Calcium Complivit D3: instructions for use

Registration number:
Trade name of the drug: Complivit® Calcium D3
International nonproprietary name or group name: Calcium carbonate + Colecalciferol.

Dosage form: chewable tablets [orange].

Composition per tablet

Active components:

Calcium - 500 mg

(in the form of calcium carbonate - 1.250 g) Colecalciferol (vitamin D3) - 0.005 mg (200 IU) (in terms of 100% colecalciferol) (in the form of granules containing colecalciferol - 0.27%, D, L-alpha-tocopherol - 0.0275%, medium chain triglycerides - 10.7%, sucrose - 36%, acacia gum - 22%, corn starch - 27%, calcium phosphate (E 341) - 0.5%, water up to 100%).

Excipients: lactose monohydrate (milk sugar) - 327.406 mg, povidone (medium molecular weight polyvinylpyrrolidone, povidone K 30) - 68.223 mg, potato starch - 20.541 mg, croscarmellose sodium - 49.875 mg, citric acid - 3.325 mg, aspartame (E 951) - 5.95 mg, magnesium stearate - 15.75 mg, orange flavor (powder) - 8.925 mg.

Description: chewable tablets: round, biconvex with a rough, porous surface from white to white with a creamy tint, with a faint fruity odor. May have small inclusions of a grayish color.

Pharmacotherapeutic group: calcium-phosphorus metabolism regulator.

ATX code: [A12AX].

Pharmacological properties Pharmacodynamics

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

bone tissue density, replenishing the lack of calcium and vitamin D3 in the body, enhances the absorption of calcium in the intestines and the reabsorption of phosphates in the kidneys, promotes the mineralization of bone tissue and dental tissue.

Calcium is involved in the formation of bone tissue, in maintaining stable cardiac activity, in the regulation of nerve conduction, muscle contractions, hormone production, and is a component of the blood coagulation system.

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

Vitamin D3 (colecalciferol) – increases the absorption of calcium in the intestine, promotes the formation and mineralization of bone and dental tissue.

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).

Pharmacokinetics

Calcium

Absorption: Calcium is absorbed in ionized form in the proximal small intestine through an active, D-vitamin dependent transport mechanism. Typically, the amount of calcium absorbed in the gastrointestinal tract is approximately 30% of the dose taken.

Distribution and Metabolism: 99% of calcium in the body is concentrated in the rigid structure of bones and teeth. The remaining 1% is found in intracellular and extracellular fluids. About 50% of the total calcium content in the blood is in physiological active ionized form, of which approximately 10% is complexed with citrate, phosphate or other anions, the remaining 40% is associated with proteins, primarily albumin.

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

Vitamin D3

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

Distribution and metabolism: colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycalciferol. It is then converted in the kidneys to the active form 1,25-hydroxycalciferol. 1,25-hydroxycalciferol is a metabolite responsible for increasing calcium absorption.

Unmetabolized vitamin D3 is stored in adipose and muscle tissue.

Excretion: Vitamin D3 is excreted by the intestines and kidneys.

Indications for use

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

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

Contraindications

Hypersensitivity to the components of the drug.
Hypercalcemia (increased concentration of calcium in the blood).
Hypercalciuria (increased calcium in the urine).
Nephrolithiasis.
Hypervitaminosis D.
Decalcifying tumors (myeloma, bone metastases, sarcoidosis).
Pulmonary tuberculosis (active form).
Severe renal failure.

The drug in tablet dosage form is not used in children under 3 years of age. Complivit® Calcium D3 contains aspartame, which is transformed into phenylalanine in the body. Therefore, the drug should not be taken by patients with phenylketonuria.

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

With caution: pregnancy, breastfeeding, renal failure.

Use during pregnancy and breastfeeding

Complivit® Calcium D3 is used during pregnancy to compensate for the deficiency of calcium and vitamin D3 in the body. During pregnancy, the daily dose 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.

Complivit® Calcium D3 is used during breastfeeding. 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.

Directions for use and doses

Complivit® Calcium D3, chewable tablets, taken orally with meals. The tablet should be chewed or dissolved. After this, if necessary, you can drink water.

Adults: for the treatment of osteoporosis - 1 tablet 2-3 times a day, for the prevention of osteoporosis - 1 tablet 2 times a day.

For calcium and/or vitamin D3 deficiency:

Adults and children over 12 years old – 1 tablet 2 times a day. Children from 5 years to 12 years – 1-2 tablets per day.

Children from 3 to 5 years old - dosage in accordance with the doctor’s recommendations.

Special patient groups

Patients with impaired liver function:

No dose adjustment is required.

Patients with impaired renal function:

The drug should not be used in severe renal failure.

Elderly patients:

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

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/or 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.

Side effect

The frequency of side effects of the drug is assessed as follows: very often: > 1/10, often: > 1/100, <1/10, infrequently: > 1/1,000, < 1/100, rarely: > 1/10,000, < 1/1,000, very rare: <1/10,000.

Metabolic and nutritional disorders: uncommon - hypercalcemia, hypercalciuria.

Gastrointestinal disorders: rarely - constipation, flatulence, nausea, abdominal pain, diarrhea, dyspepsia.

Skin and subcutaneous tissue disorders: very rarely - allergic reactions (itching, rash, urticaria).

Overdose

Symptoms of overdose (hypercalcemia): thirst, polyuria, anorexia, nausea, vomiting, constipation, abdominal pain, bone pain, muscle weakness, fatigue, mental disorders, dizziness, headache, fainting, coma, nephrocalcinosis, urolithiasis, in severe cases - cardiac arrhythmias. With long-term use of excessive doses (over 2500 mg of calcium) - kidney damage, soft tissue calcification.

Laboratory indicators in case of overdose: hypercalciuria, hypercalcemia (plasma calcium about 2.6 mmol).

If signs of overdose are detected, you 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), glucocorticosteroid drugs, calcitonin, bisphosphonates, calcium-restricted diet, hemodialysis.

It is necessary to monitor the content of electrolytes in the blood plasma, renal function and diuresis.

In severe cases, it is necessary to measure central venous pressure (CVP) and monitor the electrocardiogram (ECG).

Interactions with other drugs and foods The activity of vitamin D3 may be reduced when used concomitantly with phenytoin or barbiturates.

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 Complivit® Calcium D3.

To prevent decreased absorption of bisphosphonate drugs, it is recommended to take them at least an hour before taking Complivit® Calcium D3.

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

Simultaneous treatment with cholestyramine preparations or laxatives based on mineral or vegetable oil may reduce the absorption of vitamin D3.

With simultaneous use of thiazide diuretics, the risk of hypercalcemia increases, as they increase tubular reabsorption of calcium. When using thiazide diuretics simultaneously, serum calcium levels should be regularly monitored. Furosemide and other “loop” diuretics, on the contrary, increase calcium excretion by the kidneys.

Calcium reduces the effectiveness of levothyroxine by reducing its absorption. The period of time between doses of levothyroxine and Complivit® Calcium D3 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 Complivit® Calcium D3.

Eating foods containing oxalates (sorrel, rhubarb, spinach) and phytin (cereals) reduces calcium absorption, so you should not take Complivit® Calcium D3 within 2 hours after eating sorrel, rhubarb, spinach and cereals.

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 (see section “Interactions with other drugs and foods”) 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 D3 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.

In older people, the need for calcium is 1500 mg/day, for vitamin D3 – 0.5-1 thousand IU/day.

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 quinolone antibiotics is usually not recommended or should be done with caution (see section “Interaction with other drugs and foods”).

Effect on the ability to drive vehicles and machinery The drug Complivit® Calcium D3 does not affect the ability to drive vehicles or work with technically complex mechanisms.

Release form

Chewable tablets [orange].

30, 60, 90, 100 or 120 tablets in polymer jars. The jars are sealed with a screw-on lid. Each jar, covered with a protective heat-shrink cap, along with instructions for use, is placed in a cardboard pack.

Or jars of 60, 90, 100 or 120 tablets with a multi-page label containing the full text of the instructions for use, covered with a protective heat-shrink cap, are placed in a transport container.

Storage conditions

At a temperature not higher than 25 ºС. Keep out of the reach of children.

Best before date

3 years.

Do not use after the expiration date stated on the packaging.

Vacation conditions

Over the counter.

Marketing authorization holder/organization receiving consumer complaints:

PJSC OTCPharm, Russia, 123317, Moscow, st. Testovskaya, 10 Tel.: +7 (800) 775-98-19 Fax www.otcpharm.ru

, 450077, Russia, Republic of Bashkortostan, Ufa, st. Khudayberdina, 28, tel./fax, www.pharmstd.ru

Calcium-d3 nycomed forte 120 pcs. chewable lemon tablets

pharmachologic effect

Calcium-phosphorus metabolism regulator.

Composition and release form Calcium-d3 nycomed forte 120 pcs. chewable lemon tablets

Tablets - 1 tablet:

Active components: calcium carbonate - 1250 mg (equivalent to elemental calcium - 500 mg), colecalciferol (vitamin D3) - 10.0 mcg (400 IU) in the form of concentrate * colecalciferol 4.0 mg;
Auxiliary components: sorbitol - 390 mg, lemon granulate flavor** - 50.7 mg, povidone - 36.4 mg, magnesium stearate - 6.0 mg, aspartame - 1.00 mg.

*colecalciferol concentrate contains, including 10% excess: colecalciferol - 0.011 mg, alpha-tocopherol - 0.044 mg, modified corn starch - 3.214 mg, sucrose - 0.77 mg, sodium ascorbate - 0.176 mg, medium chain triglycerides - 0.134 mg, silicon dioxide - 0.053 mg.

**Lemon flavoring granules contain: isomalt - 49.9 mg, lemon flavoring - 0.76 mg, mono and diglycerides of fatty acids - 0.0006 mg.

30, 60 or 120 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.

1 bottle along with instructions for use is placed in a cardboard pack.

Description of the dosage form

Round, biconvex tablets, white, with lemon flavor. May have small inclusions of grayish color and uneven edges.

Directions for use and doses

Calcium-D3 Nycomed is taken orally.

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

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

For calcium and vitamin D3 deficiency:

Adults and children over 12 years old - 1 tablet 2 times a day.
Children from 5 to 12 years: 1-2 tablets per day.
Children from 3 to 5 years of age - dosage in accordance with the doctor’s recommendations.

Special patient groups

Patients with impaired liver function:

No dose adjustment is required.

Patients with impaired renal function:

The drug Calcium-Dz Nycomed should not be used in case of severe renal failure.

Elderly patients:

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

Duration of treatment

When used for prevention and in comilex therapy of osteoporosis, the duration of treatment is determined by the doctor individually.

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.

Pharmacodynamics

A combined drug that regulates the exchange of calcium and phosphorus in the body (bones, teeth, nails, hair, muscles). Reduces resorption (resorption) and increases bone density, replenishing the lack of calcium and vitamin O in the body, 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 calcium intake is especially important during growth, pregnancy and lactation.

Vitamin D3 increases calcium absorption 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).

Pharmacokinetics

Calcium

Absorption: Typically, the amount of calcium absorbed from the gastrointestinal tract is approximately 30% of the dose taken.

Distribution and Metabolism: 99% of calcium in the body is concentrated in the rigid structure of bones and teeth. The remaining 1 is found in intra- and extracellular fluids. About 50% of the total calcium content in the blood is in physiologically active ionized form, of which approximately 10% is complexed with citrate, phosphate or other anions, the remaining 40% is associated with proteins, primarily albumin.

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

Vitamin D3

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

Distribution and metabolism: colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycolecalciferol. It is then converted in the kidneys to the active form 1,25-hydroxycolecalciferol. 1,25-hydroxycolecalciferol is a metabolite responsible for increasing calcium absorption.

Unmetabolized vitamin D3; deposited in adipose and muscle tissue.

Excretion: Vitamin D3 is excreted by the intestines and kidneys.

Indications for use Calcium-d3 nycomed forte 120 pcs. chewable lemon tablets

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

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

Contraindications

Hypercalcemia (increased concentration of calcium in the blood).
Hypercalciuria (increased calcium in the urine).
Nephrolithiasis.
Hypervitaminosis D3.
Hypersensitivity to the components of the drug.
Hypersensitivity to soy or peanuts.
Severe renal failure.
Active tuberculosis.
Sarcoidosis.

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

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

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

With caution: pregnancy, lactation, renal failure.

Application of Calcium-d3 nycomed forte 120 pcs. chewable lemon tablets during pregnancy and breastfeeding

Calcium-D3 Nycomed is used during pregnancy to replenish the deficiency of calcium and vitamin D3 in the body. The daily dose during pregnancy 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.

Calcium-D3 Nycomed is used during lactation. Calcium and vitamin O can pass into breast milk, so it is necessary to take into account the intake of calcium and vitamin D3 from other sources in the mother and child.

special instructions

During long-term therapy, it is necessary to monitor the content of calcium and creatinine in the blood serum. Monitoring is especially important in elderly patients during concomitant treatment with cardiac glycosides and diurstics and in patients with an increased tendency to form kidney stones. In cases of tipercalcemia or signs of renal impairment, reduce the dose or discontinue treatment.

To avoid overdose, additional vitamin D3 intake 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 of 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 Calcium-D3 Nycomed does not affect the ability to drive vehicles or work with technically complex mechanisms.

Overdose

Symptoms of overdose (hypercalcemia): anorexia, thirst, polyuria, muscle weakness, nausea, vomiting, constipation, abdominal pain, fatigue, bone pain, mental disorders, nephrocalcic disease, 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 signs of overdose are detected, you should stop taking calcium and vitamin O, 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), glucocorticosteroids, calcitonin, bisphosphonates.

It is necessary to monitor the content of electrolytes in the blood plasma, renal function and diuresis.

In severe cases, it is necessary to measure central venous pressure (CVP) and monitor the electrocardiogram (ECG).

Side effects Calcium-d3 nycomed forte 120 pcs. chewable lemon tablets

The frequency of side effects of the drug is assessed as follows: Very common: > 110; Frequent: > 1100, 111000, 1/10 000,

Metabolic and nutritional disorders - Misfortune: hypercalcemia and hypercalciuria.

Gastrointestinal disorders - Rarely: constipation, flatulence, nausea, abdominal pain, diarrhea, dyspepsia.

Skin and subcutaneous tissue disorders - Very rare: itching, rash, urticaria/

Drug interactions

Hypercalcemia may potentiate the toxic effects of cardiac glycosides when used concomitantly with calcium and vitamin D3 supplements. Monitoring of ECG and serum calcium levels is necessary.

To prevent decreased absorption of bisphosphonate drugs, it is recommended to take them at least an hour before taking Calcium-D3 Nycomed.

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

With the simultaneous use of thiazide diurstics, the risk of hypercalcemia increases, as. 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-D3 Nycomed should be at least 4 hours.

Ingestion of foods containing oxalates (sorrel, rhubarb, spinach) and phytin (cereals) reduces the absorption of calcium, so you should not take Cadium-D3 Nycomed within two hours after eating sorrel, rhubarb, spinach, and cereals.