Orifarm UK have informed us of an error with the Patient Information Leaflet (PIL) packaged within the packs of certain batches. The product name stated in the heading of the PIL has been spelt incorrectly as “lorazolam”, instead of “loprazolam”. All other sections of the PIL are unaffected.
MDR Number
MDR 077-05/22
Company name
Orifarm UK Ltd
Product description
Loprazolam 1mg Tablets – PLPI 46927/0262
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 20001T00 | 31 Oct 2023 | 30 tablets | Nov 2021 |
| 20001T01 | 31 Oct 2023 | 30 tablets | Nov 2021 |
Active Pharmaceutical Ingredient: Loprazolam mesylate
Brief description of the problem
Orifarm UK have informed us of an error with the Patient Information Leaflet (PIL) packaged within the packs of the above batches. The product name stated in the heading of the PIL has been spelt incorrectly as “lorazolam”, instead of “loprazolam”. All other sections of the PIL are unaffected.
Advice for healthcare professionals
Healthcare professionals are advised to inform patients of this discrepancy when dispensing packs from this batch. Hard copies of the correct PIL could be provided by the Marketing Authorisation Holder upon request, so that any of the affected packs remaining in the dispensary can be supplemented with the correct PIL.
Advice for patients
There is a spelling error in the Patient Information Leaflet that accompanies these batches of loprazolam. The medicine itself is not affected and patients do not need to take any action.
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