Source: MHRA / Gov.uk 12.9.22
Quadrant Pharmaceuticals Limited have informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packaged in various parallel imported batches.
Quadrant Pharmaceuticals Limited
Bezalip Mono 400mg Tablets PLPI 20774/0036
|Batch Number||Expiry Date||Pack Size||First Distributed|
Active Pharmaceutical Ingredient: bezafibrate
Brief description of the problem
Quadrant Pharmaceuticals Limited have informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packaged in the above parallel imported batches. 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).
Advice for healthcare professionals:
There is no risk to product quality as a result of this issue, therefore the 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, where appropriate. MHRA PIL Link: Bezalip Mono 400mg Tablets PLPI 20774/0036.
Quadrant Pharmaceuticals Limited have confirmed that no further units of any of the above batches will be released, therefore this notification only applies to packs that are already at pharmacy or wholesaler level, or in the possession of patients.
Quadrant Pharmaceuticals Limited have also confirmed that all future batches will contain the updated PIL and that upon request they will send hard copies by post of the updated PIL to wholesalers and pharmacies, so that any remaining stock in the dispensary can be supplemented with the updated PIL information.
Advice for patients:
Patients should be aware that the Patient Information Leaflet (PIL) in the above batches does not contain the most up to date safety information on skin side effects.
If you experience any of the side effects listed below, you should contact your doctor immediately:
- severe form of skin rash with flushing, fever, blisters or ulcers
- severe rash involving reddening, peeling and swelling of the skin that resembles severe burns
If you have any questions about your medicine or are concerned about side effects, talk to your healthcare professional.
The medicine itself is not affected and any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Defective Medicines Report Centre
10 South Colonnade
Telephone +44 (0)20 3080 6574
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