Class 4 Medicines Defect Information: Atrolak XL Prolonged-release tablets, all strengths (quetiapine fumarate)

Accord Healthcare Ltd has informed us that the Patient Information Leaflet (PIL) for all strengths of Atrolak XL Prolonged-release tablets is missing the side effects identified from post-marketing experience.

MDR Number

MDR 143-01/20

Company Name

Accord Healthcare Ltd

Product description

Atrolak XL 50mg Prolonged-release tablets PL 20075/0213

Batch Number Expiry Date Pack Size First Distributed
322729 05/2021 60 19/12/19
Y06455 10/2021 60 03/09/19

Atrolak XL 150mg Prolonged-release tablets PL 20075/0446

Batch Number Expiry Date Pack Size First Distributed
Y04771 10/2021 60 06/11/19
Y04788 10/2021 60 27/09/19
Y02374 05/2021 60 07/08/19

Atrolak XL 200mg Prolonged-release tablets PL 20075/0214

Batch Number Expiry Date Pack Size First Distributed
X17653 02/2021 60 24/11/19
Y06710 08/2021 60 18/11/19

Atrolak XL 300mg Prolonged-release tablets PL 20075/0215

Batch Number Expiry Date Pack Size First Distributed
Y06909 09/2021 60 04/10/19
X21602 05/2021 60 07/04/19
X19649 03/2021 60 03/07/19
X19866 03/2021 60 11/06/19

Atrolak XL 400mg Prolonged-release tablets PL 20075/0216

Batch Number Expiry Date Pack Size First Distributed
X21825 05/2021 60 10/10/19
X18765 03/2021 60 05/07/19

Active Pharmaceutical Ingredient: quetiapine fumarate

Brief description of the problem

Accord Healthcare Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the above batches is missing the side effects identified from post-marketing experience that are documented in Section 4. (Possible Side Effects) of the PIL:

  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome). Stop using Atrolak XL [quetiapine] if you develop these symptoms and contact your doctor or seek medical attention immediately.

It is important that any patients who notice the symptoms seek immediate medical advice.

Advice for healthcare professionals

When dispensing this product, please check the Marketing Authorisation Holder and the batch number; if any of the above batch numbers are being dispensed, ensure that patients are aware of any missing information.

The current PILs includes the special warning and precautions and should be issued when this product is dispensed. Click here for Atrolak XL PILs available from the electronic medicines compendium (emc).

Further Information

For more information or medical information queries, please contact: Accord Medical Information Department on 01271 385257.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.

NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Download document: Class 4 medicines defect information: Atrolak XL (EL (20)A/06)

Published 12 February 2020