VITAMIN D3

Posology Adults Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. Vitamin D3 800 IU capsules are suitable for daily vitamin D supplementation. Dosage should be established by a physician.

Osteoporosis:

For the adjunct therapy of osteoporosis a daily dose of 800-1,000 IU. A daily doses equivalent of 2,000 IU vitamin D should be considered in fragile elderly patients who are at particular risk of falls and fractures. Patients should receive supplemental calcium if intake from diet is inadequate.

Vitamin D deficiency (serum levels < 25 nmol/l or < 10 ng/ml) in adults and the elderly: 800 IU-4,000 IU daily for up to 12 weeks upon the severity of the disease and the patient`s response to treatment. Vitamin D insufficiency (serum levels 25-50 nmol/l or 10-20 ng/ml) in adults and the elderly: AND Long term maintenance therapy following treatment of deficiency in adults and the elderly: AND Prevention of vitamin D deficiency: 800-1600 IU daily.

Vitamin D deficiency or insufficiency in adolescents 12-18 years: 800 IU daily depending on the severity of the disease and the patient`s response to treatment. Should only be given under medical supervision. Hepatic impairment: no dose adjustment is necessary for patients with hepatic impairment.

During vitamin D therapy, calcium and phosphor intake has fundamental significance with respect to the success of the treatment. Before starting the vitamin D therapy, the patient’s dietary habits should be carefully evaluated by the doctor and artificially added vitamin D content of certain food types should be taken into consideration.

, anticonvulsant medications, glucocorticoids) - Patients with malabsorption, including inflammatory bowel disease and coeliac disease - Those recently treated for vitamin D deficiency, and requiring maintenance therapy. 4). Paediatric population Vitamin D3 Capsules should not be used in children under 12 years.

Method of administration Oral The capsules should be swallowed whole (not chewed) with water.

The frequency of possible side effects listed below 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) Very rare (<1/10,000) 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 angio-oedema or laryngeal oedema.

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.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. uk/yellowcard

In the case of therapeutic treatment the dose should be established on an individual basis for the patients by regular checking of plasma calcium levels. During long-term treatment, serum calcium level, urinary calcium excretion and renal function should be monitored by measuring the serum creatinine level.

5), and in the case of hyperphosphataemia, as well as for patients with an increased risk of lithiasis. 5 mmol)/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued. Vitamin D should be used with caution in patients with impaired renal function.

In this case monitoring of calcium and phosphate levels is necessary, and the risk of soft tissue calcification should be taken into consideration. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used.

Similar monitoring is necessary for children whose mother receive treatment with vitamin D in pharmacological amounts. Some children may react with increased sensitivity to the effect of vitamin D. Vitamin D3 Capsules should not be taken if pseudohypoparathyroidism is present (the need for vitamin D may be reduced by the sometimes normal sensitivity to vitamin D, with a risk of long-term overdose).

In such cases, more manageable vitamin D derivatives are available. Vitamin D3 Capsules should be used with caution in patients with sarcoidosis because of the risk of vitamin D’s increased transformation to its active form. Blood and urine calcium levels should be regularly monitored in these patients.

In the case of concomitant use with other medicinal product containing vitamin D, its vitamin D content should be taken into consideration. The concomitant use of multivitamin products and dietary supplements containing vitamin D should be avoided.

1. - Diseases/conditions associated hypercalcaemia and / or hypercalciuria. - Calcium nephrolithiasis, nephrocalcinosis, D- hypervitaminosis - Severe renal impairment.