MHRA Class 4 Medicines Defect Notification: Irbesartan 150 mg and 300 mg film-coated tablets (Jubilant Pharmaceuticals NV)

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NV) as the Patient information leaflet (PIL) in the cartons for the batches listed in the notification include an outdated PIL.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

Product name: Irbesartan 300 mg film-coated, PL 19156/0090

SNOMED Code: 42375511000001107,1080311000001103, 21100511000001103, 21100611000001104, 21123811000001104, 21124111000001108, 29880311000001107, 29886711000001109

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the MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in the table above include an outdated PIL.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The out-of-date PIL last revised in September 2015 is missing important updated safety information, please refer to the table in Appendix 1 in the PDF for information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