COLECALCIFEROL

Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. Colecalciferol 800 IU and 1000 IU Film-coated Tablets are suitable for daily vitamin D supplementation, while the 7000 IU and 30000 IU doses contain amounts equal to the weekly and monthly vitamin D doses respectively, which should be taken into consideration and dosage should be established by a physician.

Please refer to the respective national guidelines. Posology Adults and elderly: • Prevention of vitamin D deficiency (maintenance): o for adults and elderly: 800-1600 IU/day or equivalent weekly or monthly dose. o for adults and elderly with osteoporosis: maximum 2000 IU/day or equivalent weekly or monthly dose.

• Treatment of vitamin D deficiency (loading dose): o 800-4000 IU/day or equivalent weekly or monthly dose. Patients should receive supplemental calcium if intake from diet is inadequate. 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.

Paediatric population Colecalciferol Film-coated Tablets should not be used in children under 12 years. Paediatric posology (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. Method of administration Colecalciferol Film-coated Tablets may be taken independently from meals.

Adverse reactions are ranked by frequency and system organ classes.

Frequency categories are defined using the following convention:

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: may not be established on the basis of 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.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

In the case of therapeutic treatment the dose should be established on an individual basis for the patients by regular checking (initially weekly, then once in every 2-4 weeks) of plasma calcium levels. During long-term treatment, serum calcium level, urinary calcium excretion and renal function should be monitored by measuring the serum creatinin 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 may be given to patients with impaired renal function with caution.

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. Colecalciferol Film-coated Tablets 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. Colecalciferol Film-coated Tablets may be carefully administered to 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.

Medicinal products having effect through the inhibition of bone resorption decrease the calcium amounts derived from bone. In order to avoid this, as well as concomitantly to treatment with medicines enhancing bone development, it is necessary to take vitamin D and ensure proper calcium levels.

Lactose:

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Sucrose:

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption should not take this medicinal product. Paediatric population Colecalciferol Film-coated Tablets should not be used in children under 12 years.

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