Overview
- The MHRA issued a Class 4 medicines defect alert after Milpharm found errors in the patient leaflet for its 2 mg loperamide orodispersible tablets.
- The leaflet wrongly tells people to swallow the tablets with water, though these tablets are designed to dissolve on the tongue without water.
- The leaflet also omits a rare side effect of a burning or prickling tongue, which may affect up to 1 in 1,000 users.
- Only two batches are involved — 25882X3 (12-pack) and 25882X2 (6-pack) — and the outer carton prints the correct directions.
- No safety signal has been detected and patients are told to keep using the medicine by following the carton, with healthcare staff asked to brief users and future packs set to carry corrected leaflets.