Letters and drug alerts sent to healthcare professionals in November 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
From:
Therapeutic area:
Please see our website for updated information for healthcare professionals and the public.
Letters
Drug alerts
Class 4 Medicines Defect Information, Kolanticon Gel 200ml, (PL 17509/0084), EL (20) A/51. Issued 9 November 2020. For one batch of this product, there is a difference in dosage instructions between the carton and label – the Patient Information Leaflet (PIL) and bottle label contain the correct instructions. When dispensing or providing this product, please check batch number and ensure that patients are aware of the correct dosing instructions.
Medicines Defect: missing safety information in some Perindopril products europeanpharmaceuticalreview.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from europeanpharmaceuticalreview.com Daily Mail and Mail on Sunday newspapers.
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).