Complivit calcium D3 forte tab. chewing 500mg+400IU No. 60 (mint)

Complivit Calcium D3 Forte chewable tablets No. 30 mint

Compound

Active substances:

* in the form of granulate containing colecalciferol - 0.27%, DL-α-tocopherol - 0.0275%, medium chain triglycerides - 10.7%, sucrose - 36%, acacia gum - 22%, corn starch - 27%, calcium phosphate (E341) - 0.5 %, water - up to 100%).
Excipients: lactose monohydrate (milk sugar) - 333.118 mg, povidone (medium molecular weight polyvinylpyrrolidone, povidone K17) - 68.24 mg, polysorbate 80 - 1.731 mg, potato starch - 18.969 mg, croscarmellose sodium - 50.282 mg, citric acid - 3.325 mg, aspartame (E951) - 5.95 mg, magnesium stearate - 15.75 mg, peppermint leaf oil - 2.625 mg.

Pharmacokinetics

Colecalciferol

Vitamin D3 is easily absorbed from the small intestine (about 80% of the dose taken). 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. Excreted through the intestines and kidneys.

Calcium

Calcium is absorbed in ionized form from the proximal small intestine through an active, D-vitamin dependent transport mechanism. Typically, the amount of calcium absorbed from the gastrointestinal tract is approximately 30% of the dose taken. 99% of calcium in the body is concentrated in the hard tissues of teeth and bones. The remaining 1% is found in intra- 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. Calcium is excreted by the intestines, kidneys and sweat glands. Renal excretion depends on glomerular filtration and tubular reabsorption of calcium.

Indications for use

• Prevention and complex therapy of osteoporosis (menopausal, senile, “steroidal”, idiopathic) and its complications (bone fractures).
• Replenishment of calcium and/or vitamin D3 deficiency.

Contraindications

Hypersensitivity to the components of the drug (including lactose intolerance, lactase deficiency, sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption), hypercalcemia, hypercalciuria, calcium nephrourolithiasis, hypervitaminosis D, decalcifying tumors (myeloma, bone metastases, sarcoidosis ), osteoporosis due to immobilization, phenylketonuria (contains aspartame), pulmonary tuberculosis (active form), chronic renal failure, children under 3 years of age.

With caution: pregnancy, lactation period.

Directions for use and doses

Inside, chew or swallow whole, preferably during meals, with 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.

To compensate for calcium and/or vitamin D3 deficiency:

• Adults and children over 12 years old - 1 tablet 1-2 times a day.
• Children from 3 to 12 years old - 1 tablet per day or as prescribed by a doctor.

Storage conditions

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

Best before date

3 years. Do not use after the expiration date stated on the package.

special instructions

To avoid overdose, additional vitamin D3 intake from other sources must be taken into account.
Complivit® Calcium Dz Forte contains aspartame, which is transformed into phenylalanine in the body, so the drug should not be taken by patients suffering from phenylketonuria.

During the treatment period, it is necessary to constantly monitor the excretion of calcium in the urine and the concentration of calcium and creatinine in the blood plasma (in case of calciuria exceeding 7.5 mmol/day (300 mg/day), it is necessary to reduce the dose or stop taking it).

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

Description

Calcium-phosphorus metabolism regulator.

Pharmacodynamics

A combined drug whose effect is determined by its constituent components.
Regulates the exchange of calcium and phosphates, reduces resorption and increases bone density, replenishes 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 bone mineralization. Calcium is involved in the formation of bone tissue, blood clotting, maintaining stable cardiac activity, and in carrying out the processes of transmission of nerve impulses.

Vitamin D3 (colecalciferol) - promotes the absorption of calcium in the intestines, the formation and mineralization of bone and dental tissue. The use of calcium and vitamin D3 prevents the increase in the production of parathyroid hormone, which is a stimulator of increased bone resorption.

Side effects

Allergic reactions. Dyspeptic disorders of the gastrointestinal tract (constipation, flatulence, nausea, stomach pain, diarrhea). Hypercalcemia and hypercalciuria (increased calcium levels in the blood and urine).

Use during pregnancy and breastfeeding

The daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Hypercalcemia, which develops against the background of an overdose, during pregnancy can cause defects in the mental and physical development of the child. Vitamin D and its metabolites 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.

Interaction

The activity of vitamin D3 may decrease when used concomitantly with phenytoin or barbiturates.

During simultaneous treatment with cardiac glycosides, monitoring of the ECG and clinical condition is necessary, since calcium preparations can potentiate the therapeutic and toxic effects of cardiac glycosides.

Calcium and vitamin D3 supplements may increase the absorption of tetracyclines: from the gastrointestinal tract. Therefore, the time interval between doses of drugs should be at least three hours.

To prevent decreased absorption of bisphosphonate drugs or sodium fluoride, it is recommended to take Complivit Calcium Dz Forte no earlier than two hours after taking them.

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

Simultaneous treatment with cholestyramine 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. Furosemide and other “loop” diuretics, on the contrary, increase calcium excretion by the kidneys.

Overdose

If you notice signs of overdose, consult a doctor.

Symptoms: thirst, polyuria, loss of appetite, nausea, vomiting, constipation, dizziness, weakness, headache, fainting, coma; with long-term use: calcification of blood vessels and tissues.

Treatment: introduction of large amounts of fluid into the body, use of loop diuretics (for example, furossmide), glucocorticosteroids, calcitonin, bisphosphoiates. If clinical symptoms of overdose develop, the concentration of calcium and creatinine in the blood should be determined. In case of increased concentration of calcium or creatinine in the blood serum, the dose of the drug should be reduced or treatment should be temporarily stopped.

Complivit calcium D3 forte tab. chewing 500mg+400IU No. 60 (mint)

Pharmacotherapeutic group: calcium-phosphorus metabolism regulator. 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 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 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).

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 intra- 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

Side effects 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. 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, replacement 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). 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 Forte. To prevent decreased absorption of bisphosphonate drugs, it is recommended to take them at least an hour before taking Complivit® Calcium D3 Forte. Glucocorticosteroids reduce calcium absorption, so treatment with glucocorticosteroids may require an increase in the dose of Complivit® Calcium D3 Forte. 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 Forte 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 Forte. Eating foods containing oxalates (sorrel, rhubarb, spinach) and phytin (cereals) reduces calcium absorption, so you should not take Complivit® Calcium D3 Forte within 2 hours after eating sorrel, rhubarb, spinach and cereals.

Special instructions During long-term therapy, the levels of calcium and creatinine in the blood serum 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 developing 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”).

Impact on the ability to drive vehicles and machinery. The drug Complivit® Calcium D3 Forte does not affect the ability to drive vehicles or operate technically complex mechanisms.