Composition, form of production and packaging
? The tablets covered with a film cover of pink color, oval, biconcave, with risk on one side.
1 tab.
calcium (in the form of calcium citrate tetrahydrate and calcium carbonate) 500 mg
Colcalciferol (Vit. D 3 ) 200 IU
Magnesium (in the form of magnesium oxide) 40 mg
zinc (in the form of zinc oxide) 7.5 mg
copper (in the form of copper oxide) 1 mg
manganese (in the form of manganese sulfate) 1.8 mg
Boron (in the form of sodium borate decahydrate) 250 mcg
Excipients: maltodextrin 25 mg, microcrystalline cellulose 49.0 mg, croscarmellose sodium 38 mg, stearic acid 16.3 mg, soy polysaccharide 15 mg, sodium lauryl sulfate 5 mg.
The composition of the membrane: hypromellose - 26.328 mg, titanium dioxide - 12.643 mg, magnesium silicate - 5 mg, triacetin - 5.689 mg, mineral oil - 2.845 mg, aluminum varnish based on the dye red charming (Red No. 40) - 316 Ојg, aluminum varnish on based dye sunset yellow (Yellow No. 6) - 79 mcg, aluminum lacquer based on the dye diamond blue (Blue No. 1) - 4 mcg.
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
Combined preparation containing vitamins, micro- and macro elements; the effect is due to the properties that make up the ingredients.
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.
Magnesium participates in the formation of muscle and bone tissue, and also takes part in the synthesis of protein (including type I collagen).
Zinc promotes the synthesis of sex hormones, which prevents the destruction of bone tissue. Favorably affects the density of bone tissue.
Zinc and magnesium are necessary for the synthesis of organic bone matrix.
Manganese is involved in the formation of proteoglycans, which improves the quality of bone tissue and forms a protein (collagen) 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® Advance are not available.
INDICATIONS
Prevention and comprehensive treatment of osteoporosis of various genesis:
- in women during the menopause (natural and surgical);
- in persons who take long-term corticosteroids and immunosuppressants.
Therapy of diseases of the musculoskeletal system:
- to improve the consolidation of traumatic fractures.
To fill the deficiency of calcium and microelements in adolescents.
DOSING MODE
The drug is taken orally, with food.
In the complex therapy of osteoporosis appoint 1 tab. 2 times / day, in order to prevent osteoporosis - 1 tablet / day. The duration of the drug for the prevention of osteoporosis and in the complex therapy of osteoporosis is determined by the physician individually. The average duration of the course for the prevention of osteoporosis is 2 months; in the treatment of osteoporosis - 3 months.
To improve the consolidation of traumatic fractures appoint 1 tablet / day; the duration of treatment is 4-6 weeks.
To fill the deficiency of calcium and microelements for adolescents with 12 years of age - appoint 1 tablet / day; the average duration of treatment is 4-6 weeks.
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;
- urolithiasis disease;
- Vitamin D hypervitaminosis;
- hypercalcemia;
- hypercalciuria;
- active form of tuberculosis;
- sarcoidosis;
- children's age till 12 years;
- an allergy to peanut butter and soybean, tk. the composition of the drug includes soy polysaccharide;
- Hypersensitivity to the components of the drug.
With caution should prescribe the drug for kidney failure, during pregnancy and lactation.
PREGNANCY AND LACTATION
During pregnancy and breastfeeding, the drug should be approved with a doctor.
The daily dose for pregnant women should not exceed 1500 mg of calcium and 600 IU of vitamin D 3 , hypercalcemia, developing against a background of an overdose during pregnancy, can cause defects in the child's mental and physical development.
In lactating women, it should be borne in mind that colcalciferol and its metabolites are excreted in breast milk. This should be taken into account when supplementing calcium and vitamin D 3 for the baby.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated use of the drug for renal failure of severe degree and urolithiasis.
With caution should prescribe the drug for kidney failure.
APPLICATION FOR CHILDREN
The use of the drug is contraindicated in children under 12 years of age.
SPECIAL INSTRUCTIONS
Do not exceed recommended dose, t. 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
There are no data on the effect of the drug on the speed of psychomotor reactions when driving a car and working with mechanisms.
OVERDOSE
An overdose of the drug can lead to hypervitaminosis of vitamin D 3 , hypercalcemia and hypercalciuria.
Symptoms: thirst, polyuria, loss of appetite, constipation, nausea, vomiting, dizziness, muscle weakness, headache, fainting, coma, fatigue, bone pain, mental disorders, nephrocalcinosis, abdominal pain, urolithiasis, in severe cases - cardiac arrhythmias. With prolonged use of calcium in doses above 2500 mg - damage to the kidneys, calcification of soft tissues.
Treatment: in case of detection of the first signs of an overdose, the patient should reduce the dose or stop using the drug, consult a doctor. In case of accidental overdose, you should induce vomiting, rinse the stomach. If necessary, conduct symptomatic therapy.
In the case of hypercalciuria, exceeding 7.5 mmol / day (300 mg / day), it is necessary to reduce the dose or stop taking the drug. Recommended rehydration, the use of "loop" diuretics (eg, furosemide), GCS, calcitonin, bisphosphonates, in severe cases - hemodialysis.
DRUG INTERACTION
With the simultaneous use of the preparation Calcemin В® Advance with vitamin A, the toxicity of vitamin D 3 decreases.
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 reduce the absorption of calcium ions.
With simultaneous use of the drug with antibiotics of the tetracycline group, the interval between doses should be at least 3 hours, with bisphosphonates and sodium fluoride (their absorption is impaired) - at least 2 hours.
With the simultaneous use of the preparation Calcemin В® Advance with cardiac glycosides, the toxicity of the latter increases (ECG and clinical control is necessary).
With the simultaneous use of the drug 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® Advance in conjunction with calcium channel blockers.
It is not recommended simultaneous reception of a preparation with antacids which contain aluminum, because of decrease in their efficiency.
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 reach of children, dry place at a temperature of no higher than 25 В° C. Shelf life - 3 years.
