AVITICOL

One capsule contains 1 000 IU colecalciferol (vitamin D3). Adult Posology - Treatment of vitamin D deficiency: 1-4 capsules (1 000- 4 000 IU) daily for 10 weeks dependent upon the severity of the disease and the patient's response to treatment, followed by maintenance therapy of 1-2 capsules (1 000- 2 000 IU) daily, as directed by your doctor.

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. - Prevention of vitamin D deficiency or treatment of vitamin D insufficiency: 1-2 capsules (1 000- 2 000 IU) daily.

g. anticonvulsant medications glucocorticoids, anti-retrovirals) • Those recently treated for vitamin D deficiency, and requiring maintenance therapy • Patients with liver or renal disease • Patients with malabsorption, including inflammatory bowel disease and coeliac disease - As an adjunct to specific therapy for osteoporosis: 1 capsule (1 000 IU) daily.

Adolescent Posology (over 12 years) Treatment of vitamin D deficiency or insufficiency in children over 12 years: 1 capsule (1 000 IU) daily depending on the severity of the disease and the patient's response to treatment. It should only be given under medical supervision.

Infants and young children (0 -12 years) Not recommended for children under 12 years. Pregnancy and breastfeeding Colecalciferol 1 000 IU 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. Frequency CategoryMedDRA System Organ Class Uncommon (affecting less 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Colecalciferol 1000 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 1000 IU Capsules should not be taken by patients with a tendency to form calcium-containing renal calculi.

5 – cardiac glycosides including digitalis). Colecalciferol 1000 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.

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. Paediatric population Colecalciferol 1000 IU Capsules should not be given to infants and children under the age of 12.

1 • Hypercalcaemia and/or hypercalciuria • Nephrolithiasis (Renal calculi) • Hypervitaminosis • Severe renal impairment