Calcichew 500mg Chewable Tablets

Per tablet: Calcium carbonate 1250mg equivalent to 500mg of elemental calcium.

Contains sorbitol, 390mg; isomalt, 62mg; and aspartame, 1mg.

For a full list of excipients see Section 6.1.

Chewable tablet.

Round, white, uncoated and convex tablets. May have small specks.

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.

Oral.

Adults and elderly:

Adjunct to osteoporosis therapy 2 to 3 tablets daily.

Dietary deficiency 2 to 3 tablets daily.

Osteomalacia 2 to 6 tablets daily.

Children:

Dietary deficiency 2 to 3 tablets daily.

Phosphate Binder:

Adults, children and elderly Dose as required by the individual patient depending on serum phosphate level.

The tablets should be taken just before, during or just after each meal. Tablets may be chewed or sucked.

• Severe hypercalcaemia and hypercalciuria, for example in hyperparathyroidism, vitamin D overdosage, decalcifying tumours such as plasmocytoma and skeletal metastases, in severe renal failure untreated by renal dialysis and in osteoporosis due to immobilisation.

• Nephrolithiasis

• Hypersensitivity to the active substance or to any of the excipients.

Calcichew 500mg chewable tablets contain aspartame (a source of phenylalanine) and should be avoided by patients with phenylketonuria.

Calcichew 500 mg Chewable Tablets contain sorbitol (E420) and isomalt (E953). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

In renal insufficiency the tablets should be given only under controlled conditions for hyperphosphataemia. Caution should be exercised in patients with a history of renal calculi.

During high dose therapy and especially during concomitant treatment with vitamin D, there is a risk of hypercalcaemia with subsequent kidney function impairment. In these patients, serum calcium levels should be followed and renal function should be monitored.

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 500mg Chewable Tablets.

Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations. For this reason, tetracycline preparations should be administered at least two hours before, or four to six hours after, oral intake of calcium.

Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.

If a bisphosphonate or sodium fluoride is used concomitantly, this preparation should be administered at least three hours before the intake of Calcichew 500mg Chewable Tablets since gastrointestinal absorption may be reduced.

Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble calcium salts. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.

The adequate daily intake (including food and supplementation) for normal pregnant and lactating women is 1000-1300 mg calcium. During pregnancy, the daily intake of calcium should not exceed 1500 mg. Significant amounts of calcium are secreted in milk during lactation. Calcichew 500mg Chewable Tablets can be used during pregnancy in case of a calcium deficiency.

There are no data about the effect of this product on driving capacity. An effect is, however, unlikely.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000).

Metabolism and nutrition disorders

Gastrointestinal disorders

Skin and subcutaneous disorders

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.

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.

Pharmacotherapeutic group: Calcium

ATC-code: A12A A04

An adequate intake of calcium is of importance during growth, pregnancy and breastfeeding.

Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose.

Distribution and metabolism: 99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins, principally albumin.

Elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.

There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.

Sorbitol (E420)

Povidone

Magnesium stearate

Aspartame (E951)

Orange flavour:

Isomalt (E953)

Flavouring (orange)

Mono, di-fatty acid glycerides

Not applicable.

3 years.

Do not store above 30ºC.

Keep the container tightly closed.

Securitainer containing 100 tablets.

No special requirements.

Shire Pharmaceuticals Ltd.

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

United Kingdom

PL 08557/0003

27 November 1987/27 November 1997

18 July 2007