Other safety alerts
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| The United Kingdom: Class 4 Medicines Notification: Accord Healthcare Limited, UK, Olmesartan Medoxomil film coated tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Accord Healthcare Limited, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the following products:
- Olmesartan Medoxomil 10mg film coated tablets (batch number: M2213437, M2213708, M2213819, M2303226)
- Olmesartan Medoxomil 20mg film coated tablets (batch number: M2203689)
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.”
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-notification-accord-healthcare-limited-uk-olmesartan-medoxomil-10mg-film-coated-tablets-el-23-a-slash-29
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Aug 23, 2023
Issued at HKT 15:00
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