FULTIUM-D3 Capsule Ref.[50030] Active ingredients: Vitamin D3

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Internis Pharmaceuticals Ltd., Linthwaite Laboratories, Linthwaite, Huddersfield, West Yorkshire, HD7 5QH, UK

4.1. Therapeutic indications

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.

4.2. Posology and method of administration

Posology

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

Method of administration

Oral

The capsules should be swallowed whole (not chewed) with water

4.9. Overdose

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.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C.

Store blister foil in original container in order to protect from light.

6.5. Nature and contents of container

Opaque, white PVC/PVdC blister tray with aluminium foil.

Pack sizes: 28, 30, 56, 60, 90.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused product should be disposed of in accordance with local requirements.

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