Calcichew 500mg Chewable Tablets

1. Name Of The Medicinal Product

Calcichew 500mg Chewable Tablets

2. Qualitative And Quantitative Composition

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.

3. Pharmaceutical Form

Chewable tablet.

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

4. Clinical Particulars

4.1 Therapeutic Indications

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.

4.2 Posology And Method Of Administration

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.

Dosage in hepatic impairment:

No dose adjustment is required.

Dosage in renal impairment:

In patients with severe renal failure having a creatinine clearance of less than 25 ml/minute, dosage adjustments may be necessary dependent on serum calcium levels. See section 4.4.

4.3 Contraindications

• Severe hypercalcaemia and hypercalciuria, for example in hyperparathyroidism, vitamin D overdosage, decalcifying tumours such as plasmacytoma 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.

4.4 Special Warnings And Precautions For Use

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 and/or medications or nutrients (such as milk) containing calcium, there is a risk of hypercalcaemia with subsequent kidney function impairment or milk alkali syndrome. In these patients, serum calcium levels should be followed and renal function should be monitored.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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.

The efficacy of levothyroxine can be reduced by the concurrent use of calcium, due to decreased levothyroxine absorption. Administration of calcium and levothyroxine should be separated by at least four hours.

The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or after intake of calcium.

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.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare: Seen usually only in overdose, see 4.9: Milk-alkali syndrome

Gastrointestinal disorders

Rare: Constipation, dyspepsia, flatulence, nausea, abdominal pain and diarrhoea.

Skin and subcutaneous disorders

Rare: Pruritus, rash and urticaria.

4.9 Overdose

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 (frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcaemia, alkalosis and renal impairment). The milk-alkali syndrome of hypercalcaemia, alkalosis and renal impairment 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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Calcium

ATC-code: A12A A04

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

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sorbitol (E420)

Povidone

Magnesium stearate

Aspartame (E951)

Orange flavour:

Isomalt (E953)

Flavouring (orange)

Mono, di-fatty acid glycerides

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 30ºC.

Keep the container tightly closed to protect from moisture.

6.5 Nature And Contents Of Container

Securitainer containing 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Shire Pharmaceuticals Ltd.

Hampshire International Business Park

Chineham

Basingstoke

Hampshire RG24 8EP

United Kingdom

8. Marketing Authorisation Number(S)

PL 08557/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

27 November 1987

10. Date Of Revision Of The Text

09-Jun-2010