Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
For the symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over.
For the symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in adults aged 18 years and over following initial diagnosis by a doctor.
The initial dose is 2 capsules (4 mg), followed by 1 capsule after every subsequent loose stool. The usual dose is 3-4 capsules (6-8 mg) a day. The total daily dose should not exceed 6 capsules (12 mg).
Not to be given to children under 12 years of age.
Two capsules (4 mg) to be taken initially, followed by 1 capsule (2 mg) after every loose stool, or as previously advised by your doctor. The maximum daily dose should not exceed 6 capsules (12 mg).
No dose adjustment is required for the elderly.
No dose adjustment is required for patients with renal impairment.
Although no pharmacokinetics data is available in patients with hepatic impairment, loperamide should be used with caution in such patients because of reduced first pass metabolism (see section 4.4 Special warnings and special precaution for use).
For oral use. The capsules should be swallowed with liquid.
In case of overdose (including relative overdose due to hepatic dysfunction), CNS depression (stupor, coordination abnormality, somnolence, miosis, muscular hypertonia, and respiratory depression), urinary retention, constipation 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.
In cases of overdose, ECG monitoring for QT interval prolongation should be initiated.
If CNS symptoms of overdose occur, naloxone can be given as an antidote. Since the duration of action of Loperamide is longer than that of naloxone (1 to 3 hours), repeated treatment with naloxone might be indicated. Therefore, the patient should be monitored closely for at least 48 hours in order to detect any possible CNS depression.
Blisters: 5 years.
Bottles: 4 years.
Store below 25°C.
Blister packaging in packs of 4, 6, 8, 10, 12, 16, 18, 20, 24, 28 and 30 capsules.
Polypropylene pots with white polyethylene caps with optional polyethylene ullage fillers in packs of 4, 6, 8, 10, 12, 18, 20 and 28 capsules.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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