Drug Description
One tablet contains:Calcium carbonate equivalent to 500 mg calcium Cholecalciferol concentrate (powder form) equivalent to 400 IU (10 microgram ) cholecalciferol (vitamin D3)Excipient(s): Sorbitol E420Sucrose Soya-bean oil, hydrogenated
Presentation
Film-coated tabletOval, white/off white, film-coated tablets. May have hardly visible grey spots.
Indications
Prevention and treatment of vitamin D and calcium deficiency in the elderly.
Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.
Adult Dosage
Adults and elderly
One film-coated tablet twice daily. The tablet may be swallowed or chewed.
Dosage in hepatic impairment
No dose adjustment is required
Dosage in renal impairment
Calcichew-D3 500 mg/400 IU Caplets should not be used in patients with severe renal impairment.
Calcichew-D3 500 mg/400 IU Caplets is not intended for use in children.
Contra Indications
Diseases and/or conditions resulting in hypercalcaemia and/or hypercalcuria
Nephrolithiasis
Hypervitaminosis D
Hypersensitivity to soya or peanut
Hypersensitivity to the active substances or to any of the excipients.
Special Precautions
During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics 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.
Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol is not metabolised normally and other forms of vitamin D should be used.
Calcichew-D3 500 mg/400 IU Caplets 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 500 mg/400 IU Caplets should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.
The content of vitamin D (400 IU) in Calcichew-D3 500 mg/400 IU Caplets should be considered when prescribing other medicinal products containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.
Calcichew-D3 500 mg/400 IU Caplets contains sorbitol E420 and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Interactions
Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Calcichew-D3 500 mg/400 IU Caplets.
