CALCICHEW - D3

Posology Adults Adjunctive therapy in osteoporosis:

One tablet 2-3 times per day Calcium and vitamin D deficiency: One tablet 2-3 times per day. Special Patient Populations Elderly patients Adjunctive therapy in osteoporosis Calcium and vitamin D deficiency Dosage as for adults. Paediatric population Calcium and vitamin D deficiency (only) One tablet 1-2 times per day.

Impaired hepatic function No dose adjustment is required. 3). Method of Administration Oral. The tablets should be chewed or sucked.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (≥1/1,000, to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≤1/10,000) or not known (cannot be estimated from the available data).

Immune system disorders Not known:

Hypersensitivity reactions such as angio-oedema or laryngeal oedema.

Metabolism and nutrition disorders Uncommon:

Hypercalcaemia and hypercalciuria.

Very rare:

Milk-alkali syndrome (frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcaemia, alkalosis and renal impairment). 9).

Gastrointestinal disorders Rare:

Constipation, dyspepsia, flatulence, nausea, abdominal pain and diarrhoea.

Skin and subcutaneous disorders Rare:

Pruritus, rash and urticaria. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurement of serum creatinine. 5) and in patients with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function, the dose should be reduced or the treatment discontinued.

Calcichew-D3 chewable tablets should be used with caution in patients with hypercalcaemia or signs of impaired renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account.

3, contraindications). During concomitant treatment with other high dose sources of vitamin D and/or medications or nutrients (such as milk) containing calcium, there is a risk of hypercalcaemia and milk-alkali syndrome with subsequent kidney function impairment.

In these patients serum calcium levels should be followed and renal function should be monitored. Calcichew-D3 chewable tablets should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form.

These patients should be monitored with regard to the calcium content in serum and urine. Calcichew-D3 Chewable Tablets should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia.

Calcichew-D3 Chewable Tablets contain isomalt (E953) and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

1 • Severe renal impairment (glomerular filtration rate < 30 ml/min) • Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria • Renal calculi (nephrolithiasis) • Hypervitaminosis D