Class 4 Medicines Defect Information: Generics [UK] Limited t/a Mylan, EL(20)A/58
Generics [UK] Limited t/a Mylan have informed us that the Patient Information Leaflet (PIL) within the packs for the products listed above is missing relevant important safety information.
MDR Number
MDR 077-11/20
Company name
Generics [UK] Limited t/a Mylan
Product description
Perindopril Erbumine 2 mg Tablets PL 04569/1348
| Batch number | Expiry date | Pack size | First distribution date |
|---|---|---|---|
| 3109619 | 11/2021 | 30 | 06 May 2020 |
| 3116084 | 04/2022 | 30 | 24 August 2020 |
Perindopril Erbumine 4 mg Tablets PL 04569/1349
| Batch number | Expiry date | Pack size | First distribution date |
|---|---|---|---|
| 3112399 | 01/2022 | 30 | 28 July 2020 |
| 8104332 | 01/2022 | 30 | 16 August 2020 |
Perindopril Erbumine 8 mg Tablets PL 04569/1350
| Batch number | Expiry date | Pack size | First distribution date |
|---|---|---|---|
| 8104319 | 01/2022 | 30 | 28 July 2020 |
Active pharmaceutical ingredient: Perindopril Erbumine
Brief description of the problem
Generics [UK] Limited t/a Mylan have informed us that the Patient Information Leaflet (PIL) within the packs for the products listed above is missing relevant important safety information. The corrected sections of the PIL include the addition of the information listed below.
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:
- search for MHRA Yellow Card in the Google Play or Apple App Store.
Advice for healthcare professionals
When dispensing the above products and batches, please check the Marketing Authorisation Holder and if any of the batches of the product above are being dispensed, ensure that patients are aware of any missing information. Generics [UK] Limited t/a Mylan have stopped distribution of all affected batches, therefore stock received from January 2021 from wholesalers will be compliant with the new leaflet.
Further Information
For more information or medical information queries, please contact: Generics [UK] Limited t/a Mylan Medical Information Direct Line +44 (0)1707 853 000 select option 1, Customer Care direct line +44 (0)1707 853 000 select option 2 or via Medical Information e-mail info@mylan.co.uk.
Recipients of this Drug Alert 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.
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