NORIMODE

Posology:

Acute Diarrhoea Adults and Children (9-17) years: 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).

Chronic Diarrhoea Adults only 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). Paediatric Population Loperamide is contraindicated in children less than 9 years of age. Elderly No dose adjustment is required for the elderly. Renal Impairment No dose adjustment is required for patients with renal impairment.

Hepatic 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

The safety of loperamide hydrochloride was evaluated in 3076 adults and children aged ≥12 years who participated in 31 controlled and uncontrolled clinical trials of loperamide hydrochloride used for the treatment of diarrhoea. Of these, 26 trials were in acute diarrhoea (N=2755) and 5 trials were in chronic diarrhoea (N=321).

1%). e. 2%). Table 1 displays adverse reactions that have been reported with the use of loperamide hydrochloride from either clinical trials (in acute or chronic diarrhoea or both) or post-marketing experience. The frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<1/10,000).

4), Abdominal distension Acute Pancreatitis Skin and Subcutaneous Tissue Disorders Rash Bullous eruption (including Stevens Johnson syndrome, Toxic epidermal necrolysis and Erythema multiforme), Urticaria, Pruritus, Angioedema Renal and Urinary Disorders Urinary retention General Disorders and Administration Site Conditions Fatigue A number of the adverse reactions reported during the clinical investigations and post-marketing experience with loperamide hydrochloride are frequent symptoms of the underlying diarrhoeal syndrome (for example abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence).

These symptoms are often difficult to distinguish from undesirable drug effects. Paediatric population The safety of loperamide hydrochloride was evaluated in 607 patients aged 10 days to 13 years, who participated in 13 controlled and uncontrolled clinical trials of loperamide hydrochloride used for the treatment of acute diarrhoea.

In general, the adverse reactions profile in this patient population was similar to that seen in clinical trials of loperamide hydrochloride in adults and children aged 12 years and over. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

). Method of administration Oral use. The tablets should be taken with liquid. 1. • In children under 9 years of age. • When inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon, in particular: o when ileus, constipation or abdominal distension develop, o in patients with acute ulcerative colitis, o in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter, o in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.

Loperamide should not be used alone in acute dysentery, which is characterised by blood in stools and elevated body temperatures. 4 Special warnings and precautions for use In patients with diarrhoea, especially young children, fluid and electrolyte depletion may occur.

Use of loperamide does not preclude the administration of appropriate fluid and electrolyte replacement therapy. Treatment of diarrhoea with loperamide is only symptomatic. Since persistent diarrhoea can be an indicator of potentially more serious conditions, loperamide should not be used for prolonged periods of time and the underlying cause of the diarrhoea should be investigated if clinical improvement is not observed within 48 hours of initiating treatment.

Whenever an underlying etiology can be determined, specific treatment should be given when appropriate. g. in cases of severe hepatic disturbance), as this might result in a relative overdose leading to CNS toxicity. Loperamide must be discontinued promptly when constipation, abdominal distension or ileus develop.

Patients with AIDS treated with loperamide for diarrhoea should have therapy stopped at the earliest signs of abdominal distension. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride.

1. • In children under 9 years of age. • When inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon, in particular: o when ileus, constipation or abdominal distension develop, o in patients with acute ulcerative colitis, o in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter, o in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.

Loperamide should not be used alone in acute dysentery, which is characterised by blood in stools and elevated body temperatures.