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A batch of Micropakine, an antiepileptic drug, has been withdrawn due to the risk of overdose linked to taking too full sachets, which can cause drowsiness or lethargy, the report said Friday. Medicines Agency (ANSM).
This is batch no. DM0059 of Micropakine LP 500 mg with expiration date March 2022 and sold in boxes of 30 sachets.
The recall of this medicine from the Sanofi-Aventis France laboratory comes after the discovery by patients, in two boxes, simultaneously, of empty sachets and sachets too full of granules of sodium valproate – the same active ingredient of Dépakine, at the center of a health scandal and which should be avoided during pregnancy.
These anomalies have been confirmed by investigations, notes the health agency.
An overfilled bag
Taking this drug with a sachet that is too full can lead to an overdose of valproate in the patient, the ANSM points out.
Affected patients should therefore return the batch boxes to their pharmacy as soon as possible for a free exchange, so as not to interrupt their treatment. If the patient cannot go to the pharmacy, he should contact the pharmacist or treating doctor.
Sanofi-Aventis France, in agreement with ANSM, has also asked pharmacists and dispensing pharmacies of health facilities to contact, by all means at their disposal, patients who may have and / or have used the specialty of game affected by this recall.
Sleepiness or lethargy
The weight of the double-filled sachets corresponds to the weight of the 1000 mg Micropakine LP sachets.
Sodium valproate overdose results in drowsiness or lethargy, ANSM adds. Recommend to patients taking this granular treatment “Contact your doctor as soon as possible in case of unusual symptoms”.
“To date, no cases of adverse effects related to this defect have been reported to ANSM”, specifies the latter.
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