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Loperamide-simethicone should not be used in children less than 12 years of age.
Loperamide-simethicone is contraindicated in patients with a known hypersensitivity to loperamide, simethicone or to any of the excipients.
Loperamide-simethicone should not be used as the primary therapy: in patients with acute dysentery, which is characterized by blood in stools and high fever; in patients with acute ulcerative colitis; in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter; in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.
Loperamide-simethicone should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon.
Loperamide-simethicone must be discontinued promptly when constipation, abdominal distension or ileus develop.
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