Special Warning : אזהרת שימוש

4.4      Special warnings and precautions for use

Over suppression of parathyroid hormone may result in elevations of serum calcium levels and may lead to low-turnover bone disease. Patient monitoring and individualised dose titration is required to reach appropriate physiological endpoints.
If clinically significant hypercalcaemia develops and the patient is receiving a calcium-based phosphate binder, the dose of the calcium-based phosphate binder should be reduced or interrupted.

Chronic hypercalcaemia may be associated with generalized vascular calcification and other soft tissue calcification.

Phosphate or vitamin D-related medicinal products should not be taken concomitantly with paricalcitol due to an increased risk of hypercalcaemia and Ca x P product elevation (see section 4.5).

Digitalis toxicity is potentiated by hypercalcaemia of any cause, so caution should be applied when digitalis is prescribed concomitantly with paricalcitol (see section 4.5).

In pre-dialysis patients, paricalcitol, like other vitamin D receptor activators, may increase serum creatinine (and therefore decrease the estimated GFR [eGFR]) without changing true glomerular filtration rate (GFR).

Caution should be exercised if co-administering paricalcitol with ketoconazole (see section 4.5).

Warning for excipients
Each 1 microgram capsule contains 0.71 mg of alcohol (ethanol). The amount per capsule of this medicine is equivalent to less than 1 ml beer or wine.

Effects on Driving

4.7     Effects on ability to drive and use machines

Zemplar has negligible influence on the ability to drive and use machines.