DELTIUS

Posology Adults Prevention of vitamin D deficiency and as an adjunct to specific therapy for osteoporosis: Recommended dose is 3-4 drops (600 IU- 800 IU) per day. Treatment of vitamin D deficiency: 4 drops (800 IU) per day. Higher doses should be adjusted dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease and the patient´s response to treatment.

The daily dose should not exceed 4,000 IU (20 drops per day).

Paediatric population Prevention:

For prevention in children (0 years to 11 years old) with an identified risk, the recommended dose is 2 drops (400 IU) per day. For prevention in adolescents (12 years to 18 years old) with an identified risk, the recommended dose is 3-4 drops (600-800 IU) per day.

Treatment of deficiency in children and adolescents:

The dose should be adjusted dependent upon desirable serum levels of 25- hydroxycolecalciferol (25(OH)D), the severity of the disease and the patient´s response to treatment. The daily dose should not exceed 1000 IU per day for infants <1 year, 2000 IU per day for children 1-10 years and 4000 IU per day for adolescents >11 years.

Alternatively, national posology recommendations in prevention and treatment of vitamin D deficiency can be followed. • Special Populations - Dosage in hepatic impairment No dose adjustment is required. - Dosage in renal impairment Patients with mild or moderate renal impairment: no specific adjustment is required Colecalciferol must not be used in patients with severe renal impairment.

- Dosage in pregnancy The recommended daily intake for pregnant women is 400 IU (2 drops), however, in women who are considered to be vitamin D3 deficient a higher dose may be required (up to 2 000 IU/day - 10 drops). - Other conditions: in obese patients, patients with malabsorption syndromes, and patients on medications affecting vitamin D3 metabolism, higher doses are required for the treatment and prevention of vitamin D3 deficiency.

2 Pharmacokinetic properties - “Absorption”). The product should be shaken before use. DELTIUS has a taste of olive oil. DELTIUS can be taken as is or to facilitate the intake it can also be mixed with a spoonful or a small amount of cold or lukewarm food immediately prior to use.

The patient should be sure to take the entire dose. In children, DELTIUS can be mixed with a small amount of children’s foods, yogurt, milk, cheese or other dairy products. The parents should be warned not to mix DELTIUS into a bottle of milk or container of soft foods in case the child does not consume the whole portion, and does not receive the full dose.

The parents should ensure that their child takes the entire dose. In children who are not breast-feeding, the prescribed dose should be administered with a meal. 6, Special precautions for handling and disposal.

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, <1/1,00 0).

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 cholecalciferol 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