Calcium - D3 Nycomed. Medicinal reference geotar Side effects Calcium D3 Nycomed

Calcium D3 Nycomed is a drug based on two main components - calcium and vitamin D3, which is also called cholecalciferol.

In turn, calcium is a vital element for teeth, bones, bone tissue, and even neurotransmission in the central and peripheral nervous system person. In addition, the drug balances the synthesis of parathyrin, a failure in the production of which can result in the appearance of periodic processes of destruction of bone tissue.

On this page you will find all the information about Calcium D3 Nycomed: full instructions on application to this drug, average prices in pharmacies, complete and incomplete analogues of the drug, as well as reviews of people who have already used Calcium D3 Nycomed. Would you like to leave your opinion? Please write in the comments.

Clinical and pharmacological group

A drug that regulates the metabolism of calcium and phosphorus.

Conditions for dispensing from pharmacies

Available without a prescription.

Prices

How much does Calcium D3 Nycomed cost? The average price in pharmacies is 400 rubles.

Release form and composition

The drug is manufactured and available in the form of chewable tablets with lemon, orange and mint flavors.

Orange-flavored tablets are produced without a shell, round in shape and white in color. Calcium-D3 Nycomed with orange contains the main substances:

• calcium carbonate – 1250 milligrams;
• vitamin D3 – 5.0 mcg (200 IU);

and minor elements:

• isomaltitol – 62.0 mg;
• glucite – 390 mg;
• orange olive – 0.97 mg;
• di and monoglycerides of carboxylic fatty acids – 0.08 mcg.

The products are produced in boxes of 20, 50, 100 pieces per box.

The mint-flavored product, which is also available on store shelves, is completely similar in composition to orange tablets.

The only difference between them is that instead of orange oil, the drug contains mint flavor essence. Available in high-density polyethylene bottles of 30 and 100 pieces.

Chewable tablets with lemon flavor are somewhat different from other types in their composition, and, more precisely, in the amount of elements they contain. They are called Calcium D3 Nycomed Forte.

Primary substances:

• calcium carbonate – 1250 mg;
• equivalent to regular Ca – 500 mg;
• cholecalciferol – 10.0 mcg (400 IU);
• colecalciferol concentrate – 4.0 mg;

and additional elements:

• Zomaltit – 49.9 mg;
• povidone (enterosorbent) – 36.4 mg;
• magnesium stearate – 6.00 mg;
• L-Aspartyl-L-phenylalanine – 1.00 mg;
• glucite – 390 mg;
• lemon oil – 0.78 mg;
• di- and monoglycerides of carboxylic fatty acids – 0.0006 mg.

The product is released in polyethylene bottles of 30, 60, 120 pieces.

Pharmacological effect

The drug refers to combined pharmaceutical preparations that regulate the metabolism of calcium and phosphorus in the body and compensate for the deficiency of the main structural element.

The biochemical role of calcium lies in the physiological construction of bone tissue, mineralization of teeth, coagulation and transmission processes nerve impulse, the implementation of muscle contractions. In response to its increase in the systemic circulation, bone tissue density increases and calcium excretion by the kidneys decreases.

Cholecalciferol is responsible for the absorption processes of the element in the gastrointestinal tract and its distribution in the body. Oral administration of the drug inhibits the synthesis of parathyroid hormone, a natural hormone of the parathyroid gland, which significantly affects phosphorus-calcium metabolism. Accordingly, the amount of calcium absorbed from the digestive tube increases and its resorption (leaching) from bones and other organs decreases.

Indications for use

Taking Calcium D3 Nycomed tablets is indicated in the following cases:

• Preventing the development of complications of osteoporosis - a pathological decrease in the level of minerals in bone tissue, which is accompanied by a significant decrease in its strength and frequent fractures.
• Treatment and prevention of conditions that are associated with insufficient levels of calcium or vitamin D3 in the body (hypovitaminosis and hypocalcemia).

The indications for taking the drug are determined by the doctor based on clinical picture and the results of additional examination confirming the presence pathological process in organism.

Contraindications

According to the instructions, Calcium D3 Nycomed cannot be used for:

• hypercalcemia;
• nephrolithiasis;
• hypercalciuria;
• severe renal failure;
• active form of tuberculosis;
• hypervitaminosis D;
• sarcoidosis;
• and also up to three years of age;
• high level of sensitivity of the body to the components included in the drug, peanuts or soy.

The drug should also not be taken by persons with phenylketonuria, since it contains aspartame, which is transformed in the body into phenylalanine.

It is also not recommended to take the drug for persons with glucose-galactose malabsorption, hereditary fructose intolerance, sucrase-isomaltase deficiency, since the tablets of the drug contain isomalt, sorbitol, and sucrose.

Use during pregnancy and lactation

Calcium and vitamin D3 are used during pregnancy to compensate for their deficiency in the body.

During pregnancy daily dose The drug should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Hypercalcemia due to overdose during pregnancy can have an adverse effect on the developing fetus.

The drug is used during lactation. Calcium and vitamin D3 can pass into breast milk, so mother and baby's intake of calcium and vitamin D from other sources must be considered.

Instructions for use

The instructions for use indicate that Calcium D3 Nycomed tablets can be chewed or dissolved and taken with meals.

• Adults for the prevention of osteoporosis - 1 tablet. 2 times/day; V complex therapy osteoporosis – 1 tablet. 2-3 times/day.
• To replenish calcium and vitamin D deficiency, adults and children over 12 years old – 1 tablet. 2 times/day, children from 5 to 12 years old - 1-2 tablets/day, children from 3 to 5 years old - dosage in accordance with the doctor’s recommendations.

Duration of treatment:

1. When used for prevention and in complex therapy of osteoporosis, the duration of treatment is determined by the doctor individually.
2. When used to replenish calcium and vitamin D3 deficiency, the average duration of treatment is at least 4-6 weeks. The number of repeat courses during the year is determined individually.

Patients with impaired liver function do not require dose adjustment.

Should not be used in severe renal failure.

Elderly patients are prescribed the same dose as for adults. A possible decrease in CC should be taken into account.

Side effects

During therapy, undesirable reactions may occur:

1. Allergic reactions: very rarely - skin rashes, itching, urticaria;
2. Laboratory indicators: infrequently - hypercalciuria and hypercalcemia (increased calcium levels in the urine or blood);
3. From the outside digestive system: rarely - gastrointestinal dysfunction (increased formation of gases in the intestines, abdominal pain, nausea, dyspepsia, diarrhea or constipation).

Overdose

An overdose of calcium is fraught with the development of hypercalcemia, its symptoms: thirst, muscle weakness, abdominal pain, constipation, nausea, vomiting, polyuria, increased fatigue, anorexia, bone pain, urolithiasis, nephrocalcinosis, mental disorders. In severe cases, cardiac arrhythmias are added.

With long-term use in excessive doses (more than 2500 mg of calcium), kidney damage and soft tissue calcification are possible. If any of the described symptoms appear, you should stop taking Calcium-D3 Nycomed and consult a doctor. First aid for overdose involves gastric lavage, then a loop diuretic (for example, furosemide), glucocorticosteroid, calcitonin and bisphosphonates are prescribed, and replenishment of lost fluid is also indicated. It is necessary to monitor diuresis, renal function and electrolyte levels in the blood; in severe cases, ECG monitoring and measurement of central venous pressure are required.

Hypercalcemia that develops as a result of overdose during pregnancy can have an adverse effect on the fetus.

special instructions

1. To avoid overdose, it is important to consider additional vitamin D intake from any other sources, including food.
2. It is not recommended to prescribe quinolone and tetracycline antibiotics at the same time. If the use of such combinations is justified, caution should be exercised.
3. The drug should be used with caution in the treatment of patients with osteoporosis if they are immobilized, since this category is at increased risk of developing hypercalcemia.

With long-term use of the drug, it is necessary to monitor the level of calcium and creatinine in the blood serum, especially in elderly people receiving concomitant diuretics and/or cardiac glycosides, as well as in patients with an increased tendency to form kidney stones. If symptoms of impaired renal function or the development of hypercalcemia appear, the dose of Calcium-D3 Nycomed Forte should be reduced or discontinued altogether.

Drug interactions

Calcium absorption is reduced by glucocorticosteroids, so an increase in the dose of the supplement may be required.

Hypercalcemia that develops as a result of taking a mineral supplement can potentiate the toxic effects of cardiac glycosides. Monitoring serum calcium concentration and ECG monitoring is necessary.

Calcium reduces absorption and reduces the effectiveness of levothyroxine, so the interval between doses should be at least 4 hours. Bisphosphonates, if necessary, are recommended to be taken no later than 1 hour before taking Calcium-D3Nycomed.

It is not recommended to take the drug simultaneously with tetracycline antibiotics and quinolone, since their absorption is reduced. If such a combination is still necessary, it is recommended to take these medications 2 hours before or 4-6 hours after taking Calcium-D3Nycomed. The patient must be under close medical supervision throughout the entire treatment period.

The risk of developing hypercalcemia increases with simultaneous use of thiazide diuretics. In this case, it is necessary to regularly monitor the concentration of calcium in the blood serum.

Chewable tablets calcium-d3 nycomed with mint flavor - a combined drug that regulates the exchange of calcium and phosphorus in the body (in bones, teeth, nails, hair, muscles). Reduces resorption (resorption) and increases bone density, replenishing 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 and is a component of the blood coagulation system. Adequate calcium intake is especially important during growth, pregnancy and lactation. Vitamin D3 increases the absorption of calcium in the intestines. The use of calcium and vitamin D3 prevents an increase in the production of parathyroid hormone, which is a stimulator of increased bone resorption (leaching of calcium from the bones).

Active ingredients

Release form

Pills

Compound

Calcium carbonate 1250 mg, equivalent to elemental calcium 500 mg, colecalciferol (vit. D3) 5.0 mcg (200 IU), in the form of colecalciferol concentrate 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.

Indications

Prevention and treatment of calcium and/or vitamin D3 deficiency, prevention and complex therapy of osteoporosis and its complications (bone fractures).

Precautionary measures

During long-term therapy, serum calcium and creatinine levels should be monitored. Monitoring is especially important in elderly patients during concomitant treatment with cardiac glycosides and diuretics and in patients with an increased tendency to form kidney stones. In cases of hypercalcemia or signs of renal impairment, reduce the dose or discontinue treatment. Vitamin D should be taken with caution in patients with renal failure. 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 soft tissue calcification. To avoid overdose, additional intake of vitamin D from other sources must be taken into account. Calcium and vitamin D3 should be used with caution in immobilized patients with osteoporosis due to the risk of hypercalcemia. Concomitant use with tetracycline or antibiotics quinolone is usually not recommended, or should be used with caution. Effects on the ability to drive vehicles and operate machinery The drug does not affect the ability to drive vehicles or operate technically complex mechanisms.

Use during pregnancy and breastfeeding

Calcium and vitamin D3 are used during pregnancy to replenish their deficiency in the body. During pregnancy, the daily dose of the drug should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Hypercalcemia due to an overdose during pregnancy can have an adverse effect on the developing fetus. The drug is used during lactation.Calcium and vitamin D3 can pass into breast milk, so it is necessary to consider the intake of calcium and vitamin D from other sources in the mother and child.

Directions for use and doses

The tablets can be chewed or dissolved and taken with meals. Calcium-D3 NycomedAdults for the prevention of osteoporosis - 1 tablet. 2 times a day, in complex therapy of osteoporosis - 1 tablet. 2-3 times/day. To replenish calcium and vitamin D deficiency, adults and children over 12 years old - 1 tablet. 2 times/day, children from 5 to 12 years old - 1-2 tablets/day, children from 3 to 5 years old - dosage in accordance with doctor's recommendations. Calcium-D3 Nycomed ForteAdults for the prevention of osteoporosis - 1 tablet. 2 times/day or 2 tablets 1 time/day, in complex therapy of osteoporosis - 1 tablet. 2-3 times/day. To replenish the deficiency of calcium and vitamin D, adults and children over 12 years old - 2 tablets/day, children from 3 to 12 years old - 1 tablet/day or as prescribed by a doctor. Duration of treatment When used for prevention and complex therapy of osteoporosis, the duration of treatment is determined by the doctor individually. When used to compensate for calcium and vitamin D3 deficiency, the average duration of treatment is at least 4-6 weeks. The number of repeated courses during the year is determined individually. Patients with impaired liver function do not require dose adjustment. Should not be used in severe renal failure. Elderly patients are prescribed the same dose as for adults. A possible decrease in creatinine clearance should be taken into account.

Side effects

Frequency side effects the drug is assessed as follows: very common (>1/10), frequent (>1/100, 1/1000, 1/10,000,

Interaction with other drugs

Hypercalcemia can potentiate the toxic effects of cardiac glycosides when used simultaneously with calcium and vitamin D preparations. Monitoring of ECG and serum calcium levels is necessary. Calcium preparations may reduce the absorption of tetracyclines from the gastrointestinal tract. Therefore, tetracycline drugs should be taken at least 2 hours before or 4-6 hours after taking the drug. To prevent a decrease in the absorption of bisphosphonates, they are recommended to be taken at least 1 hour before taking Calcium-D3 Nycomed. GCS reduce the absorption of calcium, therefore, treatment of GCS may require an increase in the dose of Calcium-D3 Nycomed. With simultaneous use of thiazide diuretics, the risk of hypercalcemia increases, because they increase tubular reabsorption of calcium. When using thiazide diuretics simultaneously, serum calcium levels should be regularly monitored. Calcium reduces the effectiveness of levothyroxine by reducing its absorption. The time period between doses of levothyroxine and Calcium-D3 Nycomed should be at least 4 hours. The absorption of quinolone antibiotics is reduced when used simultaneously with calcium preparations. Therefore, antibiotics of the quinolone group should be taken 2 hours before or 6 hours after taking Calcium-D3 Nycomed. Taking foods containing oxalates (sorrel, rhubarb, spinach) and phytin (cereals) reduces the absorption of calcium, so you should not take Calcium-D3 D3 Nycomed within 2 hours after eating sorrel, rhubarb, spinach, cereals.

special instructions

Contraindications for use: - hypercalcemia, - hypercalciuria, - nephrolithiasis, - hypervitaminosis D, - renal severe insufficiency, - active form of tuberculosis, - sarcoidosis, - hypersensitivity to the components of the drug, soy or peanuts. The drug in tablet form is not used in children under 3 years of age. The drug contains aspartame, which is transformed into phenylalanine in the body, therefore the drug should not be taken if you have phenylketonuria. The drug contains sorbitol, isomalt and sucrose, so its use is not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. With caution: pregnancy, lactation, renal failure.

Calcium - D3 Nycomed

International nonproprietary name

Dosage form

Chewable tablets with orange flavor

Cleaving

One tablet contains

active substances: calcium carbonate 1250 mg (equivalent to elemental calcium 500 mg), cholecalciferol 5.5 mcg (200 IU vitamin D3) in the form of cholecalciferol concentrate 2.0 mg.

Excipients: sorbitol, orange flavor granulate (containing isomalt, orange flavor, mono- and diglycerides of fatty acids), povidone, magnesium stearate, aspartame.

Description

Round, biconvex tablets, uncoated, white with orange flavor. May have small inclusions and uneven edges.

Pharmacotherapeutic group

Mineral supplements, calcium supplements in combination with other agents.

ATX code A12AX

Pharmacological properties

Pharmacokinetics

Calcium is absorbed in ionized form into distal section small intestine through an active vitamin D-dependent transport mechanism. Cholecalciferol is absorbed from the small intestine and enters lymphatic system, enters the liver and the general bloodstream. In the blood it binds to alpha2-globulins and partially to albumins, and is transported to the liver, bone tissue, skeletal muscle, kidneys, adrenal glands, myocardium, and adipose tissue. The maximum concentration in tissues is created 4 - 5 hours after administration, then decreases slightly, remaining at a constant level for a long time. Deposited in the liver. As a result of biotransformation in the liver and kidneys, active metabolites are formed. In the form of polar metabolites, it is localized mainly in the membranes of cells, microsomes, mitochondria and nuclei. Most of the cholecalciferol and its metabolic products are excreted with bile into the intestine, from which they can be reabsorbed, creating the enterohepatic circulation system, or excreted in feces. The half-life is several days.

Pharmacodynamics

Combination drug, regulating the exchange of calcium and phosphorus in the body. Reduces resorption (resorption) and increases the density of the bone skeleton and teeth, replenishing the lack of calcium and vitamin D in the body.

Calcium is involved in the regulation of nerve conduction, muscle contractions and is a component of the blood coagulation system.

Vitamin D3 increases the absorption of calcium in the intestines.

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

Indications for use

Prevention and complex therapy of osteoporosis (menopausal, senile, steroid, idiopathic, etc.) and its complications (bone fractures)

Replenishment of calcium and/or vitamin D deficiency associated with insufficient intake from food

Increased body need for calcium and vitamin D

During pregnancy and breastfeeding

Children and adolescents during periods of intensive growth

Directions for use and doses

Adults and children over 12 years old - 1 tablet 2 times a day. For the purpose of prevention, Calcium-D3 Nycomed is taken for 3 months 1 - 2 times a year, for treatment purposes for at least 6 months.

Children from 3 - 5 years old 1 tablet per day, 6 - 11 years old 1-2 tablets per day.

The tablet can be chewed or swallowed whole, preferably during meals.

Side effects

Hypercalcemia, hypercalciuria

Constipation, flatulence, nausea, abdominal pain, diarrhea, dyspepsia

Itching, rash, urticaria

Milk-alkali syndrome

Contraindications

Hypersensitivity to one of the components of the drug

Hypercalcemia or hypercalciuria (increased concentration of calcium in the blood or urine)

Hypervitaminosis vitamin D

Urolithiasis disease

Phenylketonuria

Drug interactions

With simultaneous use of thiazide diuretics, the risk of hypercalcemia increases, because they increase tubular reabsorption of calcium. Furosemide and other loop diuretics, on the contrary, increase calcium excretion by the kidneys.

Calcium and vitamin D preparations can reduce the absorption of tetracyclines from the gastrointestinal tract, therefore the interval between taking a tetracycline drug and Calcium-D3 Nycomed should be at least 4 hours.

The absorption of quinolone antibiotics may be impaired when taken simultaneously with Calcium-D3 Nycomed. Quinolone antibiotics should be taken two hours before or six hours after taking Calcium-D3 Nycomed.

During simultaneous treatment with cardiac glycosides, ECG and clinical condition, because Calcium preparations can potentiate the therapeutic and toxic effects of cardiac glycosides.

If bisphosphonates are used concomitantly with calcium supplements, the bisphosphonates should be prescribed at least an hour before using Calcium-D3 Nycomed, as gastrointestinal absorption may be reduced.

Glucocorticosteroids reduce the absorption of calcium, so treatment with glucocorticosteroids may require an increase in the dose of Calcium-D3 Nycomed.

The effectiveness of levothyroxine may be reduced when taking Calcium-D3 Nycomed simultaneously due to decreased absorption of levothyroxine. Administration of Calcium-D3 Nycomed and levothyroxine should be separated by at least four hours.

special instructions

In patients who are simultaneously taking cardiac glycosides and/or diuretics, it is necessary to monitor the concentration of calcium and creatinine in the blood serum.

In case of hypercalcemia or signs of renal impairment, the dose should be reduced or treatment should be temporarily discontinued.

Vitamin D should be used with caution in patients with impaired renal function and their calcium and phosphorus levels should be monitored. In patients with severe renal failure, vitamin D (in the form of cholecalciferol) is not metabolized normally and other forms of vitamin D must be used.

Calcium-D3 Nycomed should be prescribed with caution to patients suffering from sarcoidosis due to the risk of increased metabolism of vitamin D into its active form. In these patients, serum and urine calcium levels should be monitored.

Calcium-D3 Nycomed should be used with caution in immobilized patients with osteoporosis due to the risk of developing hypercalcemia.

To avoid overdose, additional vitamin D intake from other sources must be taken into account.

Patients with the rare hereditary diseases of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency should not take this medicine.

Use in pediatrics

There are no data on the use of Calcium-D3 Nycomed in children under 3 years of age.

Pregnancy and lactation

During pregnancy, the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Vitamin D and its metabolites can pass into breast milk.

Therefore, it is necessary to take into account the intake of calcium and vitamin D from other sources in the mother and child and carry out medical monitoring.

Feature of influence medicine on the ability to drive a vehicle or potentially dangerous machinery

Does not affect driving ability vehicles and mechanisms.

Overdose

Symptoms: hypercalcemia, hypervitaminosis, anorexia, thirst, polyuria, nausea, vomiting, constipation, abdominal pain, fatigue, bone pain, nephrocalcinosis, muscle weakness, emotional disorders, in severe cases - cardiac arrhythmia.

Treatment: discontinuation of the drug, introduction of large amounts of fluid into the body, use of loop diuretics (for example, furosemide), glucocorticosteroids, calcitonin, bisphosphonates. Serum electrolyte levels, renal function, and diuresis should be monitored.

Release form and packaging

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Qualitative and quantitative composition

Composition per tablet

Active ingredients: calcium 500 mg in the form of calcium carbonate 1250 mg; cholecalciferol 5.0 mcg (200 IU) as cholecalciferol concentrate (powder) 2.0 mg.

For a complete list of excipients, see the “List of excipients” section.

Description

Round, biconvex, white, uncoated tablets. May have small inclusions and uneven edges. There may be a small amount of powder at the bottom of the bottle.

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Indications for use

Prevention and treatment of vitamin D and calcium deficiency.

Meeting vitamin D and calcium requirements as an adjunct to specific osteoporosis therapy in patients at risk of vitamin D and calcium deficiency.

Directions for use and doses

Dosage regimen

Adults, including elderly patients

Complementary therapy for osteoporosis

1 chewable tablet 2-3 times a day.

Calcium and vitamin deficiencyD

1 chewable tablet 1-3 times a day.

Children from 3 years old

Calcium and vitamin deficiencyD (only)

1 chewable tablet 1-2 times a day.

Special patient groups

Kidney failure

Calcium-D3 Nycomed tablets should not be used in patients with severe renal failure (see section "Contraindications").

Liver failure

No dose adjustment is required.

Mode of application

Orally. The tablet can be chewed or dissolved. The drug is taken regardless of meals.

You should not take an additional dose of the drug if you miss a pill.

Duration of treatment

The duration of taking the drug is determined individually

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 мл/мин/1,73 м 2). - Заболевания и/или состояния, приводящие к гиперкальциемии и/или гиперкальциурии. - Почечнокаменная болезнь (нефролитиаз). - Гипервитаминоз D.

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Special instructions and precautions

During long-term treatment, it is necessary to monitor serum calcium levels and monitor renal 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 drugs"), and for patients with a strong tendency to form kidney stones. In case of hypercalcemia or signs of renal impairment, 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 renal impairment; Calcium and phosphate levels should be monitored. The risk of soft tissue calcification must be taken into account.

When used concomitantly with other sources of vitamin D and/or drugs or nutrients (such as milk) containing calcium, there is a risk of developing hypercalcemia and milk-alkali syndrome with subsequent impairment of renal function. Serum calcium levels and renal function should be monitored in these patients.

Calcium-D3 Nycomed should be used with caution in patients suffering from sarcoidosis due to the risk of increased metabolism of vitamin D3 to its active form. In these patients, serum and urine calcium levels should be regularly monitored.

Calcium-D3 Nycomed should be used with caution in immobilized patients with osteoporosis due to increased risk development of hypercalcemia.

Calcium-D3 Nycomed contains isomalt (E953) and sucrose. Patients suffering from rare hereditary disorders such as fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this drug. With long-term use, sucrose can have a negative effect on tooth enamel.

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Interaction with other medicinal products and other types of interactions

Thiazide diuretics reduce urinary calcium excretion. Due to the increased risk of hypercalcemia during use of thiazide diuretics, serum calcium levels should be regularly monitored.

Calcium carbonate may interfere with the absorption of concomitantly prescribed tetracycline drugs. For this reason, tetracycline medications should be administered at least two hours before or 4 to 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.

When concomitantly using a bisphosphonate, the latter should be taken at least an hour before taking Calcium-D3 Nycomed to avoid decreased absorption in the gastrointestinal tract.

The effectiveness of levothyroxine may be reduced with concomitant use of calcium due to decreased absorption of levothyroxine. An interval of at least four hours should be maintained between taking calcium and levothyroxine.

The absorption of quinolone antibiotics may be impaired by concomitant administration of calcium. Quinolone antibiotics should be taken two hours before or six hours after taking calcium.

Calcium salts may reduce the absorption of iron, zinc and strontium ranelate. Therefore, it is recommended to take iron, zinc or strontium ranelate supplements two hours before or two hours after taking Calcium-D3 Nycomed.

Treatment with orlistat may potentially interfere with the absorption of fat-soluble vitamins (eg vitamin D3).

Pregnancy and lactation

Pregnancy

The drug Calcium-D3 Nycomed 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 adverse effects in developing fetus. There is no data on the teratogenic effect of vitamin D in therapeutic doses in humans.

Lactation

The drug Calcium-D3 Nycomed can be used during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when supplementing vitamin D to a child.

Impact on the ability to drive vehicles and machinery

The effect of the drug Calcium-D3 Nycomed on the ability to drive vehicles and machines has not been identified.

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Side effect

Adverse reactions are listed below according to classification by system-organ class and frequency of development. Frequency defined as: uncommon (≥ 1/1000,< 1/100), редко (≥ 1/10000, < 1/1000), очень редко (< 1/10000); частота неизвестна (невозможно оценить на основании имеющихся данных).

Immune system disorders

Frequency unknown: hypersensitivity reactions such as angioedema or laryngeal edema.

Metabolic and nutritional disorders

Infrequently: hypercalcemia and hypercalciuria.

Very rarely: milk-alkali syndrome (frequent urge to urinate; prolonged headache; long-term loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcemia, alkalosis and renal failure). As a rule, it is observed only in case of overdose (see section “Overdose”).

Gastrointestinal disorders

Rarely: constipation, dyspepsia, flatulence, nausea, abdominal pain and diarrhea.

Skin and subcutaneous tissue disorders

Very rarely: itching, rash and hives.

Special patient groups

Patients with renal failure: 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 to ensure continuous monitoring of the benefit-risk relationship of the medicinal product.

If an undesirable reaction occurs, either listed or not mentioned in these instructions for medical use, patients are advised to consult their doctor.

Medical professionals and patients are recommended to report any suspected adverse reactions of the drug to the Republican Unitary Enterprise “Center for Expertise and Testing in Healthcare” (see section “Send information about adverse reactions to the address”).

Overdose

Symptoms

Overdose can lead to hypercalcemia and vitamin D hypervitaminosis. Symptoms of hypercalcemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disorders, polydipsia, polyuria, bone pain, nephrocalcinosis, kidney stones and, in severe cases, cardiac arrhythmias. Extreme hypercalcemia can lead to coma and death. Constantly high levels calcium may cause irreversible kidney damage and soft tissue calcification.

Milk-alkali syndrome can occur in patients who ingest large amounts of calcium and absorbable alkaline foods.

Treatment 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 types of interactions”). For patients with impaired consciousness, removal of gastric contents is indicated. Rehydration and, depending on the severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Monitoring of serum electrolytes, renal function and diuresis is mandatory. In severe cases, ECG and central venous pressure should be monitored.

Pharmacotherapeutic group

Mineral supplements. Combinations of calcium with vitamin D and/or other agents.

ATX Code: A12AX

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Pharmacological properties

Pharmacodynamics

Vitamin D3 increases calcium absorption in the intestines.

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 patients suffering from vitamin D deficiency showed that taking two daily calcium 500 mg/vitamin D 400 IU tablets for 6 months normalized the 25-hydroxylated metabolite of vitamin D3 and reduced the severity of secondary hyperparathyroidism and alkaline phosphatase levels.

Pharmacokinetics

Calcium

Absorption: The amount of calcium that is absorbed through gastrointestinal tract, is approximately 30% of the consumed dose.

Distribution and metabolism: 99% of calcium in the body is concentrated in solid structures bones and teeth. The remaining amount (1%) is present in intra- and extracellular fluid. About 50% of the total calcium contained in the blood is present in the physiologically active ionized form, with approximately 10% forming complexes with citrate, phosphate and other anions; the remaining 40% is 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 easily absorbed in 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. Unmetabolized vitamin D3 is stored in adipose and muscle tissues.

Excretion: Vitamin D3 is excreted from the body in feces and urine.

List of excipients

Xylitol

Isomalt

Orange flavor

Mono- and diglycerides of fatty acids

Chewable tablets 500 mg/200M.E. with tasteorange.

20, 50 or 100 tablets in a bottle made of high-density polyethylene, sealed with a screw cap, under which there is a ring for tearing off the sealing gasket, ensuring first opening control.

One bottle along with instructions for use is placed in a cardboard box.

Special precautions when disposing of the drug

No special requirements.

Conditions for dispensing from pharmacies

Without a doctor's prescription.

◊ tab. chewable (orange) 1250 mg + 5 mcg: 20, 50 or 100 pcs. Reg. No.: P N013478/01

Clinical and pharmacological group:

A drug that regulates the metabolism of calcium and phosphorus

Release form, composition and packaging

◊ Chewable tablets (orange) without shell, round, biconvex, white; with orange aroma; may have small inclusions and uneven edges.

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 made of high-density polyethylene (1) - cardboard packs.
50 pcs. - bottles made of high-density polyethylene (1) - cardboard packs.
100 pieces. - bottles made of high-density polyethylene (1) - cardboard packs.

Description of the active components of the drug " Calcium-d 3 nycomed»

pharmachologic effect

A combined drug that regulates the exchange of calcium and phosphorus in the body (in bones, teeth, nails, hair, muscles).

Reduces resorption (resorption) and increases bone density, replenishing the lack of calcium and vitamin D 3 in the body, 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, pregnancy and lactation.

Vitamin D 3 increases calcium absorption in the intestines.

The use of calcium and vitamin D 3 prevents an increase in the production of parathyroid hormone, which is a stimulator of increased bone resorption (leaching of calcium from the bones).

Indications

- prevention and treatment of calcium and/or vitamin D 3 deficiency;

— prevention and complex therapy of osteoporosis and its complications (bone fractures).

Dosage regimen

The tablets can be chewed or dissolved and taken with meals.

Calcium-D 3 Nycomed

For adults For prevention of osteoporosis- 1 tab. 2 times/day; V - 1 tab. 2-3 times/day.

For - 1 tab. 2 times/day, children from 5 to 12 years old- 1-2 tablets/day, children from 3 to 5 years old- dosage in accordance with the doctor’s recommendations.

Calcium-D 3 Nycomed Forte

For adults For prevention of osteoporosis- 1 tab. 2 times/day or 2 tablets 1 time/day; V complex therapy of osteoporosis- 1 tab. 2-3 times/day.

For replenishment of calcium and vitamin D deficiencyadults and children over 12 years old- 2 tablets/day, children from 3 to 12 years old- 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 doctor individually.

When used to replenish calcium and vitamin D 3 deficiency, the average duration of treatment is at least 4-6 weeks. The number of repeat courses during the year is determined individually.

Special patient groups

Patients with impaired liver function no dose adjustment is required.

Should not be used when severe renal failure.

Elderly patients the same dose is prescribed as for adults. A possible decrease in creatinine clearance should be taken into account.

Side effect

The frequency of side effects of the drug is assessed as follows: very frequent (>1/10); frequent (>1/100,<1/10); нечастые (>1/1000, <1/100); редкие (>1/10 000, <1/1000); очень редкие (<1/10 000).

Metabolism and nutrition: uncommon - hypercalcemia, hypercalciuria.

From the digestive system: rarely - constipation, flatulence, nausea, abdominal pain, diarrhea, dyspepsia.

From the skin and subcutaneous tissue: very rarely - itching, rash, urticaria.

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 tablet form is not used in children under 3 years of age.

The drug contains sorbitol, isomalt and sucrose, so its use is not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

WITH caution: pregnancy, lactation, renal failure.

Pregnancy and lactation

Calcium and vitamin D 3 are used during pregnancy to compensate for their deficiency in the body.

During pregnancy, the daily dose of the drug should not exceed 1500 mg of calcium and 600 IU of vitamin D 3 .

Hypercalcemia due to overdose during pregnancy can have an adverse effect on the developing fetus.

The drug is used during lactation.

Calcium and vitamin D 3 can pass into breast milk, so it is necessary to consider the intake of calcium and vitamin D from other sources in the mother and baby.

Use for renal impairment

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

During long-term therapy, serum calcium and creatinine levels should be monitored. Monitoring is especially important in elderly patients during concomitant treatment with cardiac glycosides and diuretics and in patients with an increased tendency to form kidney stones. In cases of hypercalcemia or signs of renal impairment, reduce the dose or discontinue treatment.

Vitamin D should be taken with caution in patients with renal failure. In this case, it is necessary to monitor the calcium and phosphate levels in the blood serum. The risk of soft tissue calcification must also be considered.

To avoid overdose, additional vitamin D intake from other sources must be taken into account.

Calcium and vitamin D 3 should be used with caution in immobilized patients with osteoporosis due to the risk of developing hypercalcemia.

Concomitant use with tetracycline or quinolone antibiotics is usually not recommended or should be done with caution.

Impact on the ability to drive vehicles and operate machinery

The drug does not affect the ability to drive vehicles or operate 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 long-term use of excessive doses (over 2500 mg of calcium) - kidney damage, soft tissue calcification.

If symptoms of overdose are detected, 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, use of “loop” diuretics (for example, furosemide), corticosteroids, calcitonin, bisphosphonates. It is necessary to monitor the content of electrolytes in the blood plasma, renal function and diuresis. In severe cases, measurement of central venous pressure and ECG monitoring are necessary.

Drug interactions

Conditions for dispensing from pharmacies

The drug is approved for use as a means of OTC.

Storage conditions and periods

The drug should be stored in a tightly closed bottle, in a dry place, out of reach of children, at a temperature not exceeding 25°C. Shelf life - 3 years. Do not use after expiration date.

Drug interactions

Hypercalcemia can potentiate the toxic effects of cardiac glycosides when used simultaneously with calcium and vitamin D preparations. Monitoring of ECG and serum calcium levels is necessary.

Calcium supplements may reduce the absorption of tetracyclines from the gastrointestinal tract. Therefore, tetracycline drugs should be taken at least 2 hours before or 4-6 hours after taking the drug.

To prevent decreased absorption of bisphosphonate drugs, it is recommended to take them at least 1 hour before taking Calcium-D 3 Nycomed.

GCS reduce calcium absorption, so treatment with GCS may require an increase in the dose of Calcium-D 3 Nycomed.

With simultaneous use of thiazide diuretics, the risk of hypercalcemia increases, because they increase tubular reabsorption of calcium. When thiazide diuretics are used concomitantly, serum calcium levels should be regularly monitored.

Calcium reduces the effectiveness of levothyroxine by reducing its absorption. The period of time between doses of levothyroxine and Calcium-D 3 Nycomed should be at least 4 hours.

The absorption of quinolone antibiotics is reduced when used simultaneously with calcium supplements. Therefore, quinolone antibiotics should be taken 2 hours before or 6 hours after taking Calcium-D 3 Nycomed.

Eating foods containing oxalates (sorrel, rhubarb, spinach) and phytin (cereals) reduces the absorption of calcium, so you should not take Calcium-D 3 Nycomed within 2 hours after eating sorrel, rhubarb, spinach, cereals.