Urgent alert over diarrhoea medication due to unlabelled side-effects,
Health chiefs have issued an urgent warning to people taking a common drug used to treat diarrhoea, after a packaging error was discovered in some batches.
The Medicines and Healthcare products Regulatory Agency (MHRA) has warned the patient information leaflet inside certain packs of loperamide hydrochloride 2mg tablets contains incorrect information on how to take the drug.
The drug’s manufacturer, Milpharm Limited, said the leaflet also fails to mention a rare side effect which causes a ‘burning or prickling sensation of the tongue’.
The affected medicines are from batches 25882X3 and 25882X2 and include both six-tablet and 12-tablet packs.
Loperamide works by slowing down food as it travels through the gut.
This allows the body to draw in more water from the intestines, firming up the stool.
The tablets affected by the alert – which should be dissolved on the tongue – are often dubbed Imodium Instants. But only Milpharm-branded products are affected.
Patients who have bought it at a pharmacy are advised not to follow the instructions printed on the patient information leaflet.
Loperamide is a medicine to treat diarrhoea, often sold under the brand name Imodium
Instead, the tablets should be placed on the tongue and left to dissolve in the mouth. You do not need water to swallow it
The warning continues: ‘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.’
Those who experience a burning or prickling sensation of the tongue on taking the medicine are also advised to speak to a doctor or pharmacist.
Healthcare professionals should be aware that this is a recognised adverse side effect of the dissolvable tablets and will be able to treat patients accordingly.
This side-effect is rare, affecting one in every 1,000 patients. Any suspected adverse reactions should also be reported via the MHRA Yellow Card Scheme.
More common side-effects include constipation, nausea, headache and flatulence.
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Milpharm Limited have confirmed that all future batches will be packed with the correct patient information leaflet.
Loperamide should not be taken for more than 48 hours without talking to a doctor.
The recommended dose depends on the type of diarrhoea and age of the patient.
For adults with short-term diarrhoea, the usual starting dose is two tablets taken immediately.
One tablet is then taken after each bowel movement until symptoms settle.
Patients are also encouraged not to drink alcohol whilst taking the drug as it can make side effects more likely.
Most cases of diarrhoea improve within a week. If symptoms persist, the NHS advises speaking with your doctor to rule out any underlying health conditions and manage any complications like dehydration.
It is not usually serious but changes in bowel habits can be a symptom of another problem such as bowel cancer.
