SOLICOL D3

Posology Paediatric posology: • Prevention of vitamin D deficiency 12-18 years: 20 000 IU (1 tablet) every 6 weeks • Treatment of vitamin D deficiency 12 – 18 years: 20 000 IU (1 tablet) once every 2 weeks for 6 weeks Adults: • Prevention of vitamin D deficiency: 20 000 IU/month (1 tablet), higher doses may be required in certain situations, see below • Treatment of vitamin D deficiency; 40 000 IU/week (2 tablets) for 7 weeks, followed by maintenance therapy (equivalent to 1400 – 2000 IU/day, such as 2-3 tablets per month may be required.

, anticonvulsant medications, glucocorticoids) - Patients with malabsorption, including inflammatory bowel disease and coeliac disease - Those recently treated for vitamin D deficiency, and requiring maintenance therapy. SoliCol D3 20 000 IU Tablets should not be given to children under 12 years due to the risk of choking.

Infants and young children (0 – 12 years) Not recommended for children under 12 years. Pregnancy and breast feeding SoliCol D3 20 000 IU Tablets 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 tablet should be swallowed whole with water, preferably with the main meal of the day.

Adverse events are generally associated with excessive intake of colecalciferol, leading to the development of hypercalcaemia. The symptoms of hypercalcaemia can include: anorexia, nausea, vomiting, diarrhoea, loss of weight, headache, polyuria, thirst, vertigo, constipation, fatigue, bone pain, muscle weakness, abdominal pain, mental disturbances, impaired renal function, kidney stones, and cardiac arrhythmias.

Adverse reactions are listed below, by system organ class and frequency.

Frequencies are defined as:

Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); or, Not Known (cannot be estimated from the available data).

Immune system disorders Not known:

Hypersensitivity reactions such as angioedema or laryngeal oedema.

Metabolism and nutrition disorders Uncommon:

Hypercalcaemia and hypercalciuria Skin and subcutaneous tissue 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.

SoliCol D3 Tablets should not be given to infants and children under 12 years of age. Medical supervision is required whilst on treatment to prevent hypercalcaemia. Allowances should be made for vitamin D supplements from other sources (other vitamin D products, dietary sources and the patient’s level of sun exposure) while accounting for the dose of vitamin D3 (cholecalciferol) necessary for treatment.

Dosage should be individualised. Adequate fluid intake should be maintained. All patients receiving pharmacological doses of vitamin D should have their plasma calcium concentration checked at regular intervals and whenever nausea and vomiting are present.

Vitamin D should be used with caution in patients with impaired renal function and those with renal calculi. There is no clear evidence for causation between vitamin D supplementation and renal stones, but the risk is plausible, especially in the context of concomitant calcium supplementation.

Calcium supplements should be given under close medical supervision and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should also be taken into account. 5 - Interaction with other medicinal products and other forms of interaction - cardiac glycosides including digitalis).

SoliCol D3 Tablets should be prescribed with caution in patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. Serum and urinary calcium levels should be monitored in these patients.

Patients with rare hereditary problems of galactose intolerance, fructose intolerance, glucose-galactose malabsorption, the Lapp-lactase deficiency, or sucrase-isomaltase insufficiency should not take this medicine. Oral administration of high-dose vitamin D (500,000 IU as a single annual bolus) was reported to result in an increased risk of fractures in elderly subjects, with the greatest increase occurring during the first 3 months after dosing.

1 Hypercalcaemia and/or hypercalciuria Hypervitaminosis D Severe renal impairment Kidney stones (nephrolithiasis, nephrocalcinosis)