DESUNIN

Posology Recommended dose:

One tablet per day. The dose should be adjusted dependent upon desirable serum levels of 25- hydroxycolecalciferol (25(OH)D), the severity of the disease and the patient´s response to treatment. The daily dose should not exceed 4000 IU (two tablets per day).

Pediatric population The safety and efficacy of Desunin in children under 12 years have not been established. Dosage in hepatic impairment No dose adjustment is required. 4). Method of administration The tablets can be swallowed whole or crushed.

The tablets can be taken with food.

Adverse reactions frequencies are defined as: uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000) or not known (cannot be estimated from the available data).

Immune system disorders Not known (cannot be estimated from the available data):

Hypersensitivity reactions such as angioedema or laryngeal oedema.

Metabolism and nutrition disorders Uncommon:

Hypercalcaemia and hypercalciuria.

Skin and subcutaneous tissue disorders Rare:

Pruritus, rash and urticaria. 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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Desunin should be prescribed with caution to patients suffering from sarcoidosis due to 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.

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. 5 mmol)/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued.

Desunin 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. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D may therefore be needed.

The content of vitamin D (4000 IU) in Desunin should be considered when prescribing other medicinal products containing vitamin D. Additional doses of 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.

Desunin contains sucrose and isomalt. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

• Diseases and/or conditions resulting in hypercalcaemia or hypercalciuria. • Nephrolithiasis. • Nephrocalcinosis • Hypervitaminosis D. 1. 73 m2)