| Composition |
Each chewable tablet contains:
– Loperamide HCl 2 mg.
– Simethicone 125 mg. |
| Pharmacodynamics properties |
Lopacon contains Loperamide HCl to control the symptoms of diarrhea plus simethicone to relieve bloating, pressure and cramps commonly referred to as gas. Loperamide HCl acts by slowing intestinal motility and by affecting water and electrolyte movement through the bowel.
Simethicone acts in the stomach and intestines by altering the surface tension of gas bubbles enabling them to coalesce, thereby freeing and eliminating the gas more easily by belching or passing flatus. |
| Therapeutic indications |
| Controls symptoms of diarrhea plus bloating, pressure, and cramps commonly referred to as gas. |
| Side effect |
Hypersensitivity reactions such as skin rash and urticaria. Constipation and or abdominal distension, dry mouth, abdominal pain or dizziness and fatigue may occur.
Reversible paralytic ileus may occur at a high dose level. |
| Warnings and precautions |
Warnings:
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl. Do not use if you have bloody or black stool. Ask a doctor before use if you have fever, mucus in the stool, or a history of liver disease.
Ask a doctor or pharmacist before use if you are taking antibiotics.
Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days.
Precautions:
In patients with diarrhea, fluid and electrolyte depletion may occur. In such cases administration of appropriate fluid and electrolyte replacement, is necessary.
This drug should not be given to children less than 12 years of age without medical prescription and supervision.
Patients with hepatic dysfunction should be monitored closely for signs of central nervous system toxicity because of the reduced first-pass metabolism. |
| Pregnancy and lactation |
| If pregnant or breast-feeding, ask a health professional before use. |
| Drug interactions |
| No known drug interaction. |
| DOSAGE & ADMINISTRATION |
Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
Find right dose on chart. If possible, use weight to dose; otherwise use age.
Adults and children 12 years and over: Chew 2 tablets and take with water after the first loose stool; and take 1 tablet with water after each subsequent loose stool; but not more than 4 tablets in 24 hours
Children 9–11 years (60–90 lbs): Chew 1 tablet and take with water after the first loose stool; and take ½ tablet with water after each subsequent loose stool; but not more than 3 tablets in 24 hours
Children 6–8 years (48–59 lbs): Chew 1 tablet and take with water after the first loose stool; and take ½ tablet with water after each subsequent loose stool; but not more than 2 tablets in 24 hours
Children under 6 years (up to 47 lbs): ask a doctor |
| Overdose |
Overdosage of loperamide HCl in man may result in constipation, CNS depression and nausea.
A slurry of activated charcoal administered promptly after ingestion of loperamide hydrochloride can reduce the amount of drug which is absorbed.
If vomiting occurs spontaneously upon ingestion, a slurry of 100 grams of activated charcoal should be administered orally as soon as fluids can be retained. If vomiting has not occurred, and CNS depression is evident, gastric lavage should be performed followed by administration of 100 gms of the activated charcoal slurry through the gastric tube.
In the event of overdosage, patients should be monitored for signs of CNS depression for at least 24 hours. Children may be more sensitive to central nervous system effects than adults. If CNS depression is observed, naloxone may be administered. If responsive to naloxone, vital signs must be monitored carefully for recurrence of symptoms of drug overdose for at least 24 hours after the last dose of naloxone. No treatment is necessary for the simethicone ingestion in this circumstance. |
| Package |
| Carton box of 20 chewable Tablets, blister packed, with inserted leaflet. |
| Storage |
Store in a dry place at (20–25)ºC, protected from light and moisture.
Keep away from reach of children. |
