Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos Street 3011, Cyprus
Symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over.
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.
Two capsules (4 mg) initially, and one capsule (2 mg) after each loose stool. The usual dose is 3-4 capsules (4-8 mg) per day. The total daily dose should not exceed 6 capsules (12 mg).
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).
Loperamide is contraindicated in children less than 12 years of age.
No dose adjustment is required for the elderly.
Although no pharmacokinetic data are 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).
No dose adjustment is required for patients with renal impairment.
Oral use.
The capsules should be taken 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), constipation, urinary retention, ileus may occur. Children and patients with hepatic dysfunction may be more sensitive to CNS effects.
In individuals who have ingested overdoses of loperamide HCl, 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 CNS symptoms of overdose occur, naloxone may 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 possible CNS depression.
5 years.
Store below 25ºC, in the original package, in order to protect from light and moisture.
Blister boxes with 10 or 20 capsules.
Blister boxes with 30 or 1000 capsules.
Not all pack sizes may be marketed.
Not applicable.
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