STRIVIT-D3

Posology Adults Vitamin D deficiency 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.

Vitamin D insufficiency 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.

Osteoporosis As an adjunct to specific therapy for osteoporosis, 1 capsule daily. Dosage in hepatic impairment No dose adjustment is required. 3). Paediatric population Vitamin D deficiency or insufficiency 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. Colecalciferol should not be used in children under 12 years. 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.

Method of administration Oral The capsules should be swallowed whole (not chewed) with water. The capsules should not be chewed in order to facilitate the swallowing of the capsule content. In order to enhance absorption, it is recommended to take vitamin D with a meal.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000). Immune system disorders Not known (cannot be estimated from the available data): hypersensitivity reactions such as angio-oedema or laryngeal oedema.

Metabolism and nutrition disorders Uncommon: hypercalcaemia and hypercalciuria. Skin and subcutaneous disorders Rare: pruritus, rash and urticaria. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In the case of therapeutic treatment the dose should be established on an individual basis for the patients by regular checking of plasma calcium levels. During long-term treatment with a daily dose exceeding 1,000 IU vitamin D, the serum calcium level, urinary calcium excretion and renal function should be monitored by measuring the serum creatinine level.

5), and in the case of hyperphosphataemia, as well as for patients with an increased risk of lithiasis. 5 mmol)/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued. Renal impairment Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored.

The risk of soft tissue calcification should be taken into account. 3, Contraindications). 5 – cardiac glycosides including digitalis). Monitoring in children whose mother receives treatment with vitamin D Similar monitoring is necessary for children whose mother receives treatment with vitamin D in pharmacological amounts.

Some children may react with increased sensitivity to the effect of vitamin D. Pseudohypoparathyroidism Vitamin D3 capsules should not be taken if pseudohypoparathyroidism is present (the need for vitamin D may be reduced by the sometimes normal sensitivity to vitamin D, with a risk of long term overdose).

In such cases, more manageable vitamin D derivatives are available. Sarcoidosis Colecalciferol should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form.

These patients should be monitored with regard to the calcium content in serum and urine. Use of additional supplements Allowances should be made for vitamin D supplements from other sources. The concomitant use of multivitamin products and dietary supplements containing vitamin D should be avoided.

The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision. Medical supervision is required whilst on treatment to prevent hypercalcaemia.

Paediatric population Colecalciferol should not be given to children <12 years of age. Sodium This medicine contains less than 1 mmol sodium (23 mg) per 800 IU, that is to say essentially ‘sodium-free’. SUMMARY OF PRODUCT CHARACTERISTICS

1. • Hypervitaminosis D • nephrolithiasis • Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria Severe renal impairment