Adverse reactions : תופעות לוואי

4.8        Undesirable effects

The frequencies of adverse events are ranked according to the following: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

The most frequently reported undesirable effects are hypercalcaemia and various skin reactions.
Adverse effects generally relate to abnormally elevated serum calcium levels leading to symptoms of anorexia, lassitude, nausea, vomiting, diarrhea, weight loss, polyuria, sweating, headache, thirst, vertigo, and raised plasma and urine concentrations of calcium and phosphate.

Hypercalcemia can be rapidly corrected by stopping treatment until plasma calcium levels return to normal (about 1 week). Alpha D3 treatment may then be re-started at half the previous dose.

In the case of renal impairment, elevated serum phosphate levels may be induced by Alpha D3 therapy. The dosage should be adjusted to the patient’s requirements.

Also rarely nephrocalcinosis, pruritus, rash, urticaria.

Based on data from post-market use the total undesirable effect 'reporting rate' is rare or very rare being approximately 1:10,000 patients treated.

Metabolism and Nutrition Disorders
 Hypercalcaemia
 Hyperphosphataemia

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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il