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The National Medicines Safety Agency (ANSM) announces the recall of a treatment for hypertension. In fact, a dosage error was noted. Here’s what you need to know.
If you have high blood pressure or know someone close to you who does, read this article carefully. The National Agency for the Safety of Medicines and Health Products (ANSM) has announced the recall of a drug against this pathology: Amlopidine.
What is the reason for this recall?
Amlopidine is a medication prescribed for people with high blood pressure. It is notably a preventive treatment for angina attacks, “in case of Prinzmetal’s angina (spasm of a coronary artery)” explains the ANSM.
If this treatment is the subject of a recall, it is due to a dosage error that occurred during the manufacturing of the product. “Blankets of Amlodipine EG 5 mg were packaged in boxes of Amlodipine EG 10 mg” indicates the reminder sheet. Not all batches are affected, however. The error occurred during the packaging of batch A53014, reports the EG Labo laboratory which manufactures them. These are all the boxes of this lot – Amlopidine 5mg and 10 mg – which are recalled.
In detail, the drugs and batches concerned are as follows:
- Amlodipine EG 5 mg, capsule – box of 30, lot A53014 (expiration date: 02/2028)
- Amlodipine EG 10 mg, capsule – box of 30, lot A53014 (expiration date: 02/2028).
They have been distributed since June 21, 2023.
A risk of underdosing with this batch
The risk when taking these tablets is to be the victim of an underdosage and therefore of less effectiveness of the treatment, underlines the ANSM. The batch number is indicated on the medicine box. If you are concerned, you must go to the pharmacy so that your pharmacist can carry out an exchange, with a compliant box.
If you also experience symptoms of hypertension, such as headaches or shortness of breath, do not hesitate to consult your doctor. Finally, the ANSM also invites pharmacists to contact patients who could have been provided with this treatment for an exchange.