Composition, form of production and packaging
? Tablets chewing (orange) without shell, round, biconcave, white; with the aroma of orange; can have small impregnations and uneven edges.
1 tab.
calcium carbonate 1250 mg
is equivalent to elemental calcium 500 mg
colcalciferol (Vit D3) 5.0 Ојg (200 IU)
in the form of a concentrate of colcalciferol 2.0 mg
Excipients: sorbitol 390 mg, isomalt 62.0 mg, povidone 36.4 mg, magnesium stearate 6.00 mg, aspartame 1.00 mg, orange oil 0.97 mg, mono and diglycerides of fatty acids 0.0008 mg.
20 pcs. - bottles of high-density polyethylene (1) - packs of cardboard.
50 pcs. - bottles of high-density polyethylene (1) - packs of cardboard.
100 pieces. - bottles of high-density polyethylene (1) - packs of cardboard.
? Tablets are chewing (mint) without shell, round, biconcave, white; with mint flavor; can have small impregnations and uneven edges.
1 tab.
calcium carbonate 1250 mg
is equivalent to elemental calcium 500 mg
colcalciferol (Vit D3) 5.0 Ојg (200 IU)
in the form of a concentrate of colcalciferol 2.0 mg
Excipients: sorbitol - 390 mg, mint flavor additive - 31.8 mg, povidone - 36.4 mg, magnesium stearate - 6.00 mg, aspartame - 1.00 mg.
30 pcs. - bottles of high-density polyethylene (1) - packs of cardboard.
100 pieces. - bottles of high-density polyethylene (1) - packs of cardboard.
Calcium-D 3 Nicomed Forte
? Tablets chewing (lemon) without shell, round, biconcave, white, with the aroma of lemon; can have small impregnations and uneven edges.
1 tab.
calcium carbonate 1250 mg
is equivalent to elemental calcium 500 mg
colcalciferol (Vit D3) 10.0 Ојg (400 IU)
in the form of a concentrate of colcalciferol 4.0 mg
Excipients: sorbitol - 390 mg, isomalt - 49.9 mg, povidone - 36.4 mg, magnesium stearate - 6.00 mg, aspartame - 1.00 mg, lemon oil - 0.78 mg, mono and diglycerides of fatty acids - 0.0006 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 2015.
PHARMACHOLOGIC EFFECT
Combined drug regulating the exchange of calcium and phosphorus in the body (in bones, teeth, nails, hair, muscles).
Reduces resorption (resorption) and increases the density of bone tissue, replenishing the lack of calcium and vitamin D 3 in the body, it is necessary for the mineralization of teeth.
Calcium is involved in the regulation of nerve conduction, muscle contractions and is a component of the blood coagulation system. Adequate calcium intake is especially important during growth, during pregnancy and lactation.
Vitamin D 3 increases the absorption of calcium in the intestine.
The use of calcium and vitamin D 3 prevents the increase in the production of parathyroid hormone, which is a stimulator of increased bone resorption (leaching calcium from the bones).
PHARMACOKINETICS
Calcium
Suction
Usually the amount of calcium that is absorbed from the digestive tract is approximately 30% of the dose.
Distribution and Metabolism
99% of calcium in the body is concentrated in the rigid structure of bones and teeth. The remaining 1% is in the intra- and extracellular fluids. About 50% of the total calcium content in the blood is in a physiologically active ionized form, of which about 10% in combination with citrate, phosphate or other anions, the remaining 40% are associated with proteins, primarily albumin.
Excretion
Calcium is excreted through the intestines, kidneys and sweat glands. Renal excretion depends on the glomerular filtration and tubular reabsorption of calcium.
Kolekaltsiferol
Suction
Kolekaltsiferol easily absorbed from the small intestine (about 80% of the dose).
Distribution and Metabolism
Kolekaltsiferol and its metabolites circulate in the blood in a bound state with a specific globulin. Kolekaltsiferol is metabolized in the liver by hydroxylation to 25-hydroxycolecalciferol. Then it is converted in the kidneys into the active form of 1.25-hydroxycolecalciferol. 1.25-hydroxycolecularciferol is a metabolite responsible for increasing calcium absorption. Unchanged colcalciferol is deposited in fat and muscle tissue.
Excretion
Kolekaltsiferol is excreted by the kidneys and through the intestine.
INDICATIONS
- prevention and treatment of calcium deficiency and / or vitamin D 3 ;
- prevention and comprehensive therapy of osteoporosis and its complications (bone fractures).
DOSING MODE
Tablets can be chewed or absorbed and taken with food.
Calcium-D 3 Nycomed
Adults for the prevention of osteoporosis - 1 tab. 2 times / day; in the complex therapy of osteoporosis - 1 tab. 2-3 times / day.
To compensate for the deficiency of calcium and vitamin D for adults and children over 12 years - 1 tab. 2 times / day, children from 5 to 12 years - 1-2 tablets / day, children from 3 to 5 years - the dosage in accordance with the recommendations of a doctor.
Calcium-D 3 Nicomed Forte
Adults for the prevention of osteoporosis - 1 tab. 2 times / day or 2 tab.1 times / day; in the complex therapy of osteoporosis - 1 tab. 2-3 times / day.
To compensate for the deficiency of calcium and vitamin D for adults and children over 12 years of age - 2 tab. / Day, children from 3 to 12 years - 1 tablet / day or as prescribed by a doctor.
Duration of treatment
When used for prevention and in complex therapy of osteoporosis, the duration of treatment is determined by the physician individually.
When used to fill the deficiency of calcium and vitamin D 3, the average duration of treatment is at least 4-6 weeks. The number of repeat courses during the year is determined individually.
Patients with a dysfunction of the liver dose adjustment is not required.
Do not use in severe kidney failure .
Elderly patients are given the same dose as for adults. Consider possible reduction in creatinine clearance.
SIDE EFFECT
The frequency of side effects of the drug is assessed as follows: very frequent (> 1/10); frequent (> 1/100, <1/10); infrequent (> 1/1000, <1/100); rare (> 1/10 000, <1/1000); very rare (<1/10 000).
From the side of metabolism and nutrition: infrequent - hypercalcemia, hypercalciuria.
From the digestive system: rarely - constipation, flatulence, nausea, abdominal pain, diarrhea, indigestion.
From the skin and subcutaneous tissue: very rarely - itching, rash, hives.
CONTRAINDICATIONS
- hypercalcemia;
- hypercalciuria;
- Nephrolithiasis;
- hypervitaminosis D;
- severe renal failure;
- active form of tuberculosis;
- sarcoidosis;
- Hypersensitivity to the components of the drug, soy or peanuts.
The drug in the form of tablets is not used in children under the age of 3 years.
The drug contains aspartame, which in the body is transformed into phenylalanine, so the drug should not be taken with phenylketonuria.
The drug contains sorbitol, isomalt and sucrose, therefore its use is not recommended for patients with hereditary intolerance to fructose, glucose-galactose malabsorption or sucrose-isomaltase deficiency.
With caution : pregnancy, lactation, kidney failure.
PREGNANCY AND LACTATION
Calcium and vitamin D 3 are used in pregnancy to compensate for their deficiency in the body.
In pregnancy, the daily dose of the drug should not exceed 1500 mg of calcium and 600 IU of vitamin D 3 .
Hypercalcemia against an overdose during pregnancy can have an adverse effect on the developing fetus.
The drug is used during lactation.
Calcium and vitamin D 3 can penetrate into breast milk, so you need to consider the intake of calcium and vitamin D from other sources in the mother and child.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in severe renal failure.
APPLICATION FOR CHILDREN
The dosage form of the tablet is not used in children under 3 years of age.
SPECIAL INSTRUCTIONS
With prolonged therapy, it is necessary to monitor the content of calcium and creatinine in the blood serum. Observation is especially important in elderly patients with simultaneous treatment with cardiac glycosides and diuretics and in patients with an increased tendency to form kidney stones. In cases of hypercalcemia or signs of impaired renal function, you should reduce the dose or stop treatment.
Vitamin D should be taken with caution in patients with renal insufficiency. In this case, it is necessary to monitor the calcium and phosphate levels in the blood serum. It is also necessary to take into account the risk of calcification of soft tissues.
In order to avoid an overdose, it is necessary to take into account additional intake of vitamin D from other sources.
Calcium and vitamin D 3 should be used with caution in immobilized patients with osteoporosis in connection with the risk of hypercalcemia.
The simultaneous use with antibiotics of the tetracycline or quinolone group is usually not recommended, or should be done with caution.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive vehicles or work with technically complex machinery.
OVERDOSE
Symptoms: manifestations of hypercalcemia - anorexia, thirst, polyuria, muscle weakness, nausea, vomiting, constipation, abdominal pain, fatigue, bone pain, mental disorders, nephrocalcinosis, urolithiasis and, in severe cases, cardiac arrhythmias. With prolonged use of excessive doses (over 2500 mg of calcium) - kidney damage, calcification of soft tissues.
In case of symptoms of overdose, the patient should stop taking calcium and vitamin D, as well as thiazide diuretics and cardiac glycosides, and consult a doctor.
Treatment: gastric lavage, replenishment of fluid loss, the use of "loop" diuretics (eg, furosemide), GCS, calcitonin, bisphosphonates. It is necessary to control the content of electrolytes in blood plasma, the function of the kidneys and diuresis. In severe cases, it is necessary to measure central venous pressure and ECG monitoring.
DRUG INTERACTION
Hypercalcemia can potentiate the toxic effects of cardiac glycosides when used concomitantly with calcium and vitamin D. It is necessary to monitor the ECG and calcium levels in the blood serum.
Calcium preparations can reduce the absorption of tetracyclines from the digestive tract. Therefore, tetracycline drugs should be taken at least 2 hours before or 4-6 hours after taking the drug.
To prevent the absorption of bisphosphonate preparations, they should be taken at least 1 hour prior to taking Calcium-D 3 Nycomed.
GCS decreases the absorption of calcium, so treatment with GCS may require an increase in the dose of Calcium-D 3 Nycomed.
With the simultaneous use of thiazide diuretics, the risk of hypercalcemia increases, because they increase the tubular reabsorption of calcium. With the simultaneous use of thiazide diuretics should regularly monitor the calcium content in the blood serum.
Calcium reduces the effectiveness of levothyroxine, reducing its absorption. The period of time between taking levothyroxine and Calcium-D 3 Nycomed should be at least 4 hours.
Absorption of antibiotics of the quinolone group decreases with simultaneous use with calcium preparations. Therefore, the antibiotics of the quinolone group should be taken 2 hours before or 6 hours after taking Calcium-D 3 Nycomed.
The intake of food products containing oxalates (sorrel, rhubarb, spinach) and phytin (cereals), reduces the absorption of calcium, so you should not take Calcium-D 3Nycomed for 2 hours after eating sorrel, rhubarb, spinach, cereals.
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 in a tightly closed bottle, in a dry place inaccessible to children at a temperature of no higher than 25 В° C. Shelf life - 3 years. Do not use after expiry date.
