Calcium-D3 Nycomed Osteoforte chewable tablets bottle of 60 pcs.

• 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.

• 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).

• 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;
• kidney stone disease (nephrolithiasis);
• hypervitaminosis D.

Immune system disorders Not known: hypersensitivity reactions including angioedema, laryngeal oedema.

Metabolic: 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) observed only in case of overdose.

From the digestive tract. Rarely: constipation, dyspepsia, flatulence, nausea, abdominal pain, diarrhea.

Skin and subcutaneous tissue disorders: Very rare: itching, rash, urticaria.

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.

Use during pregnancy or breastfeeding

The drug Calcium-D3 Nycomed OSTEOFORTE can be used during pregnancy for calcium and vitamin D deficiency. The daily dose should not exceed 2500 mg of calcium and 4000 IU of vitamin D.

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.

Children

The drug is not intended for use in children and adolescents.

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.

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.

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.

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.

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 the drug.

Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (e.g. vitamin D3).

Keep the bottle tightly closed at a temperature not exceeding 30 ° C. Keep out of the reach of children!