The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an urgent alert regarding a mistake in the patient information leaflet for a common diarrhoea medication. The error concerns Loperamide hydrochloride 2 mg Orodispersible Tablets, which are used to treat diarrhoea and are sold under brand names including Imodium.
What Went Wrong
The MHRA revealed that manufacturer Milpharm Limited discovered a discrepancy in the Patient Information Leaflet (PIL) approved for the tablets. Two specific errors were identified when comparing the current PIL against the appropriate orodispersible reference.
Firstly, section three of the leaflet, which covers the method of administration, incorrectly 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 administration instructions, which substantially mitigates the discrepancy at the point of use.
Secondly, section four, which lists rare side effects, is missing the entry "burning or prickling sensation of the tongue." This side effect is a recognised local effect of the orodispersible formulation and may affect up to one in 1,000 patients. It is listed in the Imodium Instants reference PIL.
Affected Batches
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 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.
Advice for Patients
The MHRA has issued clear guidance for patients who have been dispensed Loperamide hydrochloride 2 mg Orodispersible Tablets from the affected batches. Patients are advised to place the tablet on their tongue and let it dissolve in their mouth, without needing water to swallow it. They should not chew the tablet. The leaflet inside the pack may incorrectly tell patients to swallow the tablet whole with water, but they should follow the instructions on the carton and the advice in the notice instead.
Additionally, patients should be aware of a rare side effect: a burning or prickling sensation of the tongue, which may affect up to one in 1,000 people. This side effect is not currently listed in the leaflet inside the pack. If experienced, patients should speak to their doctor or pharmacist.
Patients do not need to return the medicine. They can continue to use it as prescribed, following the corrected instructions. Those who experience any adverse reactions or have concerns should seek medical advice and report suspected adverse reactions through the MHRA Yellow Card scheme.
Healthcare Professional Guidance
The MHRA has instructed healthcare professionals to take note of the leaflet discrepancies and pass the information on to their patients. Milpharm Limited has confirmed that all future batches will be packaged with the corrected leaflet.
