Instructions Calcium-D3 Nycomed with orange flavor chewable tablets bottle No. 20
Composition
active ingredients: 1 tablet contains 1250 mg of calcium carbonate, which is equivalent to 500 mg of calcium, cholecalciferol (vitamin D3) – 5 μg (200 IU), which corresponds to cholecalciferol concentrate* 2 mg;
excipients: xylitol (E 967), orange flavored granulate (isomalt (E 953), orange flavor, mono- and diglycerides of fatty acids), povidone, magnesium stearate, sucralose (E 955).
*Cholecalciferol concentrate composition: cholecalciferol, DL-ɑ-tocopherol, medium chain triglycerides, modified corn starch, sucrose, sodium ascorbate, colloidal anhydrous silicon dioxide.
Dosage form
Chewable tablets.
Main physicochemical properties: round biconvex tablets of white color without a shell. The presence of inclusions and slight irregularities of the edges is allowed. A small amount of powder is possible at the bottom of the bottle.
Pharmacotherapeutic group
Mineral supplements: Calcium, combinations with vitamin D and/or other drugs.
ATX code A12A X.
Pharmacological properties
Pharmacodynamics
Vitamin D3 increases calcium absorption in the intestines.
The use of calcium and vitamin D3 prevents the increase in parathyroid hormone (PTH) levels, which is caused by calcium deficiency and leads to increased bone resorption (leaching of calcium from bones).
A clinical study in hospitalized patients with vitamin D deficiency showed that daily administration of 2 500 mg calcium tablets and 400 IU vitamin D for 6 months normalized the level of the 25-hydroxylated metabolite of vitamin D3 and reduced the manifestations of secondary hyperparathyroidism and alkaline phosphatase levels.
Pharmacokinetics
Calcium.
Absorption: Approximately 30% of the ingested calcium dose is absorbed through the gastrointestinal tract.
Distribution and biotransformation. 99% of calcium is concentrated in the hard structures of the body (bones, teeth); 1% of calcium is contained in the intracellular and extracellular environment. Approximately 50% of calcium in the blood is in a physiologically active ionized form, almost 10% is complexed with citrates, phosphates and other anions, and the remaining 40% is part of proteins, mainly albumins.
Excretion: Calcium is excreted in the feces, urine, and sweat. Renal excretion depends on glomerular filtration and tubular reabsorption of calcium.
Cholecalciferol.
Absorption: Vitamin D3 is readily absorbed in the small intestine.
Distribution and biotransformation. Cholecalciferol and its metabolites circulate in the blood bound to a specific globulin. In the liver, cholecalciferol is converted by hydroxylation to 25-hydroxycholecalciferol. It is then converted to the active form 1,25-dihydroxycholecalciferol in the kidneys. 1,25-dihydroxycholecalciferol is the metabolite responsible for increased calcium absorption. Unmetabolized vitamin D3 is stored in adipose and muscle tissues.
Excretion: Vitamin D3 is excreted in feces and urine.
Indication
Prevention and treatment of calcium and vitamin D deficiency.
Additional use of vitamin D and calcium as an adjunct to specific osteoporosis therapy in patients at risk of developing calcium and vitamin D deficiency.
Contraindication
Hypersensitivity to the active substance or other components of the drug; severe renal failure (glomerular filtration rate <30 ml/min/1.73 m2); diseases and/or conditions associated with hypercalcemia and/or hypercalciuria; urolithiasis (nephrolithiasis); hypervitaminosis D; tuberculosis in the active phase.
Interaction with other medicinal products and other types of interactions
The activity of vitamin D3 may be reduced when used simultaneously with rifampicin.
Thiazide diuretics reduce urinary calcium excretion. With concomitant therapy, it is necessary to regularly monitor serum calcium levels, as the risk of hypercalcemia increases.
Calcium carbonate may interfere with the absorption of tetracycline drugs. Tetracycline drugs should be taken 2 hours before or 4–6 hours after taking Calcium-D3 Nycomed.
Hypercalcemia may potentiate the toxicity of cardiac glycosides (possible occurrence of arrhythmias, etc.) when using calcium and vitamin D preparations. Simultaneous use in patients taking cardiac glycosides and large doses of calcium is not recommended. If concomitant therapy with cardiac glycosides is necessary, low doses of the drug should be used. It is necessary to monitor the heart function using ECG and serum calcium levels in patients.
To prevent reduced absorption of bisphosphonates, it is recommended to take Calcium-D3 Nycomed no earlier than 1 hour after taking them.
The simultaneous use of calcium may impair the absorption of quinolone antibiotics. Quinolone antibiotics should be taken 2 hours before or 6 hours after taking Calcium-D3 Nycomed.
Calcium salts may reduce the absorption of iron, zinc and strontium ranelate. Therefore, iron, zinc and strontium ranelate preparations should be taken at least 2 hours before or after taking Calcium-D3 Nycomed.
Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (e.g. vitamin D3).
Application features
During long-term treatment with the drug, it is necessary to monitor the level of calcium and creatinine in the blood serum and renal function, especially in elderly patients with concomitant therapy with cardiac glycosides or diuretics (see section "Interaction with other medicinal products and other types of interactions") and in patients with a high tendency to calculus formation. If signs of hypercalcemia or impaired renal function appear, the dose should be reduced or the drug should be discontinued.
The drug should be used with caution in patients with hypercalcemia or signs of impaired renal function and calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal failure, vitamin D3 in the form of cholecalciferol cannot be metabolized normally, so other forms of vitamin D should be used (see section "Contraindications").
Concomitant intake of vitamin D from other sources, including medications or calcium-containing foods (e.g., milk), may cause hypercalcemia and milk-alkali syndrome with subsequent renal impairment. Supplemental calcium or vitamin D should be taken under medical supervision. Such patients should have their serum calcium and renal function monitored regularly.
Calcium-D3 Nycomed is contraindicated in patients with sarcoidosis and hypoparathyroidism due to the risk of increased metabolism of vitamin D3 into its active form.
Serum and urine calcium levels should be monitored in such patients.
Calcium-D3 Nycomed should be used with caution in immobilized patients with osteoporosis due to the risk of developing hypercalcemia.
Calcium-D3 Nycomed contains sucrose, which may be harmful to teeth. The drug also contains isomalt (E 953). Therefore, patients with rare hereditary problems of fructose intolerance, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not use the drug.
Calcium-D3 Nycomed contains less than 23 mg of sodium per tablet, meaning it is essentially sodium-free.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no known data on the effect of Calcium-D3 Nycomed on the reaction speed when driving vehicles or other mechanisms.
Use during pregnancy or breastfeeding
Pregnancy. Calcium-D3 Nycomed can be used during pregnancy in case of calcium and vitamin D deficiency. The daily dose should not exceed 2500 mg of calcium and 4000 IU of vitamin D. Animal studies have shown that vitamin D in high doses has reproductive toxicity. Pregnant women should avoid overdose with Calcium-D3 Nycomed, since prolonged hypercalcemia has adverse effects on the fetus. There is no evidence that vitamin D in recommended doses can cause teratogenic effects in humans.
Breastfeeding. Calcium-D3 Nycomed can be used during breastfeeding. Calcium, vitamin D3 and its metabolites can pass into breast milk, so it is necessary to take into account the intake of calcium and vitamin D from other sources into the child's body.
Method of administration and doses
The drug is intended for oral use. The tablet should be chewed or dissolved.
Calcium and vitamin D deficiency.
Adults and elderly patients: 1 tablet 1–3 times a day.
Children over 5 years of age: 1 tablet 1–2 times a day as recommended by a doctor.
Adjunct to osteoporosis therapy.
Adults: 1 tablet 2–3 times a day.
Patients with hepatic insufficiency do not require dose adjustment.
Patients with severe renal insufficiency should not use the drug (see section "Contraindications").
Elderly patients: The same doses as for adults are recommended.
Children
The drug should be used to treat calcium and vitamin D deficiency in children aged 5 years and older on the recommendation of a doctor.
Overdose
Symptoms. Overdose can lead to hypercalcemia and hypervitaminosis D. Symptoms of hypercalcemia are: anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, increased fatigue, mental disorders, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis, cardiac arrhythmias in severe cases. Severe hypercalcemia can lead to coma and death. Persistently high levels of calcium in the body can lead to irreversible kidney damage and soft tissue calcification.
Treatment. Symptomatic and supportive therapy. The drug should be discontinued. Thiazide diuretics and cardiac glycosides should also be discontinued (see section "Interaction with other medicinal products and other types of interactions"). Patients with impaired consciousness should be gastric lavaged and large amounts of fluid should be administered. Depending on the severity of the overdose, loop diuretics, bisphosphonates, calcitonin, corticosteroids may be required, either individually or in combination. Serum electrolytes, renal function and diuresis should be monitored. In severe cases, electrocardiogram (ECG) and central venous pressure (CVP) should be monitored.
Adverse reactions
Adverse effects are classified by frequency of occurrence as follows:
uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), unknown (frequency cannot be estimated from the available data).
From the immune system.
Not known: hypersensitivity reactions including angioedema, laryngeal edema.
On the part of metabolism.
Uncommon: hypercalcemia, hypercalciuria.
Very rare: milk-alkali syndrome (frequent urination, persistent headache, persistent loss of appetite, nausea or vomiting, unusual fatigue or weakness, hypercalcemia, alkalosis, renal failure) is observed only in case of overdose (see section "Overdose").
From the digestive tract.
Rare: constipation, dyspepsia, flatulence, nausea, abdominal pain, diarrhea.
On the skin and subcutaneous tissue.
Very rare: itching, rash, urticaria.
Special patient groups.
Patients with renal insufficiency: possible risk of developing hyperphosphatemia, nephrolithiasis and nephrocalcinosis (see section "Special warnings and precautions for use").
Expiration date
30 months.
Storage conditions
Keep the bottle tightly closed at a temperature not exceeding 30 ° C. Keep out of the reach of children!
Packaging
20 tablets in a bottle; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Takeda AS, Norway/ Takeda AS, Norway.
Location of the manufacturer and its business address
Drammensveien 852, NO-1383 Asker, Norway.
