Calcium-D3 Nycomed - instructions for use, dose, side effects, contraindications

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Dosage form: & nbsp

tablets chewing (orange, mint)

Composition:

1 tablet contains:

Tablets chewing (orange)

Active components: calcium carbonate - 1250 mg (equivalent to elemental calcium - 500 mg), colcalciferol (vitamin D₃) - 5.0 μg (200 ME) in the form of concentrate * colcalciferol a - 2.0 mg. Auxiliary components: sorbitol - 390 mg, flavoring orange granulate ** - 63.0 mg, povidone - 36.4 mg, magnesium stearate - 6.0 mg, aspartame - 1.00 mg.

Tablets chewing (mint) Active components: calcium carbonate - 1250 mg (equivalent to elemental calcium - 500 mg), colcalciferol (vitamin D₃) - 5.0 μg (200 ME) in the form of concentrate kolkaltsiferola - 2.0 mg. Auxiliary components: sorbitol - 390 mg, mint granulate flavor *** - 31.8 mg, povidone - 36.4 mg, magnesium stearate - 6.0 mg, aspartame - 1.00 mg.

* Concentrate of colcalciferol contains, including 10% excess: colcalciferol - 0.0055 mg, alpha-tocopherol - 0.022 mg, corn modified corn starch - 1.607 mg, sucrose - 0.385 mg, sodium ascorbate - 0.088 mg, triglycerides among the chain - 0.066 mg, silicon dioxide 0.026 mg.

** flavor of orange granulate contains: isomalt - 62.0 mg, orange flavoring - 0,95 mg, mono- and diglycerides of fatty acids - 0.0008 mg.

*** Mint granulate aromatizer contains: isomalt - 31.0 mg, mint flavorant - 0.80 mg, mono- and diglycerides of fatty acids

0.0004 mg.

Description:

Tablets chewing (orange)

Round biconvex tablets of white color with the aroma of orange. They can have small inclusions of yellow color and uneven edges.

Tablets chewing (mint) Round biconvex tablets of white color with a minty aroma. Can have small impregnations from white to grayish color and uneven edges.

Pharmacotherapeutic group:Calcium-phosphorus exchange regulator

Pharmacodynamics:

Combined drug regulating the exchange of calcium and phosphorus in the body (bones, teeth, nails, hair, muscles). Reduces resorption (resorption) and increases the density of bone tissue, filling the lack of calcium and vitamin D3 in the body, it is necessary for the mineralization of teeth. Calcium is involved in the regulation of nerve conduction, muscle contractions, hormone production and is a component of the blood coagulation system.

Adequate intake of calcium is especially important during growth, pregnancy and lactation.

Vitamin D3 increases the absorption of calcium in the intestine.

The use of calcium and vitamin D3 prevents the increase in the production of parathyroid hormone (PTH), which is a stimulator of increased bone resorption (leaching calcium from the bones).

Pharmacokinetics:

Calcium

Suction: Usually the amount of calcium absorbed in the gastrointestinal tract is approximately 30% of the dose taken.

Distribution and Metabolism: 99 %, 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, about 10 % in combination with citrate, phosphate or other anions, the remaining 40 % are associated with proteins, primarily with albumin.

Excretion: calcium is excreted by the intestines, kidneys and sweat glands. Renal excretion depends on the glomerular filtration and tubular reabsorption of calcium. Vitamin D3

Suction: Vitamin D3 it is easily absorbed in the small intestine (about 80% of the dose taken).

Distribution and Metabolism: colcalciferol and its metabolites circulate in the blood associated with a specific globulin. Kolekaltsiferol is converted in the liver by hydroxylation to 25-hydroxycolecalciferol. Then 1,25-hydroxycolecalciferol is converted into the active form in the kidneys. 1,25-hydroxycolecularciferol is a metabolite,responsible * for an increase in calcium absorption. Non-metabolized vitamin D3 is deposited in fat and muscle tissue.

Breeding: Vitamin D3 is excreted by the intestine and kidneys.

Indications:

- Prevention and treatment of calcium and / or vitamin deficiency D3.

- Prevention and complex therapy of osteoporosis and its complications (fractures of bones).

Contraindications:

- Hypercalcemia (elevated concentration of calcium in the blood).

- Hypercalciuria (increased calcium in the urine).

- Nephrolithiasis.

- Hypervitaminosis D.

- Hypersensitivity to the components of the drug.

- Hypersensitivity to soy or peanuts.

- Severe kidney failure.

- Active tuberculosis.

- Sarcoidosis.

The drug in tablet formulationse is used in children under the age of 3 years.

Calcium-Dz Nycomed contains aspartame, which in the body is transformed into phenylalanine. Therefore, the drug should not be taken by patients with phenylketonuria.

The preparation 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.

Carefully:pregnancy, lactation, kidney failure.

Pregnancy and lactation:

Calcium-Dz Nycomed is used in pregnancy to compensate for calcium and vitamin deficiency D in organism. The daily dose for pregnancy should not exceed 1500 mg of calcium and 600 ME vitamin A D3. Hypercalcemia against an overdose during pregnancy can have an adverse effect on the developing fetus. Calcium-Dz Nycomed is used during lactation.

Calcium and Vitamin D3 can penetrate into breast milk, so you must take into account the intake of calcium and vitamin D from other sources in the mother and child.

Dosing and Administration:

Calcium-Dz Nycomed is taken internally. Tablets can be chewed or absorbed and taken with food.

Adults: in complex therapy of osteoporosis - 1 tablet 2-3 times a day, for the prevention of osteoporosis - according to 1 tablet 2 times a day.

With a deficiency of calcium and vitamin D: Adults and children over 12 years - 1 tablet 2 times a day.

Children from 5 to 12 years: 1-2 tablets a day.

Children from 3 to 5 years - the dosage in accordance with the recommendations of a doctor.

Special groups of patients.

Patients with impaired Functions liver: No dose adjustment is required. ,

Patients from violation of Functions kidneys: Do not use the drug Calcium-Dz Nycomed with severe renal failure.

Elderly patients: The dose is the same as for adults. Consider possible reduction in creatinine clearance.

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 D3 the average duration of treatment is at least 4-6 weeks. The number of repeat courses during the year is determined individually.

Side effects:

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

Violations from hand metabolism and nutrition: Infrequent: hypercalcemia and hypercalciuria.

Disorders from the gastrointestinal tract: Rarely: constipation, flatulence, nausea, abdominal pain, diarrhea, indigestion.

Violations from skin and subcutaneous cellulose: Very rarely: itching, rash, hives.

Overdose:

Symptoms of overdose (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 signs of overdose, it is necessary to 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, use of loop diuretics (eg, furosemide), glucocorticosteroids, 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 (CVP) and monitor the electrocardiogram (ECG).

Interaction:

- Hypercalcemia can potentiate the toxic effects of cardiac glycosides when used simultaneously with. preparations of calcium and vitamin D. Control, ECG and calcium in the blood serum are needed.

- Calcium preparations can reduce the absorption of tetracyclines from ₍gastrointestinal tract. Therefore, tetracycline drugs should be taken at least 2 hours before or 4-6 hours after taking Calcium-Dz Nycomed.

- To prevent the absorption of bisphosphonate preparations, they should be taken at least an hour before taking Calcium-Dz Nycomed.

- Glucocorticosteroids reduce the absorption of calcium, so treatment with glucocorticosteroids may require an increase in the dose Calcium-Dz Nycomed:

- With the simultaneous use of diuretics of the thiazide series, the risk of hypercalcemia increases. they increase the tubular reabsorption of calcium. When - 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 doses of levothyroxine and Calcium-Dz Nycomed must 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 after 6 hours after taking Calcium-Dz Nycomed.

- The intake of food produklsnidatov containing oxalates (sorrel, rhubarb, spinach) and fitin (cereals) reduces the absorption of calcium, so you should not take Calcium - Dz

Nycomed for two hours after consuming sorrel, rhubarb, spinach, croup.

Special instructions:

With prolonged therapy, it is necessary to monitor the content of calcium and creatinine in serum. Observation is especially important in elderly patients with simultaneous treatment with cardiac glycosides and diuretics (see section "Interaction with other drugs and foods") and in patients with increased tendency to form kidney stones. In cases of hypercalcemia or signs of impaired renal function, the dose or stop treatment.

- Vitamin D should be taken with caution in patients with renal disease 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.

- To avoid an overdose, it is necessary to take into account.additional intake of vitamin D from other sources. - Calcium and - Vitamin D3should be used with caution,

immobilized patients with osteoporosis in connection with the risk of hypercalcemia.

- The simultaneous use of tetracycline or quinolone with antibiotics is generally not recommended, or should be done with caution (see section "Interaction with other medicinal products and food").

Effect on the ability to drive transp. cf. and fur:

The drug Calcium-Dz Nycomed does not affect the ability to drive vehicles or work with technically complex mechanisms.

Form release / dosage:Tablets are chewing (orange), 500 mg + 200 ME.

Packaging:For 20, 50 or 100 tablets in a bottle of high-density polyethylene, sealed with a screw cap, iodine which is a ring for tearing off the seal, providing control of the first opening.
1 bottle together with the instruction for use is placed in a pack of cardboard.
Tablets are chewing (mint), 500 mg + 200 ME.
For 30 or 100 tablets in a bottle of high-density polyethylene, sealed with a screw cap, under which is a ring for tearing off the sealing gasket, providing control of the first opening.
1 bottle together with the instruction for use is placed in a pack of cardboard.

Storage conditions:Keep the bottle tightly closed at a temperature of no higher than 25 ° C. Keep out of the reach of children!

Shelf life:

3 years

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N013478 / 01

Date of registration:16.09.2011

The owner of the registration certificate:Takeda Nycomed AcTakeda Nycomed Ac Norway

Manufacturer: & nbsp

Takeda Nycomed Ac Norway

Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.

Information update date: & nbsp24.02.2015

Illustrated instructions

Instructions

Calcium-D3 Nycomed (Calcium-D3 Nycomed)