SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Calcium-Sandoz® Syrup

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Calcium glubionate 1.09g and calcium lactobionate USP 0.727g per 5ml.

3. PHARMACEUTICAL FORM

Colourless to pale straw coloured, fruit flavoured syrup.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

a.    An adjunct to conventional therapy in the arrest or slowing down of bone demineralisation in osteoporosis.

b.    In the arrest or slowing down of bone demineralisation in osteoporosis where other effective treatment is contra-indicated.

c.    A supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are high.

d.    Neonatal hypocalcaemia.

4.2 Posology and method of administration

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

Calcium Sandoz Syrup should be taken by mouth either as provided or after dilution with syrup BP.

Indication	Daily Dose
	Syrup (5ml spoonfuls)
Adults
Osteoporosis	11-15

Therapeutic supplement (dose dependent upon severity)	3-15
Children
Calcium deficiency	6-9
Dietary supplementation	2-6

Neonatal hypocalcaemia: Calcium-Sandoz Syrup may be given at a dose of lmmol calcium/kg/24 hours in divided doses. Serum calcium levels should be monitored and the dosage adjusted if necessary. Doses may be mixed with the first (small) part of milk feeds. Note: 1 mmol of calcium is equivalent to 1.85ml Calcium-Sandoz Syrup.

Elderly: No evidence exists that tolerance of Calcium-Sandoz is directly affected by advanced age; however, elderly patients should be supervised as factors sometimes associated with ageing, such as poor diet or impaired renal function, may indirectly affect tolerance and may require dosage reduction.

4.3    Contraindications

Hypersensitivity to calcium glubionate, calcium lactobionate or to any of the excipients. Hypercalcaemia (e.g., in hyperparathyroidism, vitamin D overdosage, decalcifying tumours such as plasmocytoma, severe renal failure, bone metastases), severe hypercalciuria, and renal calculi.

Due to its galactose component Calcium-Sandoz Syrup should not be given to patients with galactosaemia.

4.4    Special warnings and precautions for use

In mild hypercalciuria (exceeding 300mg (7.5mmol)/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.

The sugar content of Calcium-Sandoz Syrup should be taken into account in diabetic patients.

4.5. Interactions with other medicinal products and other forms of interaction

High vitamin D intake should be avoided during calcium therapy, unless especially indicated (see also Section 4.9, “Overdose”).

Thiazide diuretics reduce urinary calcium excretion, so the risk of hypercalcaemia should be considered.

Oral calcium supplementation is aimed at restoring normal 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 any adverse effect on the neonate.

4.7. Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Mild gastrointestinal disturbances (e.g., 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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

The amount of calcium absorbed following overdosage with Calcium-Sandoz Syrup will depend on the individual’s calcium status. Deliberate overdosage is unlikely and acute overdosage has not been reported. It might cause gastrointestinal disturbances 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, e.g., administration of oral phosphates.

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 formulation 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/l (2.25-2.75mmol/L) of which 50-60% is present in ionized 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

There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.

6. PHARMACEUTICAL PARTICULARS

List of excipients

Orange natural flavour, tamaris flavour, benzoic acid, formic acid, sugar and water.

6.2.    Incompatibilities

None known.

6.3.    Shelf life

Three years unopened. Up to 1 year once the bottle has been opened.

6.4.    Special precautions for storage

None.

6.5.    Nature and contents of container

Amber glass bottles of 300ml with a polythene closure (polythene wad faced with PP, PVDC or PET lining).

6.6.    Instructions for use/handling

Calcium-Sandoz Syrup may be diluted with Syrup BP; the diluted syrup should be used within 14 days.

7. MARKETING AUTHORISATION HOLDER

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire SN15 2BB

MARKETING AUTHORISATION NUMBER(S)

PL 16853/0005

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31/03/2005

10    DATE OF REVISION OF THE TEXT

18/02/2015