Sandocal 400 mg Effervescent Tablets

1. Name Of The Medicinal Product

Sandocal 400 mg Effervescent Tablets

2. Qualitative And Quantitative Composition

930.8mg Calcium Lactate Gluconate and 700mg Calcium Carbonate providing 400mg calcium (10 mmol: 20 mEq Ca++ ).

For excipients, see Section 6.1.

3. Pharmaceutical Form

Effervescent tablets.

White, round and flat with a slightly rough surface.

4. Clinical Particulars

4.1 Therapeutic Indications

1. As an adjunct to conventional therapy in the arrest or slowing down of bone demineralisation in osteoporosis.

2. In the arrest or slowing down of demineralisation in osteoporosis where other effective treatment is contraindicated.

3. As a supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are high.

4.2 Posology And Method Of Administration

Distinguish between adults, children and the elderly and between different clinical indications.

Treatment of therapeutic supplementation should aim to restore or maintain normal levels of calcium (2.25 - 2.75mmol/l or 4.5 - 5.5meq/l).

Adults

Osteoporosis:	3-4 tablets/day.
Therapeutic supplement
(dose dependent upon severity):	1-4 tablets/day (dose dependent upon severity).

Children

Calcium deficiency:	1-2 tablets/day.
Dietary supplementation:	1 tablet/day.

Elderly

No evidence exists that tolerance is directly affected by advanced age. Elderly patients should be supervised, as factors sometimes associated with ageing, such as poor diet or renal function, may indirectly affect tolerance and may require dosage adjustment.

4.3 Contraindications

Hypercalcaemia (eg in hyperparathyroidism, vitamin D overdosage, decalcifying tumours such as plasmocytoma, severe renal failure, bone metastases), severe hypercalciuria and renal calculi.

4.4 Special Warnings And Precautions For Use

In mild hypercalciuria exceeding 300mg (7.5mmol) per 24 hours, or renal failure, or where there is evidence of stone formation in the urinary tract, adequate checks must be kept on urinary calcium excretion; if necessary the dosage should be reduced or calcium therapy discontinued.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

High vitamin D intake should be avoided unless especially indicated (see also Overdosage section). Thiazide diuretics reduce urinary calcium excretion so the risk of hypercalcaemia, should be considered.

Oral calcium supplementation is aimed at restoring normal calcium serum levels. Although it is extremely unlikely that high enough levels will be achieved to adversely affect digitalised patients, this theoretical possibility should be considered.

Oral calcium administration may reduce the absorption of oral tetracycline or fluoride preparations. An interval of 3 hours should be observed if the two are to be given.

4.6 Pregnancy And Lactation

The likelihood of hypercalcaemia is increased in pregnant women in whom calcium and Vitamin D are co-administered. Epidemiological studies with calcium have shown no increase in the teratogenic hazard to the foetus if used in the doses recommended. Although supplemental calcium may be excreted in breast milk, the concentration is unlikely to be sufficient to produce an adverse effect on the neonate.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Mild gastrointestinal disturbances (eg constipation, diarrhoea) have occurred rarely. Although hypercalcaemia would not be expected in patients unless their renal function were impaired, the following symptoms could indicate the possibility of hypercalcaemia: nausea, vomiting, anorexia, constipation, abdominal pain, bone pain, thirst, polyuria, muscle weakness, drowsiness or confusion.

4.9 Overdose

The amount of calcium absorbed following overdosage will depend on the individual's calcium status. Deliberate overdosage with effervescent preparations is unlikely and acute overdosage has not been reported. It might cause gastrointestinal disturbance but would not be expected to cause hypercalcaemia except in patients treated with excessive doses of vitamin D. Treatment should be aimed at lowering serum calcium levels, eg administration of oral phosphates.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Calcium is an endogenous ion of the body essential for the maintenance of a number of physiologic processes. It participates as an integral factor in the maintenance of the functional integrity of the nervous system, in the contractile mechanisms of muscle tissue, in the clotting of blood, and in the formation of the major structural material of the skeleton.

A dynamic equilibrium occurs between blood calcium and skeletal calcium, homeostasis being mainly regulated by the parathyroid hormone, by calcitonin and by vitamin D. Variations in the concentration of ionised calcium are responsible for the symptoms of hyper/hypocalcaemia. Soluble calcium salts are commonly used in the treatment of calcium deficiency and may be given by mouth or injection.

5.2 Pharmacokinetic Properties

Concentrations of plasma calcium are determined chiefly by gastrointestinal absorption, bone metabolism and renal excretion, and levels are closely regulated within the normal limits of 4.5 -- 5.5meq/1 (2.25 - 2.75mmol/l) of which 50-60% is present in ionised form. Up to 10% is present as diffusible complexes with organic acids; the remainder is present as non-diffusible complexes with proteins. More than 99% of the body calcium is deposited in bone as hydroxyapatite crystals which are available for exchange with calcium in the extracellular fluids. In bone as a whole, about 1 % of calcium is in a readily exchangeable pool. Bone therefore functions as the main reservoir of these ions from which they may be readily mobilised if the plasma concentration falls, or in which they may be deposited if the plasma level rises.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric acid (anhydrous)

Macrogol 4000

Orange flavour

Aspartame (E951)

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Protect from humidity.

6.5 Nature And Contents Of Container

The tablets are whitish, round and flat with a slightly rough surface and come in propylene tubes with polyethylene caps. Each tube contains 20 tablets. Five tubes are packed into a carton.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

United Kingdom

Trading style: Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0178

9. Date Of First Authorisation/Renewal Of The Authorisation

4 September 2000

10. Date Of Revision Of The Text

13 November 2009

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