Health chiefs have issued an urgent warning to patients taking a common diarrhoea medication after discovering a packaging error in certain batches. The Medicines and Healthcare products Regulatory Agency (MHRA) has alerted the public that the patient information leaflet inside some packs of loperamide hydrochloride 2mg tablets contains incorrect instructions on how to take the drug.
Incorrect Instructions and Missing Side Effect
The drug's manufacturer, Milpharm Limited, confirmed that the leaflet also fails to mention a rare side effect—a 'burning or prickling sensation of the tongue.' The affected batches are 25882X3 and 25882X2, available in six-tablet and 12-tablet packs.
Loperamide works by slowing down the movement of food through the gut, allowing the body to absorb more water from the intestines, which firms up the stool. The tablets in question are dissolvable on the tongue, often referred to as Imodium Instants, but only Milpharm-branded products are impacted.
Correct Usage Instructions
Patients who have purchased the medication are advised not to follow the printed leaflet. Instead, the tablets should be placed on the tongue and allowed to dissolve without water. The MHRA warning states: 'The leaflet inside the pack may incorrectly tell you to swallow the tablet whole with water—please follow the instructions on the carton (outer pack) and the advice in this notice instead.'
Anyone experiencing a burning or prickling sensation on the tongue after taking the medicine should consult a doctor or pharmacist. Healthcare professionals are reminded that this is a known adverse side effect of dissolvable tablets and can be managed accordingly. This side effect is rare, affecting approximately one in every 1,000 patients. Suspected adverse reactions should be reported via the MHRA Yellow Card Scheme.
Common Side Effects and Precautions
More common side effects include constipation, nausea, headache, and flatulence. Milpharm Limited has confirmed that all future batches will contain the correct patient information leaflet. Loperamide should not be taken for more than 48 hours without consulting a doctor. The recommended dose varies based on the type of diarrhoea and patient age. For adults with short-term diarrhoea, the usual starting dose is two tablets immediately, followed by one tablet after each bowel movement until symptoms subside.
Patients are advised to avoid alcohol while taking the drug, as it can increase the likelihood of side effects. Most diarrhoea cases improve within a week. If symptoms persist, the NHS recommends speaking with a doctor to rule out underlying health conditions and manage complications like dehydration. While diarrhoea is usually not serious, changes in bowel habits can be a symptom of other issues, such as bowel cancer.
