AVITICOL

One capsule contains 20 000 IU Colecalciferol (vitamin D3). Adult Posology - Initial treatment of clinically relevant vitamin D deficiency: 1 capsule twice per week (equivalent to 40,000 IU/week) for 7 weeks (corresponding to a loading dose of 280,000 IU).

- Maintenance therapy with lower doses of vitamin D equivalent to 800 to 1000 IU daily may be considered one month after the end of initial treatment with Aviticol 20,000 IU. For this purpose other preparations are available. The doctor in charge shall decide on the individual dosage and the duration of treatment.

Paediatric population Aviticol 20,000 IU should not be used in infants or young children (under 12 years) as they may not be able to swallow the capsules and might choke. Instead, it is advisable to 2 use drops or dissolvable tablets.

Due to the lack of data on posology the administration in adolescents between the ages of 12 – 18 years is not recommended. Patients with renal impairment/hypercalcaemia In the event of hypercalcaemia or signs of reduced renal function, the dose must be reduced or the treatment discontinued.

5 mmol equivalent to 300 mg calcium/24 hours), the dose is to be reduced or treatment discontinued. 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. 5 Frequency CategoryMedDRA System Organ Class Uncommon (affecting les than 1 in 100 people) Rare (affecting less than 1 in 1000 people) Metabolism and nutrition disorders Hypercalcaemia Hypercalciuria Skin and Subcutaneous disorders Pruritus Rash 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).

Colecalciferol 20 000 IU Capsules 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 should be used. Colecalciferol 20 000 IU Capsules should not be taken by patients with a tendency to form calcium-containing renal calculi.

5 – cardiac glycosides including digitalis). Colecalciferol 20 000 IU 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.

6). Allowances should be made for vitamin D supplements, other vitamin D containing medicines or 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. During treatment with an equivalent daily dose exceeding 1,000 IU vitamin D the serum and renal calcium levels must be monitored and renal function checked via serum creatinine determination.

5). This also applies to patients who are particularly susceptible to the formation of kidney stones that contain calcium. Paediatric population Colecalciferol 20,000 IU should not be used in infants or young children (under 12 years) as they may not be able to swallow the capsules and might choke.

Instead, it is advisable to use drops or dissolvable tablets. Due to the lack of data on posology the administration in adolescents between the ages of 12-18 years is not recommended.

1 • Hypercalcaemia and/or hypercalciuria • Pseudohypoparathyroidism (The vitamin D requirement may be reduced by intermittent normal vitamin D sensitivity, with the risk of prolonged overdose) • Nephrolithiasis (Renal calculi) • Hypervitaminosis D • Severe renal impairment • Additional intake of preparations containing vitamin D