GovWire

MDR number

103-08/23

Company name

Accord Healthcare Limited, UK

Product name

Olmesartan Medoxomil 10mg film coated tablets

SNOMED Code

34969911000001108

Active Pharmaceutical Ingredient: Olmesartan Medoxomil

Product name

Olmesartan Medoxomil 20mg film coated tablets

SNOMED Code

34970211000001102

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:

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- medinfo@accord-healthcare.com

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

DMRC@mhra.gov.uk

Download document

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