Quadrant Pharmaceuticals Limited has advised of a PIL error in the following batches of Bezalip Mono 400mg Tablets (bezafibrate).
|Batch Number||Expiry Date||Pack Size||First Distributed|
The PIL included in the batches above is an older version of the PIL, which does not include the most up to date safety information.
The information missing from the PILs are as below:
Section 4. Possible side effects
Contact your doctor immediately if you notice signs of:
- severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson Syndrome)
- severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (Toxic epidermal necrolysis).
Affected batches are not being recalled. Healthcare professionals are advised to discuss the missing information with patients and provide a copy of the updated PIL available [online] at: Bezalip Mono 400mg Tablets PLPI 20774/0036 or on request from Quadrant Pharmaceuticals.