COMPOSITION: Each tablet contains 1250 mg Calcium Carbonate equivalent to 500 mg elemental calcium.
PHARMACOLOGICAL CLASSIFICATION: A 24 Mineral substitutes, electrolytes
PHARMACOLOGICAL ACTION: Calcium is an essential element in the body, the major fraction being in the bone. It is important for the maintenance of electrolyte equilibrium and for the functioning of numerous regulatory mechanisms.
Calcium carbonate contains 40% elemental calcium in ingestible calcium salts.
INDICATIONS: As a supplemental source of calcium in the correction of dietary deficiencies or when requirements are high.
As an adjunct in the prevention and treatment of osteoporosis in patients with an inadequate calcium intake.
Phosphate binding agent in the management of renal failure in patients on renal dialysis.
CONTRA-INDICATIONS: Severe hypercalcaemiaand hypercalciuria for example in hyperparathyroidism, vitamin D overdose decalcifying tumours such as plasmacytoma and skeletal metastases, in severe renal failure untreated by renal dialysis, dehydration, sarcoidosis, milk-alkali syndrome and in osteoporosis due to immobilisation. History of renal calculi; patients with calcium renal calculi.
Calcium should not be prescribed for patients suffering from achlorhydria or hyperchlorhydia or those with a history of renal stone formation.
WARNINGS: May impair absorption of other medicines, for example, tetracyclines fluoroquinolone antibiotics, urea supplements, etidonate, phenytoin, and fluoride preparations.
Thiazide diuretics reduce urinary calcium excretion so the risk of hypercalcaemia should be considered.
Oral calcium supplementation is aimed at restoring normal serum calcium levels. Although it is extremely unlikely that high enough levels will be achieved to adversely affect digitalised patients, this theoretical possibility should be considered.
Vitamin D causes an increase in calcium absorption and plasma calcium levels may continue to rise after stopping vitamin D therapy. Patients treated with high doses of vitamin D or who are receiving prolonged calcium treatment, should undergo regular measurements of plasma calcium levels which should be interpreted in conjunction with observedplasma protein levels.
When used as a phosphate binder in patients on renal dialysis serum phosphate and calcium levels should be monitored regularly and the use of a low calcium dialysate may be necessary.
Calcium should be given cautiously to patients with impaired renal function
USE IN PREGNANCY AND LACTATION: There is epidemiological and clinical evidence of safety of standard supplemental dosages of calcium carbonate in human pregnancy.
DOSAGE AND DIRECTIONS FOR USE: Calcichew should be chewed just before, during or just after each meal. Adults and Elderly:
As part of osteoporosis therapy:
2 to 3 tablets daily
Dietary Deficiency states:
2 to 3 tablets daily.
Phosphate Binder:
Dose as required by the individual patient depending on serum calcium and phosphate levels.
SIDE EFFECTS AND SPECIAL PRECAUTIONS: Constipation and wind. Rebound acid production. Calcific renal calculi and acute hypercalcaemiahave been reported infrequently. The following symptoms could indicate the possibility of hypercalcaemia: nausea, vomiting, anorexia, constipation, abdominal pain, bone pain, thirst, polyuria, muscle weakness, drowsiness or confusion. Alkalosis with high doses and in patients on renal dialysis. On long term phosphate binding therapy there are rare reports of tissue calcification. Interactions See also “Contra-indications and Warnings”
Plasma-calcium concentrations should be monitored in patients receiving the drugs concurrently.
Excessive alcohol, caffeine or tobacco may decrease calcium absorption.
Concurrent use with calcitonin may antagonise the effect of calcitonin in the treatment of hypercalcaemia, however when calcitonin is prescribed for osteoporosis or Paget’s disease of the bone, calcium intake should be generous to prevent hypocalcaemia which might generate secondary hyperparathyroidism.
Concurrent use of calcium-channel blocking agents with calcium supplements in quantities sufficient to raise serum calcium concentrations above normal may reduce the response to verapamil and probably other calcium-channel blockers.
Concurrent use with other calcium or magnesium containing medication may increase serum calcium or magnesium concentrations in susceptible patients mainly patients, with impaired renal function.
Concurrent use with Vitamin D may result in hypercalcaemia because of increased gastro-intestinal absorption of calcium.
Concurrent use of oestrogens with calcium supplements may increase calcium absorption, however, in the prevention of osteoporosis, women are sometimes given oestrogen to prevent bone resorption to enhance calcium absorption.
Concurrent use of cellulose sodium phosphate with calcium supplements may decrease effectiveness of cellulose sodium phosphate in preventing hypercalciuria.
Concurrent and prolonged use of milk and milk products and sodium bicarbonate with calcium supplements may result in the milk alkali syndrome.
Concurrent use of thiazide diuretics with large doses of calcium supplements may result in hypercalcaemia because of reduced calcium excretion.
Calcium salts enhance the effects of digitalis glycosides in the heart and may precipitate digitalis intoxication. Parenteral calcium therapy is best avoided in patients receiving the drugs concurrently.
Concurrent use with potassium and sodium phosphates may increase potential for deposition of calcium in soft tissues if serum ionised calcium is high.
Calcium salts reduce the absorption of a number of other drugs such as bisphosphonates, fluoride, some fluroquinolones, and tetracyclines; administration should be separated by at least 3 hours.
Bran decreases the gastro-intestinal absorption of calcium, and may therefore decrease the efficacy of calcium supplements.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Early symptoms of hypercalcaemia include severe constipation, dryness of mouth, continuing headache, increased thirst, irritability, loss of appetite, mental depression, metallic taste, unusual tiredness or weakness.
Late symptoms of hypercalcaemia include confusion, drowsiness, high blood pressure, increased sensitivity of eyes or skin to light, especially in haemodialysis patients, irregular fast or slow heartbeat, nausea and vomiting, usually large amounts of urine or increased frequency of micturition.
Note: In severe hypercalcaemia, ECG changes consisting of shortened Q-T intervals are also seen.
Treatment is supportive. Should hypercalcaemia occur, discontinue administration.
IDENTIFICATION: Round, white uncoated, biconvex, orange flavoured tablets with light yellow specks.
PRESENTATION: Calcichew is supplied in securitainers each containing 20, 30, 60 or 100 tablets.
STORAGE INSTRUCTIONS: Store in a dry place (below 25°C).
Keep out of reach of children.
Keep the container well closed.
REGISTRATION NUMBER: 34/24/0392
NAME AND ADDRESS OF THE APPLICANT: Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
Midrand
1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 22 January 2003
New addition to this site: February 2005
Source: Pharmaceutical Industry
CALCICHEW (Tablets)