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  • Vitamin D3 1000
    / SAM-ON


    Active Ingredient
    Vitamin D3 1000 IU

    Status in Israel
    OTC

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    30 x 1 x 1000 IU

    not in the basket chart 69264

    Related information


    Dosage

    Vitamin D3 supplement: 1 Tablet (1000 IU) daily. As an adjunct to specific therapy for osteoporosis: 1 tablet daily. This product should not be used in children under 12 years. The tablets should be swallowed whole (not chewed) with water.


    Indications

    Vitamin D3 supplement. An adjuvant treatment for Osteoporosis patients.


    Contra-Indications

    Hypersensitivity to vitamin D or any of the excipients in the product. Hypervitaminosis D. Nephrolithiasis. Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria. Severe renal impairment. Lupus (SLE).


    Special Precautions

    Vitamin D 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.
    Caution is required in patients receiving treatment for cardiovascular disease. This product 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 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. This product should not be given to children.
    See prescribing information for full details.


    Side Effects

    Metabolism and nutrition disorders: Uncommon: Hypercalcaemia and hypercalciuria. Skin and subcutaneous disorders: Rare: Pruritus, rash and urticaria.


    Drug interactions

    Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation. Concomitant use of glucocorticoids can decrease the effect of vitamin D.
    The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium. Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D. The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase. Thiaside Diuretics.


    Pregnancy and Lactation

    Pregnancy: The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be vitamin D deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment.
    Lactation: Vitamin D and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed, however, 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.
    See prescribing information for full details.


    Overdose

    The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, hadeache, polyuria, loss of appetite, anorexia, weakness, joints and muscular pain, apathy, thirst, constipation or diarrhea, sleepinessand later on dehydration. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intakes of vitamin D and rehydration.


    Important notes

    Storage: Store under 250C.  Shelf life after first opening: 1 month.
    See prescribing information for full details.


    Manufacturer
    Sam-On Ltd., Israel
    Licence holder
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