COLECALCIFEROL

Posology Paediatric population - Prevention of vitamin D deficiency 12-18 years: 20,000 IU (1 capsule) every 6 weeks - Treatment of vitamin D deficiency 12-18 years: 20,000 IU (1 capsule) once every 2 weeks for 6 weeks Not recommended for children under 12 years due to risk of choking.

Adults: - Prevention of vitamin D deficiency: 20,000 IU/month (1 capsule), higher doses may be required in certain situations, see below - Treatment of vitamin D deficiency: 40,000 IU/week (2 capsules) for 7 weeks, followed by maintenance therapy (equivalent to 1,400-2,000 IU/day, such as 2-3 capsules per month, may be required.

Follow-up serum 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved. , anticonvulsant medications, glucocorticoids, anti-retrovirals) - Patients with liver or renal disease - Patients with malabsorption, including inflammatory bowel disease and coeliac disease - Those recently treated for vitamin D deficiency, and requiring maintenance therapy.

Pregnancy and breastfeeding Colecalciferol capsules are not recommended during pregnancy unless the clinical condition of the woman requires treatment. Colecalciferol and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed but allowance for any maternal dose should be made when prescribing vitamin D products to a breast-fed child.

Method of administration This medicine is taken orally. The capsule should be swallowed whole with water, preferably with the main meal of the day.

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 capsules 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.

During long-term treatment with an equivalent daily dose exceeding 1,000 IU vitamin D the serum calcium values must be monitored. Renal function should also be checked by measuring serum creatinine. 5 mmol / 24 hours (300 mg / 24 hours).

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. Colecalciferol capsules should not be given to children under 12 years.

Colecaliciferol capsules should not be used in patients with: - 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 This medicinal product contains traces of soya bean lecithin.

If you are allergic to peanut or soya, do not use this medicinal product.