Composition, form of production and packaging
? The tablets covered with a film shell of white color, oval, biconcave, with risk on one side.
1 tab.
calcium (in the form of calcium citrate tetrahydrate and calcium carbonate) 250 mg
colcalciferol (Vit. D 3 ) 50 IU
zinc (in the form of zinc oxide) 2 mg
copper (in the form of copper oxide) 500 Ојg
manganese (in the form of manganese sulfate) 500 Ојg
Boron (in the form of sodium borate decahydrate) 50 Ојg
Auxiliary substances: soy polysaccharide 10 mg, sodium lauryl sulfate 5 mg, silicon colloidal dioxide 3.9 mg, croscarmellose sodium 28 mg, microcrystalline cellulose 199.45 mg, stearic acid 35 mg, magnesium stearate 10 mg.
The composition of the membrane: hypromellose - 11.71 mg, triacetin - 2.53 mg, mineral oil - 1.27 mg, sodium lauryl sulfate - 4 Ојg, titanium dioxide - 7.03 mg, magnesium silicate - 5 mg.
30 pcs. - bottles of high-density polyethylene (1) - packs of cardboard.
60 pcs. - bottles of high-density polyethylene (1) - packs of cardboard.
120 pcs. - bottles of high-density polyethylene (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
A combined preparation containing calcium, vitamin D 3 , osteotropic minerals that regulate the exchange of calcium. Pharmacological action of the drug is determined by the properties of its constituent components.
Calcium is involved in the formation of bone tissue, reduces resorption and increases the density of bone tissue, prevents diseases of the musculoskeletal system, helps strengthen bone tissue and joints. Calcium citrate provides the assimilation of calcium, regardless of the functional state of the gastrointestinal tract, which is applicable for the treatment of patients with reduced secretory function of the gastrointestinal tract, as well as against treatment with drugs to reduce secretion; reduces the level of markers of bone resorption, which indicates a slowdown in the processes of destruction of bone tissue; regulates the content of parathyroid hormone, which leads to an improvement in the regulation of calcium homeostasis; does not increase the content of oxalates and calcium in the urine, hence does not cause the formation of kidney stones; does not block the absorption of iron, which reduces the risk of developing iron deficiency anemia.
Kolekaltsiferol (vitamin D 3 ) regulates the exchange of calcium and phosphorus in the body, participates in the formation of the skeleton, promotes the preservation of bone structure, enhances calcium absorption in the intestine and reabsorption of phosphorus in the renal tubules.
Zinc promotes the synthesis of sex hormones, which prevents the destruction of bone tissue.
Manganese is involved in the formation of proteoglycans, which improves the quality of bone tissue and forms a protein matrix of bone tissue.
Copper is involved in the synthesis of collagen and elastin, which is part of the bone and connective tissue, which affects the formation of bone mass.
Boron reduces the excessive activity of parathyroid hormone, improves calcium absorption, reduces the risk of developing deficiency of colcalciferol, helps prevent osteoporosis.
PHARMACOKINETICS
Data on the pharmacokinetics of the preparation Calcemin В® are not available.
INDICATIONS
- prevention and comprehensive treatment of osteoporosis of various genesis;
- Compensation of calcium and micronutrient deficiencies in children and adolescents;
- Compensation of calcium and micronutrient deficiency in women during pregnancy and during breastfeeding.
DOSING MODE
The drug is taken orally.
Adults and children over 12 years of age are prescribed 1 tab. 2 times / day during meals.
Children aged 5 to 12 years are prescribed 1 tab. 1 time / day during a meal.
From the 20th week of pregnancy and during the entire period of breastfeeding appoint 1 tab. 2 times / day.
The minimum duration of application of the drug for the treatment of osteoporosis as part of complex therapy in adults is 3 months, in order to prevent osteoporosis in adults - 1 month, with calcium and microelements deficiency in children and adults - 2-3 months. An increase in the duration of the drug is possible only after consulting a doctor.
The repeated course of taking the drug is possible after 1 month after the end of treatment.
SIDE EFFECT
On the part of the digestive system: nausea, vomiting, flatulence, diarrhea, constipation.
From the side of metabolism: hypercalcemia and hypercalciuria.
Allergic reactions: itching, rash, hives.
CONTRAINDICATIONS
- severe renal failure;
- Nephrolithiasis;
- Vitamin D hypervitaminosis;
- active form of tuberculosis;
- hypercalcemia;
- hypercalciuria;
- decalcifying tumors (myeloma, bone metastases, sarcoidosis);
- Children's age till 5 years;
- Hypersensitivity to the components of the drug.
With caution should prescribe the drug for benign granulomatosis, the simultaneous use of cardiac glycosides and thiazide diuretics, pregnancy, lactation.
PREGNANCY AND LACTATION
During pregnancy and lactation, the drug should be approved with a doctor.
The daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D 3 . Hypercalcemia, which develops against a background of drug overdose during pregnancy, can cause defects in mental and physical development in the fetus.
Nursing women should take into account that colcalciferol and its metabolites are excreted in breast milk, therefore it is necessary to take into account the intake of calcium and vitamin D 3 from other sources.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated use of the drug for renal failure of severe degree and nephrolithiasis.
APPLICATION FOR CHILDREN
Contraindicated in children under the age of 5 years.
SPECIAL INSTRUCTIONS
When using the drug, do not exceed the recommended dose, because Increased intake of calcium can inhibit absorption in the intestines of iron, zinc and other essential minerals.
Impact on the ability to drive vehicles and manage mechanisms
Does not affect.
OVERDOSE
When an overdose of the drug may develop hypervitaminosis D, hypercalcemia and hypercalciuria.
Symptoms: decreased appetite, thirst, polyuria, dizziness, fainting, constipation, nausea and vomiting. With prolonged use in high doses - calcification of blood vessels and tissues.
Treatment: it is necessary to reduce the dose or stop the use of the drug. In case of accidental overdose, you should induce vomiting, rinse the stomach. Symptomatic therapy is indicated.
DRUG INTERACTION
With simultaneous use of the preparation Calcemin В® with vitamin A decreases the toxicity of vitamin D 3 .
Phenytoin, barbiturates, glucocorticoids reduce the effectiveness of vitamin D 3 .
Laxatives reduce the absorption of vitamin D 3 .
Glucocorticoids, hormonal contraceptives for systemic use, levothyroxine impair the absorption of calcium ions.
When used simultaneously with tetracycline, the interval between doses should be at least 3 hours, with bisphosphonates and sodium fluoride - at least 2 hours (their absorption is impaired).
With the combined use of the preparation Calcemin В® with cardiac glycosides, the toxicity of the latter increases (ECG and clinical control is necessary).
With simultaneous use with thiazide diuretics, the risk of hypercalcemia, furosemide and other "loop" diuretics increases - the excretion of calcium by the kidneys increases.
Do not use Calcemin В® concomitantly with calcium channel blockers.
It is not recommended simultaneous use of the drug with antacids, which contain aluminum, due to a decrease in their effectiveness.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
