CACIT D3

Posology One or two sachets per day. Method of administration Oral. Pour the contents of the sachet into a glass, add a large quantity of water, then drink immediately.

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

Immune system disorders Not known:

Hypersensitivity reactions such as angio-oedema or laryngeal oedema Metabolism and nutrition disorders Uncommon: Hypercalcaemia and hypercalciuria.

Not known:

Milk-alkali syndrome associating hypercalcaemia, alkalosis and renal impairment. 9) Gastrointestinal disorders Rare: Constipation, flatulence, nausea, abdominal pain and diarrhoea.

Skin and subcutaneous disorders Rare:

Pruritus, rash and urticaria. 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.

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Calcium and alkali intake from other sources (food, enriched foods, or other medicinal products) should be monitored when calcium carbonate is prescribed. 9). Calcium levels in serum should be monitored when administering high doses of calcium carbonate.

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 high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function, treatment with calcium/vitamin D3 sachets should be discontinued.

Vitamin D3 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) Calcium/vitamin D3 sachets should be used with caution in patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active metabolite.

In these patients, serum calcium levels and urinary calcium excretion must be monitored. Calcium/vitamin D3 sachets should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia. The dose of vitamin D3 in the sachets should be considered when prescribing other drugs 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. Cacit D3 sachets are not intended for use in children.

Cacit D3 contains sorbitol, sucrose, potassium and sodium. 6 mg sorbitol in each sachet. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicial product.

May be harmful to the teeth. 6 mg) in each sachet. This should be taken into consideration in patients with reduced kidney function or patients on a controlled potassium diet. This medicinal product contains less than 1 mmol of sodium (23 mg) per sachet, that is to say essentially `sodium free´.

1 • Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria • Nephrolithiasis • Hypervitaminosis D