COLECALCIFEROL

Posology Vitamin D deficiency in adults and the elderly (serum levels <25 nmol/l (<10 ng/ml)) 1-4 capsules (800-3200 IU) daily for up to 12 weeks dependent upon the severity of the disease and the patient’s response to treatment. Vitamin D insufficiency in adults and the elderly (serum levels 25 – 50 nmol/l (10-20 ng/mL)) AND long term maintenance therapy following treatment of deficiency in adults and the elderly AND Prevention of vitamin D deficiency 1-2 Capsules (800-1600 IU) daily Vitamin D deficiency or insufficiency in children over 12 years – 1 capsule daily depending on the severity of the disease and the patient’s response to treatment.

Should only be given under medical supervision. As an adjunct to specific therapy for osteoporosis 1 capsule daily During pregnancy and breast-feeding Treatment of vitamin D deficiency 1 – 5 capsules (800 – 4000 IU) daily. Long term maintenance therapy following treatment of deficiency 1 – 2 capsules (800 – 1600 IU) daily.

Colecalciferol should not be used in children under 12 years. Method of administration Oral The capsules should be swallowed whole (not chewed) with water.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000).

Metabolism and nutrition disorders Uncommon:

Hypercalcaemia and hypercalciuria.

Skin and subcutaneous 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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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, contraindications).

5 - cardiac glycosides including digitalis). Colecalciferol should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regard to the calcium content in serum and urine.

Allowances should be made for vitamin D supplements from other sources. The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision.

Medical supervision is required whilst on treatment to prevent hypercalcaemia. During long-term treatment with a daily dose exceeding 1,000 IU vitamin D the serum calcium values must be monitored. Colecalciferol should not be given to children.

Hypersensitivity to vitamin D or any of the excipients in the product Hypervitaminosis D Nephrolithiasis Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria Severe renal impairment