COMPOSITION: Each effervescent tablet contains:
2 mg Loperamide hydrochloride as active ingredient ;
methylhydroxypropylcellulosephthalate, propylene glycol, hard fat, silicon dioxide hydrate, citric acid anhydrous, saccharin sodium, sodium cyclamate, sodium citrate dihydrate, sodium hydrogen carbonate, calcium lactate monohydrate, trimagnesiumdicitrate, potassium hydrogen carbonate, sodium carbonate, sodium chloride, anhydrous glucose, lemon flavour 'BSL' / or Orange Flavour "Li", ethanol 96% and purified water as in-active ingredients.
PHARMACOLOGICAL CLASSIFICATION: A.11.9 Medicines acting on the gastro-intestinal tract. Antidiarrhoeals.
PHARMACOLOGICAL ACTION : Loperamide inhibits peristalsis and gastro-intestinal secretions.
About 40% of an oral dose of loperamide is reported to be absorbed from the gastro-intestinal tract to undergo first-pass metabolism in the liver, and excretion in the faeces via the bile as inactive conjugate; there is slight urinary excretion. The elimination half-life is reported to be about 10 hours.
INDICATIONS: LOPEDIUM is indicated for symptomatic relief of acute and chronic nonspecific diarrhoea and to inhibit peristalsis and slow intestinal transit time in patients with ileostomies, colostomies and other intestinal resections.
For paediatric patients <6 years of age LOPEDIUM is indicated for inhibition of peristalsis and slowing of intestinal transit time. This indication does not directly refer to the treatment of diarrhoea.
CONTRA-INDICATIONS: LOPEDIUM is not intended for use in children under the age of 2 years. LOPEDIUM should not be given to patients with a known hypersensitivity to Loperamide.
LOPEDIUM should not be used in patients with dysentery or if constipation must be avoided.
Patients with any inflammatory bowel diseases or pseudomembranous colitis receiving LOPEDIUM should be carefully observed for signs of toxic megacolon.
DOSAGE AND DIRECTIONS FOR USE: It should be noted that the main aim in treating acute diarrhoea is the correction of fluid and electrolyte depletion with rehydration therapy.
Treatment of diarrhoea with LOPEDIUM should take place only when no causal treatment is available. IMPORTANT LOPEDIUM EFFERVESCENT TABLETS SHOULD BE TAKEN DISSOLVED IN HALF A GLASS OF WATER.
Acute Diarrhoea Adults:
Initially 2 tablets followed by 1 tablet after each subsequent loose stool, with a maximum of 8 tablets per day.
Children over 5 years:
Initially 1 tablet followed by 1 tablet after each subsequent loose stool, with the following maximum daily doses:
Body Weight (kg)
Maximum daily dose
20 30 k
3 4 tablets
If no improvement in acute diarrhoea has been observed after 48 hours, treatment with LOPEDIUM should be stopped Chronic diarrhoea (Consult your doctor)
The usual initial dose for adults is 2 - 4 LOPEDIUM tablets daily in divided doses subsequently adjusted as necessary.
The usual daily dose is also 2 - 4 LOPEDIUM tablets in divided doses up to a maximum of 8 tablets per day.
If no improvement has been observed after treatment with 8 tablets daily for 10 days, further treatment is likely to be of little benefit.
SIDE EFFECTS AND SPECIAL PRECAUTIONS: Abdominal pain, toxic megacolon, dry mouth, dizziness, fatigue, hypersensitivity reactions including skin rashes, nausea, paralytic ileus and constipation have been reported.
LOPEDIUM should be used with caution in patients with hepatic dysfunction because of the considerable first pass metabolism in the liver. It should be used with caution in young children because of the great variability in response.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Depression of the Central Nervous System, to which children may be more sensitive, may be seen in overdosage. Convulsions have been reported in children under 2 years of age. Treatment with naloxone hydrochloride has been recommended. Gastric lavage and activated charcoal may also be used in the treatment of loperamide overdose.
IDENTIFICATION: White, round biplane smooth tablets with a smell of lemon / or orange.
PRESENTATION: Tubes of 10 effervescent tablets
STORAGE INSTRUCTION : Store below 25°C. Keep out of reach of children.
REGISTRATION NUMBER: 29/11.9/0616
NAME AND BUSINESS ADDRESS OF APPLICANT: Hexal Pharma (SA) (PTY) Ltd
Unit A, 10 Fangio road