Class 4 Medicines Defect Information: Olmesartan Medoxomil 10mg & 20mg film coated tablets (Accord Healthcare Limited UK)

Class 4 Medicines Defect Information: Olmesartan Medoxomil 10mg & 20mg film coated tablets (Accord Healthcare Limited UK)

Drug alert number: EL (23)A/29

Date issued: 22 August 2023

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Olmesartan Medoxomil 10mg & 20mg film coated tablets (Accord Healthcare Limited UK)

Company name: Accord Healthcare Limited, UK

Product name: Olmesartan Medoxomil 10mg film coated tablets, PL 20075/0238

SNOMED Code: 34969911000001108

Batch Number 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

Active Pharmaceutical Ingredient: Olmesartan Medoxomil

Product name:Olmesartan Medoxomil 20mg film coated tablets, PL 20075/0239

SNOMED Code:34970211000001102

Batch Number Expiry Date Pack Size First Distributed
M2203689 02/2025 2X14T 31/01/2023

Active Pharmaceutical Ingredient: Olmesartan Medoxomil

Brief description of the 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 for 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.

View full alert here.

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

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