Alert: Dawa Paracetamol

Three batches of Dawa Ltd Paracetamol Film-Coated Tablets have incorrect PILs, Dawa have said in an alert.

The affected batches are:

Paracetamol 500mg Film-Coated Tablets:

Batch Number	Expiry Date	Pack Size	First Distributed
220103	02/2025	32	19/12/2023
220105	02/2025	32	20/10/2023

Paracetamol 1000mg Film-Coated Tablets:

Batch Number	Expiry Date	Pack Size	First Distributed
220106	02/2025	100	30/10/2023

The affected section of the PIL is Section 2, which does not contain the most up to date information on the use of flucloxacillin as a concomitant medicine.

The missing information is in bold below.

Taking other medicines with Paracetamol 500mg/1000mg film coated tablets

Some other medicines may affect or be influenced by Paracetamol 500 mg film coated tablets. Some of these drugs are mentioned below:

“Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.”

Updated PILs can be accessed via the following links:

Paracetamol 500mg Film-Coated Tablets

Paracetamol 1000mg Film-Coated Tablets

MHRA alert