其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Quadrant Pharmaceuticals Ltd, Cozaar 100mg Film-coated Tablets (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Quadrant Pharmaceuticals Limited has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Cozaar (losartan potassium) 100mg film-coated tablets (batch number: 6016W, 5584W, 5393W, 5474W, 5169W, 5164W, 5171W).
The PIL does not include the most up to date safety information as described below:
In Section 2 ‘What you need to know before you take Cozaar’, sub section ‘Cozaar with food and drink’, the following information is missing:
‘Grapefruit juice should be avoided while taking Cozaar.’
There is no risk to the product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products 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-defect-information-quadrant-pharmaceuticals-ltd-cozaar-100mg-film-coated-tablets-el-24-a-slash-01
In Hong Kong, Cozaar Tab 100mg (HK-50281) is a pharmaceutical product registered by Organon Hong Kong Limited (Organon). The product is a prescription-only medicine. As confirmed with Organon, the affected batches have not been imported into Hong Kong.
Ends/Friday, January 5, 2024
Issued at HKT 15:00
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