Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use

Content of clinically important electrolytes
• PHEBURANE contains 124 mg (5.4 mmol) of sodium per gram of sodium phenylbutyrate, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose. PHEBURANE should therefore be used with caution in patients with congestive heart failure or severe renal insufficiency, and in clinical conditions where there is sodium retention with oedema.
• Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium.

General considerations
• Even on therapy, acute hyperammonaemic encephalopathy may occur in a number of patients.
• PHEBURANE is not recommended for the management of acute hyperammonaemia, which is a medical emergency.

Excipients with known effect
• This medicinal product contains 124 mg sodium per gram of sodium phenylbutyrate, equivalent to 6.2% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this medicinal product is equivalent to 125% of the WHO recommended maximum daily intake for sodium.
•   PHEBURANE is considered high in sodium. This should be particularly taken into account for those on a law salt diet.
•   This medicinal product contains 768 mg sucrose per gram of sodium phenylbutyrate.
This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.

Effects on Driving

4.7       Effects on ability to drive and use machines
PHEBURANE has negligible influence on the ability to drive and use machines.