Class 4 Medicines Defect Information: Perindopril Erbumine 2mg, 4mg, 8mg Tablets  (Generics UK Limited T/A Mylan)

Class 4 Medicines Defect Information: Perindopril Erbumine 2mg, 4mg, 8mg Tablets  (Generics UK Limited T/A Mylan)

December 14, 2020

Class 4 Medicines Defect Information: Perindopril Erbumine 2mg, 4mg, 8mg Tablets  (Generics UK Limited T/A Mylan)

Drug alert number: EL (20)A/58

Date issued: 14 December 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Perindopril Erbumine 2mg, 4mg, 8mg Tablets PL 04569/1348, PL 04569/1349, PL 04569/1350, Generics UK Limited T/A Mylan

Generics [UK] Limited t/a Mylan have informed the MHRA that the Patient Information Leaflet (PIL) within the packs for the products listed below are missing relevant important safety information.

Perindopril Erbumine 2 mg Tablets 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 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 PL 04569/1350

Batch Number Expiry Date Pack Size First Distributed
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 the MHRA 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:

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. Additionally, patients who notice the symptoms/side effects should seek immediate medical advice.

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.

View the full alert here.

 



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