
Main physicochemical properties: oval tablets, coated with a pink shell, with a transverse notch on one side.
Pharmacotherapeutic group
Calcium, combinations with vitamin D and/or other drugs. ATX code: A12A X.
Pharmacological properties
Pharmacodynamics.
Calcium is an important structural component of bone tissue. The use of calcium corrects the deficiency of its intake with food, especially with increased need for calcium or with reduced absorption.
Calcium carbonate is the salt with the highest content of elemental calcium. Calcium citrate increases the bioavailability of the drug in patients with reduced gastric acidity, achlorhydria, while taking H2-histamine receptor blockers; reduces the risk of urinary tract stone formation with prolonged use, has a high antiresorptive potential due to inhibition of parathyroid hormone.
Vitamin D is extremely important for the absorption of calcium, phosphates, and magnesium in the small intestine. It regulates the content of these elements in body fluids and helps maintain normal blood calcium levels, and is also involved in the synthesis of organic elements and skeletal calcification.
Magnesium participates in bone metabolism, prevents bone demineralization, and inhibits calcium deposition in the walls of blood vessels, heart valves, muscles, and urinary tract.
Zinc is a cofactor for more than 200 enzymes and affects the process of bone remodeling.
Copper is involved in the construction of the most important connective tissue proteins – collagen and elastin, which form the matrix of bone and cartilage tissue.
Manganese normalizes the synthesis of glycosaminoglycans, necessary for the formation of bone and cartilage tissue. It duplicates the calcium-sparing functions of vitamin D.
Boron regulates the activity of parathyroid hormone and, through it, the metabolism of calcium, magnesium, phosphorus, and cholecalciferol.
Indication
To slow down the rate of bone loss and correct calcium metabolism disorders, to treat diseases of the musculoskeletal system and dental diseases. Recommended for children aged 12 years and older, adults, including women in the peri- and postmenopausal period, especially if there are contraindications to the use of hormone replacement therapy.
As part of the complex treatment of conditions accompanied by significant loss of bone mass.
As a basic agent in the use of antiresorptives (hormone replacement therapy, calcitonin, bisphosphonates) and bone formation stimulants.
Osteopenic conditions, systemic osteoporosis and its complications.
Contraindication
Increased individual sensitivity to any of the components of the drug (allergic reactions); hypercalcemia and/or conditions leading to hypercalcemia (sarcoidosis, malignant neoplasms and primary hyperthyroidism), severe hypercalciuria, impaired renal function, nephrolithiasis; hypervitaminosis D
Interaction with other medicinal products and other types of interactions
When using this drug simultaneously with other medications, you should consult a doctor.
Interaction with other drugs.
Calcium may reduce the absorption of other drugs by forming insoluble complexes in the gastrointestinal tract, including antibiotics (e.g., tetracyclines, quinolones) and antiviral drugs, eltrombopag, sodium fluoride. Calcium absorption may also be reduced. To avoid potential interactions, these drugs should be administered at least 2 hours before or 4-6 hours after calcium administration, unless otherwise indicated.
Interaction with protease inhibitors. Concomitant use of calcium- or magnesium-containing drugs, including buffered drugs, results in decreased plasma concentrations of all these compounds. Therefore, it is recommended to administer protease inhibitors 2 hours before or 1 hour after aluminum-, calcium-, or magnesium-containing drugs. Such effects have been observed with amprenavir, atazanavir, and tipranavir.
Phosphates, bisphosphonates, and fluorides. Calcium supplements reduce the absorption of bisphosphonates, so they should be taken at least 30 minutes before calcium, but preferably at a different time or day. Concomitant administration of the drug with antacids containing aluminum is not recommended due to reduced effectiveness.
Eltrombopag. A high-fat breakfast with calcium (427 mg) resulted in a 59% decrease in plasma eltrombopag levels, whereas a low-calcium meal (<50 mg) had no effect on plasma eltrombopag levels. Calcium-rich meals and antacids containing aluminum, calcium, and magnesium significantly reduced systemic absorption.
Calcium and/or vitamin D. Thiazide diuretics reduce urinary calcium excretion. Due to the increased risk of hypercalcemia with concomitant use of thiazide diuretics, serum calcium levels should be monitored regularly.
When used simultaneously with furosemide and other loop diuretics, renal excretion of calcium increases.
Cardiac glycosides and calcium channel blockers. Hypercalcemia increases the risk of fatal arrhythmias with cardiac glycosides such as digoxin and reduces the effectiveness of calcium channel blockers such as verapamil in atrial fibrillation. Monitoring of serum calcium, ECG, and clinical status is recommended.
Glucocorticoids and hormonal contraceptives impair the absorption of calcium ions.
Vitamin D. Some medications may reduce the absorption of vitamin D from the gastrointestinal tract. To minimize interactions, these medications and vitamin D should be taken at least 2 hours before or 4–6 hours after taking vitamin D.
Such drugs include: ion exchange resins (e.g. cholestyramine), laxatives, orlistat. Carbamazepine, phenytoin or barbiturates increase the metabolism of vitamin D to its inactive metabolites and thus reduce its effect.
Simultaneous use of Calcemin®Advance with vitamin A reduces the toxicity of vitamin D3.
Calcium interactions with foods and supplements. Oxalic acid, found in spinach and rhubarb, and phytic acid, found in whole grains, can inhibit calcium absorption. Therefore, it is not recommended to consume calcium-containing foods within two hours of consuming foods rich in oxalic and phytic acids.
Iron, zinc, magnesium. Calcium supplements may reduce the absorption of iron, zinc, and copper from food. However, for individuals with adequate iron, zinc, or magnesium stores, this is of no clinical significance with long-term use. For individuals at risk for iron, zinc, or magnesium deficiency, it is recommended that calcium supplements be taken at bedtime rather than with meals to prevent inhibition of mineral absorption from food.
Fiber: Some components of dietary fiber may reduce calcium absorption. Taking psyllium with calcium does not appear to significantly reduce calcium absorption.
Application features
Do not exceed the recommended dose. Calcemin® Advance should not be used simultaneously with other calcium or vitamin D preparations.
Overdose of calcium and vitamin D is accompanied by side effects, including hypercalcemia and hypercalciuria. Calcium and vitamin D should be used with caution so as not to exceed a total dose of 2500 mg of calcium and 4000 IU of vitamin D, taking into account food intake (see section "Overdose").
Patients receiving other preparations containing vitamin D and/or calcium or any other medicines should consult a doctor before starting to use this medicine.
During long-term treatment with calcium-containing drugs in combination with vitamin D, as well as in case of mild or moderate renal insufficiency (including in elderly patients), it is necessary to monitor the level of calcium, phosphates and creatinine in the blood serum; calcium and phosphates in the urine. If signs of hypercalcemia or impaired renal function, calciuria exceeding 7.5 mmol/day (300 mg/day) appear, the dose should be reduced or the drug should be discontinued. In case of impaired renal function and with simultaneous use of cardiac glycosides, calcium channel blockers and/or thiazide diuretics, monitoring of the functional state of the kidneys should be carried out by determining the level of creatinine in the blood serum (see section "Interaction with other medicinal products and other types of interactions").
Combination drugs should be used with caution in immobilized patients due to the increased risk of hypercalcemia.
No dose adjustment is required for patients with impaired liver function. This drug should not be used in patients with impaired renal function, nephrolithiasis, or a tendency to form calcium deposits.
Use during pregnancy or breastfeeding
During pregnancy and breastfeeding, the drug is used according to indications and under the supervision of a doctor. The use of the drug in recommended doses is considered safe. Recommended doses should not be exceeded, as chronic overdose may be harmful to the fetus and newborn.
During pregnancy and lactation, the total daily dose, taking into account intake from food and medications, should not exceed 2500 mg for calcium and 4000 IU for vitamin D.
Teratogenic effects have been observed in animals following overdose of vitamin D during pregnancy. There is no evidence to suggest a possible teratogenic effect in humans when vitamin D is administered at recommended doses.
Hypercalcemia in pregnancy due to high doses of vitamin D has been associated with fetal hypercalcemia, which may lead to adverse effects in the newborn, including parathyroid hormone suppression, hypocalcemia, tetany, seizures, and aortic stenosis syndrome, which may present with retinopathy, mental retardation, or growth retardation; and may also lead to neonatal hypercalcemia.
Vitamin D and calcium are excreted in breast milk. This should be taken into account if the child is receiving any appropriate products containing vitamin D and calcium.
Fertility: To date, there is no evidence to suggest a possible adverse effect of vitamin D and/or calcium on human fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect on the ability to drive or use machines was observed.
Method of administration and doses
Adults and children over 12 years of age should take 1 tablet with meals 1–2 times a day. Wash down with sufficient water (200 ml). The maximum daily dose should not exceed 3 film-coated tablets. The course of treatment is determined by the doctor depending on the nature of the disease.
Children: Not intended for use in children under 12 years of age.
Overdose
When used in recommended doses, no cases of overdose have been observed. The vast majority of overdose reports are associated with the simultaneous use of high doses of single-component or multivitamin preparations. In case of accidental overdose, symptomatic treatment is recommended: gastric lavage, drinking plenty of fluids, a diet low in calcium.
Long-term intake of calcium and vitamin D in excessive doses exceeding 2500 mg of calcium and 4000 IU/day of vitamin D may lead to toxic effects.
In patients with hypercalcemia or conditions associated with hypercalcemia, renal insufficiency and/or a predisposition to nephrolithiasis, toxic effects of calcium and vitamin D are likely to occur at lower doses.
Acute or prolonged overdose of calcium and vitamin D can cause hypervitaminosis D, hypercalcemia, hypercalciuria, hyperphosphatemia and increased calcium absorption. The consequences are renal failure, milk-alkali syndrome, especially in patients with impaired renal function, vascular and soft tissue calcification, including calcinosis, leading to nephrocalcinosis and nephrolithiasis, especially in patients with a predisposition to nephrolithiasis.
Nonspecific initial symptoms, such as sudden onset of headache, muscle weakness, depressed consciousness, and gastrointestinal disturbances (abdominal pain, constipation, diarrhea, nausea, and vomiting), may indicate acute overdose.
If such symptoms occur, you should stop using the drug and consult a doctor immediately.
Laboratory and clinical manifestations of poisoning and hypercalcemia may include the following symptoms: anorexia, weight loss, fatigue, thirst, polyuria, bone pain, cardiac arrhythmias, and impaired absorption of other minerals. Laboratory changes may include increased plasma aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Chronic overdose may cause calcification of blood vessels and organs due to hypercalcemia. Extremely high hypercalcemia may lead to coma and death.
Side effects
Gastrointestinal: Gastrointestinal and abdominal pain, dyspepsia (including abdominal discomfort), constipation, diarrhea, flatulence, nausea and vomiting.
Immune system disorders (allergic reactions, anaphylactic reactions, anaphylactic shock). Hypersensitivity reactions with associated laboratory and clinical manifestations, including asthma syndrome, mild to moderate reactions affecting the skin and/or respiratory system, gastrointestinal tract and/or cardiovascular system, have been reported rarely. Symptoms may include rash, urticaria, edema, flushing, itching, non-cardiogenic pulmonary edema. Severe reactions, including anaphylactic shock, have been reported very rarely.
From the laboratory data. With prolonged use in high doses, the development of hypercalcemia, hypercalciuria, and hypervitaminosis D is possible.
Expiration date
3 years. Do not use the drug after the expiration date indicated on the package.
Storage conditions
No special storage conditions are required. Store in a tightly closed bottle. Keep out of the reach of children.
Packaging
Primary: plastic bottle containing 30, 60 or 120 film-coated tablets; with a screw cap and a protective film. Secondary: cardboard box.
Vacation category
Without a prescription.
Producer
Contract Pharmacal Corporation/Contract Pharmacal Corporation
Address
135 Adams Avenue, Hauppauge, New York 11788, USA/135 Adams Avenue, Hauppauge, New York 11788, USA.
