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
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.
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.
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