The Medicines and Health products Regulatory Agency (MHRA) has issued a class four medicines defect information notice for Mylan's Perindopril Erbumine 2mg, 4mg, and 8mg tablets.
Mylan have informed the MHRA that the patient information leaflet within the packs for the products listed below are missing relevant important safety information.
The manufacturers of the drug have stopped the distribution of all affected batches, therefore stock received from January 2021 from wholesalers will be compliant with the new leaflet.
Perindopril Erbumine 2mg Tablets with PL 04569/1348
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 3109619 | 11/2021 | 30 | 06 May 2020 |
| 3116084 | 04/2022 | 30 | 24 August 2020 |
Perindopril Erbumine 4 mg Tablets with PL 04569/1349
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 3112399 | 01/2022 | 30 | 28 July 2020 |
| 8104332 | 01/2022 | 30 | 16 August 2020 |
Perindopril Erbumine 8 mg Tablets with PL 04569/1350
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 8104319 | 01/2022 | 30 | 28 July 2020 |
The active pharmaceutical ingredient used in the drug is Perindopril Erbumine.
The corrected sections of the PIL include the addition of the information listed below...
| Section in PIL | Missing information |
| Section 2 Do not take Perindopril Erbumine: | • if you are having dialysis or any other type of blood filtration. Depending on the machine that is used, Perindopril Erbumine may not be suitable for you. • if you have kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis). |
| Section 2 Warnings and precautions. Talk to your doctor or pharmacist before taking Perindopril Erbumine if you: | • have abnormally increased levels of a hormone called aldosterone in your blood (primary aldosteronism) |
| Section 4 Other possible side effects: | Concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits which may be due to inappropriate ADH (anti-diuretic hormone) secretion. If you have these symptoms contact your doctor as soon as possible |
| Section 4 Reporting of side effects: | or search for MHRA Yellow Card in the Google Play or Apple App Store. |
It is important that any patients who have been prescribed the products are provided with information on warnings and precautions whilst taking Perindopril Erbumine.
MHRA has also suggested the patients who notice the symptoms or side effects should seek immediate medical advice.
While dispensing the tablets, community pharmacists have been advised to check the marketing authorisation holder, if any of the batches of the product above are being dispensed, and ensure that patients are aware of any missing information.
