ACCRETE D3

g. one tablet in the morning and one tablet in the evening). 5. Hepatic impairment No dose adjustment is required. Renal impairment Accrete D3 film-coated tablets should not be used in patients with severe renal impairment. Children and adolescents Accrete D3 film coated tablets are not intended for use in children and adolescents.

Method of administration It is recommended that the film-coated tablet is taken within one and a half hours of a meal with a glass of water or juice, without chewing it. The tablet can be broken in half, if needed.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Immune system disorders Not known:

Hypersensitivity reactions including pruritus, wheezing, urticaria and oropharyngeal swelling have been reported in the post-marketing environment.

Metabolism and nutrition disorders Uncommon:

Hypercalcaemia and hypercalciuria. 9: Milk-alkali syndrome Gastrointestinal disorders Rare: Constipation, flatulence, nausea, abdominal pain, and diarrhoea.

Very rare:

Dyspepsia Skin and subcutaneous disorders Rare: Pruritus, rash and urticaria. Other special population Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis. 4. 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. uk/yellowcard.

e. not suitable for pharmacy supply). 5) During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. 5) and in patients with a high tendency to calculus formation.

In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued. 5 mmol/24 h (300 mg/24 h). Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored.

The risk of soft tissue calcification should be taken into account. 3). Accrete D3 film-coated tablets should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form.

These patients should be monitored with regard to the calcium content in serum and urine. Accrete D3 film-coated tablets should be used with caution in immobilised patients with osteoporosis due to increased risk of hypercalcaemia. The content of vitamin D (400 IU) in Accrete D3 film-coated tablets should be considered when prescribing other medicinal products containing vitamin D.

Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently. e. hypercalcaemia, alkalosis and renal impairment can develop when large amounts of calcium are ingested with absorbable alkali.

Accrete D3 film-coated tablets contain 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.

g. myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism). 1 (including soya or peanut). • Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.