Class 4 Medicines Notification, Accord Healthcare Limited, UK, Olmesartan Medoxomil 10mg film coated tablets, EL (23)A/29
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 name
Olmesartan Medoxomil 10mg film coated tablets
SNOMED Code
34969911000001108
|
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 |
Active Pharmaceutical Ingredient: Olmesartan Medoxomil
Product name
Olmesartan Medoxomil 20mg film coated tablets
SNOMED Code
34970211000001102
|
Batch No |
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.
Advice for 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.
Further Information
For medical information enquiries please contact:
Accord Medical Information Department on 01271 385257, email- [email protected]
For stock control enquiries please contact: Accord- Customer Services Team on 0800 373573
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Reporting of side effects
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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