Vitamin D3

• Treatment and prevention of vitamin D deficiency; • Management and prevention of primary and corticosteroid-induced osteoporosis, in conjunction with calcium; • Treatment of refractory rickets (vitamin D resistant rickets); • Treatment of familial hypophosphatemia; • Treatment of hypoparathyroidism.

CONTRAINDICATIONS • Hypersensitivity to vitamin D, any of its analogues and derivatives or to any ingredient in the formulation component of the container (see Dosage Form, Composition, and Packaging). • Hypercalcemia and/or hypercalciuria • Nephrolithiasis (renal calculi) • Severe renal impairment • Malabsorption syndrome • Abnormal sensitivity to the toxic effects of Vitamin D • Sarcoidosis • Hypervitaminosis D.

WARNINGS AND PRECAUTIONS General Chronic or acute administration of excessive doses of cholecalciferol may lead to hypervitaminosis D, manifested by hypercalcemia and its sequelae. The therapeutic index of Vitamin D analogues is narrow and there is great interindividual variation in the dose that will lead to chronic toxicity.

5 mg) in adults and 1000 IU (25 mcg) in children may result in hypervitaminosis. Other Vitamin D analogues with shorter duration of action may have a lower propensity to accumulate and to cause hypercalcemia. Cardiovascular Caution is required for patients receiving treatment for cardiovascular disease.

(See DRUG INTERACTIONS) Immune LUXA D should not be prescribed in patients with sarcoidosis, as there is increased conversion of vitamin D to its active metabolite. (See CONTRAINDICATIONS). High doses of Vitamin D can induce hypercalcemia and hypercalcuria.

Serum and urinary calcium levels sh ould be monitored. 4 Renal LUXA D should not be used in patients with severe renal impairment and should be used with caution in patients with mild and moderate impairment of renal function. (See CONTRAINDICATIONS).

The effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. 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.

The need for additional calcium supplementation should be considered f or individual patients. Calcium supplements should be given under close medical supervision. During treatment, the serum and urinary calcium levels should be monitored and the kidney function checked by measurement of serum creatinine.

These checks are particularly important in concomitant treatment with diuretics. In the case of hypercalcaemia or signs of impaired kidney function, the dose must be reduced or treatment interrupted. 5 mmol/24 hours (300 mg/24 hours).

Vitamin D must be used with particular caution in patients with disturbed urinary excretion of calcium and phosphate, in treatment with benzothiadiazine derivatives. Plasma and urinary calcium levels should be monitored in these patients.

Endocrine and Metabolism Hypercalcemia Early symptoms of hypercalcemia may include weakness, fatigue, somnolence, headache, anorexia, dry mouth, metallic taste, nausea, vomiting, vertigo, tinnitus, ataxia and hypotonia. Later and possibly more serious manifestation include nephrocalcinosis, ren al dysfunction, osteoporosis in adults, impaired growth in children, anemia, metastatic calcification, pancreatitis, generalized vascular calcification and seizures.

Extreme hypercalcaemia may result in coma and death. Special Populations Pregnant Women The recommended daily dose of Vitamin D in pregnant women in Canada is 600 IU (15 mcg) daily. Studies have shown safe use of Vitamin D at doses up to 4000 IU (100 mcg) daily during pregnancy although studies in animals have shown reproductive toxicity.

Avoid the use of vitamin D in excess of the recommended dietary allowance during pregnancy unless potential benefits outweigh the possible adverse effects. Hypercalcemia during pregnancy may also lead to suppression of parathyroid hormone release in the neonate, resulting in hypocalcemia, tetany and seizures.

Severe deficiency of vitamin D during pregnancy can result in maternal osteomalacia and lead to significant morbidity in both mother and fetus. Breast-feeding The recommended daily dose of Vitamin D in nursing women is 600 IU (15 mcg).

Vitamin D and its metabolites are excreted in breast milk. However, Vitamin D may be deficient in maternal milk; therefore, breastfed infants may require supplementation. Use of excessive amounts of Vitamin D in nursing mothers may result in hypercalcemia in infants.

A daily dose of 4,000 IU (100 mcg) should not be exceeded. When prescribing additional vitamin D to a breast-fed child the practitioner should consider the dose of any additional vitamin D given to the mother. 5 Monitoring and Laboratory Tests: Periodic monitoring of serum calcium, phosphate, magnesium, and alkaline phosphatase is recommended for patients taking Vitamin D3.

75 mmol/L. The best indicator of vitamin D status is 25-hydroxyvitamin D or 25(OH)D serum concentration, as this level reflects total vitamin D exposure (from skin synthesis, food and supplements). However, there is no clinical benefit in monitoring vitamin D levels unless a clinical condition, such as malabsorption syndromes, chronic renal or liver failure, unexplained bone pain, unusual fractures, and other evidence of metabolic bone disorders, predisposes the patient to vitamin D deficiency.

Other clinical situations where vitamin D testing is indicated include hypo- or hypercalcemia/hyperphosphatemia, hypo-or hyperparathyroidism, unexplained increases in serum alkaline phosphatase or patients with symptoms suggesting hypervitaminosis D.

Testing for […]

Prevention and treatment of vitamin D deficiency in adults and adolescents with an identified risk. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency

Posology The dosage of vitamin D depends on severity of the disease, as well as patients response to treatment. Based on patients needs, capabilities and preferences daily, weekly or monthly dosing regimens can be offered. g. 400 IU, 500 IU, 800 IU and 1,000 IU) are suitable for daily vitamin D supplementation, while higher dosage forms like 20,000 IU contain amounts equal to the weekly and monthly vitamin D doses respectively, which should be taken into consideration.

The dosage and the frequency of administration has to be established individually by a physician. The following may apply as dosage recommendation Adults Prevention of vitamin D deficiency and as an adjunct to specific therapy for osteoporosis: Recommended dose range is 600 IU- 800 IU per day.

Treatment of vitamin D deficiency: 800 IU per day. Higher doses should be adjusted dependent upon desirable serum levels of 25-Hydroxy colecalciferol (25(OH)D), the severity of the disease and the patient´s response to treatment. The daily dose should not exceed 4,000 IU.

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 4,000 IU per day. Alternatively, national posology recommendations in prevention and treatment of vitamin D deficiency can be followed.

forall Access 3200 IU capsules should not be given to children under 12 years of age due to the risk of choking. Instead, it is advisable to use drops or dissolvable tablets. 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, however, in women who are considered to be vitamin D3 deficient a higher dose may be required (up to 2 000 IU/day – 2 capsules of 1000 IU).

- Other conditions (see above): such as 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.

Adverse reactions frequencies are based on the following categories: uncommon (> 1/1,000, <1/100), rare (>1/10,000, <1/1,000) or not known (cannot be estimated from the available data) Immune system disorders Not known : Hypersensitivity reactions such as angio-oedema or laryngeal oedema.

Metabolism and nutrition disorders Uncommon:

Hypercalcaemia and hypercalciuria.

Skin and subcutaneous disorders Rare:

Pruritus, rash and urticaria. Depending on the dose and duration of treatment, severe and prolonged hypercalcaemia may be associated with its acute (cardiac arrhythmias, nausea, vomiting, mental symptoms, dysphagia) and chronic (increased urination, increased thirst, loss of appetite, weight loss, kidney stones, renal calcification, calcification in tissues outside the bone) Consequences occur.

Very rarely have fatal outcomes been reported. 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.

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1 • Hypervitaminosis D • Nephrolithiasis • Disease or conditions resulting in hypercalcemia and/or hypercalciuria • Severe Renal impairment