SAPVIT-D3

Posology The individual dose is determined by the treating physician.

In general, the following dosage guidelines apply:

Prevention of vitamin D deficiency Prevention of vitamin D deficiency Tolerable upper intake level (UL)** IU/day Drops/day IU/day 0-6 months* 400-800 1-2 1,000 6-12 months* 400-800 1-2 1,500 1-3 years* 400-800 1-2 2,500 4-8 years 600-1,000 1-3 3,000 9-18 years 600-1,000 1-3 4,000 19-70 years 600-1,500 1-4 4,000 70+ 800-1,500 2-4 4,000 *The following scheme is a guideline for prevention of vitamin D deficiency: Prophylaxis is generally undertaken from the second week of life, in the first year of life and during the low-sunlight time for the next two years.

• Newborns and infants during the first year of life: from the second week of life 1 drop daily (= 400 IU) • Premature infants during the first year of life: from the second week of life 2 drops daily (= 800 IU) Children (1-3 years) at risk during the winter months (low-sunlight time): 2 drops daily (=800 IU).

** Increased risk of side effects when exceeded, therefore do not take without medical supervision Treatment of rickets The total amount of required vitamin D depends on the severity of the disease. In existing rickets, treatment is initiated with 200,000 IU.

Subsequently, 1,000 to 5,000 IU daily (approximately 2 to 12 drops of Sapvit-D3). For the initial treatment, the use of higher dosed administration forms is recommended. Treatment of rickets IU/day Drops/day 0-6 months 6-12 months 1-3 years 4-8 years 9-18 years Individual therapy!

Initial administration of 200,000 IU (“pulse therapy”), followed by 1,000 - 5,000 IU daily. Higher dosed administration forms are recommended for the pulse therapy. Higher dosed administration forms are recommended for the pulse therapy.

Subsequently: 2-12 Treatment of vitamin D deficiency Treatment of vitamin D deficiency Tolerable upper intake level (UL)* IU/day Drops/day IU/day 0-6 months 1,000 6-12 months For 6 weeks: 2,000 Then: For 6 weeks: 5 Then: 1,500 400-1,000 1 - 3 1-3 years 2,500 4-8 years 3,000 9-18 years For 6 weeks: 2,000 Then: 600-1,000 For 6 weeks: 5 Then: 1 - 3 4,000 19-70 years 4,000 70+ For 8 weeks: 6,000 Then: 1,500-2,000 For 8 weeks: 15 Then: 3 - 5 4,000 * Increased risk of side effects when exceeded, therefore do not take without medical supervision As an adjunct to a specific therapy for osteoporosis in patients at risk of vitamin D deficiency As an adjunct to a specific therapy for osteoporosis in patients at risk of vitamin D deficiency: Tolerable upper intake level (UL)* IU/day Drops/day Drops/week IU/day Adults 800-1,500 2 - 4 14-26 4,000 * Increased risk of side effects when exceeded, therefore do not take without medical supervision Method of administration Sapvit-D3 oral drops are taken directly.

Cholecalciferol can cause the following undesirable effects, especially in overdose: Adverse reactions frequencies are not known (cannot be estimated from the available data).

Metabolism and nutrition disorders:

Hypercalcaemia, hypercaluria.

Gastrointestinal disorders:

Constipation, flatulence, nausea, stomachache, diarrhoea. 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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The extent of the vitamin D deficiency can be determined by measuring 25OHD (= 25-hydroxyvitamin D). In adults a 25OHD serum level of 80 ng/ml should not be exceeded. Values above 150 ng/ml constitute a health-threatening overdose. During long-term treatment with Sapvit-D3, calcium levels in serum and urine should be regularly monitored.

If necessary, the dose has to be adjusted according to serum calcium levels. In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued. Renal function should be monitored during long-term treatment with Sapvit-D3 by measuring serum creatinine.

Sapvit-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. In case of severe renal insufficiency, cholecalciferol is not utilized.

When indicated, other vitamin D preparations should be used. Cholecalciferol should be prescribed with caution to patients suffering from sarcoidosis (risk of increased metabolism of vitamin D into its active form) and patients with osteoporosis due to immobilisation (increased risk of hypercalcaemia).

5). 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. Paediatric population Especially in infants, concomitant use of other vitamin D-containing products should be avoided.

If in doubt, the physician decides about additional use of vitamin- enriched foods or baby foods and vitamin-D-containing medicines.

1 - Medical conditions resulting in hypercalcaemia or hypercalciuria (patients with impaired renal calcium and phosphate elimination, treatment with benzothiadiazine derivates and immobilised patients) - Calcium-containing nephroliths - Hypervitaminosis D - Severe arteriosclerosis - Severe renal impairment