Instructions for Calcium-D3 Nycomed Osteoforte chewable tablets No. 60
Composition
active ingredient: calcium carbonate, cholecalciferol;
1 tablet contains: calcium carbonate 2500 mg, which is equivalent to 1000 mg of calcium, cholecalciferol (vitamin D3) – 20 mcg (800 IU) in the form of cholecalciferol concentrate* 8 mg;
excipients: xylitol (E 967), sucralose (E 955), povidone, magnesium stearate, lemon flavored granulate (isomalt (E 953), lemon flavor, mono- and diglycerides of fatty acids).
*Cholecalciferol concentrate composition: cholecalciferol, 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 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 1000 mg calcium tablets and 800 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 bound to 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 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 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. With concomitant therapy, it is necessary to constantly monitor the level of calcium in the blood serum, as the risk of hypercalcemia increases.
Calcium carbonate may interfere with the absorption of tetracycline drugs when used simultaneously, so these drugs should be taken at least 2 hours before or 4-6 hours after oral administration of Calcium-D3 Nycomed OSTEOFORTE.
Hypercalcemia may potentiate the toxicity of cardiac glycosides when calcium and vitamin D preparations are used. It is necessary to monitor cardiac function using an electrocardiogram (ECG), serum calcium levels, and the patient's clinical condition.
To prevent reduced absorption of bisphosphonates with simultaneous use of Calcium-D3 Nycomed OSTEOFORTE, it is recommended to take it no earlier than 1 hour after taking them.
When calcium is used simultaneously, the effectiveness of levothyroxine may be reduced due to reduced absorption. Therefore, levothyroxine should be taken 4 hours before or 4 hours after taking the drug.
With simultaneous use of calcium, the absorption of quinolone antibiotics may be impaired. Quinolone antibiotics should be taken 2 hours before or 6 hours after taking Calcium-D3 Nycomed OSTEOFORTE.
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 stone 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 renal dysfunction and calcium and phosphate levels should be monitored. The possible risk of soft tissue calcification should be borne in mind. 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. To avoid overdose when prescribing other preparations containing vitamin D, it is necessary to take into account the content of vitamin D in the preparation Calcium-D3 Nycomed OSTEOFORTE (800 IU). Additional doses of calcium or vitamin D should be taken under the supervision of a physician. Such patients should have their serum calcium levels and renal function monitored regularly.
Calcium-D3 Nycomed OSTEOFORTE should be used with caution in patients with sarcoidosis due to the risk of increased metabolism of vitamin D into its active form. It is necessary to monitor the level of calcium in the blood serum and urine.
Calcium-D3 Nycomed OSTEOFORTE is used with caution in immobilized patients with osteoporosis due to the risk of developing hypercalcemia.
Patients with rare hereditary problems of fructose intolerance, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not use this medicine as it contains isomalt (E 953) 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 OSTEOFORTE on the reaction speed when driving vehicles or other mechanisms.
Use during pregnancy or breastfeeding
Pregnancy. The drug Calcium-D3 Nycomed OSTEOFORTE 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 OSTEOFORTE 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.
Adults and elderly patients: 1 tablet once 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 and adolescents.
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, fatigue, mental disorders, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis, cardiac arrhythmias in severe cases. In very severe cases - hypercalcemia, which can lead to coma and death. Prolonged overdose with high doses of the drug can cause irreversible kidney damage and soft tissue calcification. Milk-alkali syndrome can develop when using large doses of calcium and easily digestible alkaline substances.
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").
Patients with impaired consciousness should be given an empty stomach. Rehydration and a calcium-restricted diet should be considered. Depending on the severity of the overdose, loop diuretics, bisphosphonates, calcitonin, corticosteroids, alone or in combination, may be necessary. Serum electrolytes, renal function and urine output should be monitored. In severe cases, ECG and central venous pressure 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 determined from 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
60 tablets in a bottle; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Takeda AS.
Location of the manufacturer and its business address
Drammensveien 852, NO-1383 Asker, Norway.
