Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Neon Healthcare Limited, 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom
Calcichew 500mg Chewable Tablets are to be chewed as a supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are high.
Calcichew 500mg Chewable Tablets may be used as an adjunct to conventional therapy in the prevention and treatment of osteoporosis. They may be used as a phosphate binding agent in the management of renal failure in patients on renal dialysis.
Adjunctive therapy in osteoporosis: 2 to 3 tablets daily.
Prevention and treatment of calcium deficiency: 2 to 3 tablets daily.
Phosphate binder: Dose as required by the individual patient depending on serum phosphate level.
Dosage as for adults.
Prevention and treatment of calcium deficiency: 2 to 3 tablets daily.
Phosphate Binder: Dose as required by the individual patient depending on serum phosphate level.
In patients with severe renal failure having a creatinine clearance of less than 30 ml/minute, dosage adjustments may be necessary dependent on serum calcium levels. See section 4.4.
No dose adjustment is required.
Oral.
Tablets may be chewed or sucked.
For phosphate binding, the tablets should be taken just before, during or just after each meal in order to bind phosphate in the food.
Overdose can lead to hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification.
Milk-alkali syndrome may still occur in patients who ingest large amounts of calcium and absorbable alkali. It is not uncommon as a cause of hypercalcaemia requiring hospitalisation. The syndrome has also been reported in a patient taking recommended doses of antacids containing calcium carbonate for chronic epigastric discomfort, and in a pregnant woman taking high, but not grossly excessive, doses of calcium (about 3 g of elemental calcium daily). Metastatic calcification can develop.
Treatment of hypercalcaemia: The treatment with calcium must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued. Treatment: rehydration, and, according to severity of hypercalcaemia, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.
3 years.
Do not store above 30°C.
Keep the container tightly closed to protect from moisture.
Securitainer containing 100 tablets.
No special requirements.
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