VITAMIN D3

Posology Adults Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. The patient’s dietary habits should be carefully evaluated and artificially added vitamin D content of certain food types should be taken into consideration.

Prevention of Vitamin D deficiency: • Starting dose of 1 capsule (20,000 IU) once a month, higher doses may be required in certain situations, see below • As an adjunct to specific therapy for osteoporosis: 1 capsule (20,000IU) once a month Treatment of Vitamin D deficiency: • 2 capsules (40,000 IU) once weekly for 7 weeks, followed by maintenance therapy (equivalent to 1400 - 2000 IU/day, such as 2-3 capsules per month, as directed by your doctor.

Follow-up 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). 4). , anticonvulsant medications, glucocorticoids) - Patients with malabsorption, including inflammatory bowel disease and coeliac disease - Those recently treated for vitamin D deficiency, and requiring maintenance therapy.

Special populations:

Patients with hepatic impairment No posology adjustment is required in patients with hepatic impairment Paediatric population Vitamin D3 20,000 IU Capsules should not be used in children. Method of administration Oral The capsules should be swallowed whole (not chewed) with water.

2 Pharmacokinetic properties -“Absorption”).

The frequency of possible side effects listed below are defined as:

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 (cannot be estimated from the available data) Metabolism and nutrition disorders: Uncommon: Hypercalcaemia and hypercalciuria.

Gastrointestinal disorders:

Not known: Constipation, flatulence, nausea, abdominal pain, diarrhoea.

Skin and subcutaneous disorders:

Rare: Pruritus, rash and urticaria. Dependent on dose and duration of treatment of serious and persistent hypercalcemia with its acute (heart rhythm disturbances, nausea, vomiting, psychiatric symptoms, loss of consciousness) and chronic (increased urination, increased thirst, loss of appetite, weight loss, kidney stones, kidney calcification, calcification may in tissues outside the bone) episodes occur.

9 "overdose"). 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.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. uk/yellowcard

Vitamin D3 20,000 IU Capsules should be used with caution in patients with impaired renal function, impaired renal calcium and phosphate excretion, a tendency to form kidney stones (calculi), treatment with benzothiadiazine derivatives and in immobilized patients with caution (risk of hypercalcemia, hypercalciuria).

In these patients, the calcium levels in plasma and urine are monitored. The risk of soft tissue calcification should be taken into account. 3, contraindications). The active metabolite of vitamin D3 (1, 25-dihydroxycholecalciferol) may affect the phosphate balance.

Therefore, in conditions with increased phosphate levels, treatment with a phosphate binder may be considered. Caution should be taken in patients who are suffering from sarcoidosis or other granulomatous disorders because of the risk of increased conversion of vitamin D to its active metabolite.

These patients should be monitored with regard to the calcium content in serum and urine. During long-term treatment with Vitamin D3 20,000 IU Capsules, or in patients with renal insufficiency serum and urine levels of calcium should be monitored and the renal function monitored by measurement of serum creatinine.

Allowances should be made for vitamin D supplements from other sources. Vitamin D is fat soluble and may accumulate in the body. This may cause toxic effects in case of overdose and long term treatment with excessive doses. Recommended treatment should therefore not be exceeded.

In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or treatment interrupted. 5 mmol/24 hours (300 mg/24 hours). 5 – cardiac glycosides including digitalis or diuretics). In patients with renal insufficiency treated with Vitamin D3 20,000 IU Capsules close medical supervision is required to monitor the calcium and phosphate balance.

Oral administration of high-dose vitamin D (500,000 IU by 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.

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.

In such cases, the calcium levels monitored in serum and urine (see above). Paediatric population Vitamin D3 20,000 IU Capsules is not indicated for use in children. This product contains sorbitol liquid partially dehydrated. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

1. - Diseases or conditions resulting in hypercalcemia and / or hypercalciuria. - Pseudohypoparathyroidism. - Hypervitaminosis D. - Nephrolithiasis. - Severe renal impairment.