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The Dark Truth


Deprived of sunlight, 16% of the UK adult population has severe vitamin D deficiency* during winter and spring.2


Once daily capsules


Colecalciferol Vitamin D encapsulated


* serum 25OHD < 25 nmol/L


as high doses of colecalciferol may affect the fetus. Fultium-D3 Each Fultium-D3


of vitamin D deficiency As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin Dinsufficiency. Fultium-D3


20,000 IU capsule contains colecalciferol 20,000 IU equivalent to 500 micrograms vitamin D3


colecalciferol 3,200 IU equivalent to 80 micrograms vitamin D3 . Indication: Fultium-D3


to 20 micrograms vitamin D3


3,200 IU capsule contains . Each Fultium-D3


800 & 20,000 IU capsules Prevention and treatment 3,200 IU capsules


only Treatment of vitamin D deficiency Dosage and administration: Adults and the elderly Treatment of Vitamin D deficiency (serum levels <25nmol/l (<10ng/ml)) Depending


Prevention of vitamin D deficiency 1-2 Fultium-D3 (800-1600IU) daily or 1 Fultium-D3


on the severity of the disease and the patient’s response to treatment: 1-4 Fultium-D3 800 IU capsules daily for up to 12 weeks or 1 Fultium-D3 12 weeks or 2 Fultium-D3


3,200 IU capsule daily for up to


20,000 IU capsules per week for 7 weeks 800 IU capsules


20,000 IU capsule per month Long term maintenance therapy following deficiency treatment or vitamin D


20,000 IU every 2 weeks to 6 weeks (treatment) Should only be given under medical Date of preparation: January 2016 FUL-361


insufficiency (serum levels 25-50nmol/l (10-20 ng/ml) 1-2 Fultium-D3 800 IU capsules daily. Children over 12 years Depending on the severity of the disease and the patient’s response to treatment: 1 Fultium-D3 treatment), or 1 Fultium-D3


800 IU capsule daily (for prevention/ 20,000 IU every 6 weeks (prevention), or 1 Fultium-D3


Information Please refer to the appropriate Summary of Product Characteristics (SmPC) before prescribing Fultium-D3


Fultium-D3


800 IU, 3,200 IU & 20,000 IU Capsules Abbreviated Prescribing Use care when prescribing in pregnancy,


capsules:


800 IU capsule contains colecalciferol 800 IU equivalent . Each Fultium-D3


supervision. Not recommended for use in children under 12 years For oral use. Swallow capsules whole 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: Use with caution in patients with impaired renal function or sarcoidosis and monitor the effect on calcium and phosphate levels. 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. In cases of long-term daily doses exceeding 1,000 IU, monitor serum calcium levels. Use caution 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. Attenuation of digitalis and other cardiac glycosides. Absorption of vitamin D may be reduced by ion exchange resins and laxatives. 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 hypercalcaemia and hypercalciuria. Rare adverse reactions include: pruritus rash and urticaria. Overdose: Refer to SmPC. Legal Category: POM Pack size: Fultium-D3


capsules x90 – NHS Price £10.80 Fultium-D3 Fultium- D3


800 IU capsules x 30 – NHS Price £3.60 Fultium-D3


– NHS Price £17.04 Fultium-D320,000 capsules x30 – NHS Price £29.00 MA Number: 40861/0002 [Fultium-D3


40861/0004 [Fultium-D3 20,000 IU capsules] MA Holder: Internis Pharmaceuticals Ltd.


3,200IU capsules x90 – NHS Price £39.96 Fultium-D3 800 IU capsules] 40861/0003 [Fultium-D3


Linthwaite Laboratories, Linthwaite, Huddersfield, West Yorkshire HD7 5QH, UK Full Prescribing Information is available from Internis Pharmaceuticals Ltd


Date of preparation: Sept 2015 unique ID no. FUL-252


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 0870 851 0207.


Reference: 1. Data on file. Internis Pharmaceuticals Ltd. R1. 2. Pearce SHS and Cheetham TD. Clinical Review, BMJ. 2010 Jan;340:142-7.


800 IU


3,200 IU capsules x30 – NHS Price £13.32 20,000 capsules x15


3,200 IU capsules]


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