Class 4 Medicines Notification, Accord Healthcare Limited, UK, Olmesartan Medoxomil 10mg film coated tablets, EL (23)A/29

Added

8 months ago

Author

Cathy

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Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.

MDR Number: 103-08/23

Company name: Accord Healthcare Limited, UK

Product descriptions:

Olmesartan Medoxomil 10mg film coated tablets

Batch No	Expiry Date	Pack Size	First Distributed
M2213437	08/2025	2X14T	28/06/2023
M2213708	08/2025	2X14T	09/05/2023
M2213819	08/2025	2X14T	31/03/2023
M2303226	04/2026	2X14T	16/05/2023

Olmesartan Medoxomil 20mg film coated tablets

Batch No	Expiry Date	Pack Size	First Distributed
M2203689	02/2025	2X14T	31/01/2023

Brief description of problem:

Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the above batches of these products. The PIL does not include the most up to date safety information regarding the signs and symptoms of liver issues and the need to seek medical advice if they occur.

The information missing from the PILs is included below:

"Section 4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped.

Although not many people may get them, the following side effects can be serious:
If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started therapy with Olmesartan Medoxomil a longer time ago, contact your doctor immediately who will evaluate your symptoms and decide on how to continue your blood pressure medication.”

Advice to Healthcare Professionals:

There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL. The updated PIL is available electronically and can be downloaded from the Accord website.

If it is not possible to provide an updated PIL please advise patients of the missing information and the need to seek medical advice if these signs or symptoms occur.

Advice to Patients:

This issue is about missing information on the Patient Information Leaflets (PILs) in specific batches of Olmesartan Medoxomil tables for high blood pressure. The medicine itself is not affected and therefore patients do not need to take any action.

There have been some reports of liver problems in patients taking this medicine, but these do not happen to all patients. If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started therapy with Olmesartan Medoxomil a long time ago, contact your doctor immediately.

These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care. Patients should continue to take medicines from these batches as prescribed by your healthcare professional. If you have any concerns, please speak with your pharmacy team in the first instance.

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.

Company contacts for further information:

For medical information enquiries please contact: Accord Medical Information Department on 01271 385257, email- medinfo@accord-healthcare.com

For stock control enquiries please contact: Accord- Customer Services Team on 0800 373573

To access the full recall: Class 4 Medicines Notification, Accord Healthcare Limited, UK, Olmesartan Medoxomil 10mg film coated tablets, EL (23)A/29