Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Lennon
LENIDE-T TABLETS SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): LENIDE-T TABLETS COMPOSITION Each tablet contains 2 mg loperamide hydrochloride. PHARMACOLOGICAL CLASSIFICATION: A 11.9 Medicines acting on gastro-intestinal tract: Antidiarrhoeals. PHARMACOLOGICAL ACTION: LENIDE-T is a piperidine derivative. It slows gastro-intestinal motility by effects on the circular and longitudinal muscles of the intestine. It normalises the stool in both chronic and acute diarrhoea. LENIDE-T is partially absorbed in the gastro-intestinal tract. It undergoes considerable first-pass metabolism in the liver and is excreted mainly in the faeces. INDICATIONS: LENIDE-T is indicated for the control of acute and chronic diarrhoea. LENIDE-T controls intestinal transit time in patients with ileostomies, colostomies and other intestinal resections. CONTRA-INDICATIONS: LENIDE-T should not be used in the treatment of acute infective diarrhoea, and should also not be used when hepatic dysfunction exists, which may result in relative overdosing. LENIDE-T should not be administered to children under 5 years. It is contraindicated in patients hypersensitive to the active ingredient and in those in whom inhibition of peristalsis must be avoided, in particular where constipation is present or in patients with inflammatory bowel disease. Safety in pregnancy has not been established. WARNING: Patients with inflammatory bowel disease receiving LENIDE-T should be carefully observed for signs of toxic megacolon. Patients should be told not to continue medication if no response is obtained within 48 hours; medical advice should then be sought. Discontinue use immediately if constipation, abdominal distension or subileus develop. Do not use in patients with acute ulcerative colitis or pseudomembranous colitis associated wi Read the complete document