Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland
As an adjunct in the management of acute diarrhoea, together with appropriate fluid and electrolyte replacement.
In the symptomatic control of diarrhoea associated with chronic inflammatory bowel disease, eg., Crohn’s disease and ulcerative colitis, as an adjunct to specific measures such as corticosteroids and sulphasalazine. Use in these conditions should be under specialist supervision.
In the adjunctive short-term, control of post-surgical diarrhoea, including ileostomy.
For the occasional use in the control of intractable diarrhoea under specialist supervision.
Since persistent diarrhoea can be an indicator of potentially serious conditions, the underlying cause must always be investigated.
For oral administration. The capsules should be taken with water.
1 to 2 capsules (2 to 4 mg) is the usual initial dose, followed by 1 capsule (2 mg) three times daily. The maximum daily dose should not exceed 10 mg.
A total maximum daily dose of 4 mg in divided doses (see 4.4 Special warnings and precautions for use).
Not recommended.
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, Imodium should be used with caution in such patients because of reduced first pass metabolism (see 4.4 Special warning and precautions for use).
Studies have shown that patients may need differing amounts of loperamide. The starting dosage should be between 4 to 8 mg (2 to 4 capsules) per day in divided doses depending on severity. If required, this dose can be adjusted according to response. Having established the patient’s daily maintenance dose, the capsules may be administered on a twice daily regimen.
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 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 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 hrs), 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.
This medicinal product does not require any special storage conditions.
Imodium Capsules are packaged in blister packs consisting of polyvinylchloride, glass clear 250 micrometre and aluminium foil (thickness 20 micrometre) coating on the inner side with a colourless heat seal lacquer: PVC mixed polymers with acrylates 6 g/m², in an outer cardboard carton.
The packs contain 60 capsules.
No special requirements.
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