(and dosage form):
Each tablet contains 2 mg loperamide hydrochloride.
A 11.9 Medicines acting on gastro-intestinal tract: Antidiarrhoeals.
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.
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.
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.
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 with broad spectrum antibiotics.
DOSAGE AND DIRECTIONS FOR USE:
LENIDE-T should not be administered to children under 5 years.
The usual initial dose of LENIDE-T is two tablets (4 mg) followed by one tablet (2 mg) after each loose stool, up to a total of 8 tablets (16 mg) daily.
CHILDREN OVER 5 YEARS
1 mg per 12,5 kg body mass followed by 0,5 mg per 12,5 kg body mass after each loose stool.
Daily dosage should not exceed 3 mg per 12,5 kg body mass.
The initial dosage is 2 - 4 tablets daily in divided doses for adults.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Abdominal pain and other gastrointestinal disturbances, dry mouth, dizziness, and fatigue have occurred.
Skin rash has also been reported. Reversible paralytic ileus may occur at a high dose level.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may result in constipation.
Depression of the central nervous system may be seen in overdosage.
Excessive inhibition of peristalsis with nausea and dryness of the mouth.
Children may be more sensitive to central nervous system depressant effects of loperamide than adults. Convulsions have been reported in children under the age of 2 years.
Treatment is symptomatic and supportive.
Tablets A flat, white, bevelled edged tablet bisected on one side.
Tablets Blister packs of 6 tablets.
Store below 25°C, in well-closed containers.
KEEP OUT OF REACH OF CHILDREN.
LENIDE -T Tablets: 28/11.9/0140
NAME AND BUSINESS ADDRESS OF APPLICANT:
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 September 1994
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