Loperamide hydrochloride 2 mg Orodispersible tablet

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.

Section 4 (Rare side effects): the PIL omits the entry “Burning or prickling sensation of the tongue” (rare, may affect up to 1 in 1,000 patients), a recognised local effect of the orodispersible formulation that is listed in the Imodium Instants reference PIL.

All other PIL content including indication, dose, dosing frequency, maximum daily dose, contraindications, warnings, precautions, drug interactions, and overdose information — is correctly reflected. No related adverse drug reactions or safety signals have been identified in the company pharmacovigilance database.

Medicine Details

Loperamide hydrochloride 2 mg Orodispersible Tablets

PL: 16363/0784

Active ingredient: Loperamide hydrochloride

SNOMED code: 6 pack: 27980211000001103, 12 pack: 27851511000001108

GTIN: 6 pack: 5060035110667, 12 pack: 5060035110674

Affected Lot Batch Numbers

Batch No. ExpiryDate Pack Size First Distributed

25882X3 30/11/2029 12 orodispersible tablets 17/12/2025

25882X2 30/11/2029 6 orodispersible tablets 17/12/2025

Please refer to the below link for additional information:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-milpharm-limited-loperamide-hydrochloride-2-mg-orodispersible-tablets-el-26-a-slash-23