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Kalcemin Silver tablets p/o No. 60 No. 1

Name

Kalcemin Silver tablet p/o in bottle No. 60 in pack No. 1

Description

Oval tablets of light gray color, with a notch on one side.

Release form

Pills

Pharmacological properties

Calcium is an important structural component of bone tissue. Vitamin D3 (cholecalciferol) increases the absorption of calcium in the small intestine, activates the processes of restructuring (remodeling) of bone tissue by increasing the formation of the synthesis of type I collagen and osteoblasts. Improves bone quality by inhibiting osteoclast activity. Taking calcium and vitamin D prevents an increase in the release of parathyroid hormone (PTH), which is caused by calcium deficiency and is one of the causes of osteoporosis (bone resorption). Magnesium takes part in bone metabolism. Zinc is a cofactor for more than 200 enzymes that take part in the synthesis of proteins and nucleic acids responsible for cell growth and restoration. Copper takes part 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, Boron regulates the activity of parathyroid hormone and, through it, the metabolism of calcium, magnesium, phosphorus and vitamin D.

Indications for use

Prevention of osteoporosis and other calcium deficiency conditions. In the complex treatment of osteoporosis, when a deficiency of calcium and vitamin D is diagnosed. Reducing the risk and complex treatment of fractures of various locations in calcium deficiency conditions in people over 50 years of age.

Directions for use and doses

Adults and children over 12 years of age: 1 tablet 1-2 times a day with meals. The duration of use is determined by the doctor. If necessary, repeat courses of treatment are carried out. Patients with impaired liver function: no dose adjustment is required. Patients with impaired renal function: Kalcemin Silver should not be used in cases of severe renal impairment. Elderly patients: the dose is the same as for adults. A possible decrease in renal function should be taken into account.

Use during pregnancy and lactation

It is not recommended to use the drug during pregnancy and lactation. Chronic overdose can be harmful to the fetus and newborn. Hypercalcemia during pregnancy due to the use of increased doses of vitamin D can lead to the development of side effects in the fetus: inhibition of parathyroid hormone, hypocalcemia, tetany, epileptic seizures and aortic stenosis syndrome, symptoms of which may include retinopathy, mental retardation or growth impairment, and also lead to to the development of hypercalcemia in newborns. Vitamin D and calcium are excreted into breast milk.

Precautionary measures

In order not to exceed the total dose of calcium 2500 mg and vitamin D 4000 IU / day, which can lead to toxic effects, it is recommended to take into account the intake of elements from other sources (for example, from food). During treatment, it is recommended to check calcium levels in the blood serum and urine. During long-term treatment with drugs containing calcium in combination with vitamin D, it is necessary to monitor serum calcium concentrations and renal function by determining serum creatinine levels. Especially in elderly patients with simultaneous use of cardiac glycosides, calcium channel blockers and/or thiazide diuretics, as well as in patients with a tendency to form stones. If signs of hypercalcemia, renal dysfunction, or calciuria exceeding 7.5 mmol/day (300 mg/day) appear, the dose should be reduced or the drug should be discontinued. Combination drugs should be used with caution in immobilized patients due to the increased risk of hypercalcemia. The drug contains sodium, which is taken into account during a sodium-controlled diet.

Interaction with other drugs

Calcium may reduce the absorption of other drugs (including antibiotics (eg, tetracyclines, quinolones, some cephalosporins) and antivirals, protease inhibitors, eltrombopag) from the gastrointestinal tract. Calcium absorption may also be reduced. Therefore, you should wait between the use of these drugs for at least 2 hours before or 4-6 hours after consuming calcium, unless otherwise indicated. Levothyroxine should be used at least 4 hours before or 4 hours after calcium intake; fluoroquinolones - 2 hours before or 6 hours after; phosphates, bisphosphonates - 1 hour before, fluorides and iron preparations - 3 hours before calcium use. Concomitant use of the drug with antacids containing aluminum is not recommended due to a decrease in their effectiveness. Thiazide diuretics reduce urinary calcium excretion. Due to the increased risk of hypercalcemia when thiazide diuretics are used concomitantly, serum calcium levels should be monitored regularly. When used simultaneously with furosemide and other “loop” diuretics, calcium excretion by the kidneys 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 and atrial fibrillation. It is recommended to monitor serum calcium concentration, ECG and the patient's clinical condition. Glucocorticoids and hormonal contraceptives impair the absorption of calcium ions. Ion exchange resins (eg cholestyramine), laxatives, orlistat may reduce the absorption of vitamin D in the gastrointestinal tract. To minimize interactions, use should be taken at least 2 hours before or 4-6 hours after taking vitamin D. Carbamazepine, rifampicin, phenytoin, or barbiturates increase the metabolism of vitamin D into its inactive metabolites and thus reduce its effect . With simultaneous use of the drug Kalcemin Silver with vitamin A, the toxicity of vitamin D3 is reduced. Interaction with food and food additives. Oxalic acid, found in spinach and rhubarb, and phytic acid (in whole grains) can inhibit calcium absorption. Therefore, it is not recommended to take preparations containing calcium within two hours after eating food rich in oxalic and phytic acid. Calcium may reduce the absorption of iron, zinc and magnesium from food. This should be considered in patients at high risk of deficiency of these minerals. To avoid dietary mineral inhibition, it is best for these patients to take calcium at bedtime rather than with meals.

Contraindications

Hypersensitivity to any of the components of the drug; hypercalcemia and/or conditions leading to hypercalcemia (for example, sarcoidosis, malignant neoplasms, primary hyperparathyroidism), hypercalciuria, renal dysfunction, urolithiasis; hypervitaminosis D; age up to 12 years.

Compound

Active ingredients: calcium (calcium citrate and calcium carbonate) 500 mg, vitamin D3 400 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: microcrystalline cellulose (E460), stearic acid (E570), croscarmellose sodium, soy polysaccharide, sodium lauryl sulfate, magnesium stearate (E572). Shell: hypromellose, magnesium silicate (E553a), titanium dioxide (E171), triacetin (E1518), mineral oil (E905), FD&C Blue No. 2 Varnish (E132), FD&C Yellow No. 6 Varnish (E110).

Overdose

An overdose may be accompanied by symptoms similar to side effects. Taking calcium and vitamin D in doses exceeding 2500 mg calcium and 4000 IU/day vitamin D may cause toxic effects. In patients with hypercalcemia or conditions associated with hypercalcemia, renal failure and/or a tendency to nephrolithiasis, toxic effects of calcium and vitamin D may occur when using low doses of the drug. Acute or chronic overdose of calcium and vitamin D can cause hypervitaminosis D, hypercalcemia, hypercalciuria and hyperphosphatemia. The consequences are renal failure, “milk-alkali syndrome,” calcification of blood vessels and soft tissues, including calcification, which leads to nephrocalcinosis and nephrolithiasis. Nonspecific primary symptoms such as sudden onset of headache, muscle weakness, depression of consciousness and gastrointestinal disorders (abdominal pain, constipation, diarrhea, nausea and vomiting) may indicate acute overdose. If such symptoms occur, you should stop using the drug. Laboratory and clinical manifestations of poisoning and hypercalcemia may also include the following symptoms: anorexia, weight loss, fatigue, thirst, polyuria, bone pain, muscle weakness, cardiac arrhythmias, mental disorders, polydipsia, polyuria and impaired absorption of other minerals, increased aspartate aminotransferase and alanine aminotransferase in blood plasma. Chronic overdose can cause calcification of blood vessels and organs due to hypercalcemia. Extremely high hypercalcemia can lead to irreversible kidney damage and soft tissue calcification, coma and death. In case of accidental overdose, symptomatic treatment is recommended: gastric lavage, plenty of fluids, a low-calcium diet, rehydration, loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolyte concentrations, renal function, and diuresis should be monitored. In severe cases, monitor ECG and CVP.

Side effect

The following undesirable reactions have been registered, the frequency of which is unknown (based on the available data, the frequency of occurrence cannot be determined): From the gastrointestinal tract: abdominal pain, dyspepsia, constipation, diarrhea, flatulence, nausea, vomiting. From the immune system: allergic reactions, including anaphylactic reactions, anaphylactic shock. Hypersensitivity reactions accompanied by associated laboratory and clinical manifestations, including asthma syndrome, mild to moderate reactions of the skin and/or respiratory system, gastrointestinal tract and/or cardiovascular system, have been rarely reported. Symptoms may include rash, urticaria, swelling, redness of the skin, itching, and noncardiogenic pulmonary edema. Severe reactions, including anaphylactic shock, have been reported very rarely. From laboratory parameters: hypercalcemia, hypercalciuria, hypervitaminosis D (with long-term use in high doses). Reporting Adverse Reactions If you experience any adverse reactions, consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the Adverse Drug Events Information Database, including reports of drug failure. By reporting side effects, you can help provide more information about the safety of the drug.

Storage conditions

At a temperature not exceeding 25 °C, out of the reach of children.