Calcium-D3 Nycomed Osteoforte chewable tablets with lemon flavor 1000mg/800mg №30

Name:
Calcium-D3 Nycomed Osteoforte tab.zhev. with vk.lim. 1000mg800IU per vial No. 30 in the pack. No. 1
Description:
Round, biconvex tablets without a shell of white color. May have small inclusions and jagged edges. A small amount of powder may be present at the bottom of the vial. The main active ingredient Cholecalciferol + calcium carbonate Release form tablets Dosage 200 IU + 1.25 g Special instructions and precautions During long-term treatment, it is necessary to monitor serum calcium levels and monitor kidney function by determining serum creatinine. Monitoring is especially important for elderly patients receiving concomitant treatment with cardiac glycosides or diuretics (see section “Interactions with other medicinal products”), and for patients with a pronounced tendency to form kidney stones. In case of hypercalcemia or signs of impaired renal function, the dose should be reduced or treatment discontinued. Calcium carbonate tablets with cholecalciferol should be used with caution in patients with hypercalcemia or signs of impaired renal function; calcium and phosphate levels should be monitored. The risk of soft tissue calcification must be taken into account. When combined with other sources of vitamin D and / or drugs or nutrients (such as milk) containing calcium, there is a risk of hypercalcemia and milk-alkali syndrome, with subsequent impaired renal function. Serum calcium levels and renal function should be monitored in these patients. Calcium-D3 Nycomed Osteoforte should be used with caution in patients with sarcoidosis due to the risk of increased metabolism of vitamin D3 to its active form. These patients should regularly monitor the content of calcium in the blood serum and urine. Calcium-D3 Nycomed Osteoforte should be used with caution in immobilized patients with osteoporosis due to an increased risk of hypercalcemia. Calcium-D3 Nycomed Osteoforte contains isomalt (E953) and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. With prolonged use, sucrose can have a negative effect on tooth enamel. Pharmacological properties Pharmacodynamics Vitamin D3 increases the absorption of calcium in the intestine. The administration of calcium and vitamin D3 counteracts the increase in parathyroid hormone (PTH) levels caused by calcium deficiency and leading to increased bone resorption. A clinical study in vitamin D deficient patients showed that supplementation with 1000 mg calcium and 800 IU vitamin D daily for 6 months normalized the 25-hydroxylated vitamin D3 metabolite and reduced secondary hyperparathyroidism and alkaline phosphatase levels. In an 18-month, double-blind, placebo-controlled study of 3270 women aged 84±6 years who received 800 IU of vitamin D and 1200 mg of calcium (as calcium phosphate) per day, there was a significant decrease in parathyroid hormone secretion. After 18 months of treatment, there were 80 hip fractures in the test group and 110 hip fractures in the placebo group (p = 0.004). After 36 months of follow-up, there were 137 women with hip fracture in the test group (n = 1176) and 178 women with hip fracture in the placebo group (n = 1127) (p ≤ 0.02). PharmacokineticsCalcium Absorption: On average, the amount of calcium that is absorbed through the gastrointestinal tract is approximately 30% of the dose consumed. Distribution and metabolism: 99% of the calcium in the body is concentrated in the hard structures of bones and teeth. The rest (1%) is present in the intra- and extracellular fluid. About 50% of the total calcium contained in the blood is present in a physiologically active ionized form, with approximately 10% complexed with citrate, phosphate and other anions; the remaining 40% are associated with proteins, mainly albumin. Excretion: Calcium is excreted in feces, urine and sweat. Renal excretion depends on glomerular filtration and tubular reabsorption. Cholecalciferol Absorption: Vitamin D3 is readily absorbed from the small intestine. Distribution and metabolism: Cholecalciferol and its metabolites circulate in the blood in association with a specific globulin. Cholecalciferol is converted in the liver by hydroxylation to the active form 25-hydroxycholecalciferol. The latter is then converted in the kidneys to 1,25-dihydroxycholecalciferol, a metabolite responsible for increasing calcium absorption. Non-metabolized vitamin D3 is stored in adipose and muscle tissues. Excretion: Vitamin D3 is excreted from the body with feces and urine. Indications for use Prevention and treatment of vitamin D and calcium deficiency in the elderly. Replenishment of vitamin D and calcium requirements as an adjunct to specific osteoporosis therapy in patients at risk of vitamin D and calcium deficiency. Method of administration and doses Dosage regimen Adults, including elderly patients 1 chewable tablet 1 time per day. Children Calcium-D3 Nycomed Osteoforte is not used in children and adolescents. Special groups of patients Renal insufficiency Calcium-D3 tablets Nycomed Osteoforte should not be used in patients with severe renal insufficiency (see section “Contraindications”). Liver failure Dose adjustment is not required. Method of application Orally. The tablet can be chewed or sucked. Use during pregnancy and lactation Pregnancy Calcium-D3 Nycomed Osteoforte can be used during pregnancy in case of vitamin D and calcium deficiency. During pregnancy, the daily dose should not exceed 2500 mg of calcium and 4000 IU of vitamin D. Animal studies have shown reproductive toxicity of high doses of vitamin D. Overdose of calcium and vitamin D should be avoided in pregnant women, as persistent hypercalcemia has been associated with side effects in developing fetus. There are no data on the teratogenic effects of vitamin D in humans at therapeutic doses. Breastfeeding Calcium-D3 Nycomed Osteoforte can be used during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when additionally prescribing vitamin D to a child. Interaction with other drugs Thiazide diuretics reduce the excretion of calcium in the urine. Due to the increased risk of hypercalcemia during the use of thiazide diuretics, serum calcium levels should be regularly monitored. Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline drugs. For this reason, tetracycline preparations should be taken at least two hours before or 4-6 hours after oral calcium intake. The development of hypercalcemia during treatment with calcium and vitamin D may increase the toxicity of cardiac glycosides. In such patients, electrocardiogram (ECG) and serum calcium levels should be monitored. With the concomitant use of a bisphosphonate, the latter should be taken at least one hour before taking Calcium-D3 Nycomed Osteoforte in order to avoid a decrease in absorption in the gastrointestinal tract. The effectiveness of levothyroxine may decrease with the simultaneous use of calcium by reducing the absorption of levothyroxine. Between taking calcium and levothyroxine, an interval of at least four hours should be observed. Absorption of quinolone antibiotics may be impaired by concomitant administration of calcium. Quinolone antibiotics should be taken two hours before or six hours after calcium intake. Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, preparations of iron, zinc or strontium ranelate are recommended to be taken two hours before or two hours after taking Calcium-D3 Nycomed Osteoforte. Treatment with orlistat has the potential to interfere with the absorption of fat-soluble vitamins (eg, vitamin D3). Contraindications Hypersensitivity to the active substances or to any of the excipients listed in the “List of excipients” section. Severe renal failure (glomerular filtration rate < 30 ml/min/1.73 m2). or hypercalciuria. Kidney stone disease (nephrolithiasis). Hypervitaminosis D. Composition Composition per tablet Active ingredients: calcium 1000 mg in the form of calcium carbonate 2500 mg; cholecalciferol 20.0 mcg (800 IU) as cholecalciferol concentrate (powder) 8.0 mg. For a complete list of excipients, see the "List of excipients" section. OverdoseSymptoms Overdose may lead to hypercalcemia and vitamin D hypervitaminosis. Symptoms of hypercalcemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, kidney stones and, in severe cases, cardiac arrhythmias. Extreme hypercalcemia can lead to coma and death. Persistently high calcium levels can lead to irreversible kidney damage and soft tissue calcification. Milk-alkaline syndrome may occur in patients who take large amounts of calcium or absorbable alkaline foods orally. Treatment of hypercalcemia Treatment is mainly symptomatic and supportive. Treatment with calcium and vitamin D should be discontinued. It is also necessary to stop treatment with thiazide diuretics and cardiac glycosides (see section "Interaction with other drugs and other forms of interaction"). Patients with impaired consciousness are shown the removal of gastric contents. Rehydration and, depending on severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin, and corticosteroids. Control of electrolytes of blood serum, renal function and diuresis is obligatory. In severe cases, electrocardiogram and central venous pressure should be monitored. Side effects Undesirable reactions are listed below according to the classification by system organ class and frequency of development. The frequency is defined as: infrequently (? 1/1000, < 1/100), rarely (? 1/10000, < 1/1000), very rarely (< 1/10000); frequency unknown (cannot be estimated from available data). Immune system disorders Not known: hypersensitivity reactions such as angioedema or laryngeal edema. Metabolic and nutritional disorders Uncommon: hypercalcemia and hypercalciuria. Very rare: milk-alkaline syndrome (frequent urge to urinate; prolonged headache; prolonged loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcemia, alkalosis and renal failure). As a rule, it is observed only with an overdose (see the section "Overdose"). Gastrointestinal disorders Rare: constipation, dyspepsia, flatulence, nausea, abdominal pain and diarrhea. Skin and subcutaneous tissue disorders Very rare: pruritus, rash and urticaria. Special groups of patients Patients with renal insufficiency: potential risk of developing hyperphosphatemia, nephrolithiasis and nephrocalcinosis (see section "Special instructions and precautions"). Reporting suspected adverse reactions It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk ratio of the medicinal product. If an adverse reaction occurs that is indicated in this package leaflet or not mentioned in it, patients are advised to contact their doctor. Medical workers and patients are encouraged to report any suspected adverse drug reactions to the Republican Unitary Enterprise "Center for Expertise and Testing in Health Care" (see section "Send information about adverse reactions to the address"). Storage conditionsStore at a temperature not exceeding 30°C in a place protected from moisture. Store out of reach of children. with lemon flavor 1000mg/800mg №30