Source: Medicines & Healthcare Products Regulatory Agency (GB) | Revision Year: 2016 | Publisher: Kyowa Kirin Ltd., Galabank Business Park, Galashiels, Scotland, TD1 1QH
Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe renal failure untreated by renal dialysis. Hypersensitivity to any of the tablet ingredients.
Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.
Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria.
Urinary calcium excretion should also be measured. In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria.
With long-term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5mmol/24 hours.
Allowances should be made for calcium and vitamin D supplements from other sources.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcaemia must be avoided in digitalised patients.
The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium.
Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium.
Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone and tetracycline antibiotics or iron. It is advisable to allow a minimum period of four hours before taking the calcium.
Calcium absorption is reduced in patients receiving systemic corticosteroid therapy. This should be taken in to account when patients are receiving concomitant therapy.
During pregnancy and lactation treatment with Adcal should be under the direction of a physician. During pregnancy and lactation, requirements for calcium are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources. If Adcal and iron supplements are both required to be administered to the patient, they should be taken at different times (see Section 4.5).
The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain, diarrhoea.
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.
Not applicable, oral preparation.
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