STRIVIT-D3 800 IU Capsule, soft Ref.[7158] Active ingredients: Vitamin D3

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Strides Arcolab International Ltd., Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire WD18 9SS, United Kingdom

Therapeutic indications

For 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.

Colecalciferol is indicated in adults, the elderly and adolescents.

Posology and method of administration

Posology

For 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.

For Vitamin D insufficiency in adults and the elderly (serum levels 25–50 nmol/l (10-20 ng/mL)), 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.

As an adjunct to specific therapy for osteoporosis, 1 capsule 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.

Dosage in hepatic impairment

No Dose adjustment is required.

Dosage in renal impairment

Colecalciferol should not be used in patients with severe renal impairment (see section 4.3).

Paediatric population

Colecalciferol should not be used in children under 12 years.

Method of administration

Oral

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

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.

Shelf life

24 months.

Special precautions for storage

This medicinal product does not require any special temperature storage conditions.

Keep the blister in the outer carton in order to protect from light.

Nature and contents of container

Coated PVC film with aluminum blister foil packed in cartons.

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

Special precautions for disposal and other handling

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

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