MHRA Class 4 Medicines Defect Notification: Irbesartan 150 mg and 300 mg film-coated tablets (Jubilant Pharmaceuticals NV)
Drug alert number: EL(25)A/02
Date issued: 13 January 2025
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Irbesartan 150 mg and 300 mg film-coated tablets (Jubilant Pharmaceuticals NV) as the Patient information leaflet (PIL) in the cartons for the batches listed in the notification include an outdated PIL.
DMRC reference number: DMRC- 34132023
Company name: Jubilant Pharmaceuticals NV
Product name: Irbesartan 150 mg film-coated tablets, PL 19156/0089
SNOMED Code: 42375311000001101, 1126711000001102, 21123311000001108, 21123511000001102, 29880111000001105, 29880211000001104
Batch Number
Expiry Date
Pack Size
First Distributed
IR222002A
08/2025
28
5 December 2023
IR222003A
08/2025
28
8 January 2024
IR222004A
09/2025
28
16 November 2023
IR222006A
09/2025
28
5 February 2024
IR222007A
09/2025
28
1 March 2024
IR222008A
09/2025
28
2 April 2024
IR224001A
03/2027
28
5 September 2024
IR224002A
03/2027
28
12 September 2024
IR224003A
03/2027
28
19 September 2024
IR224004A
06/2027
28
20 November 2024
Product name: Irbesartan 300 mg film-coated, PL 19156/0090
SNOMED Code: 42375511000001107,1080311000001103, 21100511000001103, 21100611000001104, 21123811000001104, 21124111000001108, 29880311000001107, 29886711000001109
Batch Number
Expiry Date
Pack Size
First Distributed
IR322001C
02/2025
28
5 December 2023
IR322002C
02/2025
28
1 February 2024
IR322003A
08/2025
28
16 November 2023
IR324002A
06/2027
28
11 November 2024
IR324003A
06/2027
28
26 November 2024
IR324004A
06/2027
28
6 December 2024
Active Pharmaceutical Ingredient: Irbesartan
Brief description of the problem
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in the table above include an outdated PIL. These packs contain a PIL which was last revised in September 2015. The latest current approved PIL is dated August 2022.
The out-of-date PIL last revised in September 2015 is missing important updated safety information, please refer to the table in Appendix 1 in the PDF for information regarding updated safety information that is included in the most recent PIL from August 2022. The latest (current) PIL is already available on the MHRA’s 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 product from batch included in the table is supplied or dispensed, please ensure that patients are aware of the missing information. As the patients would not find current PIL (dated: Aug 2022) in the packs, please inform the patients that this latest (current) PIL of Irbesartan Jubilant film-coated tablets is already available on the MHRA’s website.
Advice for patients
Patients should continue to take medicines from the impacted batch as prescribed by your healthcare professional. This does not affect the quality of the product. There are updated safety information in the latest patient information leaflet (PIL) which accompanies the medicine. The latest (current: last revised in Aug 2022) PIL is already available on the MHRA’s website.
As per current PIL there is some missing information which is presented below:
What you need to know before you take Irbesartan Jubilant
Warnings and precautions
Talk to your doctor or pharmacist before taking Irbesartan Jubilant if
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes.
You may need to have blood checks if you take:
repaglinide (medication used for lowering blood sugar levels)
Possible side effects
Decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, severe allergic reactions (anaphylactic shock) and low blood sugar levels.
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.
Further information
For medical information enquiries please contact: safety.uk@lambda-cro.com, Telephone number: 0080089013370
For stock control enquiries please contact: JPUK.Customerservice@jubl.com, Telephone: +4401233 552293
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