Complivit Calcium D3 Chewable tablets orange, 120pcs

Composition

Active ingredients:

Calcium – 500 mg (in the form of calcium carbonate-1,250 g).

Colecalciferol (vitamin D₃) – 0.005 mg (200 IU) (in recalculation on 100% colecalciferol) (in the form of granules containing colecalciferol and 0.27%, respectively, of D, L-alpha-tocopherol – 0,0275%, triglycerides medium-chain – 10,7%, sucrose – 36%, gum acacia – 22%, corn starch – 27%, calcium phosphate (E 341), and 0.5%, water up to 100%).

Excipients: lactose monohydrate – 327,406 mg, povidone (polyvinylpyrrolidone srednemolekularna-tion, povidone K 30) – 68,223 mg, potato starch – 20,541 mg, croscarmellose sodium – 49,875 mg, citric acid (in the form of citric acid monohydrate) – 3,325 mg, aspartame (E 951) – 5,95 mg, magnesium stearate – is 15.75 mg, orange flavor (powder) – 8,925 mg.

Pharmacological properties

Pharmacotherapeutic group: calcium-phosphorus metabolism regulator.

ATX code: [A 12 AH].

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 density, replenishing the lack of calcium and vitamin D3 in the body, increases the absorption of calcium in the intestines and reabsorption of phosphates in the kidneys, promotes mineralization of bones and teeth.

Calcium-participates in the formation of bone tissue, in maintaining stable heart activity, in regulating nerve conduction, muscle contractions, hormone production, and is a component of the blood clotting system.

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

Vitamin D3 (colecalciferol) – increases the absorption of calcium in the intestines, promotes the formation and mineralization of bone and tooth 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 bone).

Pharmacokinetics.

Calcium

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

Distribution and metabolism: 99% of the body’s calcium is concentrated in the rigid structure of bones and teeth. The remaining 1% is found in intra-and extracellular fluids.

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

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, associated with a specific globulin. Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycalciferol.

Then it is converted in the kidneys to the active form of 1,25-hydroxycalciferol, which is responsible for increasing the absorption of calcium in the intestine and tubular reabsorption in the kidneys. Unmetabolized vitamin D3 is deposited in adipose and muscle tissue.

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

Indications

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

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

Use during pregnancy and lactation

Complivit®  CalciumD3 is used during pregnancy to make up for the lack of calcium and vitamin D 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 lactation. Calcium and_vitamin D3 can enter breast milk, so it is necessary to take into account the intake of calcium and vitamin D from other sources in the mother and child.

Contraindications

• Hypersensitivity to the components of the drug.

• Hypercalcemia (increased concentration of calcium in the blood).

• Hypercalciuria (increased calcium content in the urine).

• Nephrolithiasis.

• Hypervitaminosis D.

• Decalcifying tumors (myeloma, bone metastases, sarcoidosis).

• Active tuberculosis.

• Severe renal failure.

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

Complivit ® Calcium D₃ contains aspartame, which is converted to 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 lactose intolerance, fructose, glucose-galactose malabsorption, lactase or sucrose/isomaltase insufficiency.

With caution: pregnancy, lactation, renal failure.

Side effects

The frequency of side effects of the drug is estimated 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

Metabolic and nutritional disorders: infrequently-hypercalcemia, hypercalciuria.

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

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

Interaction

Vitamin D3 activity may be reduced when co-administered with phenytoin or barbiturates.

Hypercalcemia may potentiate the toxic effects of cardiac glycosides when used concomitantly with calcium and vitamin D supplements. It is necessary to monitor the ECG and the content of calcium in the blood serum.

Calcium supplements may reduce the absorption of tetracyclines from the gastrointestinal tract. Therefore, tetracycline preparations should be taken at least 2 hours before or 4-6 hours after taking Complivit® Calcium D₃.

To prevent a decrease in the absorption of bisphosphonate preparations, it is recommended to take them at least one hour before taking Complivit ® Calcium D₃.

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

Concomitant treatment with colesteramine or mineral or vegetable oil-based laxatives may reduce the absorption_{of vitamin}D3.

Concomitant use of thiazide-type diuretics increases the risk of hypercalcemia, as they increase the tubular reabsorption of calcium. When thiazide diuretics are used concomitantly, serum calcium levels should be regularly monitored. Furosemide and other “loop” diuretics, on the contrary, increase the excretion of calcium by the kidneys.

Calcium reduces the effectiveness of levothyroxine by reducing its absorption. The time interval between levothyroxine and Complivit® Calcium D3 should be at least 4 hours.

The absorption of quinolone antibiotics decreases when used concomitantly with calcium supplements. Therefore, quinolone antibiotics should be taken 2 hours before or 6 hours after taking Complivit® Calcium D₃.

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

How to take, course of use and dosage

Complivit ® Calcium D₃, chewable tablets, used orally during meals. The tablet should be chewed or absorbed. After that, if necessary, you can wash it down 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.

If you are deficient in calcium and / or vitaminD3:

Adults and children over 12 years of age – 1 tablet 2 times a day.

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

Children from 3 to 5 years – dosage according to 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 patients with severe renal insufficiency.

Elderly patients:

The dose is the same as for adults. Possible decrease in creatinine clearance should be considered.

Duration of treatment

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

When used to compensate for calcium and/or 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.

Overdose

Symptoms of overdose (hypercalcemia): thirst, polyuria, anorexia, nausea, vomiting, constipation, abdominal pain, dizziness, muscle weakness, fatigue, bone pain, mental disorders, headache, fainting states, coma, nephrocalcinosis, urolithiasis, in severe cases-cardiac arrhythmias.

With prolonged use of excessive doses (over 2500 mg of calcium) – kidney damage, soft tissue calcification.

Laboratory parameters for overdose: hypercalciuria, hypercalcemia (plasma calcium is about 2.6 mmol).

If you find signs of overdose, 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, the use of “loop” diuretics (for example, furosemide), glucocorticosteroid drugs, calcitonin, bisphosphonates, a diet with limited calcium, hemodialysis.

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

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

Special instructions

With long-term therapy, the content of calcium and creatinine in the blood serum should be monitored. Monitoring is particularly important in elderly patients who are receiving concomitant treatment with cardiac glycosides and diuretics (see section “Interactions with other medications and foods”) and in patients with an increased tendency to form kidney stones.

In cases of hypercalcemia or signs of impaired renal function, the dose should be reduced or treatment should be discontinued.

Vitamin D3 should be taken with caution in patients with renal insufficiency. In this case, it is necessary to monitor the content of calcium and phosphates in the blood serum. It is also necessary to consider the risk of soft tissue calcification.

To avoid overdose, additional vitamin D intake from other sources should be considered.

In the elderly, the need for calcium is 1500 mg / day, in vitamin D₃ – 0,5-1 ths.

Calcium and vitamin D3 should be used with caution in immobilized patients with osteoporosis due to the risk of hypercalcemia.

Concomitant use with antibiotics of the tetracycline or quinolone group is usually not recommended or should be carried out with caution (see the section “Interaction with other medicines and food products”).

Influence on the ability to drive vehicles and mechanisms.

Complivit®preparation Calcium D₃ it does not affect the ability to drive vehicles or work with technically complex mechanisms.

Storage conditions

At a temperature not exceeding 25 0 C.

Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

: Calcium carbonate, Colecalciferol

Dosage form

chewable tablets

Indications

Bone Strengthening