Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11

Source: MHRA/ Gov.uk 11.3.25

Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in the table include an outdated PIL. These packs contain a PIL which was revised in October 2021. The latest approved PIL is dated February 2025.

DMRC reference number

DMRC-34866680

Marketing Authorisation Holder

Jubilant Pharmaceuticals NV

Medicine Details

Azithromycin 250 mg Capsules

Licence: PL 19156/0138

Active ingredient: azithromycin dihydrate

SNOMED code: 1303911000001105 (4 Cap/pack), 1135911000001109 (6 Cap/pack)

GTIN: See Table in Appendix 1 attached

Affected Lot Batch Numbers

Background

Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in the table above include an outdated PIL. These packs contain a PIL which was revised in October 2021. The latest approved PIL is dated February 2025.

The out of date PIL, revised in October 2021, is missing important updated safety information, please refer to the table in Appendix 2 for information regarding updated safety information that is included in the most recent PIL from February 2025. The latest PIL is available on the MHRA website.

Advice for Healthcare Professionals:

Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing this product. When products from batches included in the table is supplied or dispensed, please ensure that patients are aware of the missing information which is summarised in the ‘Advice for Patients’ box below and provided in Appendix 2. As the patients would not find current PIL (dated: February 2025) in the packs, please inform the patients that the latest PIL for Azithromycin Capsules is available on the MHRA website.

Advice for Patients:

Patients should continue to take medicines from the impacted batches as prescribed by your healthcare professional. This does not affect the quality of the product. There is updated safety information in the latest patient information leaflet (PIL) which accompanies the medicine. The latest PIL is available on the MHRA website. As per current PIL there is some missing information which is presented below:

What you need to know before you take Irbesartan Jubilant – Other medicines and Azithromycin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines

• Hydroxychloroquine or chloroquine (used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria): Taking these medicines at the same time as azithromycin may increase the chance of you getting side effects that affect your heart.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Additional information:

For medical information enquiries please email safety.uk@lambda-cro.com or telephone 0080089013370

For stock control enquiries please email JPUK.Customerservice@jubl.com , or telephone 01233 552293

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.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11

Click here for the source.