To the medical and pharmaceutical professions

Each capsule contains:
Loperamide hydrochloride                            2 mg

Lopodium inhibits peristaltic activity by a direct effect on the circular and longitudinal muscles of the intestinal wall. Lopoduim prolongs the transit time of the intestinal contents. It reduces the daily fecal volume, increases the viscosity and bulk density and diminishes the loss of fluid and electrolytes.

The apparent elimination half-life is 10.8 hours. Plasma levels of uncharged drug remain below 2 nanograms per ml after the intake of a 2 mg lopodium capsule. Plasma levels are highest five hours after administration of the capsule. Most of the administered drug is excreted in feces.

Indications & usage:

Lopoduim is indicated for the control and symptomatic relief of acute non specific diarrhea and of chronic diarrhea associated with inflammatory bowel disease.

Lopodium is contraindicated in patients with known hypersensitivity to the drug and in those in whom constipation must be avoided.

Side effects:
The most common side effects are:
- Hypersensitivity reactions.
- Abdominal pain, distention or discomfort.
- Nausea and vomiting.
- Constipation.
- Tiredness.

Warnings & precautions:
- Lopodium should not be used in the case of acute dysentry which is characterized by blood in stool and high fever.
- Lopodium should be discontinued promptly if abdominal distention, constipation or ileus occurs.
- Lopodium should be used with special caution in young children.
- In acute diarrhea, if clinical improvement is not observed in 48 hours, the drug should be discontinued.
- Patients with hepatic dysfunction should be monitored closely for signs of CNS toxicity.
- This drug must not be used in patients with bloody diarrhea or systemic toxicity because of the risk of worsening their case.

            Lopodium should be used during pregnancy only if clearly needed.

            Caution should be exercised when Lopodium is administered to a nursing woman.
            In case of overdosage, paralytic ileus and CNS depression may occur. Children may be more sensitive to CNS effects than adults.

-  If vomiting occurs spontaneously upon ingestion, a slurry of 100 gms of charcoal should be administered orally as soon as fluids can be retained.
-  If vomiting has not occurred, gastric lavage should be performed followed by administration of 100 gms of the activated charcoal slurry through the gastric tube.
-  If CNS depression is observed, naloxone may be administered.

Dosage and administration:
             Patients should receive appropriate fluid and electrolyte replacement as needed.

Acute diarrhea.
      4 mg (2 capsules) followed by 2 mg (one capsule).
      After each unformed stool.
      Daily dosage should not exceed 16 mg (8 capsules)

       2–5 years:    1 mg, three times daily.
       6–8 years:    2 mg, two times daily.
       8–12 years:  2 mg, three times daily.

Chronic diarrhea.
Adults: The recommended initial dose is 4 mg (2 capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled.

Children: The therapeutic dose of chronic diarrhea has not been established.

Therapeuitic category: Antidiarrheal.

Legal category: Prescription only medicine (POM).

Package: Box containing 10 capsules.
Storage: Store in a dry place, at a temperature below 30° C, protect form light.

Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.