The 1
Dark Truth
Deprived of sunlight, 16% of the UK adult population has severe vitamin D deficiency* during the winter and spring
*serum 250HD < 25nmol/L
Fultium-D3 800 IU & 3,200 IU Capsules Abbreviated Prescribing Information. Please refer to the appropriate Summary of Product Characteristics (SmPC) before prescribing Fultium-D3. Use care when prescribing in pregnancy, as high doses of colecalciferol
may affect the fetus. Fultium-D3 capsules: Each Fultium-D3 800 IU capsule contains colecalciferol 800 IU equivalent to 20 micrograms vitamin D3. Each Fultium-D3 3,200
IU capsule contains colecalciferol 3,200 IU equivalent to 80 micrograms vitamin D3. Indication: Fultium-D3 800 IU capsules only: Prevention and treatment of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. Fultium-D3 3,200 IU capsules only: Treatment of vitamin D deficiency. Dosage and administration: Vitamin D deficiency in adults and the elderly (serum levels <25nmol/l (<10ng/ml)): 1-4 Fultium-D3 800 IU capsules (800-3,200IU) or 1 Fultium-D3 3,200 IU capsule (3,200 IU) daily for up to 12 weeks dependent upon the severity of the disease and the patients response to treatment. Vitamin D insufficiency in adults and the elderly (serum levels 25-50nmol/l (10-20 ng/ml) AND Long term maintenance therapy following treatment of deficiency AND Prevention of deficiency: 1-2 Fultium-D3 800 IU capsules (800-1,600IU) daily. As an adjunct to specific therapy for osteoporosis 1 Fultium-D3 800 IU capsule daily. Vitamin D deficiency or insufficiency in children over 12 years: 1 Fultium-D3 800 IU capsule daily, depending on the severity of the disease and the patient’s response to treatment. Should only be given under medical supervision. Fultium-D3 800 IU capsules should not be used by children under 12 years Fultium-D3 3,200 IU capsules for use by the adults and the elderly ONLY. The capsules should be swallowed whole (not chewed) with water. Contraindications: 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. Warnings and Precautions: Vitamin D should be used with caution in patients with impairment of renal function or sarcoidosis and the effect on calcium and phosphate levels should be monitored. 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. Close monitoring of calcium levels should be carried out under medical supervision. Caution is required in patients receiving treatment for cardiovascular disease. Consider vitamin D supplementation from other sources. Interactions: Concomitant treatment with phenytoin, barbiturates and glucocorticoids can decrease the effect of vitamin D. Interactions have also been seen with digitalis and other glycosides, ion exchange resins, laxatives such as paraffin and cytotoxic agents. Pregnancy and lactation: There are limited data from the use of colecalciferol in pregnant women. Animal studies have shown reproductive toxicity. The recommended daily intake for pregnant women is 400 IU, however, in women considered to be vitamin D deficient, a higher dose may be required. During pregnancy women should follow the advice of their GP, as their requirements may vary depending on the severity of their disease and their response to treatment. 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. Effects on ability to drive and use machines: Fultium-D3 has no influence on the ability to drive and use machines. Undesirable effects: Allergic reactions are possible. Uncommon adverse reactions include metabolic and nutrition disorders; hypercalcaemia
and hypercalciuria. Rare adverse reactions include: skin and subcutaneous disorders; pruritus rash and urticaria. Overdose: Refer to SmPC. Legal Category: POM Pack size: 800 IU capsules x90 –
NHS Price £8.85. Fultium-D3 3,200 IU capsules x30 – NHS Price £13.32. Fultium-D3 3,200IU capsules x90 – NHS Price £39.96. MA Number: 40861/0002 [Fultium-D3 800 IU capsules] 40861/0003 [Fultium-D3 3,200 IU capsules] MA Holder: Internis Pharmaceuticals Ltd., Linthwaite Laboratories, Linthwaite, Huddersfield, West Yorkshire HD7 5QH, UK.
Fultium-D3 800 IU capsules x 30 – NHS Price £3.60. Fultium-D3
Full Prescribing Information is available from Internis Pharmaceuticals Ltd. Date of preparation: July 2017 unique ID no. FUL-MIS-229
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard Adverse events should also be reported to 01484 848164
Reference: 1. Pearce SHS and Cheetham TD. Clinical review, BMJ. 2010 Jan; 340:142-7.
Date of preparation: January 2018 Job code: FUL-452
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