Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Tillomed Laboratories Ltd, 220 Butterfield, Great Marlings, Luton, LU2 8DL, United Kingdom
The symptomatic treatment of acute diarrhoea of any aetiology including acute exacerbations of chronic diarrhoea for periods of up to five days, in adults and children over nine years.
The symptomatic treatment of chronic diarrhoea in adults.
The initial dose is two tablets (4mg) for adults and one tablet (2mg) for children, followed by one tablet (2mg) after every subsequent loose stool for up to five days.
The maximum daily dose should not exceed six tablets (12mg).
The initial dose is two tablets (4mg) daily. This initial dose should be adjusted until one to two solid stools per day are obtained, which is usually achieved with a maintenance dose of one to six tablets (2mg-12mg) daily.
The maximum daily dose should not exceed six tablets (12mg).
Loperamide is contraindicated in children less than 9 years of age.
No dose adjustment is required for the elderly.
No dose adjustment is required for patients with renal impairment.
Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide HCl should be used with caution in such patients because of reduced first pass metabolism (See section 4.4 Special warnings and precautions for use).
Oral use. The tablets should be taken with liquid.
In cases of overdose (including relative overdose due to hepatic dysfunction), CNS depression (stupor, coordination abnormality, somnolence, miosis, muscular hypertonia, and respiratory depression), constipation, urinary retention and ileus may occur. Children, and patients with hepatic dysfunction, may be more sensitive to CNS effects.
In individuals who have ingested overdoses of loperamide, cardiac events such as QT interval and QRS complex prolongation, torsades de pointes, other serious ventricular arrhythmias, cardiac arrest and syncope have been observed (see section 4.4). Fatal cases have also been reported. Overdose can unmask existing Brugada syndrome.
In cases of overdose, ECG monitoring for QT interval prolongation should be initiated.
If the patient develops respiratory depression, airway obstruction, vomiting with impaired consciousness or other CNS symptoms of overdose, give naloxone urgently. Since the duration of action of loperamide is longer than that of naloxone (1 to 3 hours), repeated treatment with naloxone might be indicated, the patient should be kept under constant observation for at least 48 hours in order to detect any possible CNS depression. Other measures should be as indicated by the patient’s clinical condition.
4 years.
Store below 25°C, store in the original package in order to protect from light and moisture.
Blister Strip.
PVC: 250 micron, colourless.
Aluminium Foil: 20 micron.
3 such blister strips containing 10 tablets in an outer cardboard carton which also contains a Patient Information Leaflet.
No special requirements.
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