Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Internis Pharmaceuticals Ltd., Linthwaite Laboratories, Linthwaite, Huddersfield, West Yorkshire, HD7 5QH, UK
The 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 is indicated in adults, the elderly and adolescents.
Vitamin D deficiency in adults and the elderly (serum levels <25 nmol/l (<10 ng/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))
AND
long term maintenance therapy following treatment of deficiency in adults and the elderly
AND
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. Should only be given under medical supervision.
As an adjunct to specific therapy for osteoporosis
1 capsule daily
During pregnancy and breast-feeding
Treatment of vitamin D deficiency
1–5 capsules (800–4000 IU) daily.
Long term maintenance therapy following treatment of deficiency
1-2 capsules (800–1600 IU) daily.
Fultium-D3 should not be used in children under 12 years
Oral
The capsules should be swallowed whole (not chewed) with water
The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of vitamin D and rehydration.
36 months.
Store below 25°C.
Store blister foil in original container in order to protect from light.
Opaque, white PVC/PVdC blister tray with aluminium foil.
Pack sizes: 28, 30, 56, 60, 90.
Not all pack sizes may be marketed.
Any unused product should be disposed of in accordance with local requirements.
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