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MHRA issues warning about missing Cozaar 100mg tablets information

Health & NHS

MHRA issues warning about missing Cozaar 100mg tablets information

This story was originally published by Independent Community Pharmacist.

The Medicines and Healthcare products Regulatory Agency has warned pharmacists that patient leaflets in some batches of Cozaar 100mg film-coated tablets are missing up-to-date safety information and urged them to talk to patients about the error and discuss whether the medicine is suitable for them.

The regulator said the sentence ‘grapefruit juice should be avoided while taking Cozaar’ is missing from the sub-section ‘Cozaar with food and drink’ under section two of the leaflet entitled ‘what you need to know before you take Cozaar.’

The affected batches are 6016W, 5584W, 5393W, 5474W, 5169W, 5164W and 5171W. 

The MHRA said the product was not being recalled because “there is no risk to product quality” but urged pharmacists to “exercise caution when dispensing the products and where possible, provide an updated patient information leaflet (PIL).”

The product’s manufacturer Quadrant Pharmaceuticals Ltd assured the MHRA that all future imported batches will contain the correct PIL. The MHRA also said Quadrant Pharmaceuticals Ltd will post hard copies of the updated PIL to wholesalers and pharmacies if they request them “so that any remaining stock in the dispensary can be supplemented with the correct PIL information.”

The MHRA said: “Patients should continue to take medicines from these batches as prescribed by (their) healthcare professional. Patients are advised that grapefruit juice should be avoided while taking Cozaar.”

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