EFFERVESCENT Uncoated tablets Ref.[7787] Active ingredients: Calcium gluconate

Calcium salts should be given cautiously to patients with cardiac disease or sarcoidosis.

Careful monitoring of blood levels and urinary calcium excretion is necessary, particularly when high dose or parenteral calcium therapy has been used, especially in children.

In mild hypercalciuria (exceeding 300mg (7.5mmol)/24 hours) as well as in mild to moderate 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. High vitamin D intake should be avoided during calcium therapy, unless especially indicated.

Effervescent Calcium Gluconate Tablets BP must be used with care in patients receiving alternative compound vitamin or mineral preparations, which often contain sources of additional calcium.

Treatment should be suspended if blood calcium levels exceed 2.625-2.75mmol/litre (105-110mg/litre) or if urinary calcium excretion exceeds 5mg/kg.

This medicinal product contains 102.8 mg sodium per tablet, equivalent to 5.14% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product (20 tablets) is equivalent to 102.8% of the WHO recommended maximum daily intake for sodium. Effervescent Calcium Gluconate Tablets is considered high in sodium. This should be particularly taken into account for those on a low salt diet.

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

Systemic corticosteroids reduce calcium absorption.

Patients receiving therapy with cardiac glycosides such as digoxin must not be given calcium supplements.

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

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.

None known.

Mild gastrointestinal disturbances have occurred rarely (eg constipation, diarrhoea).

Cardiac arrhythmias and bradycardia may also occur.

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; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.