Instructions for Calcium-D3 Nycomed Forte chewable tablets No. 60
Composition
active ingredient: 1 tablet contains 1250 mg of calcium carbonate, which is equivalent to 500 mg of calcium, cholecalciferol (vitamin D3) – 10 mcg (400 IU) in the form of cholecalciferol concentrate* 4 mg;
excipients: xylitol (E 967), lemon flavored granulate (isomalt (E 953), lemon 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, white biconvex tablets without a shell; inclusions and small irregularities of the edges are 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: In general, 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 the level of 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 in adult patients at identified risk.
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 to any of the 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.
Interaction with other medicinal products and other types of interactions
Thiazide diuretics reduce urinary calcium excretion. During concomitant therapy, serum calcium levels should be monitored as the risk of hypercalcemia increases.
Calcium carbonate may interfere with the absorption of tetracycline drugs, so these drugs should be taken at least 2 hours before or 4-6 hours after taking Calcium-D3 Nycomed Forte.
Hypercalcemia may potentiate the toxicity of cardiac glycosides when used with calcium and vitamin D preparations. It is necessary to monitor cardiac function using ECG, serum calcium levels, and the patient's clinical condition.
To prevent reduced absorption of bisphosphonates, it is recommended to take Calcium-D3 Nycomed Forte no earlier than 1 hour after taking them.
With simultaneous use of calcium, the effectiveness of levothyroxine may be reduced due to reduced absorption. Levothyroxine should be taken at least 4 hours after taking Calcium-D3 Nycomed Forte.
Simultaneous use of calcium may affect the absorption of quinolone antibiotics. Quinolone antibiotics should be taken 2 hours before or 6 hours after taking Calcium-D3 Nycomed Forte.
Treatment with orlistat may potentially affect 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. In case of signs of hypercalcemia or impaired renal function, 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 monitor calcium and phosphate levels. It is necessary to remember the possible risk of soft tissue calcification. In patients with severe renal failure, vitamin D in the form of cholecalciferol cannot be metabolized normally, so other forms of vitamin D should be used. Simultaneous intake of vitamin D from other sources, in particular from medicines or products containing calcium (e.g. milk), can cause hypercalcemia and milk-alkali syndrome with subsequent renal dysfunction. In such patients, serum calcium levels and renal function should be regularly monitored.
Calcium-D3 Nycomed Forte should be used with caution in patients with sarcoidosis due to the risk of increased metabolism of vitamin D3 into its active form. It is necessary to monitor the level of calcium in the blood serum and urine.
Calcium-D3 Nycomed Forte should be used with caution in immobilized patients with osteoporosis due to the risk of developing hypercalcemia.
To avoid overdose, it is necessary to take into account the intake of calcium and vitamin D3 from other sources within the recommended daily intake of calcium and vitamin D3.
Patients with rare hereditary problems of fructose intolerance, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not take this medicine as it contains isomalt and sucrose.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no known data on the effect of Calcium-D3 Nycomed Forte on the reaction speed when driving vehicles or other mechanisms.
Use during pregnancy or breastfeeding
Pregnancy. The drug Calcium-D3 Nycomed Forte 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 of the drug, 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 Forte 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 D3 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.
Adults and elderly patients: 1 tablet 2 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").
Children
The drug is not intended for use in children.
Overdose
Symptoms. Overdose of the drug can lead to hypervitaminosis D and hypercalcemia. 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.
Patients who take large amounts of calcium and alkalis that are absorbed may develop milk-alkali syndrome; such patients require hospitalization.
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 forms of interaction"). The stomach should be emptied in patients with impaired consciousness. It is necessary to administer large amounts of fluids and follow a diet with a limited amount of calcium. Depending on the severity of the overdose, it may be necessary to use loop diuretics, bisphosphonates, calcitonin, corticosteroids separately or in combination. It is necessary to monitor serum electrolyte levels, renal function and diuresis. In severe cases, electrocardiogram (ECG) and central venous pressure (CVP) should be monitored.
Adverse reactions
uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), unknown (frequency not determined from the 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
60 tablets per bottle. 1 bottle per carton.
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.
