CALCICHEW-D3

Posology Adults and elderly One tablet, once daily.

Special Patient Populations Paediatric population:

Calcichew-D3 Citron are not intended for use in children and adolescents. 3).

Impaired hepatic function:

No dose adjustment is required. Method of Administration Oral. The tablet 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), or 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 tissue disorders Very rare:

Pruritus, rash and urticaria. Other special population Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis. 4. 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. uk/yellowcard

During long-term treatment, serum calcium levels should be monitored. Renal function should also be monitored, through measurements 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.

Calcium carbonate with cholecalciferol 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.

During concomitant treatment with other 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 and renal function should be monitored.

Calcichew-D3 Once Daily chewable tablets should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine.

Calcichew-D3 Once Daily chewable tablets should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia. Calcichew-D3 Once Daily chewable tablets contains isomalt (E953) and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

73m2) • Diseases and/or conditions resulting in hypercalcaemia and/or hypercalcuria • Renal calculi (nephrolithiasis) • Hypervitaminosis D