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(AFP) – A batch of Micropakine, an antiepileptic drug, has been withdrawn due to the risk of overdose, linked to taking too full sachets, which can cause drowsiness or lethargy, the Medicines Agency said Friday. ANSM).
This is batch No. DM0059 of Micropakine LP 500mg with expiration date March 2022 and sold in boxes of 30 sachets.
The recall of this drug from the Sanofi-Aventis France laboratory follows the discovery by patients in two boxes, simultaneously, of empty sachets and sachets overfilled with granules of sodium valproate – the same active ingredient as Dépakine, at the center of a scandal health care, to be avoided during pregnancy.
These anomalies have been confirmed by investigations, notes the health agency.
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 must 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 attending physician.
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.
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, adds the ANSM. Advise patients taking this granular treatment to “contact their doctor as soon as possible if they have unusual symptoms”.
“To date, no cases of negative effects related to this defect have been reported to ANSM”, specifies the latter.
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