NeLM news service
Fultium-D3 (colecalciferol) capsules approved by MHRA and due for launch in January 2012

Source: Personal communication

Date published: 30/11/2011 16:42

Summary
by: Nicola Pocock

The MHRA has recently approved Fultium-D3 capsules containing colecalciferol 800IU (equivalent of 20 micrograms vitamin D).  The capsules, which come in packs of 30 at a cost of £3.60, are expected to be launched in the UK in January 2012. 

 

The SPC (see link below) states that the product is licensed for the prevention and treatment of vitamin D deficiency, and as an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.  The doses are as follows: 

 

• Vitamin D deficiency in adults and the elderly (serum levels <25 nmol/L (<10ng/mL)): 1-4 capsules (800-3200 IU) daily for up to 12 weeks dependent upon the severity of the disease and the patient’s response to treatment

 

• Vitamin D insufficiency in adults and the elderly (serum levels 25 – 50 nmol/L (10 - 20 ng/mL)):  1-2 capsules (800-1600 IU) daily

 

• Long-term maintenance therapy following treatment of deficiency in adults and the elderly: 1-2 capsules (800-1600 IU) daily

 

• Prevention of vitamin D deficiency: 1-2 capsules (800-1600 IU) daily

 

• Vitamin D deficiency or insufficiency in children over 12 years – 1 capsule daily depending on the severity of the disease and the patient’s response to treatment.

 

• As an adjunct to specific therapy for osteoporosis: 1 capsule daily

 

Fultium-D3 is not licensed for use in children under 12 years, and is contra-indicated in those with peanut or soya allergy. 

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