Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Notification: Milpharm Limited, Loperamide hydrochloride 2 mg Orodispersible Tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets (batch number: 25882X3 and 25882X2). 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.
Healthcare professionals are asked to note the PIL discrepancies described above for batches 25882X3 and 25882X2 of Loperamide hydrochloride 2 mg Orodispersible Tablets (PL 16363/0784) and share this information with patients, where appropriate.
The correct administration instructions are printed on the carton. Milpharm Limited have confirmed that all future batches will be packed with the corrected PIL.
Healthcare professionals should be aware that “burning or prickling sensation of the tongue” is a recognised rare local adverse effect (frequency up to 1 in 1,000) of the orodispersible formulation, even though it is not currently listed in the affected PIL. Should a patient report this symptom following administration, it should be considered a potential medication-related effect and managed accordingly.
The product is indicated for the symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. It is also indicated for the symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in adults aged 18 years and over following initial diagnosis by a doctor.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-milpharm-limited-loperamide-hydrochloride-2-mg-orodispersible-tablets-el-26-a-slash-23
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, May 12, 2026
Issued at HKT 15:30
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