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
