Patients urged to check packs of blood pressure medicine lercanidipine after labelling error

Patients who take the common blood pressure medicine Lercanidipine HCI 20 mg tablets (lercanidipine hydrochloride) from the manufacturer Recordati Pharmaceuticals Limited, should, as a precautionary measure, urgently check if they have the batch number MD4L07 with an expiry date of 01/2028 on any packs they have at home. The batch number is printed on the foil of the blister strips.

This follows an error in the strength of the product printed on some of the sides of the pack. The error is limited to one batch of the medicine only.

The packs are incorrectly labelled as 10 mg on some sides of the pack when they are 20 mg tablets. The correct strength (20 mg) is printed on the top of the carton and on the blister strips.

Patients prescribed 10 mg tablets

Patients prescribed 10 mg tablets and have received tablets with this batch number should contact their pharmacist or GP immediately.

If a patient cannot speak to a healthcare professional before they are due to take their next dose, they should:

1. verify the strength of the tablets is 20 mg from the information on the foil of the blister strips
2. remove one tablet from the blister as normal
3. locate the break line on the tablet
4. snap the tablet in half across the break line and take half of the tablet. This is permitted for the 20 mg tablets and is in line with information included in the patient information leaflet (where it states ‘The tablet can be divided into equal doses’). This is a temporary measure until you can talk to your pharmacist or doctor.

Patients prescribed 20 mg tablets

Patients who were prescribed 20 mg tablets should verify the strength of the tablets by checking the information on the foil of the blister strips prior to taking the tablet. Patients should continue to take the tablets as prescribed by their doctor.

Patients should not stop taking their medicine without consulting their healthcare provider. Patients who are concerned about the strength of the medication they have received should check it with their dispensing pharmacy.

Patients concerned they may have accidentally taken a higher dose of the medication than they were prescribed should talk to a pharmacist, their GP or call NHS 111.

Patients who experience side effects or have any questions about the medication should seek medical attention. Any suspected side effects should also be reported via the MHRA Yellow Card scheme.

Healthcare professionals such as pharmacists are also being asked to stop supplying medicine from the affected batch and to return it to the supplier.Patient safety is our top priority. We ask patients to check their medicine packaging and follow our advice.

Recordati Pharmaceuticals Limited is initiating a recall of the specified batches as a precautionary measure.

Source:

Medicines and Healthcare products Regulatory Agency (MHRA)