Treatment of high blood pressure: the ANSM warns of a packaging error in this medication: Femme Actuelle Le MAG

In its news of October 27, the National Agency for the Safety of Medicines and Health Products (ANSM) warns of an error in the packaging of the medicines Amlodipine EG 5 mg and 10 mg, in capsule form.

“We were informed by the EG Labo laboratory of a error occurred during the packaging of batch A53014 of Amlodipine EG 5 mg”, writes the ANSM. Also, “packets of Amlodipine EG 5 mg were packaged in boxes of Amlodipine EG 10 mg”. These have been distributed since June 21, 2023. As a reminder, this is a treatment for high blood pressure.

Amlodipine EG 5 mg: batches affected by this error

Here are the batches affected by this packaging error:

• Amlodipine EG 5 mg, in capsule. These are boxes of 30 (from batch A53014 with an expiry date of 02/2028)
• Amlodipine EG 10 mg, in capsule. These are boxes of 30 (from lot A53014, whose expiry date is 2/2028)

But what are the risks for patients? As the ANSM explains, “the risk for patients affected by this error is an underdosageand so a reduction in the effectiveness of the treatment”. In addition, the authorities specify thatno pharmacovigilance case linked to the quality defect has been reported to the laboratory to date”.

Amlodipine: what to do with the drugs concerned?

If you are a patient, check the lot on your medicine box. “If a reference other than A53014 is written on your box, you are not affected by the recall”, underlines the ANSM. In this case, “do not stop or change your treatment without medical advice” and return the box to the pharmacy.“Your pharmacist will check your box and if necessary issue you with a new box from a compliant batch”, underlines the ANSM.

If you experience symptoms “suggestive of hypertension, such as headacheshortness of breath, dizzinessetc”, the ANSM recommends consulting your doctor and completing a declaration on the reporting portal.

For pharmacy practitioners, the ANSM requests “contact patients likely to have the batches affected by this recall so that they can return their box to you”. Then observe the box. Two scenarios can arise:

• If the box of Amlodipine EG 10 mg, capsule and contains “Amlodipine EG 5 mg, capsule” blisters, the ANSM invites it to be exchanged with a compliant box corresponding to the patient’s treatment.
• If Amlodipine EG 5 mg, capsule contains “Amlodipine EG 5 mg, capsule” blisters, you can “indicate to your patient that he can keep his box and continue his treatment”.

Source : Safety information – Amlodipine EG 5 mg and 10 mg, capsule – ANSM (sante.fr)

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