The Medicines and Healthcare products Regulatory Agency (MHRA) has explained what to do
People taking a popular medication are being warned about a mistake regarding how it should be correctly administered. The Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert on Monday.
The watchdog revealed that manufacturer Milpharm Limited had discovered a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets. The medicine is used to treat diarrhoea.
The MHRA said: “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.”
The agency clarified that section three of the leaflet — covering the method of administration — wrongly instructs patients to swallow the tablets whole with a drink of water. The correct guidance for an orodispersible tablet is to place it on the tongue and allow it to dissolve, without water.
However, the outer packaging for both affected batches carries the correct orodispersible administration instructions, substantially mitigating this discrepancy at the point of use, it added. The MHRA also noted that section four – rare side effects – was missing the entry “burning or prickling sensation of the tongue” (rare, may affect up to one in 1,000 patients), a recognised local effect of the orodispersible formulation listed in the Imodium Instants reference PIL.
It added: “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.”
Two batches of the tablets are affected. The first is batch number 25882X3, with an expiry date of November 30, 2019, relating to a pack of 12 orodispersible tablets first distributed on December 17, 2025. The second batch is 25882X2, relating to a pack of six tablets, with identical expiry and distribution dates.
The MHRA stated that healthcare professionals had been instructed to take note of the leaflet discrepancies and pass the information on to their patients. It stressed that the correct administration instructions were printed on the carton, and that Milpharm Limited had confirmed all future batches would be packaged with the corrected leaflet.
Advice to people taking loperamide
In its guidance to patients, the MHRA stated: “If you have been dispensed Loperamide hydrochloride 2 mg Orodispersible Tablets from batch 25882X3 (pack of 12) or batch 25882X2 (pack of 6), please note the following.”
How to take the tablets: Place the tablet on your tongue and let it dissolve in your mouth. You do not need water to swallow it. Do not chew the tablet. 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.
Possible side effect to be aware of: A rare side effect (which may affect up to one in 1,000 people) of this orodispersible tablet is a burning or prickling sensation of the tongue. This side effect is not currently listed in the leaflet inside the pack. If you experience this, please speak to your doctor or pharmacist.
You do not need to return the medicine. You can continue to use it as prescribed, following the corrected instructions above.
Those who experience any adverse reactions or have concerns regarding their medication should seek medical advice. Any suspected adverse reactions should also be reported through the MHRA Yellow Card scheme.
