This document communicates a safety update for the product Teysuno (a combination of tegafur, gimeracil, and oteracil), based on a reviewed safety signal (EPITT no 20115) concerning Hyperammonaemia (elevated blood ammonia levels).
1. Update to the Summary of Product Characteristics (SmPC):
- Section 4.4 (Special Warnings):
- A new warning states that hyperammonaemia has been observed with Teysuno.
- It recommends measuring ammonia levels in patients who develop unexplained neurological symptoms (like ataxia, lethargy, or mental status changes).
- If symptoms worsen to hyperammonaemic encephalopathy, discontinuation of Teysuno should be considered.
- Section 4.8 (Undesirable Effects):
- Hyperammonaemia has been added as a rare/very rare adverse reaction under Metabolism and nutrition disorders.
2. Update to the Package Leaflet:
- Section 2 (Warnings and Precautions):
- Patients are advised to contact their doctor immediately if they develop symptoms like lack of energy, confusion, sleepiness, seizures, or impaired consciousness.
- Section 4 (Possible Side Effects):
- High blood ammonia levels are listed as a rare/very rare side effect.
Purpose
The update informs healthcare professionals and patients of the risk of hyperammonaemia associated with Teysuno, providing clear guidance on monitoring, symptom recognition, and management to ensure patient safety.
