COLECALCIFEROL

33ml) for 10 weeks (280,000 IU in total). 67ml) (occasionally up to 4000 IU daily may be required). 67 ml per day).

Dosage in hepatic impairment:

No dose adjustment is required. 73m2). 13ml), however, in women who are considered to be vitamin D deficient a higher dose may be required as recommended by the doctor.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (≥1/1,000 to <1/100) or rare (≥1/10,000 to <1/1,000).

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.

During long-term treatment, serum and urinary calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. 5) and in patients with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued.

Patients with mild to moderate impairment of renal function should be supervised carefully and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. 3). In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria.

Colecalciferol should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine.

Colecalciferol should be used with caution in immobilised patients with osteoporosis due to increased risk of hypercalcaemia. g. those suffering from malignancies. Patients with primary hyperparathyroidism and vitamin deficiency should have their serum calcium measured.

The content of vitamin D in Colecalciferol oral solution should be considered when prescribing other medicinal products containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.

For patients with elevated levels of parathyroid hormone (PTH) or clinical evidence of rickets, calcium should be supplemented along with vitamin D. This is because vitamin D replacement and a normalisation of PTH levels can precipitate hypocalcaemia by suppressing bone resorption and from increased bone mineralisation, also referred to as the "hungry bone" syndrome.

Patients being treated specifically for vitamin D deficiency require a repeat 25(OH)D measurement approximately three to four months after initiating therapy as necessary. Patients with obesity, malabsorption syndromes or taking concomitant medications may not respond to this treatment or may require higher doses due to the impact on vitamin D absorption.

In such cases, vitamin D levels in the patient should be monitored and the dose should be followed as per the advice of their medical practitioner. Patients who remain deficient or insufficient on the proposed doses will need to be treated with alternative therapies.

Excipient(s) Warnings Almond oil (nut oil):

Not suitable for someone with nut allergy.

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