Class 4 Medicines Defect Information: Cozaar® 100mg film-coated tablets (Quadrant Pharmaceuticals Ltd)

Class 4 Medicines Defect Information: Cozaar® 100mg film-coated tablets (Quadrant Pharmaceuticals Ltd)

Drug alert number: EL (24)A/01

Date issued: 04 January 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Cozaar® 100mg film-coated tablets (Quadrant Pharmaceuticals Ltd)

Company name: Quadrant Pharmaceuticals Ltd

Product name: Cozaar® 100mg film-coated tablet, PLPI 20774/1830

Batch Number Expiry Date Pack Size First Distributed
6016W 31/08/2025 28 08/11/2023
5584W 31/08/2025 28 23/10/2023
5393W 31/08/2025 28 18/10/2023
5474W 31/08/2025 28 18/10/2023
5169W 31/03/2025 28 11/10/2023
5164W 30/06/2025 28 10/10/2023
5171W 31/08/2025 28 06/10/2023

Active Pharmaceutical Ingredient: Losartan Potassium

Brief description of the problem

Quadrant Pharmaceuticals Ltd has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Cozaar® 100mg film-coated tablets.

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®.’

Advice for healthcare professionals

There is no risk to 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.

The updated PIL is available here: https://www.medicines.org.uk/emc/product/7798/pil or by contacting licensing@maxearn.co.uk

If it is not possible to provide an updated PIL please advise patients of the missing information and discuss with them whether the medicine is suitable for them. Quadrant Pharmaceuticals Ltd has confirmed that all future imported batches will contain the correct PIL.

Upon request, Quadrant Pharmaceuticals Ltd will post hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information.

View full alert here.

Advice for patients

Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients are advised that grapefruit juice should be avoided while taking Cozaar.

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 licensing@maxearn.co.uk

For stock control enquiries please contact licensing@maxearn.co.uk

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