ADCAL-D3

Oral.

Adults and Elderly and children above 12 years of age:

Two tablets to be taken twice a day, preferably two tablets each morning and two tablets each evening.

Children:

Not recommended for children under 12 years.

Hypersensitivity reactions including pruritus, wheezing, urticaria, oropharyngeal swelling and angioedema have been reported in the post- marketing environment. The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain or diarrhoea.

Following administration of vitamin D supplements occasional skin rash has been reported. Hypercalciuria, and in rare cases hypercalcaemia, have been seen with long term treatment at high dosages. 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. uk/yellowcard

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully including periodic checks of plasma calcium levels and urinary calcium excretion. In patients with a history of renal stones, urinary calcium excretion should be measured to exclude hypercalciuria.

5 mmol/24 hours (300 mg/24 hours). 9). In these patients, serum calcium levels and renal function should be monitored. 5 – thiazide diuretics and cardiac glycosides including digitalis). g. patients with sarcoidosis or those suffering from malignancies.

This product contains small quantities of sucrose. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Allowances should be made for calcium and vitamin D supplements from other sources.

Adcal-D3 Caplets should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.

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. Hypersensitivity to any of the tablet ingredients.

Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.