THORENS

Posology The dosage must be determined individually by the treating doctor depending on the extent of the necessary vitamin D supplementation. The dose should be adjusted dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), severity of the disease and patients response to treatment.

000 IU every week. After first month, lower doses may be considered. Following this initial treatment, maintenance therapy may be required with a dose determined individually by the treating doctor. Alternatively, national posology recommendations in treatment of vitamin D deficiency can be followed.

Special populations Renal impairment THORENS must not be used in patients with severe renal impairment. Hepatic impairment No posology adjustment is required in patients with hepatic impairment. 000 IU capsules is not recommended in children and adolescents under 18 years of age.

000 IU capsules is not recommended. Method of administration The capsules should be swallowed whole. 2 Pharmacokinetic properties - “Absorption”).

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D have to be used.

Caution is required in patients receiving treatment for cardiovascular disease (see section

1. Hypercalcaemia, hypercalciuria. Hypervitaminosis D. Kidney stones (nephrolithiasis, nephrocalcinosis) in patients with current chronic hypercalcaemia. Severe renal impairment.