Due to an error in transcribing the dosage on the medicine box, an anti-inflammatory prescribed in particular to relieve joint pain is recalled by the Medicines Agency.
A Non-steroidal anti-inflammatory drug (NSAIDs) based on naproxen indicated in adults in cases of inflammation, pain and fever (in case ofosteoarthritis, tendonitis, bursitis, lower back pain, rheumatism, painful periods…) is the subject ofa reminder because of’an error of braille transcription of the dosage on the box which could lead to a risk of overdoseinforms the Medicines Agency (ANSM) in a press release dated September 27, 2023.
On these boxes, it is mentioned, in Braille, “500 mg” instead of “1000 mg”
On these boxes, it is mentioned, in braille, “500 mg” instead of “1000 mg”. For this reason, this specialty will no longer be available in pharmacies until the end of October 2023. New compliant batches will be available end of October 2023. “We ask you to contact by any means available to you, the patients likely to hold the batches affected by this recall, in order to present to them the reasons and terms of the recall“, insists the ANSM to pharmacists. The medicine concerned is Naprosyne® 1000 mg (boxes of 8 tablets) marketed by the laboratory Grunenthal. The information printed on the box complies, only braille encoding is wrong. THE batches concerned are the following :
- Lot n° 237T02 / Expiry date: 05/31/2025
- Lot n° 237T03 / Expiration date: 05/31/2025
- Lot n° 237T04 / Expiration date: 05/31/2025
- Lot n° 238V01 / Expiry date: 12/31/2025
What should a patient in possession of the affected batches do?
► If you are blind or visually impaired, the ANSM asks that the boxes be returned to the pharmacy, even if they have been opened. If your treatment is not finished, consult your doctor so that he can prescribe a therapeutic alternative or another dosage of Naprosyne®.
► There is no impact for other patients. The information on the box being compliant, you can keep and use your boxes. The tablets, blisters and instructions contained in the boxes with the braille defect correspond to Naprosyne® 1000 mg tablets.
What are the possible side effects?
In case of overdose or accidental poisoning, stop treatment and consult a doctor immediatelycan we read on the medication leaflet. Among side effects that may occur during treatment: digestive disorders (nausea, vomiting, bloating, diarrhea, constipation, stomach aches, gastrointestinal discomfort, more rarely inflammation of the intestine), headachedizziness, high blood pressure, palpitations or muscle weakness…