The Medicines and Healthcare products Regulatory Agency (MHRA) has warned that a batch of Zestoretic 20mg/12.5mg Tablets contains outdated safety information.

It has not recalled the batch but said that healthcare professionals should ‘exercise caution’ when dispensing batch SB012 of the medication.

If possible, they should provide the patient with an updated copy of the patient information leaflet (PIL), which can be downloaded from the MHRA or requested from manufacturer and wholesaler Atnahs Pharma UK.

The incorrect leaflets do contain a warning about side effects but do not elaborate on them.

Section 4 of the PIL should read: ‘Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion)’ could be a potential very rare side effect of the medication.

The PIL should also contain an alert that warns patients to talk to their doctor or pharmacist before taking Zestoretic: ‘If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Zestoretic, seek medical attention immediately’.

MHRA has said that ‘there is no risk to product quality as a result of this issue,’ but has advised healthcare professionals to ‘exercise caution’ when dispensing the affected batch.

It said that where available, Atnahs Pharma UK will be providing the updated PIL with all future deliveries of Zestoretic 20mg/12.5mg Tablets.

MHRA said that patients experiencing adverse reactions or who have any questions should seek medical attention, and that any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.

Atnahs Pharma UK has been approached for comment.