Loperamide hydrochloride 2 mg Orodispersible Tablets
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 4 defect notification · DMRC - 39394163
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Loperamide hydrochloride 2 mg Orodispersible Tablets | PL: 16363/0784 | Loperamide hydrochloride |
Batches (expiry): 25882X3 (30/11/2029), 25882X2 (30/11/2029)
Background: Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets. There are two errors that have been identified in the current PIL when compared against the appropriate orodispersible reference: Section 3 (Method of administration): the PIL incorrectly instructs patients to swallow the tablets whole with a drink of water. The correct instruction for an orodispersible tablet is to place the tablet on the tongue and allow it to dissolve, without water. The carton (outer packaging) for both affected batches carries the correct orodispersible method of administration, substantially mitigating this discrepancy at the point of use.